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The device is indicated for use in general soft tissue approximation and/or ligation, including use in allograft tissues for orthopedic procedures

The proposed device is a braided synthetic, non-absorbable surgical suture made of ultra-high molecular weight polyethylene and medical adhesive at both ends of the suture. The proposed device is undyed and uncoated. The sutures are available in a range of sizes. The device does not contain needle. And the device is provided in sterile.

I'm sorry, but the provided text from the FDA 510(k) submission for the "High Strength Suture" does not contain information about an AI/ML medical device. It pertains to a physical surgical suture, and the "acceptancce criteria" mentioned in the document refer to non-clinical test conclusions and biocompatibility, not performance metrics of an AI model.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves an AI/ML device meets them, as there is no such information in the provided document.

The document discusses:

• Device: High Strength Suture (a physical surgical suture).
• Regulation: 21 CFR 878.5000 (Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture).
• Non-Clinical Tests: Mechanical properties (tensile strength, diameter), packaging integrity, and biocompatibility (cytotoxicity, irritation, sensitization, pyrogenicity, systemic toxicity, genotoxicity, implantation tests).
• Predicate Device: HS Fiber® Suture.
• Conclusion: Substantial Equivalence to the predicate device based on these non-clinical tests.

There is no mention of AI, algorithms, machine learning, human readers, ground truth establishment for a test set, etc., which are all concepts relevant to the performance evaluation of an AI/ML diagnostic or assistive device.

To answer your question, I would need a document describing the validation of an AI/ML medical device.

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