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The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

The subject device consists of a stainless steel, straight needle attached to a strand of MaxBraid suture. The two ends of the strand of suture are crimped into the needle. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polvethylene (UHMWPE) fibers and a blue and white co-braid configuration consisting of Deklene II, Polypropylene suture braided into 100% UHMWPE fibers. The suture is provided uncoated. The colorant used in the blue and white co-braid consists of [phthalocyaninato (2-)] copper

This document is a 510(k) premarket notification for the "ExpressBraid Graft Manipulation" device. It is a re-submission due to the addition of a new contraindication, not a new device or significant modification. As such, it relies heavily on the data and conclusions from the previously cleared K152868 submission. Therefore, detailed acceptance criteria and a new study proving performance are not present in this document because it references prior clearance.

However, based on the provided text, we can infer some information about the device and its assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this 510(k) is not for a new device but for an update to its Indications for Use (specifically, adding a contraindication), explicit acceptance criteria and new performance data are not provided. The document states:

• "The performance of ExpressBraid Graft Manipulation device has not changed since its last clearance in K152868 as there are no changes to design, material, or intended use. The performance data submitted in K152868 is still valid and therefore no additional testing was performed."

Therefore, the acceptance criteria and performance would be consistent with what was submitted and accepted for the K152868 clearance. This current document simply reaffirms that the device still meets those (unspecified in this document) criteria because its fundamental design and function have not changed.

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

• Since no new testing was performed for this specific 510(k), no new sample size or data provenance details are provided. This information would be found in the K152868 submission.

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

• Not applicable for this 510(k) as no new testing was conducted, and it's not a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set:

• Not applicable, as no new clinical or non-clinical tests requiring adjudication were performed for this submission.

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 for soft tissue approximation/ligation, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical surgical suture, not an algorithm.

7. The type of ground truth used:

• Not applicable as it is a physical medical device, not a diagnostic or AI-based product requiring ground truth for validation. The "ground truth" for a surgical suture would typically involve mechanical testing (e.g., tensile strength, knot security) and biocompatibility, which were presumably assessed in K152868.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable for the same reason as above.

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