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The Energex® system is intended to be used as an adjunct to medical therapy for the temporary symptomatic relief of mild to moderate chronic anterior knee pain which is not caused by meniscal, ligament, or cartilage injury.

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I am sorry, but the provided text does not contain information about acceptance criteria or specific studies proving a device meets them. The document is an FDA 510(k) clearance letter for the Energex System®, which primarily confirms its substantial equivalence to a predicate device for marketing purposes.

It outlines the device's name, regulation number, regulatory class, product code, and indications for use. However, it does not detail:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about test sets.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
• Details on standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set or how ground truth for training was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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