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Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409.

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 MS822

The provided document is a 510(k) clearance letter from the FDA for a replacement battery (Alexander Manufacturing Co. Rechargeable Battery Part Number MS822). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would be relevant for a medical device with an algorithm or AI component.

This letter is a regulatory document confirming that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but raises no new questions of safety and effectiveness and is as safe and effective as a legally marketed device.

Therefore, I cannot provide the requested information based on the input document. The type of information you're asking for (acceptance criteria, study details, expert involvement, etc.) would typically be found in a detailed submission summary, clinical study report, or a performance testing document, not in the 510(k) clearance letter itself for a simple replacement battery.

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