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Non-absorbable Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
Non-absorbable Polyester Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
Non-absorbable Polyamide suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.

The applicant devices of Non-absorbable Polypropylene Suture consist of polypropylene surgical suture made of polypropylene and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by §74.3045 [Phthalocyaninato(2-)] copper.(CI Number 74160) which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polypropylene Suture are available in 11-0, 10-0, 8 -0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The applicant devices of Non-absorbable Polyester Suture consist of a polyester surgical suture made of polyester and a stainless steel needle. It is braided and coated with silicone. It is EO sterilized, and prygon-free.It is undyed (natural white) or dyed green with § 74.3206 D&C Green No. 6. (CI Number 61565), which is less than 0.1 % by weight. The applicant devices of Non-absorbable Polyester Suture are available in 9-0, 8-0, -0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The applicant devices of Non-absorbable Polyamide suture consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by § 74.3102 FD&C Blue No. 2. ( CI Number 73015) or § 73.1410 Logwood Black (CI Number 75290), which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polyamide suture are available in 11-0, 10-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The proposed devices are provided sterile and single use.
The proposed device is composed of suture with or without the needle.
The needle is made of stainless steel. The needles are available in six types: Taper, Cutting, Taper Cutting, Reverse Cutting, Diamond, Premium Cutting and Spatula. The Arc (Circle) of needle has 1/4 circle, 3/8circle,1/2circle,5/8circle,compound curve, straight.
The proposed devices are provided in various combinations of suture length, diameter, color (dyed or undyed), quantity of needle and needle types.
The proposed devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

Here's a breakdown of the acceptance criteria and study information for the "Surgical Sutures with or without Needle" device based on the provided FDA 510(k) summary.

It's important to note that this document is a 510(k) summary for a medical device that demonstrates substantial equivalence to a predicate device, not necessarily a study proving clinical effectiveness or improvement with AI. The focus is on demonstrating that the new device is as safe and effective as devices already on the market. Therefore, many standard AI/ML study components (like multi-reader multi-case studies, ground truth establishment for a training set, the role of experts for ground truth, or effects of AI on human readers) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established standards for surgical sutures. The reported performance indicates compliance with these standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each non-clinical test. The testing was conducted to verify compliance with various established standards (USP, ISO, ASTM). The data provenance is generally "non-clinical tests" performed by the manufacturer in China (Huaian Seamen Medical Technology Co., LTD) to support the 510(k) submission. This is considered retrospective in the sense that the test results are being summarized for submission, not generated as part of a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving diagnostic interpretation or machine learning where "ground truth" is established by experts in an interpretative capacity. The "ground truth" here is compliance with technical specifications and safety standards as measured by laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data where disagreements need to be resolved. The test results are objective measurements against defined 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

Not applicable. This document is for a physical surgical device (sutures), not an AI/ML-driven diagnostic or interpretative device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

The "ground truth" in this context refers to the defined acceptable parameters and thresholds within the cited standards (USP, ISO, ASTM). For example, the "ground truth" for suture diameter is the range specified in USP . For biocompatibility, the "ground truth" is the absence of adverse biological reactions as defined by ISO 10993 series. These are objective, measurable standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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