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The purpose of this clinical study is to evaluate the imaging performance of the Carestream PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the "investigational devices") as compared to the currently marketed Carestream DRX-1 Detector (referred to as the "predicate device"). Both detectors are flat panel digital imaging devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors 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 clinical study is to evaluate the imaging performance of the investigational devices as compared to the currently marketed predicate device. The evaluation will consist primarily of comparing the diagnostic image quality of pediatric and adult cadaver studies and adult live human subject studies acquired under the same exposure technique.
Under the same position and radiological technique, pediatric and adult cadaver studies, and adult live human subject studies, using double-exposed images will be acquired to evaluate the diagnostic image quality of the investigational device versus the predicate device. Target images will be assembled and reviewed in a side-by-side Comparative Evaluation to statistically confirm the findings of this evaluation.
The live human subject portion of this study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which they will have two (2) x-rays taken.The first x-ray will follow standard technique using the cleared predicate detector currently in use at the site. Following the first x-ray, we will take one additional x-ray of the same part of the body with one (1) of the investigational detectors. The x-ray from the investigational detector will not be used to diagnose.
If the x-ray obtained by the standard DR x-ray detector shows any unforeseen, unusual or abnormal findings, these findings will be communicated to the subject and their doctor by USPS mail.
Reason for Observational Study Type: There are three (3) physical detectors being used in this study. Each detector is 35 centimeters by 43 centimeters. None of the subjects will given a detector. All subjects are healthy volunteers recruited by flyer. All subjects will be imaged with the same predicate detector and one (1) of the investigational detectors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predicate & Invest-GOS | Experimental | Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector. |
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| Predicate & Invest-CsI | Experimental | Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector. |
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| Predicate & Invest.-Cadavers GOS & CsI | Experimental | Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector. |
| Measure | Description | Time Frame |
|---|---|---|
| Radlex Scale for Diagnostic Capability Ratings | 1-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-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-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. | 9 weeks after last x-ray capture |
| Measure | Description | Time Frame |
|---|---|---|
| Pair Preference Rating Scale | During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Hobbs, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Predicate & Invest.-GOS | Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector. |
| FG001 | Predicate & Invest.-CsI | Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector. |
| FG002 | Predicate & Investigational-Cadavers | Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Predicate & Invest.-GOS | Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector. |
| BG001 | Predicate & Invest.-CsI |
| 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 Capability Ratings | 1-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-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-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. | A total of 177 image pairs were included for the reader study. Of the 177 pairs, 160 were cadaver image pairs. A total of seventeen (17) adult live human subject pairs were included in the reader study. | Posted | Mean | Standard Error | units on a scale | 9 weeks after last x-ray capture | images | Participants |
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AE's were monitored for one month, March 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.-GOS | Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Pate, Senior Clinical Affairs Manager | 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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|
| 9 weeks after last x-ray capture |
Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
| BG002 | Predicate & Invest.-Cadavers GOS & CsI | Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector. |
| BG003 | Total | Total of all reporting groups |
| participants |
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| Sex/Gender, Customized | Number | participants |
|
| OG000 | Predicate | DRX-1 Detector, Live Subjects and Cadavers |
| OG001 | Investigational | DRX PRO 3543/C (GOS & CsI) Detectors, Live Subjects & Cadavers |
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| Secondary | Pair Preference Rating Scale | During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative. | cadavers and live human subjects | Posted | Mean | Standard Error | units on a scale | 9 weeks after last x-ray capture | units | Participants |
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| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Predicate & Invest.-CsI | Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector. | 0 | 10 | 0 | 10 |
| EG002 | Predicate & Invest.-Cadavers GOS & CsI | Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors. | 0 | 3 | 0 | 3 |
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