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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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