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GalaFLEX mesh is indicated for use as a transitory scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.

GalaFLEX mesh is a sterile, knitted, resorbable mesh, constructed of non-dyed monofilament fibers made from poly-4-hydroxybutyrate (P4HB). It is provided in single sheets of varying widths, lengths and shapes, and may also be cut to the shape or size desired for a specific application.

The provided text describes the regulatory filing for the GalaFLEX® Mesh, a surgical mesh. This document focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study with detailed acceptance criteria for an AI device. Therefore, a direct table of acceptance criteria and reported device performance in the context of an AI study (as requested in the prompt) cannot be extracted from this text.

However, I can extract the information related to the study performed to establish substantial equivalence for the GalaFLEX® Mesh device itself based on its safety and performance.

Here's the breakdown of the information relevant to the device's evaluation, framed to address the prompt's categories where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As this K140533 filing is a medical device submission (GalaFLEX® Mesh) and not an AI device, the "acceptance criteria" are related to demonstrating substantial equivalence for the surgical mesh. These criteria are comparative metrics against predicate devices and biocompatibility standards. "Reported device performance" refers to the results of these tests for the GalaFLEX® Mesh.

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

• Sample Size for Test Set:
  • Mechanical Testing: Not explicitly stated, but the tests performed were comparative burst strength, suture pull-out strength, tensile strength, and tear resistance strength. The number of samples for each test is not specified.
  • In vivo Testing: Not explicitly stated for the subcutaneous implantation study, but it was performed in rabbits.
  • Biocompatibility Testing: Not explicitly stated for each test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity), except for the remark that the subcutaneous implantation studies were conducted in "rabbits" (plural, but not an exact number).
• Data Provenance: The studies were internal testing by Tepha, Inc. The in vivo and biocompatibility studies involved animal subjects (rabbits). It is not specified if any human data was used, but the context is pre-market notification (510(k)) based on substantial equivalence, often relying on non-clinical data. These studies are prospective from the perspective of their execution for this submission.

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

This type of information is generally not applicable to a 510(k) submission for a non-AI medical device. "Ground truth" in this context refers to the measured physical properties of the mesh and biological responses in animal models, not expert interpretations of images or patient data. The "experts" would be the scientists and engineers conducting the tests and interpreting the results according to established scientific and regulatory standards (e.g., ISO-10993). No specific number or qualifications are mentioned for these individuals beyond the performing entity being Tepha, Inc.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here comprises physical and biological measurements. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on subjective interpretations (e.g., image reading) in clinical trials or AI performance evaluations, not for objective mechanical or biocompatibility testing.

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. This is a 510(k) submission for a surgical mesh, not an AI device. Therefore, no MRMC study, human reader performance, or AI assistance elements are present or relevant in this document.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a surgical mesh, not an algorithm or AI device.

7. The Type of Ground Truth Used

• Mechanical Testing: Objective physical measurements (e.g., burst strength, tensile strength) determined by standardized test methods.
• In vivo Testing: Biological observation and measurement of strength retention in animal models.
• Biocompatibility Testing: Bioreactivity responses (e.g., cytotoxicity, irritation, sensitization, toxicity, pyrogenicity, genotoxicity, implantation reactions) according to ISO-10993 standards and protocols.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no "training set." The development of the GalaFLEX® Mesh would involve research, material science, and engineering, not machine learning training.

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

Not applicable. Since there is no training set for an AI algorithm, there is no corresponding ground truth to establish.

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