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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adult Volunteers | Minimum of ten (10) subjects meeting the eligibility criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oximeter | Device | Devices (2) were placed on the finger and the fingertip. Blood samples were taken at each stable level of oxygenation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RMSE compared to arterial blood SaO2 | Root Mean Squared Error between Movano Ring SpO2 measurement and the arterial blood SaO2 calibrated using arterial blood gas. | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy adult participants 18 to 49 years old, of which 2 or 15% of the subject pool is darkly pigmented.
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| Name | Affiliation | Role |
|---|---|---|
| Phillip E Bickler, MD, PhD | University of California at San Francisco (UCSF) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypoxia Research Laboratory | San Francisco | California | 94133 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38838332 | Derived | Mastrototaro JJ, Leabman M, Shumate J, Tompkins KL. Performance of a Wearable Ring in Controlled Hypoxia: A Prospective Observational Study. JMIR Form Res. 2024 Jun 5;8:e54256. doi: 10.2196/54256. |
| Label | URL |
|---|---|
| Pulse Oximeters - Premarket Notification Submissions \[510(k)s\]: Guidance for Industry and Food and Drug Administration Staff \| FDA | View source |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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