(58 days)
TephaFLEX light 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 light 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.
The provided document describes the TephaFLEX® Light Mesh, a surgical mesh, and its substantial equivalence to predicate devices. However, the document does not contain details of a clinical study or a study proving the device meets specific acceptance criteria in the manner typically associated with diagnostic AI/imaging devices.
The "Safety and Performance" section states: "Mechanical testing, biocompatibility testing, and in vivo animal testing was performed based on recommendations identified in the FDA surgical mesh guidance document: The Guidance for the Preparation of a Pre-market Notification Application for a Surgical Mesh. Specifically, comparative burst strength, suture pull-out strength, tensile strength and tear resistance strength was characterized. In vivo strength retention was characterized via a subcutaneous implantation study. The mechanical and in vivo data collected determined the mesh to be substantially equivalent to the predicate devices."
This indicates that the "study" conducted was a series of non-clinical performance tests (mechanical and animal studies) to demonstrate substantial equivalence, rather than a clinical trial with human subjects, a test set, or ground truth as understood in the context of an AI/imaging device.
Therefore, many of the requested categories (2-7, 9) are not applicable or cannot be extracted from this document, as they pertain to clinical studies or AI algorithm evaluation.
Here's the information that can be extracted or deduced:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Properties | The TephaFLEX® Light Mesh must demonstrate comparable mechanical properties (burst strength, suture pull-out strength, tensile strength, tear resistance strength) to its predicate devices, as specified by the FDA surgical mesh guidance document. This is implicitly the acceptance criterion for demonstrating safety and effectiveness based on equivalence. | "Comparative burst strength, suture pull-out strength, tensile strength and tear resistance strength was characterized." The conclusion states: "The mechanical... data collected determined the mesh to be substantially equivalent to the predicate devices." (Specific numerical values for these properties are not provided in the summary.) |
| Biocompatibility | The TephaFLEX® Light Mesh must demonstrate biocompatibility comparable to predicate devices, following guidelines for surgical mesh. | "Biocompatibility testing... was performed based on recommendations identified in the FDA surgical mesh guidance document." The conclusion states: "Based on the indications for use, technological characteristics, and safety and performance testing, the TephaFLEX light mesh has been shown to be substantially equivalent to predicate devices..." (Specific results or details of biocompatibility are not provided in the summary.) |
| In Vivo Strength Retention | The TephaFLEX® Light Mesh must exhibit strength retention in vivo comparable to predicate devices over a defined period. This is crucial for its intended function as a resorbable mesh. | "In vivo strength retention was characterized via a subcutaneous implantation study." The conclusion states: "...in vivo data collected determined the mesh to be substantially equivalent to the predicate devices." (Specific duration or quantitative results are not provided in the summary.) |
2. Sample Size for the Test Set and Data Provenance:
- Not applicable. No clinical test set involving human data for algorithm evaluation is described. The "test set" refers to mechanical and animal studies. Details on the sample sizes for these tests (e.g., number of animals, number of mesh pieces tested for mechanical properties) are not provided in the summary.
- Data Provenance: The studies were internal (Tepha, Inc.) and based on FDA guidance for surgical mesh. The "in vivo animal testing" implies animal studies, but the origin country for these studies is not specified. They were likely prospective, conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. This pertains to clinical studies involving expert review, which is not described.
4. Adjudication Method for the Test Set:
- Not applicable. This pertains to clinical studies involving expert review.
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 device is a surgical mesh, not an AI/imaging device, and thus no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm.
7. The type of ground truth used:
- Not applicable to clinical ground truth for AI algorithms. For the non-clinical studies:
- Mechanical testing: The "ground truth" would be the established performance characteristics of the predicate devices and accepted industry standards for surgical mesh properties.
- Biocompatibility: The "ground truth" would be established safety profiles for materials and predicate devices, assessed through standardized biocompatibility tests.
- In vivo strength retention: The "ground truth" would be the expected or observed strength retention profiles of the predicate devices in animal models.
8. The sample size for the training set:
- Not applicable. This refers to training data for an AI algorithm. No AI algorithm is part of this device.
9. How the ground truth for the training set was established:
- Not applicable. This refers to training data for an AI algorithm.
§ 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.