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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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PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) 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 (PSDV-SG) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States.

The product consists of a loading unit which includes two (2) buttresses, one for the anvil (ANV) and one for the cartridge (CART) side of the stapler. 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 occurs via ethylene oxide. The bovine pericardium buttress and acrylic adhesive are intended for permanent implant.

This document is a 510(k) summary for a medical device called PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG). It describes the device, its intended use, comparison to predicate devices, and performance data.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

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

The document lists various assessments for design verification. It doesn't present these as formal "acceptance criteria" with specific pass/fail values in a table, but rather as "assessments" with the general outcome mentioned as "Testing passed the acceptance criteria" for biocompatibility and "demonstrate the performance of the PSDV-SG device is substantially equivalent to the predicate devices" for bench testing.

Based on the text, here's a conceptual table:

2. Sample sizes used for the test set and the data provenance:

• Sample Sizes: The document does not specify sample sizes for any of the tests (bench studies, biocompatibility, human factors, or surgeon validation). It broadly mentions "testing" or "studies" without numerical details.
• Data Provenance: The document implies that the data was generated by Synovis Life Technologies, Inc. (now Baxter International Inc.) as part of their 510(k) submission. There is no information about the country of origin of the data explicitly stated. The studies are pre-clinical bench studies and validation studies, which are typically conducted in a controlled environment as part of product development, not necessarily from a "retrospective" or "prospective" clinical data sense.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • For the "Human Factors Study," "user comprehension" was assessed, implying user participants, but not "experts" in the sense of ground truth establishment.
  • For the "Surgeon Validation," "surgeons" were involved, but their number and specific qualifications (e.g., years of experience, specialty) are not provided. They were involved in assessing functionality and satisfaction, not necessarily establishing a "ground truth" that would be typical for, say, an AI model's diagnostic accuracy.

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

• Not applicable / None specified. The studies described (bench, biocompatibility, human factors, surgeon validation) do not involve subjective interpretation of medical images or data requiring an adjudication method common in diagnostic accuracy studies. They are focused on physical and functional performance, safety, and usability.

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 MRMC study was done. This device is a surgical mesh for staple line reinforcement, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, a study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.

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

• Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI. Standalone performance for an algorithm is not relevant here.

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

• Not applicable in the typical sense of diagnostic "ground truth." For this device, "ground truth" relates to the functional performance of the device against engineering specifications, biocompatibility standards, and usability criteria.
  • For bench testing, the "ground truth" is likely defined by engineering specifications and comparative performance to predicate devices.
  • For biocompatibility, the "ground truth" is defined by the passing criteria of the ISO 10993-5 standard.
  • For human factors, "ground truth" is user comprehension and ability to use the device as intended.
  • For surgeon validation, "ground truth" is customer satisfaction and functionality assessment by the surgeons.

8. The sample size for the training set:

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

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

• Not applicable. As above, no training set for an AI/ML algorithm.

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Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).

Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.

An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

The provided text does not contain a table of acceptance criteria or specific performance metrics of the device as would typically be found in a formal study. Instead, it describes a 510(k) Premarket Notification for the Veritas® Collagen Matrix, which asserts substantial equivalence to previously marketed predicate devices.

However, based on the provided text, we can infer some information relevant to the "acceptance criteria" through the lens of a substantial equivalence determination and the single study mentioned.

Here's an attempt to structure the information based on your request, highlighting what is present and what is not:

Acceptance Criteria and Device Performance for Veritas® Collagen Matrix

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The text only states "An animal study was conducted."
• Data Provenance: The study was an "animal study," implying pre-clinical data (not human clinical data). The location/country of origin is not specified. It is inherently prospective as it was conducted for this specific submission to evaluate the new indication.

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

• This information is not provided. As an animal study for a pre-market notification, the "ground truth" would likely be established by the researchers/veterinarians involved in the study, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided. Given that it's an animal study assessing physical characteristics (tissue attachment), formal adjudication methods like 2+1 or 3+1 are typically not applicable in the same way they would be for image-based diagnostic studies. The evaluation method would be part of the individual study's protocol.

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

• No, a MRMC comparative effectiveness study was not done. The study described is an animal study, not a human clinical trial involving multiple readers. Therefore, there is no effect size of human readers improving with AI assistance vs. without AI.

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

• Not applicable. This document describes a physical medical device (surgical mesh), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The "standalone" performance here would refer to the device's functional characteristics in the animal model.

7. Type of Ground Truth Used

• The ground truth for the animal study (regarding tissue attachment) would be based on direct observation and histopathological analysis (implied) of the animal tissues post-implantation, assessing the degree of attachment. This would fall under direct scientific observation and potentially pathology.

8. Sample Size for the Training Set

• Not applicable/Not provided. This is a physical device, not an AI algorithm, so there is no "training set" in the machine learning sense. The device itself is "trained" through its manufacturing process and design based on prior knowledge and predicate devices.

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

• Not applicable. As above, there is no training set for an AI algorithm. For the development of the device itself (manufacturing, processing), ground truth is established through extensive material science testing, bio-compatibility studies, and prior pre-clinical/clinical data from its own previous iterations and predicate devices, ensuring it meets specified material properties and safety profiles. The specific animal study discussed was for a new indication, not for the fundamental development/training of the device itself.

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