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The PFS-043 is indicated for use to help train the pelvic floor muscles using electrical stimulation. The PFS-043 is a rectal applicator that is used with the UMP Liberty PFS System (PFS), which is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the applicator.

The device consists of an injection molded thermoplastic applicator that supports two stainless steel electrode rings that apply electrical stimulation to a patient in order to help train neuromuscular tissue in the pelvic floor for improvement or restoration of urinary continence in men and women. The electrical stimulation energy is conducted to the electrodes via a two conductor cable and connector that plugs into the Liberty Stimulator.

The provided text is a 510(k) summary for a medical device called the "Liberty Rectal Pelvic Floor Exerciser (PFS-043)". This document describes the device and claims substantial equivalence to previously cleared devices. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/ML device or diagnostic tool.

Therefore, I cannot fulfill the request for information on acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The document states:

• "Laboratory tests of the UMP PFS-043 probe and the ICAA applicator demonstrated that they provide equivalent electrical stimulation of the pelvic floor muscles."

This is the only mention of a "test" or "study," but it lacks all the specifics requested in your prompt. It indicates equivalence in electrical stimulation, which implies a functional assessment, but no details on the methodology, acceptance criteria, results, sample size, or any other specific elements of the requested output are provided.

In summary, the provided document is a regulatory submission for substantial equivalence based on technological characteristics and functional testing, not a detailed performance study with the metrics and methodologies you've asked about.

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