(272 days)
Continuous or spot monitoring of non-invasive arterial oxygen saturation.
Multicompatible EnviteC Disposable and Reusable Oximeter Sensor(s)
The provided text is a 510(k) clearance letter from the FDA for a medical device: "Multicompatible EnviteC Disposable and Reusable Oximeter Sensors." This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device.
However, the letter does not contain any information regarding:
- Acceptance criteria or reported device performance for a study.
- Sample sizes, data provenance, number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set or how ground truth for the training set was established.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study details based on the provided text. The document is a regulatory clearance letter, not a detailed study report.
§ 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).