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SafePath Suturing System - Silk Suture: The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polyamide (Nylon) Suture: The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polypropylene Suture: The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.

The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 36 in. Jength, swaged on a single-armed 1½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The nylon suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of long chain aliphatic polymers - nylon 6,6. SafePath nylon sutures are dyed with Logwood extract, FDA approval number §73.1410. The nylon suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a singlearmed ½ circle. 26 mm reverse cutting needle. The suture is pre-loaded in a handheld, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The polypropylene suture provided with the SafePath Suturing System is a monofilament synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula is (C3H6)n. The Safepath suture is dyed with [Phthalocyaninato(2-)] copper, FDA approval number §74.3045. The polypropylene suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.

This document discusses the FDA clearance for the SafePath Suturing System, which includes silk, polyamide (nylon), and polypropylene sutures. However, the provided text does not contain information about a study based on AI/ML. All the performance criteria and testing mentioned relate to the physical and biological properties of the sutures and the suturing system, not to an AI component.

Therefore, I cannot answer your request with the specific details about acceptance criteria and studies related to AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document highlights the following non-clinical performance criteria and testing for the sutures:

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

2. Sample size used for the test set and the data provenance: Not applicable as this is a non-AI/ML device. The testing was physical and biological, not based on data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a non-AI/ML device. Ground truth as typically understood in AI/ML is not relevant here.

4. Adjudication method for the test set: Not applicable as this is a non-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: Not applicable as this is a non-AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a non-AI/ML device.

7. The type of ground truth used: For physical testing, ground truth would be established by the specifications of the USP standards. For biocompatibility, it's about meeting pre-defined safety thresholds as per recognized standards (e.g., ISO 10993).

8. The sample size for the training set: Not applicable as this is a non-AI/ML device.

9. How the ground truth for the training set was established: Not applicable as this is a non-AI/ML device.

The study described is a non-clinical performance testing study that evaluated the physical and biocompatibility characteristics of the sutures and the suturing system. The conclusions state that the device met or exceeded USP criteria for physical properties and met the test criteria for a battery of biocompatibility evaluations. The safety evaluation for the nylon and polypropylene sutures leveraged information from a previously cleared device (K180701) and used identical raw materials, packaging, and sterilization conditions as the predicate devices.

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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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NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures.

Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation. including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures.

Nylon Surgical Suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological procedures.

SILK Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Stainless Steel Sutures are indicated for use in abdominal wound closure, hernia repair, sternal closure, and orthopedic procedures, including cerclage and tendon repair.

Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.

Gabbay-Frater™ is a device for organizing, arranging and counting multiple interrupted sutures in an orderly fashion.

Deknatel Nonabsorbable Surgical Sutures are available in five (5) different material options.

• 1. Poly(ethylene terephthalate) a polyester fiber.
  • The three types of polyester sutures are 'cottony'™ II, 'silky' II POLYDEK, and ● TEVDEK II. 'cottony' II is uncoated polyester suture. 'silky' II POLYDEK® suture has a light coating of Polytetrafluoroethylene (PTFE) and TEVDEK II has a heavy PTFE coating.
  • . NextStitch Cardiovascular Valve Suture is a combination of 'silky' II POLYDEK and/or TEVDEK II polyester suture. NextStitch is a continuous chain of linked sutures designed to provide an alternative suturing technique for cardiovascular valve replacement procedures.
• 2. Polypropylene: DEKLENE II and DEKLENE® MAXX are the two varieties of this material.
• 3. NYLON is composed of monofilament synthetic polyamide fiber.
• 4. SILK is composed of grade 4A Chinese silk derived from the domesticated species Bombyx mori (B mori) of the family Bombycidae.
• 5. STERNOTOMY STAINLESS STEEL sutures are composed of 316 LVM stainless steel.

All sutures are provided in a variety of lengths, with and without needles, and (if applicable) with and without pre-attached pledgets (if applicable).

An accessory that can be used with the Nonabsorbable Surgical Sutures is the Gabbay-Frater Suture Guide which is a convenient suture organizer which keeps suture ends tangle-free.

This document is a 510(k) summary for the Deknatel Nonabsorbable Surgical Sutures. It aims to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a shelf-life extension and ownership transfer. Clinical performance criteria or studies in the context of device accuracy for diagnosis or treatment are not applicable here, as this is a surgical suture, not a diagnostic or AI-powered device.

Therefore, the requested information elements such as acceptance criteria, reported device performance, sample size for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set details are not applicable or available in this submission because the device is a surgical suture, not an AI-powered diagnostic tool.

The "acceptance criteria" and "study" described in the document relate to the physical and mechanical properties of the sutures and their packaging for shelf-life extension, not to diagnostic or performance accuracy in the way an AI medical device would be evaluated.

Here's the relevant information based on the provided document regarding the substantiation of the shelf-life extension:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that non-clinical real-time aging testing was performed in accordance with specific standards. However, it does not explicitly present a table of acceptance criteria alongside reported device performance values in a comparative format for each individual suture property. Instead, it broadly states that "the proposed Deknatel Nonabsorbable Surgical Sutures are substantially equivalent to the predicate devices."

The standards referenced imply the properties that were measured and thus, the implicit acceptance criteria would be compliance with these standards within expected ranges for surgical sutures.

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

• Sample Size: The document does not specify the exact sample size used for the real-time aging testing. It generally refers to "non-clinical real-time aging testing."
• Data Provenance: The data is non-clinical, likely generated in a laboratory setting by Teleflex Medical, Inc. or its contractors. The document does not specify country of origin for the data, but the company is based in Morrisville, NC, USA. The testing is prospective in the sense that the sutures were aged in real-time to assess performance over 5 years.

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

• Not Applicable. For the physical and mechanical testing of surgical sutures, ground truth is established by adherence to recognized international and national standards (e.g., ISO, USP) and laboratory testing protocols, not by expert consensus or interpretation of images. The "ground truth" is the objective measurement against these standards.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations where human interpretation is involved, such as reading medical images. For physical property testing of sutures, measurements are objective and usually do not require adjudication.

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

• No. This is not an AI-powered diagnostic device, so MRMC studies are not relevant.

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

• Not Applicable. This is a physical medical device (suture), not an algorithm or AI.

7. The Type of Ground Truth Used:

• Objective Measurement against Recognized Standards: The "ground truth" for demonstrating the shelf-life and performance of the sutures are the established specifications and test methods outlined in ISO and USP standards for medical device packaging and surgical sutures.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI device that requires a "training set." The performance data is for physical characteristics of the manufactured product.

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

• Not Applicable. As there is no "training set," this question is not relevant.

In summary, this 510(k) pertains to a traditional physical medical device (surgical suture). The "study" referenced is non-clinical real-time aging testing to support a shelf-life claim, using recognized industry standards for material properties and packaging integrity. The concepts of acceptance criteria, test sets, experts, and ground truth are applied differently in this context compared to AI/diagnostic devices.

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Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.

This document is a 510(k) premarket notification for surgical sutures, not an AI/ML device. Therefore, the requested information (acceptance criteria and study details for an AI-powered device) is not present in the provided text.

The document describes traditional medical devices (surgical sutures) and asserts their substantial equivalence to predicate devices based on:

• Intended use
• Material
• Design
• Performance (Diameter, Needle attachment, and Tensile strength)
• Sterilization method
• Biocompatibility evaluation

The performance testing summarized indicates that the sutures meet the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Non-absorbable Sutures. It also mentions biocompatibility evaluation, rabbit pyrogen and LAL testing, and compliance with ASTM F138-13 for steel sutures.

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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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RiverBond, RiverSilk, RiverPro, and RiverLon non-absorbable sutures are intended to be used for soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

HS Fiber non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

Riverpoint Medical non-absorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. They are composed of the applicable suture material and a standard medical grade suture needle as applicable (sutures can be provided without needles as well).

The provided text describes a 510(k) summary for Riverpoint Medical's non-absorbable surgical sutures. It outlines the device description, intended use, and states that the sutures are designed to meet specific safety and effectiveness criteria. However, it does not contain a study report with specific acceptance criteria or performance data in the format requested.

The document states:
"Riverpoint Medical non-absorbable sutures have been designed to meet the requirements for diameter, tensile strength, and needle attachment strength as specified within USP 32. Testing is performed on each lot of product to verify that USP requirements have been met prior to release."

This sentence indicates the acceptance criteria are based on USP 32 standards for these parameters. However, the document does not provide a table with these specific USP 32 requirements or the reported device performance against them. It also does not include information about sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance studies, training sets, or how ground truth for training was established.

Therefore, I cannot populate the table or provide the detailed study information as requested. The document confirms that testing is performed to verify compliance with USP 32, but it does not present the results of such testing or the study design in a way that allows for the extraction of the requested metrics.

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For safe and reliable soft tissue approximation, wound closure and ligation.

General soft tissue approximation and/or ligation including use in Cardiovascular, Opthalmic, and Neurological procedures.

AMERICAN SUTURE™ Non-Absorbable Surgical Sutures with/without Needle are Non-Pyrogenic devices used for safe and reliable soft tissue approximation, wound closure, and ligation. American Sutures are made of Silk, Nylon, Polypropylene, and Polyester materials. Sterile, Single Use, Non Absorbable. With or without Needles attached.

The provided document describes a 510(k) premarket notification for "AMERICAN SUTURE™ Non Absorbable Surgical Sutures with/without Needles." This is a medical device clearance, not an AI/ML device, and therefore the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size, etc.) is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices based on material, design, intended use, and performance testing against recognized standards.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria Met:

The acceptance criteria are met through a series of "performance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility," by testing the AMERICAN SUTURE™ against several FDA Recognized Standards and Mexican Norms. The application states that "The American Sutures™ Surgical sutures intended to be introduced have been tested in compliance with the following test methods," followed by a list of standards. The overall study approach is one of verification against established performance standards for surgical sutures.

Regarding the AI/ML specific questions (2-9):

2. Sample size used for the test set and the data provenance: N/A (not an AI/ML device)
3. Number of experts used to establish the ground truth... and qualifications: N/A (not an AI/ML device)
4. Adjudication method: N/A (not an AI/ML device)
5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: N/A (not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (not an AI/ML device)
7. The type of ground truth used: N/A (not an AI/ML device). For this physical device, the "ground truth" is defined by the requirements and specifications set forth in recognized standards (e.g., USP monographs, ISO 10993) for mechanical properties, biocompatibility, and sterility.
8. The sample size for the training set: N/A (not an AI/ML device)
9. How the ground truth for the training set was established: N/A (not an AI/ML device)

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