Search Results

Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing

The synthetic mesh is constructed of knitted filaments of an alternative polypropylene resin. This material change does not affect the device description (or the device description on the package and instructions for use.) The proposed VitaMESH™ with the material supplier change is knitted by the same process as the predicate VitaMESH™, which interlinks each fiber junction and which provides for elasticity in both directions are.

The document describes a 510(k) summary for the VitaMESH™ Macroporous PP Surgical Mesh. The submission is based on a material supplier change for the polypropylene resin used in the mesh. The primary goal is to demonstrate that the device, with the new material, is substantially equivalent to the predicate device (VitaMESH™ Macroporous PP Surgical Mesh, K060520).

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 doesn't provide a direct "acceptance criteria" table in the form of specific numerical thresholds for each test. Instead, it states that the tests were performed to show that the device with the alternative polypropylene continues to meet specifications or that the properties are the same as the predicate device. The performance is reported as meeting these specifications or showing substantial equivalence.

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

The document does not explicitly state the specific sample sizes for each mechanical, microbiological, or chemical test. It generally refers to "VitaMESH™ units manufactured using an alternative polypropylene resin." The provenance is implied to be from Proxy Biomedical Ltd. in Ireland, as they are the submitter and manufacturer. The studies are prospective in the sense that they were conducted specifically for this submission to assess the performance of the device with the new material.

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 section is not applicable. The device under review is a surgical mesh, not an AI or diagnostic imaging device that requires expert interpretation for ground truth establishment. The evaluation relies on laboratory and in-vitro testing against established international standards and internal specifications.

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

This section is not applicable. As this is a physical medical device, there is no need for adjudication methods typically used in diagnostic studies involving human readers. The performance is objectively measured through standardized lab tests.

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

This section is not applicable. The device is a surgical mesh, not an AI-assisted diagnostic tool. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant to this submission.

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

This section is not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

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

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

• Industry Standards: I.S. EN ISO 10993-7: 2008 for Ethylene Oxide Sterilization Residuals and I.S. EN ISO 10993-1: 2009 for Biocompatibility.
• Internal Specifications: Proxy Biomedical Ltd.'s own established acceptance criteria for various tests (e.g., bioburden, mechanical properties).
• Comparison to Predicate Device: The primary ground truth is the performance and characteristics of the legally marketed predicate device (VitaMESH™ Macroporous PP Surgical Mesh, K060520) which the new device aims to be substantially equivalent to.

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of this traditional medical device submission. Machine learning models use training sets, but this is a physical product evaluated through laboratory testing.

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

This section is not applicable for the same reasons as point 8.

Ask a specific question about this device

VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh, a modification of VitaMesh™ Surgical Mesh, is a non-absorbable, synthetic mesh, with a blue colorant to enhance visibility. The more open weave and reduced thickness provides a more drapeable and lighter texture.

The provided document is a 510(k) premarket notification for a medical device, VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing an extensive clinical study with specified acceptance criteria and detailed performance metrics as would be found in a clinical trial report.

Therefore, many of the requested elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this type of regulatory submission. The document primarily describes design verification and comparative testing to a predicate device.

Here's an attempt to extract relevant information based on the prompt, with clarifications where data is not present:

Acceptance Criteria and Device Performance Study (VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh)

The submission describes the VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh as a modification of a previously cleared device (VitaMesh™ surgical mesh, K060520). The primary and overall "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device. This is achieved by showing that the modifications (addition of a blue colorant and physical property adjustments for lighter/more drapeable mesh) do not introduce new risks and that the fundamental performance remains comparable.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided document. The submission mentions "design verification tests" and an "animal implant comparative study" but does not give specific numbers of samples or animals used.
• Data Provenance: The studies appear to be pre-market regulatory tests conducted by the manufacturer, Proxy Biomedical Ltd., located in Ireland.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable/Not specified. This type of 510(k) submission does not typically involve expert review panels to establish clinical ground truth in the way a diagnostic AI device might. The "ground truth" here is based on physical property testing and animal study observations, which would be interpreted by qualified laboratory personnel and veterinary pathologists, respectively, but their specific numbers or qualifications are not detailed.

4. Adjudication Method

• Not applicable/Not specified. Adjudication methods (e.g., 2+1) are typically used in clinical studies where multiple human readers interpret data. This submission relies on objective engineering tests and animal study observations.

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

• No. This is not a study assessing human reader performance with or without AI assistance. This is a submission for a surgical mesh device.

6. Standalone (Algorithm Only) Performance Study

• No. This is not an AI/algorithm-based device. It is a physical surgical mesh.

7. Type of Ground Truth Used

• For the design verification tests: Objective physical and mechanical properties measured in a laboratory setting (e.g., mesh porosity, weight, tensile strength, drapeability). The detailed metrics and their measurement methodologies would be defined in quality system documents, though not provided in this summary.
• For the animal implant study: Histopathological and macroscopic observations from animal tissue after implantation, comparing healing responses to the predicate device.

8. Sample Size for Training Set

• Not applicable. This medical device is not an AI/machine learning algorithm, so there is no "training set."

9. How Ground Truth for Training Set Was Established

• Not applicable. As there is no training set for an algorithm, this question is not relevant.

Ask a specific question about this device

Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

The VITAMESH TM is a non-absorbable, synthetic mesh, constructed of knitted filaments of Polyproylene. The VITAMESH™ is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the patient's needs. The mesh is approximately 0.010" thick, and exhibits high burst strength and tensibe strength The VITAMESH™ is knitted by a process which provides for elasticity in both digetions. Use of VITAMESH™ allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.

The provided text describes a 510(k) submission for a surgical mesh device, VITAMESH™, and not a diagnostic AI device. Therefore, the questions related to acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies, which are standard for AI/ML device evaluations, are not directly applicable to this document.

However, I can extract the information relevant to the device's performance assessment and substantial equivalence claim as presented in the document.

Here's a summary based on the provided text, adapted to the context of a medical device submission rather than an AI/ML diagnostic:

Acceptance Criteria and Study for VITAMESH™ Surgical Mesh

VITAMESH™ is a non-absorbable, synthetic surgical mesh made of knitted polypropylene filaments. Its acceptance criteria and proof of meeting them are based on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility assessments, rather than diagnostic performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated in terms of a numerical count of devices or test samples. The document refers to "Bench test data" and "biocompatibility test results" generally.
• Data Provenance: Not explicitly stated, but assumed to be laboratory testing conducted by or for Proxy Biomedical, Ltd. No information about country of origin, retrospective or prospective nature of data collection, as these are not relevant for bench testing of medical devices in this context.

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

• This question is not applicable as the evaluation is not based on interpreting diagnostic images or clinical scenarios requiring expert ground truth in the traditional sense. The "ground truth" here is the established scientific and engineering principles for material and mechanical performance, and biological response to materials.

4. Adjudication Method for the Test Set

• This question is not applicable as there is no human interpretation or adjudication of diagnostic outputs involved. The "adjudication" is through standardized test methods and comparison to predicate device specifications.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic devices (often imaging-based) where human readers interpret cases, and an AI's impact on their performance is assessed. This is not relevant for a surgical mesh device's pre-market submission for mechanical and biocompatibility properties.

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

• This question is not applicable. VITAMESH™ is a physical surgical implant, not an algorithm or AI device. Its performance is inherent in its physical properties, not in a standalone algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for VITAMESH™'s evaluation is primarily based on:
  • Validated laboratory test methods: For mechanical properties (burst strength, tensile strength, elasticity) and material characterization.
  • Established biocompatibility standards: For assessing non-toxicity and non-sensitizing properties to biological tissues, likely following ISO 10993 standards.
  • Predicate device specifications: The performance of legally marketed predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh) serves as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

• This question is not applicable. This device is not an AI/ML algorithm that requires a "training set." The polypropylene material and knitting process are engineered and manufactured, not "trained."

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

• This question is not applicable, as there is no training set for a physical surgical mesh device.

Ask a specific question about this device

Proxy Biomedical MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

Proxy Biomedical MotifMesh 100 Soft Tissue Patch is a non-absorbable, inert, sterile, porous surgical soft tissue patch produced from expanded polytetrafluoroethylene. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The Soft tissue patch measures 0.006" +/- 0.001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESHTM Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a fibrous wall.

The provided document is a 510(k) summary for a medical device (surgical mesh). This type of document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device. It primarily focuses on regulatory approval based on comparison to existing technology, rather than detailed clinical studies with acceptance criteria and AI performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided text.

The document states:

• SUMMARY of TESTING: "Bench test data reveal MOTIFMESH TM Soft Tissue Patch has mechanical and material characterization values that are substantially equivalent to the predicate devices. The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues consistent with their intended use."

This indicates that the "study" conducted for this submission was primarily focused on bench testing for mechanical, material characterization, and biocompatibility, to demonstrate substantial equivalence to an already cleared predicate device (MOTIFMESH™ Soft Tissue Patch with the hexagonal shape previously cleared under K050678). This is typical for Class II medical devices seeking 510(k) clearance and does not involve AI performance metrics or the types of clinical studies you are asking about.

Ask a specific question about this device

Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Polyform™ Synthetic Mesh is intended to be utilized for surgical procedures pertaining to the pelvic floor. Polyform Synthetic Mesh is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the individual patient's needs. Polyform Synthetic Mesh is manufactured from monofilament polypropylene fibers.

The provided text is a 510(k) summary for the Polyform™ Synthetic Mesh. It describes the device, its intended use, and a summary of testing. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or AI algorithm performance.

The "SUMMARY of TESTING" section states that:

• "Bench test data reveal Polyform™ Synthetic Mesh has mechanical and material characterization values that are substantially equivalent to the predicate devices."
• "The biocompatibility test results show that the material used in the design and manufacture of the device is non-toxic and nonsensitizing to biological tissues consistent with their intended use."
• "Updated test data on the bench and the rodent, as summarized in the updated product brochure, shows comparable technical properties to the more contemporary material properties like those in the Gynemesh PS."

This indicates that the device's substantial equivalence was established through bench testing, biocompatibility testing, and rodent studies comparing its material properties and mechanical characteristics to predicate devices. These are not studies that would involve clinical acceptance criteria, human readers, ground truth established by experts, or AI algorithm performance as typically understood for diagnostic or prognostic AI devices.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These specific requirements pertain to studies evaluating the performance of AI/CADe devices, which this document does not describe. The summary focuses on the physical and biological properties of a surgical mesh, not a software or AI-driven diagnostic tool.

Ask a specific question about this device

MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hemia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

MOTIFMESH™ Soft Tissue Patch is a nonabsorbable, inert, sterile, macro porous surgical soft tissue patch Produced from polytetrafluoroethylene. The MotifMesh TM Soft Tissue Patch is designed to facilitate the reinforcement and repair of damaged or ruptured soft tissue structures. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The soft tissue patch measures 0.006''+/. 001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESH™ Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.

The provided text describes a 510(k) summary for the MOTIFMESH™ Soft Tissue Patch. The submission focuses on demonstrating substantial equivalence to predicate devices based on mechanical characterization and biocompatibility testing. The document does not contain specific acceptance criteria, reported device performance metrics in a structured table, details on sample sizes for test sets, data provenance, ground truth establishment for a test set, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), or a standalone algorithm performance study. It also doesn't specify a training set or how its ground truth was established.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can be extracted and what information is missing:

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

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (likely from internal lab testing at Proxy Biomedical, Ltd. in Ireland, but not explicitly stated).
• Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is a medical device for physical repair, not an image analysis or diagnostic device requiring expert interpretation of a test set. Ground truth relates to mechanical properties and biocompatibility.

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

• Not applicable for the type of testing described (mechanical and biocompatibility).

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. This is not a diagnostic device or an AI-assisted device. The study described is a bench test and biocompatibility study for a surgical mesh.

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

• No. This is not an algorithm or AI device.

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

• For mechanical characterization: Benchmark values of predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh).
• For biocompatibility: Established biocompatibility standards and testing methodologies (e.g., ISO 10993 series, though not explicitly mentioned, implied by "non-toxic and non-sensitizing"). The "ground truth" would be the successful passing of these tests according to predefined criteria for toxicity and sensitization.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set. The "training" here would be for the manufacturing process to consistently produce the device.

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

• Not applicable due to the nature of the device (surgical mesh, not an AI/ML device).

Ask a specific question about this device