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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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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 is available in 6-0, 5-0, 4-0, 2-0, 0 and 1, which are the sizes 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, USP 35 and USP35 .

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

Here's an analysis of the provided text regarding the acceptance criteria and study for the WEGO-PGCL Absorbable Surgical Monofilament Suture:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

• Sample Size: The document does not specify the exact sample sizes used for each non-clinical test (diameter, tensile strength, needle attachment, residual strength, absorption rate, biocompatibility). It only indicates that "tests were conducted."
• Data Provenance: The document does not specify the country of origin of the data. Since the manufacturer is "Foosin Medical Supplies Inc., Ltd" located in China, it's highly probable the non-clinical tests were conducted in China. The data is retrospective in the sense that these are pre-market tests performed on the device to demonstrate performance against established standards.

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

This information is not applicable and not provided for this type of device and study. The "ground truth" for a surgical suture's physical properties (diameter, strength, etc.) is established by comparing its performance against a universally accepted standard (e.g., United States Pharmacopoeia - USP) using validated laboratory equipment and methodologies, not by expert consensus in the typical sense for diagnostic or prognostic devices. Experts may design the tests and interpret the results, but they don't establish the ground truth through subjective assessment in this context.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for studies involving human interpretation (e.g., diagnostic image reading) where there's subjectivity and potential disagreement among reviewers. For physical device testing against objective standards, the results are typically quantitative and directly measured, not subject to human adjudication for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers (e.g., radiologists) use the device to interpret cases. The WEGO-PGCL Absorbable Surgical Monofilament Suture is a physical medical device (suture) used in surgical procedures, not a diagnostic tool requiring human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept is not applicable to this device. A "standalone" performance study refers to the performance of an algorithm or AI model without human intervention, typically in diagnostic or analytical applications. This device is a physical surgical product. Its performance is evaluated through physical and material tests, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is established by objective, predefined standards and methodologies outlined in recognized pharmacopeias (United States Pharmacopoeia - USP) and international standards (ISO 10993 series). These standards define the acceptable range or minimum/maximum values for properties like diameter, tensile strength, and biocompatibility. The device's test results are then compared directly to these established benchmarks.

• Expert Consensus: Not used for objective physical properties.
• Pathology: Not used in this context.
• Outcomes Data: Not used for establishing the direct physical properties in these non-clinical tests, though clinical outcomes from predicate devices would inform the safety profile.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. A "training set" is relevant for machine learning or AI algorithms. This submission is for a physical medical device (a surgical suture), not an AI-driven device.

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

This information is not applicable and not provided, as there is no "training set" for this physical medical device.

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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, USP 35 and USP35 . 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 (Diameter), USP 35 (Needle Attachment), USP 35 (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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Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular , ophthalmic and neurological procedures.
Nonabsorbable Polypropylene Suture with Needle is indicated for use in soft tissue approximation and/or ligation including use in general cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyester Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyamide suture with needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures.

The applicant devices of nonabsorbable silk suture with needle consist of a silk surgical suture made of natural silk and a stainless steel needle. It is EO sterilized, and prygon-free. Nonabsorbable silk suture is braided.
The applicant devices of nonabsorbable polypropylene suture with needle consist of a silk surgical suture made of polypropylene and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of nonabsorbable polyester suture with needle consist of a polyester surgical suture made of polyester and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of nonabsorbable polyamide suture with needle consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is EO sterilized, and prygon-free.

The provided 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a submission for a medical device (surgical sutures) seeking substantial equivalence to predicate devices, not reporting performance against specific acceptance criteria.

The information primarily focuses on:

• Manufacturer and Contact Information: Foosin Medical Supplies Inc., Ltd.
• Device Identification: Nonabsorbable Silk Suture with Needle, Nonabsorbable Polypropylene Suture with Needle, Nonabsorbable Polyester Suture with Needle, and Nonabsorbable Polyamide Suture with Needle.
• Device Description: Composition (natural silk, polypropylene, polyester, polyamide, stainless steel needle), sterilization method (EO sterilized), and braided/not braided.
• Intended Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
• Predicate Devices: Citing K-numbers (K041514, K070243, K060165, K0060471).
• Substantial Equivalence Determination: A claim that the applicant devices are substantially equivalent to their respective predicate devices.
• FDA Correspondence: A letter from the FDA confirming the substantial equivalence determination and outlining regulatory requirements.
• Indications for Use Forms: Standard FDA forms specifying the intended use for each suture type.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies based on the provided text, as it is not present in this document. Such information would typically be found in a separate section detailing performance testing (e.g., tensile strength, knot security, biocompatibility, sterility assurance level) within a more comprehensive regulatory submission.

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Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

Absorbable Polydioxanone Suture with Needle is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.

The applicant devices of absorbable polyglycolic acid suture with needle consist of a polyglycolic acid surgical suture made of polyglycolic acid and a stainless steel needle. It is EO sterilized, and prygon-free.

The applicant devices of absorbable polydioxanone suture with needle consist of a polydioxanone surgical suture made of polyester and a stainless steel needle. It is unbraided. It is EO sterilized, and prygon-free.

The document describes the acceptance criteria and supporting studies for two types of absorbable surgical sutures with needles: Absorbable Polyglycolic Acid Suture with Needle and Absorbable Polydioxanone Suture with Needle.

Here's a breakdown of the requested information:

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

The document does not explicitly list "acceptance criteria" with numerical targets and then "reported performance" against those targets in a table format. Instead, it states that performance data was collected in accordance with recognized standards, implying that meeting these standards constitutes the acceptance criteria.

Absorbable Polyglycolic Acid Suture with Needle & Absorbable Polydioxanone Suture with Needle (both devices)

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 size used for any of the tests (physical, biocompatibility, or in vivo strength).
The data provenance (country of origin, retrospective/prospective) is also not mentioned.

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 as the studies are focused on material properties and biocompatibility, not diagnostic interpretations requiring expert ground truth establishment.

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

This information is not applicable for material performance testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for surgical sutures.

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-driven system.

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

The "ground truth" for the performance testing of these sutures is established through predefined, standardized test methods and specifications (e.g., USP 30, ISO 10993) which define the acceptable range or characteristics of the material. For in-vivo testing, it would be direct measurement of tensile strength and mass loss over time.

8. The sample size for the training set

This information is not applicable as the device is a manufactured medical product, not a machine learning model that requires a "training set."

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

This information is not applicable for the same reason as above.

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