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Force Fiber® Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.

The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in white or white/blue cobraid, sizes 5-0 through 5 meeting USP requirements except for oversized diameter.

The provided text describes a 510(k) PreMarket Notification for the Force Fiber® Polyethylene Non-Absorbable Surgical Suture. It details the device, its intended use, and substantial equivalence to predicate devices, along with a summary of testing performed.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The text states "All sizes of Force Fiber® Polyethylene Non-Absorbable Surgical Suture have been tested." This implies that every available size (from 5-0 through 5) was included in the testing, but a specific numerical sample size for each test (e.g., number of sutures per size tested for tensile strength) is not provided.
• Data Provenance: The standard tests (USP 30, Class II Special Controls Guidance, ISO 10993 Part 1) are internationally recognized standards. The country of origin for the data generated from these tests is not explicitly stated, but it is implied to be from testing conducted by Teleflex Medical or accredited labs as part of their submission to the FDA in the USA. The testing is implicitly prospective, as it was conducted to demonstrate the safety and effectiveness of the new device for regulatory submission.

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

This information is not provided in the text. The ground truth for this type of device is established by adherence to recognized testing standards rather than expert consensus on interpretive data.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods like "2+1, 3+1" are typically used for studies involving human interpretation (e.g., image reading), not for physical performance tests of surgical sutures against objective standards. The "adjudication" is essentially handled by the objective pass/fail criteria defined within the USP and ISO standards.

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:

This information is not applicable and therefore not provided. The device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable and therefore not provided. The device is a physical medical device (suture), not an algorithm.

7. The type of ground truth used:

The ground truth used for this device is based on objective, quantitative measurements defined by established performance standards and guidance documents. Specifically:

• Knot Pull Tensile Strength: Based on USP 30 requirements.
• Needle Attachment: Based on USP 30 requirements.
• Diameter: Based on USP 30 requirements (with the noted exception for oversized diameter).
• Biocompatibility: Based on ISO 10993 Part 1 "Biological Evaluation of Medical Devices" for safety.

8. The sample size for the training set:

This information is not applicable and therefore not provided. This is not an AI/ML device that requires a "training set." The product is a manufactured physical device, and its performance is evaluated against established physical and biological standards.

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

This information is not applicable and therefore not provided, as there is no "training set" for a surgical suture.

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