(80 days)
The TephaFLEX® mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desire surgical result.
The TephaFLEX mesh is a resorbable mesh prepared from poly-4- hydroxybutyrate (P4HB). The mesh is prepared from undyed, size 5-0 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.
Here's a breakdown of the acceptance criteria and study information for the TephaFLEX® Mesh, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in numerical or precise terms. Instead, it relies on a comparison to predicate devices and general performance characteristics. The study aimed to demonstrate "substantial equivalence" to predicate devices.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Substantially equivalent to predicate devices | Characterized via comparative burst strength, suture pull-out strength, tensile strength, and tear resistance strength. |
| In Vivo Strength Retention | Substantially equivalent to predicate devices | Characterized via a subcutaneous implantation study. |
| Overall Performance & Safety | Substantially equivalent to predicate devices | Mechanical and in vivo data collected determined the mesh to be substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the sample size for any of the mechanical or in vivo tests.
- The data provenance is also not specified (e.g., country of origin, retrospective or prospective). The in vivo study is explicitly an animal study (subcutaneous implantation study).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the studies are primarily mechanical and in vivo animal studies, not human clinical trials requiring expert ground truth for interpretation of images or patient outcomes. The "ground truth" for these tests would be the measurement results themselves against scientific standards or predicate device results.
4. Adjudication Method for the Test Set
- This information is not applicable for the type of tests described (mechanical and animal in vivo studies). Adjudication methods are typically used in clinical studies for ambiguous cases, which is not the context here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study was not done. The document describes mechanical testing and an in vivo animal study, not human reader studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a physical surgical mesh, not an algorithm or AI-powered diagnostic tool. The performance described is that of the physical device itself.
7. The Type of Ground Truth Used
- For mechanical properties, the ground truth appears to be direct physical measurements (e.g., burst strength, tensile strength, suture pull-out force, tear resistance). These measurements would be compared against values obtained from predicate devices to establish substantial equivalence.
- For in vivo strength retention, the ground truth was derived from the results of a subcutaneous implantation animal study. This would involve measuring the mesh's integrity and strength after a period of implantation in animals.
8. The Sample Size for the Training Set
- This information is not applicable as the device is a physical surgical mesh and does not involve AI or machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no training set for this type of device.
In summary: The provided documentation describes a 510(k) submission for a surgical mesh. The "studies" involve mechanical characterization and an in vivo animal study to demonstrate substantial equivalence to legally marketed predicate devices, rather than human clinical trials or AI performance evaluations. Therefore, many of the requested categories related to AI and human reader studies are not relevant to this specific document.
§ 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.