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The Air Pressure Therapy System is intended to temporarily relieve minor muscleaches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Air Pressure Therapy System."

This document does not contain any information about:

• Acceptance criteria
• Device performance results
• Details of a study (e.g., sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls and other regulations. It also includes the "Indications for Use" statement for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device

The Air Pressure Therapy System is intended to temporarily relieve minor muscleaches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Not Found

The provided document is an FDA 510(k) clearance letter for the "Air Pressure Therapy System (VU-IPC04B)". It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses on regulatory compliance, outlining general controls, additional controls for Class II devices, and various regulations such as the Quality System regulation, UDI Rule, and adverse event reporting.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This information would typically be found in the 510(k) submission itself or in a separate study report, which is not part of this FDA clearance letter.

Ask a specific question about this device