(45 days)
The FluoroTex™ Surgical Mesh is intended to be used for the repair of soft tissue and the reconstruction of hernias.
The FluoroTex Surgical Mesh consists of porous expanded polytetrafluoroethylene (ePTFE) reinforced with fluorinated ethylene propylene (FEP).
The provided text describes a 510(k) summary for the FluoroTex™ Surgical Mesh, demonstrating its substantial equivalence to a predicate device, the GORE-TEX® Soft Tissue Patch. It does not contain information about a study proving the device meets acceptance criteria in the sense of a clinical trial or performance evaluation against predefined thresholds for classification (e.g., sensitivity, specificity, accuracy) that are typical for diagnostic or AI-driven medical devices. Instead, the "acceptance criteria" here are implicit in demonstrating substantial equivalence through mechanical and chemical testing.
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided document for several categories:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the FluoroTex™ Surgical Mesh were implicitly met by demonstrating that its mechanical and chemical characteristics were "substantially equivalent" to those of the predicate device, the GORE-TEX® Soft Tissue Patch. The study involved direct comparison of key material properties.
| Acceptance Criteria (based on predicate) | Reported Device Performance (FluoroTex™ Surgical Mesh) |
|---|---|
| Material Composition: 100% ePTFE | ePTFE reinforced with FEP |
| Pore Size: 10 to 30 microns | 10 to 30 microns |
| Material Strength (Kg/cm, 1mm thick): 14.8 | 13.8 |
| Suture Retention Strength (Kg/pin, 1mm thick): 4.9 | 2.2 |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: n=15 for Material Strength and Suture Retention Strength for the FluoroTex™ Surgical Mesh. An identical sample size (n=15) is reported for the predicate device's data, which was sourced from Gore literature.
- Data Provenance: The FluoroTex™ Surgical Mesh data was generated internally at Bridger Biomed, Inc. labs. The predicate device's data was reported in Gore literature. The country of origin is not specified but given the company names and FDA context, it is likely the United States. The data is retrospective in the sense that the predicate's data already existed, while the new device's data was generated specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for this type of device comparison is based on established engineering and materials science testing standards (ASTM methods) rather than expert consensus on medical image interpretation or clinical outcomes.
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Adjudication method for the test set:
- Not applicable. Data was derived from standardized ASTM test methods, not expert adjudication of subjective assessments.
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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 document describes a medical device (surgical mesh), not an AI-driven diagnostic tool, and therefore no MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- Standardized engineering and materials testing (ASTM methods) for mechanical and chemical properties. The "truth" is based on the measurable physical properties of the materials as determined by these validated tests.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.