(204 days)
Replacement for Nellcor Patient Module; to connect oximeter sensors to oximeter monitor. For use with Nellcor® N200® and N100® 5 button oximeters only.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an "Oximeter Pre-AMP Cable." This document primarily grants marketing clearance for the device based on its substantial equivalence to a predicate device.
It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way you've outlined. The FDA letter is a regulatory approval, not a performance study report.
Therefore, I cannot populate the requested table and information based on the provided text. The document doesn't include:
- Acceptance criteria or reported device performance metrics.
- Sample sizes used for test sets.
- Details about experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm-only) performance studies.
- Type of ground truth used.
- Sample size for training set.
- How ground truth for the training set was established.
The document states that the device is a "Replacement for Nellcor Patient Module; to connect oximeter sensors to oximeter monitor. For use with Nellcor® N200® and N100® 5 button oximeters only." This indicates its intended use, but not specific performance criteria or test results.
§ 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).