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To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.

Rossmax Automatic Wristwatch Blood Pressure Monitor, model Z40

The provided document is a 510(k) Pre-Market Notification decision letter from the FDA for a blood pressure monitor. It does not contain the detailed study information required to answer your request about acceptance criteria and device performance for an AI/algorithm-based device.

This document predates widespread AI in medical devices and focuses on the regulatory approval process based on "substantial equivalence" to existing predicate devices, rather than detailed performance metrics derived from a specific clinical study with ground truth and expert adjudication for an algorithm.

Therefore, I cannot provide the information requested in your numbered points based on the provided text. The document only states the device's indications for use:

Indications For Use:
To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patients over 18 years and wrist circumference between 5.3 to 7.7 inches.

To answer your request, you would typically need a separate clinical study report or performance summary submitted as part of the 510(k) application, which is not included in this decision letter. Such a report would detail the methods, results, and statistical analyses used to demonstrate the device's accuracy against a reference standard.

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