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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 Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Peri-Strips is intended to be used for reinforcement of suturelines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

An implantable surgical patch comprised of crosslinked bovine pericardium

The provided text is a 510(k) summary for a medical device called "Peri-Strips Staple Line Reinforcement." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include acceptance criteria, details of a study that proves the device meets specific performance criteria, or any of the detailed information requested in points 2-9 of your prompt (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details).

Medical devices like the Peri-Strips Staple Line Reinforcement, when cleared via the 510(k) pathway, typically demonstrate substantial equivalence to a legally marketed predicate device. This process often relies on showing that the new device has the same technological characteristics and similar indications for use as the predicate, and does not raise new questions of safety and efficacy. This usually involves engineering testing (e.g., tensile strength, burst pressure) and biocompatibility testing, rather than clinical efficacy studies with the detailed metrics you've asked for that are more common for AI/ML-based devices.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, expert involvement, or AI/ML performance because the provided document does not contain this information.

Based on the provided text, the device is cleared on the basis of substantial equivalence to a predicate device, and the submission does not detail efficacy studies with specific performance metrics or the involvement of AI/ML.

Here is what can be inferred or explicitly stated from the document regarding comparative testing, but it does not fit the format of your requested table for acceptance criteria and device performance as those specific values are not provided.

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical performance criteria (e.g., accuracy, sensitivity, specificity, or device-specific mechanical performance thresholds) or corresponding reported values are provided in the document. The basis for clearance is "substantial equivalence" to a predicate device, implying that its performance is presumed to be similar without needing to meet new, explicit, quantitative acceptance criteria for efficacy or exact performance metrics publicly disclosed in this summary. Engineering and biocompatibility testing would have been submitted, but the detailed results are not in this public summary.

Regarding the other questions:

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

   • Not provided. The document refers to "testing" as part of establishing substantial equivalence, but gives no details about sample sizes, data provenance, or study design (retrospective/prospective). This often indicates that the testing was primarily mechanical, chemical, or biocompatibility-related, rather than clinical efficacy studies with patient data.

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 / Not provided. The device is a "Surgical Mesh" (an implantable patch/reinforcement), not an imaging or diagnostic device that typically relies on expert interpretation to establish ground truth for performance evaluation in the way an AI/ML diagnostic tool would. Expert review would be part of the design and risk assessment, but not typically in establishing "ground truth" for a performance test set as envisioned for AI.

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

   • Not applicable / Not provided. Since there's no mention of a test set requiring expert ground truth or interpretation, an adjudication method isn't relevant to the information provided.

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. The device is "Peri-Strips Staple Line Reinforcement," a physical surgical implant, not an AI/ML-based diagnostic or assistive device that would involve 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 surgical device, not an algorithm.

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

   • Not applicable / Not provided. For a physical device like this, "ground truth" in the AI/ML context doesn't apply. Performance would be assessed through established physical/mechanical testing standards (e.g., burst strength, suture retention), biocompatibility, and potentially animal or limited human clinical data to assess safety and gross functional equivalence. These details are not in the summary.

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable. This is not an AI/ML device, so there is no "training set" or associated ground truth establishment.

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intended to reinforce staple lines during lung and bronchus resections including; pneumonectomy, pneumoreduction, pneumectomy, segmental resections) wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions of lung and bronchus.

Dehydrated bovine pericardium strips cross-linked with glutaraldehyde. Affixed to the stapler forks with PSD Gel, a hydrogel.

This document is a Summary of Safety and Effectiveness for a medical device called "Peri-Strips Dry". It describes the device, its intended use, and compares it to existing products. However, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The provided text is a regulatory submission, likely to the FDA, demonstrating substantial equivalence to previously approved devices. It focuses on:

• Applicant Information: Name, address, contact, date.
• Device Identification: Common name, classification, substantial equivalence to prior devices (K942583 & K940205).
• Device Description: What it's made of (dehydrated bovine pericardium, glutaraldehyde, PSD Gel) and how it's used (affixed to stapler forks).
• Intended Use: Reinforcing staple lines in lung and bronchus resections.
• Summary/Comparison of Technological Characteristics: How "Peri-Strips Dry" is similar to and different from existing "Peri-Strips" products (material, dimensions, manufacturing process, sterilization, attachment method).
• Conclusion: States that the product design basis is the same and testing (including animal implants) indicates equivalent performance to current products.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions "testing conducted, including the animal implants, indicate that the product performs in a manner equivalent to our current product" but provides no specific criteria, metrics, or performance data.
2. Sample sized used for the test set and the data provenance: No details on animal implant study size, type, or origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it's an animal study, not human expert-based assessment.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: 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: For the animal implants, it would likely be histological analysis or physical assessment of the staple lines, but this is not specified.
8. The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a medical device in the context of a regulatory submission but does not contain the detailed study information (acceptance criteria, performance data, sample sizes, ground truth establishment, etc.) that would typically be found in a clinical study report or a more detailed efficacy/safety study summary.

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