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The Bionx Duet™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Duet™ Suture Anchor is threaded, bioabsorbable suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Diameter of the anchor is 6.0mm and length 16.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a punch. The Duet™ Suture Anchor is made of poly-L/D-lactide copolymer.

The provided text describes a 510(k) premarket notification for a medical device called the Duet™ Suture Anchor. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, the requested information elements related to acceptance criteria, device performance, study design (test/training sets, ground truth, expert opinions, MRMC studies) are not explicitly described in the provided text.

Here's a breakdown of what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

• Not explicitly provided. The document focuses on demonstrating that the Duet™ Suture Anchor has the "same intended use and principles of operation and very similar technological characteristics" as existing predicate devices. It states that "the minor technological differences between the Bionx Implants Inc. Duet™ Suture Anchor and the predicate devices do not raise any new issues of safety or effectiveness." This implies that the device is expected to perform comparably to its predicates, but no specific performance metrics or acceptance criteria are listed for the Duet™ itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. This document is a 510(k) submission, not a clinical study report. It does not describe a test set or data provenance in the context of device performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. Ground truth establishment is not discussed in the context of device performance in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. Adjudication is not mentioned as no performance study is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a bioabsorbable surgical anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable/Not provided. Ground truth is not discussed.

8. The sample size for the training set

• Not applicable/Not provided. Training sets are relevant for AI/machine learning models, which this device is not.

9. How the ground truth for the training set was established

• Not applicable/Not provided. Ground truth for a training set is not discussed.

Summary of what the document does provide:

• Intended Use: Reattachment of soft tissue to bone by arthroscopy or direct visualization.
• Predicate Devices: A long list of existing bioabsorbable suture anchors with similar intended uses and principles of operation.
• Material: Self-Reinforced (96/4D) PLA Copolymer, with the material provenance being previously cleared Bionx Implants Inc. devices.
• Mechanism of action: Retains 90% strength through 20 weeks and completely resorbs over several years, allowing gradual strength loss as collagen fibers heal.
• Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not raise new issues of safety or effectiveness. This is the primary "proof" of meeting regulatory requirements for this type of submission.

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