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AM-100 is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• · Strengthening, Toning and Firming of buttocks and thighs.

The AM-100 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the AM-100 helps to strengthen and firm the abdomen, buttocks and thighs. The AM-100 is equipped with a color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen, buttons and knob on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The provided text is a 510(k) summary for the AM-100 device, which is a powered muscle stimulator. The document states that the substantial equivalence determination for the AM-100 is not based on clinical testing. Instead, the device's safety and efficacy were demonstrated by comparison of technical characteristics between the AM-100 and a predicate device (Torc Body K131291).

Therefore, the study design and criteria typically requested for proving a device meets acceptance criteria through clinical or AI-based performance are not applicable in this specific 510(k) submission. The FDA clearance for this device was based on non-clinical testing and a comparison to a predicate device, focusing on technical specifications rather than clinical study outcomes.

For your reference, if this were a clinical study for a device that uses AI or required performance validation, the information you requested would be directly relevant. However, based on the provided document, I cannot extract the information you've asked for because no such clinical study or AI performance evaluation was conducted or presented for this 510(k) submission.

Summary based on the provided document:

• No acceptance criteria related to a clinical study or AI performance were stated in the document, as the submission was based on non-clinical testing and predicate device comparison.
• The document explicitly states: "The substantial equivalence determination for the AM-100 is not based on clinical testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the AM-100 and the predicate device."

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details as they pertain to a clinical or AI performance study.

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