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The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage:

• · Relief of minor muscle aches and pain, relief of muscle spasm
• · Temporary improvement of local blood circulation
• · Temporary reduction in the appearance of cellulite.

EndyMed's EndyMed Contour Handpiece is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (Imagine K08346). The EndyMed Contour Handpiece combines suction module that creates vacuum energy and emits bipolar RF energy that flows between the electrodes to create thermal heating of the tissue.

The Vacuum is used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage contributes to the sub-dermal and adipose tissues shrinkage and improves the contact surface between electrodes and tissue.

The provided document is a 510(k) premarket notification for the EndyMed Contour Handpiece. It details the device's intended use, technological characteristics, and a claim of substantial equivalence to predicate devices. However, this document does not contain the specific information requested regarding acceptance criteria for an AI/ML device study, and the detailed study description you've outlined.

The document discusses performance tests for the EndyMed Contour Handpiece itself (e.g., power output, temperature, vacuum pressure), but this is validation of a physical medical device, not a study proving an AI/ML algorithm meets acceptance criteria.

Here's why the requested information cannot be found in the provided text:

• No AI/ML Component: The EndyMed Contour Handpiece is described as an electrosurgical cutting and coagulation device accessory that uses RF energy and vacuum mechanical manipulation. There is no mention of an AI/ML component or algorithm in its description or intended use.
• Study Type: The "performance data" and "summary of clinical performance data" refer to lab performance tests, design validation, and software verification and validation for the physical device, and a claim that no clinical studies were necessary to show substantial equivalence with its predicate devices because it has the same intended use, clinical indication, and technology. This explicitly states new clinical studies were not performed for this submission.
• Ground Truth: Since no clinical studies were performed, there is no discussion of establishing ground truth, expert consensus, pathology, or outcomes data for a test set.
• Sample Sizes/Experts/Adjudication/MRMC: These are all concepts relevant to clinical or performance studies evaluating an AI/ML algorithm's effectiveness against a ground truth, which were not conducted for this submission.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study proving device meets acceptance criteria, as the provided text does not describe such a study for an AI/ML-driven medical device.

The document is a regulatory submission for a physical medical device (EndyMed Contour Handpiece), focusing on its technical specifications and substantial equivalence to existing devices, rather than the performance evaluation of a novel AI/ML algorithm.

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