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Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days.

The proposed device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. The proposed device is dyed blue. The color additive is FD&C BLUE NO. 2, the weight percentage for color additive is less than 0.1%.

The document provided describes a 510(k) summary for a medical device called "Non Absorbable Surgical Nylon Suture." It details the device's characteristics, its comparison to a predicate device, and the results of non-clinical tests conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides a comparative table (Table 1: Comparison of Technology Characteristics) that implicitly lists acceptance criteria by showing the proposed device's performance against established standards or in comparison to the predicate device.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific non-clinical test. It lists the standards and states "The test results demonstrated that the proposed device complies with the following standards." For biological evaluations (e.g., cytotoxicity, irritation, systemic toxicity), these studies typically involve in vitro tests and animal models, governed by the respective ISO 10993 standards and USP monographs. The number of samples/animals would be specified within those standard protocols, but are not detailed in this 510(k) summary.
• Data Provenance: The tests were "non clinical tests" and involved compliance with ASTM, ISO, and USP standards. This indicates laboratory testing, likely performed by or for the manufacturer. The country of origin of the data is not specified beyond the manufacturer being in China. The data would be considered prospective for the purpose of this submission (i.e., new tests were conducted for this device clearance).

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 typically not included in a 510(k) summary for non-clinical testing of a surgical suture. The "ground truth" for these tests are the established thresholds and methodologies defined within the cited international and national standards (ASTM, ISO, USP). Compliance is determined by whether the device's performance falls within the acceptable ranges or meets the pass/fail criteria outlined in these published standards. These standards are developed and updated by expert committees in relevant fields, but individual expert assessment for a specific test set, as might be done for clinical image analysis, is not applicable here.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation (e.g., radiology reads) where there can be inter-reader variability. For non-clinical tests against defined standards, results are typically objective measurements or observations that either meet or fail the established criteria.

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 510(k) submission for a surgical suture, which is a physical medical device, not an AI-assisted diagnostic tool. No MRMC studies or AI assistance were involved.

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. The tests were performed on the physical suture device.

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

The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and methodologies. These include:

• ASTM International Standards: For material testing (e.g., seal strength, seal leaks).
• ISO 10993 Series of Standards: For biological evaluation of medical devices (e.g., cytotoxicity, sensitization, irritation, implantation, systemic toxicity, genotoxicity, ethylene oxide residuals, hemolysis).
• United States Pharmacopeia (USP) Monographs: For physical characteristics of sutures (e.g., diameter, tensile strength, needle attachment, pyrogen, bacterial endotoxins).

The tests determine if the device meets quantitatively defined thresholds or qualitative observations specified by these authoritative standards, rather than expert consensus on individual cases or clinical outcomes data.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set. The tests performed are to evaluate the physical and biological characteristics of the manufactured suture.

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

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

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CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues.

The CROWNJUN Nylon Suture is a sterile nonabsorbable polyamide surgical suture. The CROWNJUN Nylon Suture is composed of long-chain aliphatic polymers polyamide 6,6 which is available undyed or dyed black using logwood extract (Hematein) per 21 CFR 73.1410. The CROWNJUN Nylon Suture is offered in diameters ranging from USP size 12-0 through USP 0 and available in various lengths from 2.5 cm to 90 cm with pre-attached needles. The needle is composed of 300 series stainless steel of various types of tip shapes, curvatures, and sizes. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical sutures.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "CROWNJUN Nylon Suture." It describes the device, its intended use, and a comparison with a predicate device to establish substantial equivalence.

Based on the provided text, the device is a surgical suture, not an AI/ML powered device, therefore most of the requested information (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance) is not applicable or unavailable.

However, I can extract the acceptance criteria and reported device performance related to this specific medical device from the non-clinical tests section:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (CROWNJUN Nylon Suture), the "acceptance criteria" are generally derived from established standards for surgical sutures. The reported "device performance" indicates that the device conforms to or meets these requirements.

The remaining sections of your request are explicitly related to studies involving AI/ML devices, which this document does not describe. Therefore, the information is largely not applicable.

2. Sample size used for the test set and the data provenance: Not Applicable (not an AI/ML device)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (not an AI/ML device)

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not Applicable (not an AI/ML device)

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 (not an AI/ML device)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No (not an AI/ML device)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this non-AI/ML device, the "ground truth" is established by the compliance with recognized standards (USP, ISO, FDA Guidance) through laboratory testing, material characterization, and manufacturing controls.

8. The sample size for the training set: Not Applicable (not an AI/ML device)

9. How the ground truth for the training set was established: Not Applicable (not an AI/ML device)

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RiverLon Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

The Riverpoint Medical RiverLon Nylon Sutures are inert, non-absorbable, sterile surgical sutures composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6/6. RiverLon sutures are available in common sizes and length with or without pre-attached needles.

The provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary for Riverpoint Medical's RiverLon Nylon Suture, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

However, it does mention some general performance requirements and tests performed. Here's a breakdown of the available information:

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

The document broadly states that the RiverLon Sutures meet requirements established by the United States Pharmacopeia (USP). Specific acceptance criteria (e.g., minimum tensile strength values, diameter ranges) are not provided, nor are the precise reported device performance metrics beyond the general statement of compliance.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document only mentions that the sutures are "tested" per USP requirements. No information on country of origin or whether the data is retrospective or prospective is present.

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 and not provided. The testing relates to physical and chemical properties of the suture, primarily against pharmacopeial standards (USP), not clinical or expert-reviewed interpretative data.

4. Adjudication method for the test set

Not applicable. The testing is against defined physical/chemical standards, not interpretive data 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 technology.

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

The "ground truth" for the device's technical characteristics is compliance with the United States Pharmacopeia (USP) performance requirements for surgical sutures, as well as biological evaluation standards like ISO 10993-1:2009. These are often established through standardized testing methodologies and specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

Not applicable.

Summary of the Study Mentioned:

The document describes a "Performance Data" section stating that:

• "The Riverpoint Medical RiverLon Sutures meet requirements established by the United States Pharmacopeia."
• "The RiverLon Sutures are tested per USP performance requirements for needle attachment, diameter, and tensile strength."
• "FDA Guidance 'Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA' was followed during the preparation of this submission."
• "Materials used were evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices."

This indicates that standard pharmacopeial and international standards testing was performed to demonstrate the device's compliance. However, the specific details of these tests (e.g., number of samples, exact values of acceptance criteria, detailed results, specific test methods used beyond "per USP") are not provided in this 510(k) summary. The purpose of this document is primarily to establish substantial equivalence to a predicate device (K100006 – Riverpoint Medical RiverLon (Nylon)) based on similar materials, manufacturing processes, intended use, and meeting established performance standards.

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Aurolab nonabsorbable, synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

This nonabsorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in suitable construction for the intended size to meet current USP specifications. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of Suture. The braided suture may be uncoated or have a silicone coating, or a paraffin wax coating. The mono nylon suture is uncoated. The suture thread has a needle attached to it.

The provided text describes a 510(k) summary for a Nylon Suture manufactured by Aurolab. The study focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance metrics against pre-defined acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI-specific studies (e.g., sample size for test set, number of experts, MRMC studies, training set details) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and the performance results related to the device itself (the suture), even though it's not an AI device.

Here's the information based on the provided text, with clarifications where AI-specific details are not applicable:

Acceptance Criteria and Device Performance for Aurolab Nylon Suture

1. 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 explicitly state the sample size used for the testing of diameter, tensile strength, and suture-needle attachment. It mentions that tests were conducted "according to methods presented in United States Pharmacopoeia (U.S.P)".

Data Provenance: Not explicitly stated beyond "tests according to methods presented in United States Pharmacopoeia (U.S.P)". The manufacturer is Aurolab, located in India. The studies were likely performed internally or by a contracted lab. The study appears to be a bench study to assess physical properties, not a clinical study on patient data.

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

Not applicable. This device is a physical medical device (suture), and its performance was assessed against established physical standards (USP) through laboratory testing, not through expert review of data.

4. Adjudication method for the test set

Not applicable. The assessment was based on objective measurements against USP standards, not subjective interpretation 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 is not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

The ground truth used was United States Pharmacopoeia (U.S.P) standards for physical properties of sutures, specifically:

• Diameter
• Tensile Strength
• Suture-Needle Attachment

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a physical device, not an AI/ML algorithm. The "ground truth" for the performance evaluation was established by the USP standards themselves.

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Sutralon nonabsorbable synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

This non-absorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in a suitable construction for the intended size to meet current USP specifications.

Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of suture.

The braided suture may be uncoated or have a silicone coating, or a paraffin wax The mono nylon suture is uncoated. The suture thread has a needle coating. attached to it.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sutralon device:

This document is a 510(k) summary for a medical device called Sutralon, which is a non-absorbable synthetic polyamide suture. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and efficacy through extensive clinical trials.

Therefore, the type of "study" described here is primarily focused on bench testing to meet established industry standards, rather than a clinical study with human patients, AI, or expert readers.

Here's the information extracted and organized according to your request:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Notes:

• The document explicitly states that "Performance tests to demonstrate substantial equivalency" were conducted "according to methods presented in United States Pharmacopia (U.S.P.)".
• The results show that "SutraTec devices tested meet USP standards and are technically equivalent to the predicate devices tested."

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

• Sample Size: Not explicitly stated. The document only mentions "SutraTec devices tested."
• Data Provenance: Not explicitly stated, however, the tests were conducted to meet United States Pharmacopia (U.S.P.) standards, implying adherence to US-recognized methodologies and specifications for medical devices. The nature of the tests (diameter, tensile strength, suture-needle attachment) suggests they are laboratory-based bench tests rather than data from human subjects.

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

• Not applicable. This submission relies on objective, measurable physical properties (diameter, tensile strength, attachment strength) as defined by established USP standards. The "ground truth" is the USP specification itself, not a consensus of human experts interpreting images or clinical data.

4. Adjudication method for the test set:

• Not applicable. As the "ground truth" is defined by objective USP standards for physical properties, there is no need for expert adjudication. Measurements are taken directly against the specified limits.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data, often with or without AI assistance. This device is a surgical suture, and its performance is evaluated by physical characteristics, not diagnostic interpretation.

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

• No. This device is not an AI algorithm. Its performance is based on the physical properties of the suture material.

7. The type of ground truth used:

• Established Industry Standards/Specifications: The ground truth for performance evaluation is derived from the United States Pharmacopia (U.S.P.) standards for suture diameter, tensile strength, and suture-needle attachment.

8. The sample size for the training set:

• Not applicable. This document describes the testing of a physical medical device (suture) against established standards. There is no AI model or algorithm that requires a "training set" in this context.

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

• Not applicable. As there is no training set, this question is irrelevant to the Sutralon 510(k) submission.

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