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The Tissue Approximation System (TAS) is indicated for use in soft tissue approximation, including use in general surgery procedures such as minimally invasive ventral hernia and abdominal wall closure less than 10cm, but not for use in ophthalmic, neurologic, or cardiovascular procedures.

The Tissue Approximation System (TAS) consists of a polyamide (nylon) "zip-tie" attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots.

When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.

The provided text describes the regulatory clearance of a medical device, the Tissue Approximation System (TAS), and discusses its substantial equivalence to a predicate device. However, the text does not contain the specific information requested about acceptance criteria for a study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device performance study.

The document is a 510(k) summary for a physical medical device (suture-like "zip-tie") and not for an AI/software as a medical device (SaMD). Therefore, the questions related to AI/algorithm performance studies (e.g., acceptance criteria for model performance metrics like sensitivity/specificity, sample size for test sets with ground truth established by experts, MRMC studies, standalone performance, training sets, etc.) are not applicable to the content provided.

The performance data mentioned in the document relates to:

• Large animal GLP compliant study: Comparing incision healing, absence of adverse events (swelling, necrosis, dehiscence, hematoma, extrusion) for TAS versus the predicate device.
• Biocompatibility testing: Per ISO 10993.
• Sterilization validation: Per ISO 11137.
• Individual device testing: To demonstrate function.
• Shelf-life validation: Using accelerated aging.
• Human factors validation: To demonstrate usability by intended users without errors.
• USP Monograph testing: For tensile strength, length, and security compared to a standard square knot.

These are standard tests for a physical medical device. The document does not describe the kind of study that would involve acceptance criteria for AI model performance metrics, expert adjudication, or MRMC studies that involve human readers interacting with AI.

Therefore, I cannot fulfill the request for information on acceptance criteria for an AI/software performance study based on the provided text, as the text describes a different type of medical device and associated testing.

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The Golnit Nylon Monofilament 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 neurological procedures.

The Golnit Nylon Monofilament Suture is a synthetic monofilament nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6,6. The suture is pigmented black (logwood extract) or blue (FD&C Blue No. 2) to enhance visibility or is also available undyed (clear). The suture has been designed to meet the requirements of the United States Pharmacopeia (USP) related to diameter, needle attachment and tensile strength. The suture is supplied sterile and is provided according to customer specifications. The device is available in pre-cut lengths from 10 cm to 300 cm in 5 cm intervals and in USP sizes 10-0 through 2. It can be attached to a stainless-steel needle or be without a needle. Needles are available with various tip shapes (taper, cutting, reversecutting, taper-cutting, spatula, and diamond), curvatures (1/2, 3/8, 5/8, 1/4 or straight) and lengths (4 mm to 70 mm). Each suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The suture is sterilized by ethylene oxide and is intended for single use only.

Here's a breakdown of the acceptance criteria and the study information for the Golnit Nylon Monofilament Suture device, based on the provided FDA 510(k) summary:

This document is a 510(k) summary for a medical device (Golnit Nylon Monofilament Suture), which seeks substantial equivalence to a legally marketed predicate device. As such, it focuses on demonstrating that the new device performs as safely and effectively as the predicate, rather than establishing absolute efficacy against a disease target. Therefore, many standard clinical study elements like "number of experts," "adjudication method," "MRMC study," and "effect size" are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a numerical sample size. The testing referred to "tests in accordance with the USP monographs for non-absorbable sutures, including an evaluation of diameter, tensile strength, and needle attachment strength." This implies an unspecified but sufficient number of samples were tested to meet USP standards for each characteristic.
• Data Provenance: The testing was likely conducted in a laboratory setting by the manufacturer or a contracted testing facility, as is typical for device performance testing for 510(k) submissions. No specific country of origin or retrospective/prospective classification is mentioned, as this is laboratory-based physical and chemical performance data, not patient-level data.

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

• Not Applicable. The "ground truth" for this device's performance is established by standardized, objective physical and chemical tests (e.g., measuring diameter, tensile strength) against published specifications from the United States Pharmacopeia (USP) and FDA Special Controls Guidance. It does not involve expert interpretation of clinical images or patient outcomes.

4. Adjudication Method for the Test Set

• Not Applicable. As the "ground truth" is determined by objective physical and chemical measurements against established standards, no human adjudication of results is required.

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 such study was done or is applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not Applicable. This device is a physical surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

• The ground truth is established by objective, quantitative measurements against pre-defined specifications outlined in the United States Pharmacopeia (USP) monographs for non-absorbable sutures (specifically USP for diameter, USP for needle attachment, and USP for tensile strength), and FDA Class II Special Controls Guidance: Surgical Sutures. Biocompatibility is assessed against ISO 10993-1.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI algorithm that requires a "training set." Performance is evaluated through physical and chemical testing.

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

• Not Applicable. No training set is involved.

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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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REXLON 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.
REXSIL 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.

REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).
REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture.

REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).
REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture.

The provided text describes acceptance criteria and the results of a study to demonstrate substantial equivalence for two medical devices: REXLON (nonabsorbable polyamide surgical suture) and REXSIL (nonabsorbable silk surgical suture). Both devices are sutures and their acceptance criteria are based on established USP (United States Pharmacopoeia) and ISO (International Organization for Standardization) standards.

Here's a breakdown of the requested information, focusing on the REXLON and REXSIL devices as described:

REXLON (Nylon Monofilament Suture)

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 for each individual test conducted (e.g., how many sutures were measured for diameter or tensile strength). It only states that "REXLON were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing rather than human subject data. There is no information regarding country of origin for the data.

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

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established 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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXLON (and REXSIL) is based on established industry standards and pharmacopoeia monographs, specifically:

• United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
• ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
• ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable.

REXSIL (Nonabsorbable Silk Suture)

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 for each individual test conducted. It only states that "REXSIL were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing. No information on country of origin for the data is provided.

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

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established 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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXSIL is based on established industry standards and pharmacopoeia monographs, specifically:

• United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
• ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
• ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable.

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Dafilon Nonabsorbable Polyamide Surgical Sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neurological procedures.

Dafilon is a nonabsorbable monofilament surgical suture which is supplied sterile. Dafilon is composed of the long-chain aliphatic polymers polyamide 6 and/or 6,6. The Dafilon suture is offered undyed and dyed with FDA approved colorants Logwood extract in accordance with Title 21 CRF, §73.1410 or [Phthalocyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Dafilon suture will be offered in diameters ranging from USP size 11-0 through 5 and will be available in a variety of cut lengths with out needles attached.

This document is a 510(k) premarket notification for a surgical suture, not a device that involves performance criteria typically associated with AI/ML algorithms or interpretative medical devices. Therefore, many of the requested sections regarding acceptance criteria and study design are not applicable in the context of this document. This submission primarily focuses on demonstrating substantial equivalence to existing predicate devices based on material composition, indications for use, and mechanical/biocompatibility testing, rather than an AI model's diagnostic or predictive performance.

However, based on the provided text, I can extract the relevant "acceptance criteria" and "performance data" for this suture device where applicable.

Here's an interpretation of the document in the context of your request, focusing on the available information:

Device: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture

Since this is a surgical suture, the "acceptance criteria" are related to its physical properties, sterility, and biocompatibility, rather than diagnostic accuracy or sensitivity/specificity of a predictive model.

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 specifies "tests were conducted for diameter, tensile strength, and needle attachment" and "biocompatibility testing." However, it does not specify the sample sizes for these tests. The provenance is internal testing by Aesculap, Inc. against USP (United States Pharmacopeia) requirements and ISO (International Organization for Standardization) standards. The tests are likely prospective, conducted on manufactured samples of the device.

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

This question is not applicable to a nonabsorbable surgical suture device. The "ground truth" for suture performance is established by standardized physical and biological tests (USP, ISO standards), not by human expert interpretation or consensus in the way it would be for an AI diagnostic device.

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

Not applicable for a surgical suture. Adjudication methods are relevant for subjective interpretations of data, typically in diagnostic studies. Here, the "truth" is determined by objective measurements against established 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

Not applicable. This device is a surgical suture, not an AI-assisted diagnostic tool. No human reader involvement or AI assistance is relevant to its performance evaluation for this 510(k) submission.

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

Not applicable. This device is a physical medical device (suture), not an algorithm.

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

The "ground truth" is based on established industry standards and regulatory requirements:

• USP Requirements: For physical characteristics such as diameter, length, needle attachment, and tensile strength.
• ISO 10993-1: For biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic and Muscle Implantation).
• 21 CFR §73.1410 and §74.3045: For colorant approval.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

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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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The nonabsorbable sutures (Monofilament Nylon, Polypropylene and Silk) are indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device, specifically nonabsorbable surgical sutures. It confirms that the device is substantially equivalent to a legally marketed predicate device.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is an administrative clearance based on substantial equivalence to existing devices, not a detailed report of performance testing or clinical trials.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.

To answer your request, I would need a document such as:

• A performance testing report.
• A clinical study report.
• The 510(k) summary or premarket notification submission itself, which would typically contain such information for device clearance.

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The Kumar T-ANCHORS Hernia Set provides a means for fixation of prosthetic material and passage of sufure during repair of hernia and soft tissue.

Kumar T-Anchors Hernia Set supplies 8 T-Anchors that carry size 0 polyamide suture. These are deployed in pairs percutaneously through a 16 ga, needle. The sutures are tied to anchor the prosthetic material to the abdominal wall in repair of hernia or the soft tissues.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, as it does not include details on a performance study or testing with specific metrics.

The document is a 510(k) premarket notification letter from the FDA regarding the "Kumar T-ANCHORS Hernia Set". It primarily discusses the device's substantial equivalence to predicate devices and regulatory compliance.

Therefore, I cannot generate the requested table and information points.

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FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is indicated for use in general soft tissue approximation and/or ligation including use in ophthalmic and neurological procedures.

FSSB Nylon Surgical Suture is a monofilament non-absorbable sterile surgical suture composed of the long chain aliphatic polymers Nylon 6,6. The suture is provided dyed (black). The pigment for the black dyed suture is Hematein black (Logwood: Color Code 75290). All products meet the requirements of 21 CFR 70.5(c) regarding the use of color additives in sutures.

The product is available in several lengths and USP diameters. The FSSB Surgical Suture is equipped with single or double high-grade stainless steel needles of various types of points, lengths, diameters and curves (Product List provided as Appendix A). The product meets all requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures.

The provided 510(k) summary for FSSB Nylon Surgical Sutures does not describe a study involving a device with AI or machine learning components, nor does it detail acceptance criteria and performance against those criteria in the typical sense of a diagnostic or predictive device.

Instead, this document establishes substantial equivalence of the FSSB Nylon Surgical Suture to existing predicate devices based on material composition, intended use, and performance testing that meets established industry standards (USP, ISO) and FDA guidance for surgical sutures.

Therefore, the requested information, which is relevant for AI/ML-driven devices, cannot be extracted from this document in its entirety. However, I can interpret the provided information within the context of demonstrating substantial equivalence, which is a form of "acceptance" for a medical device.

Here's an attempt to structure the information based on the request, noting where the information is not applicable (N/A) for this type of device:

Acceptance Criteria and Study for FSSB Nylon Surgical Sutures

1. Table of Acceptance Criteria and Reported Device Performance

For a surgical suture, "acceptance criteria" are primarily defined by adherence to recognized standards and demonstrated equivalence to legally marketed predicate devices in terms of material properties and performance.

2. Sample Size for Test Set and Data Provenance

This information is not explicitly detailed in the provided summary. For a surgical suture, "testing" primarily refers to bench testing of material properties, not a clinical "test set" for diagnostic performance.

• Sample Size for Test Set: Not specified in terms of distinct patient data or a clinical "test set." Testing refers to physical samples of the suture material.
• Data Provenance: N/A for this type of physical product testing. The testing is conducted on manufactured suture product.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is N/A for this type of device. "Ground truth" in the context of AI/ML devices typically refers to expert labels on data. For surgical sutures, "ground truth" is established by adherence to recognized material and performance standards (e.g., USP monographs, ISO) and empirical testing against these standards.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (e.g., 2+1, 3+1) are relevant for human interpretation of data/images to establish ground truth in diagnostic studies, not for the physical properties testing of a surgical suture.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. An MRMC study is relevant for evaluating the impact of an AI tool on the diagnostic performance of human readers. This concept does not apply to a surgical suture.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

N/A. This is a physical medical device (suture), not an algorithm or software. Its performance is inherent in its physical properties and how it functions during surgical use.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Industry and Regulatory Standards: Specific quantitative and qualitative requirements outlined in the United States Pharmacopeia (USP 28 , , ) and ISO 10993 standards for biocompatibility.
• Comparison to Predicate Devices: Demonstrating that its material composition, intended use, and technological characteristics are "substantially equivalent" to previously cleared surgical sutures. "Equivalence" serves as the functional ground truth for regulatory acceptance.

8. Sample Size for the Training Set

N/A. This device does not use an AI/ML model that requires a "training set."

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

N/A. As there is no training set for an AI/ML model, this question is not applicable.

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