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MaxBraid™ Polyethylene Plus and Polyester Plus suture is indicated for general soft tissue approximation and/or ligation

Two configurations of MaxBraid™ suture are included in this submission. The first consists of a polyester core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyester Plus Suture. The second type consists of a polyethylene core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyethylene Plus Suture. Both types are supplied in lengths of 38" with or without attached suturing needles. The suture is size 2 in keeping with currently recognized United States Pharmacopoeia (USP) standards. Both white and blue suture will be marketed. The suture is coated with silicone in order to ease passage through tissue. When desired, the MaxBraid™ Polyester Plus and Polyethylene Plus Suture may be used with a commercially available suture anchor.

The provided text is a 510(k) summary for the MaxBraid™ Suture, which is a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with detailed performance metrics.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth establishment
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used (beyond general "USP standards")
• Sample size for the training set
• How ground truth for the training set was established

The document explicitly states: "Clinical Testing: None provided." This indicates that no clinical studies were performed, which would be the typical source for the detailed performance data requested.

Instead, the document states:

• Non-Clinical Testing: "Testing demonstrated that MaxBraid™ Suture met or exceeded the USP 24 standards for nonabsorbable sutures and are substantially equivalent to the predicate devices."

This means the acceptance criteria are adherence to USP 24 standards for nonabsorbable sutures, and the "study" demonstrating this involves non-clinical (i.e., bench or lab) testing. However, the specific metrics, their measured values, sample sizes, and detailed methodology of these non-clinical tests are not provided in this 510(k) summary.

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