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Replacement battery for Sherwood Medical Systems 0100003, 10280 Electronic Thermometer Models 520, 528, 1010 (includes 5-pin connector), 510(k) Number K853713.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Rechargeable Battery Part Number MS61010

The provided text is a 510(k) premarket notification approval letter for a replacement battery, the Alexander Manufacturing Company Rechargeable Battery Part Number MS61010. This document addresses regulatory approval and substantial equivalence to a predicate device, rather than the performance of a novel medical device or AI system against specific acceptance criteria in a clinical study.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study results, or standalone performance for an AI/medical device) is not present in the provided text.

The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...". This signifies a regulatory determination based on comparison to an existing device, not a performance study against predefined acceptance criteria as would be typical for a new diagnostic or AI-based device.

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