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| Name | Class |
|---|---|
| Clinimark, LLC | OTHER |
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The purpose of this study is to conduct a Respiratory and Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda), and a standard ECG reference (respectively).
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| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate accuracy validation | Respiratory Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda). | From admission to discharge, up to 2 hours |
| Pulse Rate accuracy validation | Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, a standard ECG. | From admission to discharge, up to 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular areas utilized.)
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The study population is carefully designed to represent the intended population for the intended use of the Binah.ai Visual Vitals Application. The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute certain proportions of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, Diabetes and Obesity).
The goal is to include a range of skin pigmentations, including at least 5 darkly pigmented subjects or 15% of the subject pool, whichever is larger.
Subject enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of the exclusion criteria, a satisfactory health screen, and the subject and data demographics needed for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark, LLC | Louisville | Colorado | 80027 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2022 | Oct 11, 2022 | ICF_000.pdf |
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