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Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Modified Polysorb* Suture is composed of a glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids). The suture is coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate.

The provided text is a 510(k) summary for a "Modified Polysorb Suture." This document focuses on demonstrating substantial equivalence to a predicate device (Polysorb Suture, K970863) to gain market clearance. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way one would typically describe a clinical or algorithmic performance study.

Medical devices like sutures are often evaluated based on material properties, biocompatibility, and mechanical strength to ensure they function as intended and are safe for use. However, the provided text does not detail the specific tests conducted or their results.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I discuss sample sizes for test sets, data provenance, ground truth establishment, or multi-reader multi-case studies, as these types of studies are not described in the given documents for this product.

Instead, the document primarily focuses on:

• Device Description: Modified Polysorb Suture is composed of a glycolide/lactide copolymer and coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate.
• Intended Use: Soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
• Materials: All component materials are in accordance with ISO Standard # 10993-1, which addresses biocompatibility.
• Predicate Device: Polysorb* Suture (K970863). The substantial equivalence is based on the similarities in composition, intended use, and general characteristics to this already legally marketed device.
• FDA Clearance: The FDA found the device substantially equivalent to transitional devices reclassified into Class II, subject to general controls and specific limitations regarding manufacturing materials.

For a medical device like a suture, performance would typically be evaluated through:

• Mechanical Testing: Tensile strength, knot security, degradation profile.
• Biocompatibility Testing: According to ISO 10993 standards (which is mentioned for the materials).
• Sterilization Validation: Ensuring the device can be effectively sterilized.
• In vivo animal studies: To assess tissue reaction, absorption, and wound healing in a biological environment.

However, the provided K981935 summary does not contain the detailed results of such studies. It only states that the materials conform to ISO 10993-1 and that manufacturing processes and material changes would require new premarket notification.

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Modified USSC* POLYSORB* Sutures are indicated for use in soft tissue approximation or ligation and opthalmic surgery, but not in cardiovascular or neural tissue.

Modified USSC* POLYSORB* sutures are composed of LACTOMER* glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids). The suture is coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate.

This K970863 submission for the Modified USSC* POLYSORB* Suture is a premarket notification for a Class II medical device. The information provided heavily focuses on the material composition, intended use, and conformance to general standards rather than a detailed clinical study demonstrating specific performance metrics against acceptance criteria. Therefore, several requested elements cannot be fully addressed from the given text.

Here's the breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated. The submission refers to meeting USP Monograph requirements, which are standardized tests performed on a representative sample of the device. However, the specific sample size, country of origin, or whether the data was retrospective or prospective (clinical trial data) is not detailed in this summary. USP monographs typically outline the methodology and sample sizes for testing physical characteristics.

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

• Not applicable. This submission focuses on the physical and material properties of a surgical suture, not on diagnostic accuracy requiring expert interpretation of images or clinical data. The "ground truth" here is defined by objective, measurable physical properties as outlined by the USP Monograph.

4. Adjudication method for the test set:

• Not applicable. See point 3. The assessment relies on standardized laboratory testing protocols, not on human adjudication of subjective interpretations.

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 device is a surgical suture, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

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

• Not applicable. This device is a surgical suture, not an algorithm.

7. The type of ground truth used:

• Standardized Physical Properties/Laboratory Measurements. The "ground truth" for this device is defined by the objective, quantifiable requirements outlined in the U.S.P. (United States Pharmacopeia) Synthetic Absorbable Suture Monograph for characteristics such as tensile strength, needle attachment, and diameter.

8. The sample size for the training set:

• Not applicable. This submission is for a physical medical device (suture), not a machine learning algorithm that requires a "training set."

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

• Not applicable. See point 8.

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