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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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Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days.

The proposed device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed 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. The proposed device is dyed blue. The color additive is FD&C BLUE NO. 2, the weight percentage for color additive is less than 0.1%.

The document provided describes a 510(k) summary for a medical device called "Non Absorbable Surgical Nylon Suture." It details the device's characteristics, its comparison to a predicate device, and the results of non-clinical tests conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document provides a comparative table (Table 1: Comparison of Technology Characteristics) that implicitly lists acceptance criteria by showing the proposed device's performance against established standards or in comparison to the predicate device.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific non-clinical test. It lists the standards and states "The test results demonstrated that the proposed device complies with the following standards." For biological evaluations (e.g., cytotoxicity, irritation, systemic toxicity), these studies typically involve in vitro tests and animal models, governed by the respective ISO 10993 standards and USP monographs. The number of samples/animals would be specified within those standard protocols, but are not detailed in this 510(k) summary.
• Data Provenance: The tests were "non clinical tests" and involved compliance with ASTM, ISO, and USP standards. This indicates laboratory testing, likely performed by or for the manufacturer. The country of origin of the data is not specified beyond the manufacturer being in China. The data would be considered prospective for the purpose of this submission (i.e., new tests were conducted for this device clearance).

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):

This information is typically not included in a 510(k) summary for non-clinical testing of a surgical suture. The "ground truth" for these tests are the established thresholds and methodologies defined within the cited international and national standards (ASTM, ISO, USP). Compliance is determined by whether the device's performance falls within the acceptable ranges or meets the pass/fail criteria outlined in these published standards. These standards are developed and updated by expert committees in relevant fields, but individual expert assessment for a specific test set, as might be done for clinical image analysis, is not applicable here.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation (e.g., radiology reads) where there can be inter-reader variability. For non-clinical tests against defined standards, results are typically objective measurements or observations that either meet or fail the established criteria.

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 510(k) submission for a surgical suture, which is a physical medical device, not an AI-assisted diagnostic tool. No MRMC studies or AI assistance were involved.

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. The tests were performed on the physical suture device.

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

The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and methodologies. These include:

• ASTM International Standards: For material testing (e.g., seal strength, seal leaks).
• ISO 10993 Series of Standards: For biological evaluation of medical devices (e.g., cytotoxicity, sensitization, irritation, implantation, systemic toxicity, genotoxicity, ethylene oxide residuals, hemolysis).
• United States Pharmacopeia (USP) Monographs: For physical characteristics of sutures (e.g., diameter, tensile strength, needle attachment, pyrogen, bacterial endotoxins).

The tests determine if the device meets quantitatively defined thresholds or qualitative observations specified by these authoritative standards, rather than expert consensus on individual cases or clinical outcomes data.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set. The tests performed are to evaluate the physical and biological characteristics of the manufactured suture.

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

Not applicable, as there is no training set for this device.

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