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1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.

Not Found

The provided FDA 510(k) summary for the Accusonic Advantage Model AA170 does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data.

The document is a substantial equivalence determination letter, indicating that the device is similar enough to previously approved devices that it does not require a new premarket approval application. This type of FDA letter typically refers to information submitted by the manufacturer, but the letter itself does not detail the studies or criteria used.

Therefore, for each of your requested points, the answer is:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document.
2. Sample size used for the test set and the data provenance: This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.
4. Adjudication method for the test set: This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not provided in the document. The device is an ultrasonic diathermy device, not an AI diagnostic tool, so an MRMC study for AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided in the document. The device is a physical therapy device and not a standalone diagnostic algorithm.
7. The type of ground truth used: This information is not provided in the document.
8. The sample size for the training set: This information is not provided in the document.
9. How the ground truth for the training set was established: This information is not provided in the document.

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The indications for use are:

1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.

Not Found

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter confirming that the Accusonic Advantage – AA 170 device is substantially equivalent to legally marketed predicate devices.

This type of document primarily focuses on regulatory approval rather than providing details about specific performance acceptance criteria or the study data used to establish them. It mentions general controls and regulations but does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about the test set.
• Information on experts for ground truth or adjudication methods.
• Details about MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used.
• Training set sample size or how its ground truth was established.

To obtain this information, you would typically need to refer to the full 510(k) submission summary or technical reports related to the device's testing and validation, which are not included in this document.

Ask a specific question about this device