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The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery, and peripheral neural tissue.

DemeTECH PTFE Suture is a nonabsorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene. The DemeTECH PTFE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is undyed and contains no additives and is white in appearance and may be provided with or without an attached needle(s).

The provided document describes the FDA 510(k) clearance for the DemeTECH PTFE Nonabsorbable Surgical Suture. This is a medical device, not an AI/ML device, therefore, many of the requested criteria are not applicable. However, I can extract the relevant information regarding acceptance criteria and the studies performed.

Here's the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the exact sample sizes for the non-clinical tests (e.g., number of sutures tested for tensile strength, needle attachment).
• The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to meet USP (United States Pharmacopeia) and ISO (International Organization for Standardization) standards, which are internationally recognized. The studies were non-clinical (laboratory/bench top) and in-vitro/in-vivo.
• The study was not a "test set" in the context of an AI/ML model; rather, it was a series of physical and biological tests on the device itself.

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

• This question is not applicable as the device is a surgical suture, not an AI/ML system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this device is its physical and biological performance as measured by established standards.

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

• This is not applicable as there was no "test set" in the context of human interpretation or AI/ML model output requiring adjudication. The tests involved direct measurement against predefined 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 is not applicable. No MRMC study was conducted as this is a physical medical device (suture), not an AI/ML diagnostic or assistive tool. No human "readers" are involved in its performance assessment in this context.

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

• This is not applicable. This is a physical nonabsorbable surgical suture, not a software algorithm or AI/ML device.

7. The type of ground truth used:

• The "ground truth" for the device's performance was established by internationally recognized standards:
  • United States Pharmacopeia (USP 39) monograph for nonabsorbable surgical sutures: This defines the physical and performance characteristics such as diameter, length, knot pull tensile strength, and needle attachment strength.
  • ISO 10993-1 for Biocompatibility: This defines the standards for evaluating the biological safety of medical devices.

8. The sample size for the training set:

• This is not applicable as the device is a physical medical device and does not involve AI/ML models that require training sets.

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

• This is not applicable for the same reason as point 8.

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