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WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The propose device, WEGO-PDO Barbed Suture, is monofilament, absorbable surgical suture. It is intended for soft tissue approximation where use of an absorbable suture is appropriate. The proposed devices are provided sterile and single use. The proposed device is composed of suture with or without the needle. The sutures with no needle attachments are only available with bi-directional barbs of 77 cm, 1010 cm, 2424 cm and 3030 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2. The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots. The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight. The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types. The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

The provided document is a 510(k) Summary for a medical device (WEGO-PDO Barbed Suture), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or standalone study.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning performance metrics for an AI or imaging device.

The document describes pre-market notification for a surgical suture, not an AI or imaging device. The "Non-Clinical Test Conclusion" and "Clinical Test Conclusion" sections clearly state the types of tests performed (primarily material and sterility standards, with no clinical study included). The "SE Comparison" table compares the proposed suture device to predicate suture devices based on physical characteristics, material properties, and regulatory standards, not diagnostic performance.

To answer your prompt, you would need a document related to the clearance or approval of an AI/imaging medical device, which would detail its performance study, acceptance criteria (e.g., sensitivity, specificity, AUC), sample sizes, ground truth establishment, and expert involvement. This document does not provide such information.

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The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

The proposed device, WEGO-STAINLESS STEEL, is monofilament, non-absorbable surgical suture composed of stainless steel. WEGO-STAINLESS STEEL is undyed and uncoated. The proposed device is composed of suture and needle. The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes. WEGO-STAINLESS STEEL complies with the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.

The provided document is a 510(k) summary for the "WEGO-STAINLESS STEEL" surgical suture, in which the manufacturer asserts substantial equivalence to a predicate device (Surgical Stainless Steel Suture K170767). The document describes non-clinical tests conducted to support this claim, but it does not describe an AI/ML powered device, nor does it detail acceptance criteria related to AI/ML performance, or comparative effectiveness studies of AI vs. human readers.

Therefore, the requested information regarding AI/ML acceptance criteria, study details, expert involvement, and MRMC studies cannot be extracted from this document, as it is outside the scope of a traditional medical device (surgical suture) 510(k) submission.

However, I can provide the available information regarding the non-clinical tests performed to demonstrate substantial equivalence for the surgical suture:

Acceptance Criteria and Device Performance (for Non-Clinical Tests of Surgical Suture)

The acceptance criteria for the "WEGO-STAINLESS STEEL" surgical suture were based on compliance with established international and pharmacopeial standards. The reported device performance indicates that the proposed device met these standards.

The subsequent questions are related to AI/ML device studies and are not applicable to this document, as it concerns a conventional surgical suture.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes non-clinical tests on a physical device, not an AI/ML model.
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): Not applicable. Ground truth for AI/ML is not relevant here.
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. No clinical study was included, and this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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WEGO-PGA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGA RAPID is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

WEGO-PGA RAPID sutures are synthetic, absorbable, braided, sterile surgical sutures composed of Polyglycolic Acid (PGA). The formula of the polymer is (CH2O2)n. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular WEGO-PGA suture. WEGO-PGA RAPID sutures are available undyed violet with D&C Violet No.2 (Colour Index number 60725). WEGO-PGA RAPID sutures are coated with polycaprolactone and calcium stearate.

The performance of this absorbable suture complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 40, USP 40 and USP 40 .

The Synthetic Absorbable Suture is provided EO sterilized as a single use device.

The provided text describes the regulatory clearance of a medical device (WEGO-PGA RAPID sutures) and includes information about non-clinical tests conducted to demonstrate its performance and substantial equivalence to a predicate device. However, it does not include information about a study proving the device meets acceptance criteria in the context of AI/ML performance, nor does it present acceptance criteria in terms of metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.

Therefore, I cannot fulfill the request as it pertains to AI/ML device acceptance criteria and a study proving those criteria are met. The document focuses on regulatory compliance for a traditional medical device (surgical sutures) through non-clinical testing against established standards and comparison to a predicate device.

Here's an analysis of the provided text in relation to your specific questions, highlighting what is not present for an AI/ML device:

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

   • Not present for an AI/ML device. The document lists standards the device complies with (e.g., USP monographs for suture properties, ISO standards for biocompatibility) and states that "The physical performance and stability of proposed device have been demonstrated by testing on samples before and after real-time-aging." It does not provide specific acceptance criteria values (e.g., "Accuracy > 90%") or reported performance metrics (e.g., "Accuracy achieved 92%") as would be expected for an AI/ML device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not present for an AI/ML device. The non-clinical tests described involve physical and biological testing of suture samples (e.g., diameter, tensile strength, sterility, biocompatibility). The document does not specify sample sizes for these tests in an AI/ML context, nor does it refer to "data provenance" as it would for a dataset used to evaluate an AI model.

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):

   • Not present for an AI/ML device. Ground truth establishment by experts is not relevant to the non-clinical testing of surgical sutures described.

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

   • Not present for an AI/ML device. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, not for physical and biological testing of sutures.

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 present. This type of study is specifically for evaluating the impact of AI assistance on human performance. The document explicitly states: "No clinical study is included in this submission."

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

   • Not present. There is no algorithm or AI component described for this device. The testing pertains to the physical and biological properties of the suture itself.

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

   • Not present for an AI/ML device. The "ground truth" for the non-clinical tests consists of established scientific and regulatory standards (e.g., USP monographs for tensile strength, biocompatibility test results).

8. The sample size for the training set:

   • Not applicable. There is no AI model, and therefore no training set, for this device.

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

   • Not applicable. There is no AI model, and therefore no training set or ground truth establishment process for it.

In summary: The provided document is a 510(k) clearance letter and summary for a traditional medical device (surgical sutures) and details compliance with physical, chemical, and biological standards, along with a comparison to an existing predicate device. It does not provide any information relevant to the acceptance criteria or study design for an AI/ML-powered medical device.

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WEGO-PGLA RAPID sutures are intended for use in superficial soft tissue approximation of skin and mucosa where only short-term wound support is required. WEGO-PGLA RAPID is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

WEGO-PGLA RAPID sutures are synthetic, absorbable, braided, sterile surgical sutures composed of a copolymer made from 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. The characteristic rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than regular WEGO-PGLA (Polyglactin 910) suture. WEGO-PGLA RAPID sutures are available undyed and dyed violet with D&C Violet No.2 (Colour Index number 60725).

WEGO-PGLA RAPID sutures are available in a range of gauge sizes and lengths, with and without stainless steel needles of varying types and sizes.

WEGO-PGLA RAPID sutures are uniformly coated with poly (glycolide-co-lactide) (30/70) and calcium stearate.

WEGO-PGLA RAPID sutures comply with the requirements of the European Pharmacopoeia for "Sutures, Sterile Synthetic Absorbable Braided" and the requirements of United States Pharmacopoeia for "Absorbable Surgical Suture" (except for an occasional slight oversize in diameter).

The Synthetic Absorbable Suture is provided EO sterilized as a single use device.

The provided document describes a 510(k) premarket notification for a medical device called "WEGO-PGLA RAPID" sutures. The submission aims to demonstrate substantial equivalence to a predicate device, VICRYL Rapide Suture (K944110), through non-clinical testing.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with established standards (USP and ISO). The reported device performance indicates that the WEGO-PGLA RAPID sutures met these standards.

Note: For the ISO and ASTM standards listed, the document states "The test results demonstrated that the proposed device complies with the following standards," implying that compliance with these standards serves as the acceptance criteria. Specific numerical performance data for these biological and packaging tests are not provided in this summary.

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

• Sample Size for Test Set: The document does not explicitly state the sample size for each specific test (e.g., number of sutures tested for tensile strength). It refers to "testing on samples" for physical performance and stability.
• Data Provenance: The studies were non-clinical tests conducted by the manufacturer, Foosin Medical Supplies Inc., Ltd, based in Weihai, Shandong, China. The data would be prospective as it's generated specifically for this submission.

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

Not applicable. This submission is for a surgical suture and relies on objective, standard-based non-clinical testing rather than expert-based ground truth for the device's technical specifications. The "ground truth" here is compliance with the specified international and national standards.

4. Adjudication method for the test set

Not applicable. The testing involves objective measurements against predefined criteria in standards, not subjective assessments requiring adjudication by multiple experts.

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 submission for a surgical suture, not an AI-powered diagnostic device, and therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This is for a surgical suture, not an algorithm or AI device.

7. The type of ground truth used

The ground truth used is the standards and specifications outlined in the referenced USP and ISO documents. The device's performance is compared against the requirements within these standards (e.g., specific diameter ranges, tensile strength thresholds, biocompatibility criteria).

8. The sample size for the training set

Not applicable. There is no AI component in this device; thus, no training set is relevant.

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

Not applicable. As there is no AI component, there is no training set or ground truth for a training set.

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WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

The proposed device, WEGO-PTFE, is monofilament, synthetic, non-absorbable surgical suture composed of 100% polytetrafluoroethylene without any additives. The molecular formula is (C-F2)n. WEGO-PTFE is undyed and uncoated.

The proposed device is composed of suture and needle.

WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes.

WEGO-PTFE complies with the requirements of the European Pharmacopoeia for Sterile Non-Absorbable Strands and the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.

This document describes the premarket notification for the WEGO-PTFE surgical suture, asserting its substantial equivalence to a predicate device. It includes information on non-clinical testing performed to establish this equivalence, but no clinical study was conducted. Therefore, the device does not have acceptance criteria based on clinical performance.

Here's a breakdown of the requested information based on the provided text:

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

Since this is a premarket notification for a surgical suture claiming substantial equivalence to a predicate device, the "acceptance criteria" are based on compliance with recognized standards and biocompatibility, rather than clinical performance metrics. The "reported device performance" refers to the results of non-clinical tests demonstrating this compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each of the non-clinical tests. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is not explicitly stated in terms of country of origin, but the submitting company is "Foosin Medical Supplies Inc., Ltd." located in Weihai, Shandong, China. The studies are non-clinical, likely laboratory-based, and therefore not categorized as retrospective or prospective in the human study sense.

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 not applicable. The "ground truth" for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., USP, ISO, ASTM), not by expert consensus on clinical cases. The tests themselves are designed to measure against predefined physical and biological parameters.

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

This information is not applicable as no clinical study or expert-based evaluation of a test set for performance was conducted. The tests are laboratory procedures with defined pass/fail criteria based on 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

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." This device is a surgical suture, not an AI-assisted diagnostic tool, so such a study would not be relevant.

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

This information is not applicable as the device is a surgical suture, not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements outlined in the referenced standards (e.g., USP for tensile strength and diameter, ISO for biocompatibility categories). These standards provide quantifiable criteria that the device must meet.

8. The sample size for the training set

This information is not applicable. There is no training set mentioned or implied as this is a physical medical device and not an AI/machine learning model.

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

This information is not applicable as there is no training set for this device.

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