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The BioButton™ is a cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.

The BioButton™ is a sterile, single-use fixation device made from an absorbable homopolymer derived from Poly (L-lactic) Acid that will gradually be metabolized by the body. The implant is attached to a soft tissue or bone-tendon-bone allograft during anterior and posterior cruciate ligament autograph or reconstruction. The implant is radiotranslucent with regard to intraoperative fluoroscopy, but it can be visualized with MRI and CAT scan.

The provided text describes the BioButton™ - Recessed Ligament Button, a medical device. However, it does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to the performance of an AI/ML powered device.

The document is a 510(k) Summary of Safety and Effectiveness for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics for an AI algorithm.

Therefore, I cannot populate the requested table or answer the specific questions about AI/ML device performance from the provided text.

Here's what I can extract based on the type of document provided:

Summary of what the document does offer:

• Device Name: BioButton™ - Recessed Ligament Button
• Intended Use: Cortical fixation device used for secondary fixation in conjunction with an interference screw to secure soft tissue or bone-tendon-bone grafts in ACL and PCL reconstruction.
• Predicate Devices: Hewson Ligament Button (Richards Manufacturing Co., Inc.) for function and intended use, and BioScrew® Absorbable Interference Screw (Linvatec Corporation) for materials.
• Testing: "Testing has been done to prove safety and effectiveness of the device." (No details provided)
• Regulatory Conclusion: Substantially equivalent to legally marketed predicate devices.

Missing Information (as it pertains to AI/ML device performance studies):

All the specific questions you asked are geared towards the evaluation of an AI/ML-powered device. The provided text describes a physical surgical implant, not an AI algorithm. Therefore, none of the following information is present:

• Acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, AUC, etc.)
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective for AI data).
• Number of experts or their qualifications for establishing AI ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results (effect size of AI assistance).
• Standalone (algorithm-only) performance.
• Type of ground truth used for AI models.
• How ground truth for training sets was established.

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