(58 days)
TephaFLEX mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
The TephaFLEX mesh is a resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB). The mesh is prepared from non-dyed or dyed (D&C Violet #2) monofilament P4HB fiber that is knitted into a surgical mesh. It is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application.
This is a medical device submission (K113723) for TephaFLEX® Mesh, which is a surgical mesh. The provided document does not describe an AI/ML powered device, but rather a traditional medical device that undergoes mechanical and biological testing for safety and performance. Therefore, many of the requested fields related to AI/ML device studies will not be applicable.
Here's the breakdown of the information as it relates to the provided document:
Acceptance Criteria and Device Performance
The "Safety and Performance" section states that "Mechanical testing, in vivo animal testing, and biocompatibility testing, were performed based on recommendations identified in the FDA surgical mesh guidance document." The conclusion is that the mesh was determined to be "substantially equivalent to the predicate devices."
The specific acceptance criteria are not explicitly detailed in quantifiable targets within the provided summary, but rather by comparison to predicate devices and established guidance. The reported performance is that the device met these comparative standards.
| Acceptance Criteria Category | Reported Device Performance (as stated in document) |
|---|---|
| Mechanical Testing: | Comparative burst strength, suture pull-out strength, tensile strength, and tear resistance strength were characterized. The collected mechanical data determined the mesh to be substantially equivalent to the predicate devices. |
| In Vivo Animal Testing: | In vivo strength retention was characterized via a subcutaneous implantation study. The collected in vivo data determined the mesh to be substantially equivalent to the predicate devices. |
| Biocompatibility Testing: | Performed based on recommendations in FDA surgical mesh guidance. Results are not detailed but contribute to the overall conclusion of substantial equivalence. |
| Overall Conclusion: | The TephaFLEX mesh has been shown to be substantially equivalent to predicate devices based on indications for use, technological characteristics, and safety and performance testing. |
Study Details (as applicable)
Since this is a traditional medical device and not an AI/ML device, many of the requested fields are not applicable.
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Sample sizes used for the test set and the data provenance:
- The document mentions "in vivo animal testing" (subcutaneous implantation study) and "mechanical testing." Specific sample sizes for these tests are not provided in this summary.
- Data provenance (e.g., country of origin, retrospective/prospective) is not specified.
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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 as this is not an AI/ML device relying on expert-established ground truth from images or data. The testing involves physical and biological evaluations.
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Adjudication method for the test set:
- Not applicable. The testing methods for mechanical and in vivo studies would follow standard scientific protocols for data collection and analysis, not expert adjudication in the context of diagnostic interpretation.
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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 is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
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The type of ground truth used:
- For mechanical testing: The "ground truth" would be the direct physical measurement of properties like burst strength, tensile strength, etc., compared against specified benchmarks or predicate device performance.
- For in vivo animal testing: The "ground truth" would be the observed biological response and strength retention in the animal model, again compared to expected outcomes or predicate device performance.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that uses a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that uses a training set.
§ 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.