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The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.

The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operale one in escripted Description of the Device. The Atlena Perio Missic Trans 15 a raginal vide of the remote control and is activated upon removal from the cradle.

The provided text is purely a 510(k) premarket notification summary and an FDA clearance letter. It describes the device and its intended use, but it does not contain any information about acceptance criteria, study methodologies, or performance results.

Therefore, I cannot fulfill your request for:

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

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