(127 days)
The Philips reusable and disposable SpO2 Sensors are intended for non-invasive measurement of oxygen saturation (SpO2) and pulse rate.
Philips Reusable SpO2 Sensors M1191T, M1192T, and M1193T: M1191T is indicated for adult patients, M1192T is indicated for pediatric patients, and M1193T is indicated for neonatal patients.
Philips SpO2 Reusable Clip Sensor Model M1196T: M1196A and M1196T are indicated for patients > 40 kg (typically adult patients).
Philips Disposable SpO2 Sensor M1131A: M1131A is indicated for adult patients/pediatric patients
Philips Disposable SpO2 Sensors M1132A and M1133A: M1132A is indicated for infant patients, and M1133A for adult/infant/neonatal patients.
Not Found
The provided text discusses regulatory approval for Philips SpO2 sensors but does not contain information about acceptance criteria or a study proving device performance against specific criteria. The document describes a 510(k) submission for a labeling change to add compatibility with non-Philips monitors. The testing mentioned in the document states "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the pulse oximetry sensors functionality meets all reliability requirements and performance claims." However, it does not provide details on specific acceptance criteria values, reported device performance metrics, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).