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The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new CARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US. The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.
The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The study undertaken will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 2D imaging functionality by comparing against the predicate CARESTREAM DRX-1 GOS detector used on adult cadaver specimens to capture the image pairs.
The study will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 3D imaging functionality by comparing against the reference PHILLIPS Multi Detector Computed Tomography (MDCT) scanner used on adult cadaver specimens (body part) to capture 3D volumetric exams using the anatomy of both upper and lower extremity specimens. The adult cadaver specimens will receive multiple x-ray exposures using the predicate devices for both 2D and 3D imaging. Target images from cadaver specimens will be reviewed by radiologist readers to rate diagnostic image quality, and the data will be included in a comparative evaluation.
The live human subject portion of the study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which will receive only one 3D volumetric exam using the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) scanner. Target images will be reviewed by radiologist readers to rate diagnostic image quality according to a radiologist reader scale applicable to 3D volumetric imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predicate & Invest.- Cadavers 2D & 3D | Experimental | Radiation - Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). |
|
| Investigational - Human Subjects 3D | Experimental | Radiation - Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only. |
| Measure | Description | Time Frame |
|---|---|---|
| Radlex Scale for Diagnostic Quality Ratings - 2D Images | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 12 weeks after last image capture |
| Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 12 weeks after last image capture |
| Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Marzo, MD | UBMD Orthopaedics & Sports Medicine | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Predicate & Invest.- Cadavers 2D & 3D | Cadaveric specimens will be imaged with 2D devices CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). |
| FG001 | Investigational - Human Subjects 3D | Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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2D predicate and 3D reference devices were used on cadaveric specimens. Investigational CBCT 3D was used to image live humans.
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| ID | Title | Description |
|---|---|---|
| BG000 | Predicate & Invest.- Cadavers 2D & 3D | Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph. Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radlex Scale for Diagnostic Quality Ratings - 2D Images | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 140 total image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for each of the above two arms. | Posted | Mean | Standard Error | units on a scale | 12 weeks after last image capture | images | images |
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AE's were collected for 3 months, September - November 2015
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Predicate & Invest.- Cadavers 2D | Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Pate, RN, MS, RAC | Carestream Health, Inc. | 585-627-6557 | susan.pate@carestream.com |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| 12 weeks after last image capture |
| Radlex Scale for Diagnostic Quality Ratings - 3D Images SND | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 12 weeks after last image capture |
| Investigational - Human Subjects 3D |
Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only. |
| BG002 | Total | Total of all reporting groups |
| participants |
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| Sex/Gender, Customized | gender not collected for human subjects or cadaveric specimens | Number | participants |
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| OG000 |
| Predicate - Cadavers 2D |
The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly. All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits. |
| OG001 | Investigational - Cadavers 2D | The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly. All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits. |
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| Primary | Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-High Resolution arm above. | Posted | Mean | Standard Error | units on a scale | 12 weeks after last image capture | images | images |
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| Primary | Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-FDK arm above. | Posted | Mean | Standard Error | units on a scale | 12 weeks after last image capture | images | images |
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| Primary | Radlex Scale for Diagnostic Quality Ratings - 3D Images SND | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. | 140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-SND arm above. | Posted | Mean | Standard Error | units on a scale | 12 weeks after last image capture | images | images |
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| 0 |
| 35 |
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| 35 |
| EG001 | Reference & Invest. - Cadavers 3D | Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT. | 0 | 35 | 0 | 35 |
| EG002 | Investigational - Human Subjects 3D | Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only. | 0 | 13 | 0 | 13 |
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