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The Button Loop is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

The proposed device, Button Loop is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments. It consists of a titanium implantable button with a pre-attached loop. This implantable loop has non-absorbable suture attached to the button for assisting in the button placement and is discarded after the device placement. The button is offered in 12mm one size and loop is available in size ranges of 10~60mm in 5mm increments to accommodate different graft sizes.

This FDA 510(k) premarket notification for the "Button Loop" device does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML algorithm.

The document describes a medical device called the "Button Loop," which is a metallic bone fixation fastener used for soft tissue to bone fixation in orthopedic procedures like ACL repair. The submission is focused on demonstrating substantial equivalence to a predicate device (RIGIDLOOP Cortical Fixation System) based on non-clinical tests (biocompatibility, mechanical tests, sterilization) and technological characteristics.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this device is not an AI/ML powered device, nor does the document describe such a study.

The "Non-Clinical Test Conclusion" (Section 6) and "Table 1 Comparison of Technology Characteristics" (Section 7) of the 510(k) summary are the closest to performance evaluation in this document. They cover aspects like mechanical strength, biocompatibility, and sterilization, but these do not involve the types of acceptance criteria and studies typically associated with AI/ML device performance.

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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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