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The GORE BIOABSORBABLE MESH is intended for use in the reinforcement of soft tissue. Examples of applications where the GORE BIOABSORBABLE MESH may be used include, but are not limited to: Hernia repair (inguinal, femoral, umbilical, abdominal, diaphragmatic, incisional, epigastric, gastroesophageal, hiatal, intermuscular). Muscle flap reinforcement Perforated tissue repair General tissue reconstruction's (periosteum, thoracic wall, reinforcement of the bladder wall, suture line reinforcement, tissue deficit, etc.)

The GORE BIOABSORBABLE MESH is used to reinforce soft tissue during the phases of wound healing by filling or bridging soft-tissue void spaces or defects. The GORE BIOABSORBABLE MESH elicits a physiological tissue response, which fills the defect with native tissue and gradually absorbs the device. GORE® BIOABSORBABLE MESH is comprised of a microporous structure of synthetic bioabsorbable poly (67% glycolide: 33% trimethylene carbonate by weight) (PGA: TMC) copolymer fiber. As packaged, the GORE BIOABSORBABLE MESH is a tailorable, bioabsorbable material intended to be a temporary bridge of defects until the absorptive nature of the device stimulates the body to fill the defect with native tissue. The device is available in sheets and preformed, three-dimensional shapes. The GORE BIOABSORBABLE MESH is provided STERILE for single use only. Due to the absorptive nature of the GORE BIOABSORBABLE MESH, an overlay patch should be used in corrections requiring high strength (e.g., groin hernia repair)

The provided document is a 510(k) Pre-market Notification for the GORE BIOABSORBABLE MESH. It details the device description, indications for use, and a comparison to predicate devices, but does not contain a detailed study proving performance against specific acceptance criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "W. L. Gore & Associates, Inc. performed device integrity testing to support that the GORE BIOABSORBABLE MESH is equivalent to the predicate devices. All device integrity test results for the GORE BIOABSORBABLE MESH met specified requirements."

However, the specific "specified requirements" (acceptance criteria) and the "device integrity test results" are not detailed or provided in this summary. Therefore, a table cannot be constructed with this information.

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

The document mentions "device integrity testing," implying a test set was used for these tests. However, the sample size for this test set is not specified, nor is the data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable and not present in the document. The "tests" mentioned are device integrity tests, likely mechanical or material property tests, not clinical or diagnostic performance studies requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable and not present in the document. As noted above, the tests are "device integrity tests" not studies requiring adjudication of clinical or diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through material composition and device integrity testing, not clinical performance comparison with human readers.

6. Standalone (Algorithm Only) Performance Study:

This concept is not applicable to a physical bioabsorbable surgical mesh. There is no algorithm involved.

7. Type of Ground Truth Used:

The "ground truth" for the device integrity testing would likely be based on:

• Material specifications: Conformance to pre-defined physical, chemical, and mechanical properties.
• Predicate device characteristics: Demonstrated performance or properties of the predicate devices.
• Engineering standards: Relevant industry or regulatory standards for mesh materials.

However, the document does not explicitly state the type of ground truth used beyond mentioning that "device integrity test results for the GORE BIOABSORBABLE MESH met specified requirements."

8. Sample Size for the Training Set:

This information is not applicable as there is no mention of machine learning or an "algorithm" being trained. The document describes a physical medical device.

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

This information is not applicable as there is no training set mentioned or implied.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence based on material composition and device integrity testing, rather than a clinical performance study with detailed acceptance criteria and ground truth establishment typically associated with diagnostic devices or those involving human interpretation. The specific details of the "device integrity testing" and their "specified requirements" are not elaborated in the provided text.

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