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ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.

Orthocord® Suture is a synthetic, sterile, braided, composite suture composed of dyed (D&C Violet #2 or D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.

The provided text does not contain a study or detailed performance data that would allow for a complete answer to your request. The document is a 510(k) summary for a medical device (Small Size Orthocord® Suture) seeking substantial equivalence to previously cleared devices.

Instead of a detailed study with acceptance criteria and performance metrics, it states that:

• "The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards."
• "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures, except for oversized diameter."

This indicates that the device's equivalence and safety/performance were established primarily through comparison to existing predicate devices and adherence to general standards, rather than a novel clinical or non-clinical study with specific acceptance criteria and reported device performance as you've requested for AI/software-based devices.

Therefore, I cannot populate the table or answer most of your detailed questions because the information is not present in the provided text.

However, I can extract the following limited information:

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

2. Sample sized used for the test set and the data provenance: Not applicable. No specific "test set" or data provenance (country of origin, retrospective/prospective) is described for a study in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is not mentioned for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 surgical suture, not an AI/imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be its physical and mechanical properties conforming to established standards and predicate device performance, not clinical ground truth in the AI sense.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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ORTHOCORD Suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.

ORTHOCORD suture is a synthetic, sterile, braided composite suture composed of dyed (D&C Violet #2) absorbable polydioxnone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.

The provided document is a 510(k) summary for the ORTHOCORD Suture and does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance. This type of document is a regulatory submission for medical devices that demonstrates substantial equivalence to a legally marketed predicate device, rather than a detailed report of clinical or performance studies with specific acceptance criteria.

However, based on the information provided, here's what can be extracted and what cannot:

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

Missing Information: Specific quantitative acceptance criteria (e.g., tensile strength thresholds, degradation rates, knot security values) are not provided in this 510(k) summary. The document broadly states "conformance to consensus and voluntary standards" and "USP monograph for absorbable sutures" as the basis for performance.

2. Sample size used for the test set and the data provenance

Missing Information: The document states "Non-clinical laboratory testing was performed" but does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically contained in the full testing report, not the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: For a suture device, "ground truth" established by experts as in an image-based diagnostics study is not relevant in the same way. Performance is typically assessed through laboratory testing against established physical and mechanical standards.

4. Adjudication method for the test set

Not Applicable: See point 3.

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 is a physical medical device (suture), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

Not Applicable: See point 5.

7. The type of ground truth used

For a suture, "ground truth" would be established by:

• Physical and Mechanical Standards: Measurements against the USP monograph for absorbable sutures, and other consensus/voluntary standards (e.g., tensile strength, knot pull strength, degradation profile, biocompatibility, sterility). These standards themselves define what "truth" means for a functional suture.
• Comparison to Predicate Devices: Performance characteristics were compared to already approved predicate devices (PDS II suture and FiberWire suture) to demonstrate substantial equivalence.

8. The sample size for the training set

Not Applicable: As a physical medical device, there is no "training set" in the context of machine learning or AI models. Performance is evaluated through laboratory testing of the manufactured product.

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

Not Applicable: See point 8.

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