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Replacement battery for Sonicaid 1000-0007 Fetal Monitoring System D205, 510(k) Number K780487. 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 M007

This document is a 510(k) Premarket Notification from the FDA regarding a Rechargeable Battery Part Number M007 for a Fetal Monitoring System. It does not contain any information about acceptance criteria or a study proving device performance in relation to an AI/medical device.

The letter is a notification of substantial equivalence for a replacement battery, indicating that the FDA has determined the battery is substantially equivalent to devices marketed before May 28, 1976. This process is for device classification and market entry, not for performance evaluation against specific clinical acceptance criteria or a study with human subjects or AI algorithms.

Therefore, I cannot provide the requested information. The document pertains to regulatory approval of a hardware component (a battery) and not a software-based medical device with performance metrics related to diagnostic accuracy or human-AI interaction.

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