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HyperSutures (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation. including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture cables are available in USP 2-0, USP 2, and USP 5 and meet all surqical suture requirements established by the USP for class II non- absorbable surgical sutures.

HyperSuture tapes are non-absorbable, sterile, braid for surgery composed of multiple multifilament strands of ultra-high molecular weight polvethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in Threadstone tape size 0.5 (USP 2-0 equivalent), tape 1.5 (USP 2 equivalent), and tape 2.5 (USP 5 equivalent).

Both HyperSuture cables and tapes are available in white/black, 40 inches in length, and with or without pre-attached needles.

The provided text is a 510(k) summary for the device "HyperSuture." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include specific acceptance criteria for performance, nor does it detail a study that explicitly "proves the device meets the acceptance criteria" in terms of statistical comparisons or clinical outcomes for an AI/software device. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material, manufacturing, and general performance requirements for surgical sutures.

Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it is for a physical medical device (surgical sutures), not a diagnostic AI/software device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document states "HyperSuture cables... meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures." and "HyperSuture tapes... meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures." The specific numerical or qualitative targets for these USP requirements are not detailed in this summary document, but the device states it meets them.)

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. This document is for a physical medical device (suture) and the "test set" would refer to physical or mechanical bench testing, not a data-driven clinical study. The performance data section refers to "HyperSuture cables are tested per USP performance requirements..." but does not specify sample sizes or data provenance in the context of an AI/software device.

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. Ground truth in the context of expert consensus is not relevant for the performance testing of a surgical suture.

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

• Not Applicable. This pertains to expert review of data, not physical device testing.

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-assisted diagnostic tool.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Standards-based performance: The ground "truth" or reference standard for this device's performance is established by the United States Pharmacopeia (USP) requirements for surgical sutures, as well as Threadstone's internal specifications for tape width. Biological evaluations followed ISO 10993-1:2018 and endotoxin assessments followed FDA guidance for "Pyrogens and Endotoxins Testing."

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device.

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

• Not Applicable. This is not an AI/machine learning device.

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