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PERI-GUARD is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias).

SUPPLE PERI-GUARD is intended for use as a prosthesis for soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral. incisional, inguinal, lumbar, scrotal, and umbilical hernias).

PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25℃ (68-77°F).

PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.

PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.

The provided document is a 510(k) summary for medical devices, specifically Peri-Guard and Supple Peri-Guard surgical meshes. This type of document is used to demonstrate substantial equivalence to a predicate device, not to present a study proving a device meets specific acceptance criteria for AI/ML performance.

Therefore, the information required to answer your prompt regarding acceptance criteria and performance studies (e.g., sample sizes, expert involvement, adjudication methods, MRMC studies, ground truth establishment, training set details) is not present in the provided text. The document focuses on demonstrating the safety and effectiveness of a material and physical design change (sterilization method and packaging) for a surgical mesh, not on evaluating the performance of an AI-driven medical device.

To directly address your request for a table of acceptance criteria and study details, based solely on the provided text, I must state that this information is not available.

The document details non-clinical bench testing and animal studies to support the substantial equivalence claim for the modified surgical mesh. These studies are focused on material properties, biocompatibility, and physical performance of the mesh, and not on the performance of an AI model.

Here's how I would summarize the relevant information from the document, while acknowledging the absence of AI/ML-specific details you requested:

Acceptance Criteria and Device Performance (as described for the surgical mesh, not an AI device):

The document does not present a table of quantitative acceptance criteria for the mesh's performance in the way one would for an AI model (e.g., sensitivity, specificity, AUC thresholds). Instead, it discusses the equivalence of the modified device to its predicate through various non-clinical and animal studies. The overall "acceptance criterion" implicit in a 510(k) is the demonstration of substantial equivalence to a predicate device, meaning the new device is as safe and effective as the legally marketed predicate.

Reported Device Performance (for the surgical mesh):

The document states that the results of performance testing demonstrate that the modified PERI-GUARD and SUPPLE PERI-GUARD devices are substantially equivalent to the predicate devices.

Specific performance aspects evaluated include:

• Bench Testing: Visual, Suture retention, Dimensional, Burst strength, Collagenase digestion, Denaturation Temperature, Water Permeability, Pliability, Chemical and heavy metal residuals, Bioburden, Pyrogenicity/Endotoxins, Temperature Excursion Testing.
  • Conclusion: The results of these tests support substantial equivalence.
• Animal Studies:
  • Implantation (Porcine incisional hernia repair model for 6 months per ISO 10993-6): "No test material-related changes among clinical observations, bodyweights, veterinary physicals, clinical pathology parameters, mortality, significant macroscopic or microscopic differences, tensile or burst strength, or clinical performance between the subject and predicate devices..."
    • Conclusion: "The subject and predicate devices performed equivalently and had an equivalent safety profile in the in vivo porcine model for incisional hernia repair."
  • 3-week Rat Calcification Potential Study: "No significant mineralization was noted microscopically for either the subject or predicate device."
    • Conclusion: "No significant difference in calcification potential."
• Biocompatibility: Demonstrated biocompatibility in accordance with ISO 10993-1:2018 for a permanent implant, including cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, genotoxicity, implantation, hemolysis, and subchronic toxicity endpoints.
• Shelf Life: 1-year shelf life claim supported by aging testing.
• Sterilization and Packaging: Validation per ISO 11137 parts 1 and 2 (sterilization) and ISO 11607-1 (packaging integrity, supported by ASTM F88-15 and ASTM F2096-11).
• Human Factors Testing: Confirmed that redesigned packaging allows for aseptic transfer without compromising sterility and does not impact the tissue patch surface.

Detailed breakdown of AI/ML specific information (Not Found in these documents):

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable. Studies conducted were animal (porcine and rat) and bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for the mesh's performance attributes (e.g., tensile strength, burst strength, calcification) is established through standardized laboratory and animal model measurements, not expert consensus interpreting images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance relies on direct physical measurements (e.g., tensile strength, burst strength), chemical analysis (e.g., residuals), and histopathological evaluation in animal models. It's not a diagnostic AI that generates predictions requiring expert-adjudicated ground truth labels.
8. The sample size for the training set: Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary is for a traditional medical device (surgical mesh) and lacks any information pertaining to AI/ML device performance, acceptance criteria, or study methodologies.

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PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.

PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is crosslinked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25°C (68-77°F).

PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.

PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.

This is a 510(k) premarket notification for the PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch. This document describes the device, its intended use, and the performance data provided to demonstrate substantial equivalence to predicate devices. The submission focuses on changes to packaging and sterilization parameters, with a reliance on historical data for many performance aspects.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding "device performance" results for each criterion in the typical sense of a clinical or standalone performance study. Instead, it lists various performance tests conducted to support substantial equivalence. The "reported device performance" is implicitly that the devices "meet" or "demonstrate equivalence" to the predicate devices.

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

The document does not specify exact sample sizes for each performance test. It mentions "aging testing" for shelf life, but without a specific sample size. The studies are non-clinical (laboratory/bench testing, in vitro), not based on patient data. Therefore, questions about country of origin and retrospective/prospective nature are not applicable in this context.

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

Not applicable. This is a submission for a medical device (a patch), and the evaluation is based on non-clinical performance data and substantial equivalence to existing devices, not on diagnostic accuracy against a "ground truth" established by human experts.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a physical medical device, not an AI/software as a medical device (SaMD) that involves human readers or AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic accuracy. For the performance tests listed, the "ground truth" or reference standards are the established industry standards, test methodologies (e.g., ASTM, ISO), and the performance characteristics of the predicate devices. For example, for "Burst Strength," the "ground truth" would be the measurement obtained using a validated testing procedure, and the performance would be compared to that of the predicate.

8. The Sample Size for the Training Set

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

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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VASCU-GUARD Vascular Repair Patch is used in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial vessels and arteriovenous access revisions.

VASCU-GUARD Vascular Repair Patch (VASCU-GUARD) is derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross-linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25° (68-77°F). VASCU-GUARD is terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. VASCU-GUARD is MR Safe. VASCU-GUARD utilizes animal tissue; patient must be informed prior to any procedure.

The provided text is a 510(k) summary for the VASCU-GUARD Vascular Repair Patch. It describes the device, its intended use, and comparison to predicate devices, along with performance data. However, this document does not contain information about acceptance criteria or specific studies that demonstrate the device meets those criteria in the context of an AI/ML medical device.

The performance data listed (Visual, Suture retention, Dimensional, Burst strength, Collagenase digestion, Denaturation Temperature, Water Permeability, Pliability, Chemical and heavy metal residuals, Bioburden, Pyrogenicity/Endotoxins, Temperature Excursion Testing, Biocompatibility Assessment) are for physical and material properties of the vascular repair patch itself, not for an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device, as the supplied text pertains to a physical medical device (a vascular repair patch) and not an AI/ML product.

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