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PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.

PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age, originating from the United States.

There are two types of PSDV-SG configurations based on the tissue buttress thickness range. The Standard configuration has a tissue buttress thickness range of 0.20-0.60mm. The Thin configuration has a tissue buttress thickness range of 0.20-0.40mm.

The product consists of a loading unit which includes two (2) buttresses, one for the anvil and one for the cartridge side of the stapler. The buttresses are held in a foam/sheath configuration for loading of the buttress to the stapler jaws. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch.

PSDV-SG utilizes animal tissue; patient must be informed prior to any procedure.

PSDV-SG is provided sterile and intended for single use. Sterilization is accomplished via ethylene oxide (ETO). The bovine pericardium buttress and acrylic adhesive are considered permanent implants per ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

This document describes the PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) device, which is a surgical mesh intended for staple line reinforcement. It is a Special 510(k) submission, meaning the changes are relatively minor compared to a predicate device.

Based on the provided text, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner with numerical targets for clinical performance metrics (e.g., specific reduction in anastomotic leaks, burst pressure thresholds). Instead, it focuses on demonstrating substantial equivalence to a predicate device by showing that the technological characteristics and performance (functional, manipulation, dimensional, usability, and shelf-life) are similar.

The "performance" described is largely comparative to the predicate device and verification/validation results. The core of the performance claim is that the device maintains the same intended use, indications for use, materials, and principles of operation as the predicate, despite changes in size and design for stapler compatibility.

Note: The document states "Verification and validation of the product have been completed using the same test methods as the predicate device, or accepted industry standard methods. No new issues of safety and effectiveness have been identified." This implies that the results from these tests met the internal acceptance criteria established by the manufacturer, which were aligned with the predicate or industry standards. However, the specific numerical acceptance criteria (e.g., minimum burst pressure, maximum staple pull-through force) are not provided in this summary.

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

The document states "Testing performed to support the new product models subject of this submission included manipulation, functional, and dimensional testing, as well as usability and shelf-life." It does not provide details on the sample sizes used for these tests.

Regarding data provenance:

• Country of Origin: Not specified for the testing data.
• Retrospective or Prospective: Not specified. These appear to be benchtop and perhaps simulated use tests, not clinical studies involving patients.

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

N/A. This submission focuses on engineering and bench testing performance for substantial equivalence, not clinical diagnostic accuracy or efficacy. There is no mention of "ground truth" derived from expert review in the clinical sense.

4. Adjudication Method for the Test Set

N/A. As there's no mention of expert review or clinical studies for ground truth establishment, no adjudication method is described.

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

No. There is no mention of a human reader or AI comparative effectiveness study. This device is a surgical mesh, not a diagnostic imaging or AI-assisted interpretation device.

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

N/A. This device is a physical surgical mesh, not a software algorithm.

7. The Type of Ground Truth Used

For the engineering and functional tests conducted, the "ground truth" would be established by:

• Measurement Standards: Adherence to predefined dimensional and physical property specifications.
• Performance Specifications: Meeting functional requirements (e.g., tear strength, adhesion, burst pressure if these were tested) derived from predicate device performance or industry standards.
• Visual Inspection: For manipulation and usability tests, often a qualitative or semi-quantitative assessment against predefined criteria.

No pathology or outcomes data is mentioned as "ground truth" in this context of bench testing for substantial equivalence for the device itself.

8. The Sample Size for the Training Set

N/A. This device is not an AI/ML algorithm that requires a training set.

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

N/A. Not an AI/ML device.

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

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 prepared from bovine pericardium which is cross-linked with glutaraldehyde. SUPPLE PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation.

SUPPLE PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

PERI-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. PERI-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. PERI-GUARD is terminally sterilized using gamma irradiation.

PERI-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.

The provided document is a 510(k) premarket notification for two devices: SUPPLE PERI-GUARD Pericardium Patch and PERI-GUARD Repair Patch. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a comparative effectiveness study with human readers or presenting detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI or advanced clinical performance studies.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance in the format requested (likely due to the nature of a 510(k) submission not requiring explicit performance metrics in this way for equivalence).
• Any details about sample sizes used for a test set, data provenance, ground truth establishment, or expert involvement as typically found in studies for AI/diagnostic devices.
• Information on adjudication methods.
• A multi-reader multi-case (MRMC) comparative effectiveness study with effect sizes for human reader improvement with AI.
• A standalone (algorithm only) performance study.
• Sample sizes or ground truth establishment for a training set (as this is not an AI/machine learning device).

Instead, the document focuses on non-clinical testing to demonstrate safety and performance for substantial equivalence. The studies mentioned are:

1. Bench testing: Assessed aspects like suture retention, thickness, burst strength, ultimate tensile strength, collagenase digestion, chemical residuals, pyrogenicity/LAL, sterilization validation, and packaging/shelf-life. The document states, "Bench testing results support the performance requirements."
2. Biocompatibility testing: Performed in accordance with ISO 10993-1: 2009.
3. Animal studies: Conducted to support safety and efficacy.

These studies are conducted to show the new device is "substantially equivalent" to predicate devices, mainly due to changes in packaging and sterilization methods. The document repeatedly states that the devices (SUPPLE PERI-GUARD and PERI-GUARD) are acting as their own predicates.

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