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The Vibrance® Pelvic Trainer is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.

The Vibrance® Pelvic Trainer is a repeat use, non-sterile intra-vaginal exercise device intended to strengthen the pelvic floor musculature by offering resistance to an individual's voluntary contractions of these muscles. The Vibrance® Pelvic Trainer incorporates an active vibration biofeedback mechanism for the identification of the pelvic floor muscles, and the sheaths provide graduated resistance levels for the progressive strengthening of the pelvic floor muscle. The device is intended for home use.

The therapeutic effect is from the user using the device to exercise the pelvic floor muscles in accordance with the exercise program included in the instructions. The device provides biofeedback information that allows the user to verify the use of the correct muscles in the exercise routine and thus the effectiveness of the exercises undertaken. The device also includes a resistive component to the training program to strengthen the pelvic floor muscle via physiologic principles. The biofeedback mechanism works by directly sensing the force applied by the pelvic floor muscle.

The device consists of the Main Body and three Resistance Sheaths with varying degrees of stiffness. It has a PCB assembly and is a battery-powered device (140mAh, 3.7V lithium polymer battery) with USB charging capability, operating on two independent, enclosed electronic circuits for the vibration biofeedback loop and the other for audio guided training. The maximum diameter of the Vibrance® Pelvic Trainer shaft is 2.4 cm. The maximum inserted length of the shaft is 6 cm.

The provided text is a 510(k) summary for the Vibrance® Pelvic Trainer (K162689). It details the device's characteristics, its intended use, and its comparison to a predicate device (Vibrance® Kegel Device, K141893) to establish substantial equivalence.

However, the document does not contain information about acceptance criteria, device performance studies, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training data was established.

The document focuses on non-clinical performance data to demonstrate safety and effectiveness for a Class II device, specifically:

• Mechanical Testing: To measure forces required for sensor vibration and sheath removal.
• Biocompatibility Testing: In vitro cytotoxicity, skin sensitization, and vaginal irritation tests performed according to ISO 10993.
• Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Compliance with IEC 60601 standards.
• Software Information: Provided in accordance with FDA guidance.
• Risk Analysis: Performed according to ISO 14971.

The studies mentioned are primarily engineering and bench testing to demonstrate that the device meets safety and functional requirements, rather than clinical performance studies demonstrating diagnostic accuracy or efficacy improvement (as would be typical for an AI/ML medical device).

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies in the context of an AI/ML device from the provided text. The device described, a pelvic trainer with biofeedback and resistance, is a mechanical and electrical device, not an AI/ML diagnostic or prognostic system.

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