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The AVITA BPM1x Series device automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125 mm to 210 mm (approx. 4.9 ~ 8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.

AViTA BPM1x series Wrist Type Blood Pressure Monitor

The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information required to answer your questions about acceptance criteria, study design, ground truth establishment, or performance metrics.

Specifically, the document:

• Declares the device substantially equivalent to a predicate device. This means the new device performs similarly to an existing, legally marketed device.
• Lists the indications for use (wrist blood pressure monitor for adults, 125-210 mm wrist circumference, home use, detects irregular heartbeats).
• Outlines regulatory requirements for the manufacturer (registration, labeling, MDR, GMP, etc.).
• Identifies the product code and regulatory class.

It does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, or expert qualifications.
• Information on ground truth methods, training/test set sizes, or how ground truth was established for these sets.
• Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

To answer your questions, one would need access to the actual 510(k) submission, which would include the performance study reports and data. The provided letter is the FDA's decision based on that submission, not the submission itself.

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