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Replacement battery for Ross Laboratories, Div. of Abbott Labs Flexiflo II Infusion Pump, 510(k) Number K821661. 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 GL625

This document is solely a 510(k) clearance letter for a replacement battery, indicating its substantial equivalence to a previously marketed device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details that would allow for a discussion of AI performance or comparative effectiveness.

Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving device performance based on the provided text.

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Replacement battery for Nellcor, Inc. 0810-0103 N-200 Pulse Oximeter with Factory Replacement Block, 510(k) Number K863784.

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.

Replacement battery for Nellcor, Inc. 0810-0103 N-200 Pulse Oximeter with Factory Replacement Block, 510(k) Number K863784.

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a replacement battery, and it primarily focuses on the regulatory approval and substantial equivalence determination for this specific device. It does not include any details about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

Ask a specific question about this device