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Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232.

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 Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232.

I apologize, but the provided text from the FDA 510(k) clearance letter for the GL825-200 replacement battery does not contain information about acceptance criteria or a study demonstrating device performance as it pertains to AI/ML software.

The document is a standard clearance letter for a medical device (a replacement battery) and focuses on the regulatory determination of substantial equivalence to a predicate device. It addresses:

• Device Name: GL825-200
• Intended Use: Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor.
• Regulatory Classification: Class II
• Substantial Equivalence: A determination that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Responsibilities: Information regarding annual registration, good manufacturing practices, labeling, etc.

There is no mention of:

• Performance metrics (sensitivity, specificity, AUC)
• Sample sizes for test or training sets
• Ground truth establishment
• Expert review or adjudication
• Multi-reader multi-case (MRMC) studies
• Standalone performance studies

Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the provided input. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) clearance letter.

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