Search Results

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.

Ask a specific question about this device