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Non absorbable Surgical Silk Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.

Non absorbable Surgical silk Suture is a nonabsorbable, braided surgical suture which is supplied sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori of the family Bombycidae. Silk for braided material is processed to remove the natural waxes and gums. Silk suture is dyed black(Logwood extract) and coated with silicone. The quantity of color additive is not to exceed 1.00% by weight of the suture. The device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. Silk suture meets all the requirements of USP for nonabsorbable surgical suture. The suture needle are made from medical stainless steel, the grade of medical stainless steel is SUS 420 J2.

The provided document is a 510(k) premarket notification letter from the FDA regarding a Non-absorbable Surgical Silk Suture. This type of device is a physical medical product, not an AI/software device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as it applies to AI/software performance metrics (like sensitivity, specificity, AUC, human reader improvement with AI assistance, etc.) is not applicable here.

Instead, for a physical medical device like a surgical suture, the "acceptance criteria" and "proof" relate to:

• Material properties: Does the suture material meet established standards (e.g., USP requirements for diameter, tensile strength)?
• Biocompatibility: Is the material safe for use in the human body (e.g., non-toxic, non-irritating, non-hemolytic)?
• Sterilization: Is the device effectively sterilized and free from harmful residuals?
• Packaging integrity: Is the packaging designed to maintain sterility until use?
• Performance: Does the device perform as intended (e.g., needle attachment strength)?

The document details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance.

Here's a breakdown of the relevant information from the document, reinterpreting "acceptance criteria" for a physical device:

Acceptance Criteria and Device Performance for Non-absorbable Surgical Silk Suture (K232355)

The acceptance criteria for this medical device are based on compliance with various established standards and the demonstration of substantial equivalence to a legally marketed predicate device (K161633, REXSIL). The performance is evidenced by non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The following sections (2-9) are not applicable as they relate to AI/software performance studies, which are not relevant for this physical surgical suture device. The information provided in the document confirms that this is a traditional medical device submission for which clinical trials (and thus clinical data for training/testing or expert adjudication for ground truth) were not required.

2. Sample size used for the test set and the data provenance: Not applicable for this physical device. Testing would involve a statistically significant number of physical samples for each test (e.g., tensile strength, diameter, biocompatibility). Data provenance would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP) and laboratory measurements by qualified technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is a physical device, not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" is adherence to established engineering specifications, material standards, and biological safety standards (e.g., precise diameter measurements, specific tensile strength values, confirmed absence of cytotoxicity, etc.). These are objectively measured in laboratories according to validated test methods.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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