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The WEGO-PGLA Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

The WEGO-PGLA Absorbable Surgical Suture is a multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. It is composed of PGLA suture and needle. The PGLA Suture is composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); it is coated with the copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The PGLA suture is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture. The proposed suture is available in 6-0, 5-0, 4-0, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia. The Synthetic Absorbable Suture is provided EO sterilized as a single use device.

The acceptance criteria for the WEGO-PGLA Absorbable Surgical Suture are defined by its compliance with various United States Pharmacopoeia (U.S.P.) monograph requirements and several international standards for medical devices. The study conducted to prove the device meets these criteria involved a series of bench tests.

Here's a breakdown of the requested information:

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

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

The document does not specify the exact sample sizes used for each individual test. It generally states that "Bench tests were conducted to verify that the proposed device met all design specifications."

Data Provenance: Not explicitly stated, however, the manufacturer is Foosin Medical Supplies Inc., Ltd in Weihai, Shandong, China. The testing was conducted to U.S. and International standards.

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

This information is not applicable to this type of device and study. The "ground truth" for surgical sutures is established by compliance with published, objective, and quantitative technical standards (like USP and ISO standards) and not by expert consensus on subjective observations. The performance metrics are physical and biological measurements.

4. Adjudication method for the test set

Not applicable. The tests are based on objective measurements against predefined thresholds within the standards, not on subjective interpretations requiring adjudication.

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 for human readers. Therefore, an MRMC comparative effectiveness study involving AI is not relevant.

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

Not applicable. This device is a physical medical product (surgical suture), not an algorithm or software. Its performance is evaluated through physical and biological bench tests.

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

The ground truth for this device is based on objective, quantitative measurements and adherence to established technical standards (e.g., USP monographs for diameter, tensile strength, needle attachment, and biological evaluation standards like ISO 10993).

8. The sample size for the training set

Not applicable. This study does not involve machine learning or AI, so there is no concept of a "training set."

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

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

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The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.

The WEGO-PGCL Absorbable Surgical Monofilament Suture is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery. The Synthetic Absorbable Suture is composed of poly (glycolide-co-caprolactone) (PGCL): and it is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture. The proposed suture size is 3-0, which is the size identified in the currently recognized United States Pharmacopoeia. The performance of this absorbable sutures complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35<861>, USP 35<871> and USP35 <881>. The Synthetic Absorbable Suture is provided EO sterilized as a single used device.

Acceptance Criteria and Device Performance Study for WEGO-PGCL Absorbable Surgical Monofilament Suture

The WEGO-PGCL Absorbable Surgical Monofilament Suture was evaluated for substantial equivalence to a predicate device (MoNo Q (PGCL), K100461) by demonstrating compliance with established performance standards for absorbable surgical sutures.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes for "test sets" in the context of individual tests. Instead, it refers to the performance of "non clinical tests" conducted to verify compliance with various established standards (USP, ASTM, ISO). The nature of these tests (e.g., tensile strength, diameter measurement, biocompatibility) implies that a sufficient number of samples were tested to meet the statistical requirements outlined in the respective standards.

Data Provenance: The document does not explicitly state the country of origin for the data generated from the non-clinical tests. However, the sponsor is Foosin Medical Supplies Inc., Ltd, located in Weihai, Shandong, China. The studies were non-clinical, meaning they were laboratory-based tests of the device's physical, chemical, and biological properties, not human subject data. Therefore, the data would be retrospective in the sense that it reflects the performance of manufactured batches, and its origin would be related to the manufacturing and testing facilities in China.

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

This section is not applicable to this submission. The "ground truth" for the non-clinical tests described is established by objective, standardized measurements and criteria defined in recognized international and national standards (USP, ASTM, ISO). These tests do not involve human expert interpretation or adjudication to establish a "ground truth" in the way that, for example, medical image analysis requires expert reads. The standards themselves dictate the acceptable ranges and methodologies.

4. Adjudication Method for the Test Set

This section is not applicable as the tests are objective, standardized measurements against predefined criteria. There is no mention of subjective interpretation of results requiring an adjudication process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without the assistance of an AI algorithm in diagnostic tasks, often with a focus on clinical endpoints or diagnostic accuracy. The current submission is for a medical device (surgical suture) and involves physical and biological property testing, not diagnostic imaging or clinical interpretation by multiple readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This section is not applicable. The device is a surgical suture, not an AI algorithm. Therefore, there is no "standalone algorithm" performance to report. The "device performance" refers to its inherent physical, chemical, and biological attributes as measured in laboratory tests.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests conducted is defined by the objective, quantitative criteria and methodologies specified in globally recognized standards and monographs. These include:

• USP (United States Pharmacopeia) Monographs: Specifically USP 35 <861> (Diameter), USP 35 <871> (Needle Attachment), USP 35 <881> (Tensile Strength), and the general Monograph of Absorbable Surgical Suture. These documents define the precise methods and acceptable ranges for these physical properties.
• ASTM (American Society for Testing and Materials) Standards: Such as ASTM F88-09, ASTM F1140-07, and ASTM F1929-98(2004) for packaging integrity. These standards provide exact testing procedures and pass/fail criteria.
• ISO (International Organization for Standardization) Standards: Specifically SO 11135-1:2007 for sterilization and various parts of ISO 10993 (Biological Evaluation of Medical Devices) for biocompatibility. These standards specify how tests should be performed and what constitutes an acceptable biological response.
• FDA Class II Special Controls Guidance Document: Surgical Sutures: This document provides guidance on residual strength and absorption rate studies, outlining the expectations for acceptable performance.

Essentially, the ground truth is compliance with established, quantitative, and scientifically validated testing standards.

8. The Sample Size for the Training Set

This section is not applicable. This submission is for a medical device (surgical suture), not a machine learning model or AI algorithm. Therefore, there is no "training set" in the context of algorithm development. The testing conducted is to demonstrate product quality and compliance with established standards.

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

This section is not applicable for the same reasons as point 8; there is no training set for this device.

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