(114 days)
The PARIETEX™ COMPOSITE Mono PM Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
PARIETEX™ COMPOSITE Mono PM Mesh is made from a monofilament polyester fabric, covered with an absorbable hydrophilic film. The meshes are available in two different designs. Both are round in shape.
The first design is made from a three-dimensional monofilament polyester fabric and has a circular opening in the center. It is completely covered on one side with an absorbable hydrophilic film made of collagen from porcine origin, polyethylene glycol and glycerol.
The second design is made from a three dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the second design is completely covered with the hydrophilic film. On the opposite side, only the two dimensional central band is coated with the absorbable hydrophilic film.
On both designs the film extends 5 mm over the external edge of the reinforcement, and also extends around the internal edge of the circular opening if any.
The provided text describes a 510(k) submission for a surgical mesh, the PARIETEX™ COMPOSITE Mono PM Mesh, and its substantial equivalence to a predicate device. The review focuses on bench testing and material biocompatibility rather than clinical studies or AI-driven performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 | Materials evaluated for biocompatibility in accordance with ISO 10993-1. |
| Similar performance characteristics to the predicate device via mechanical properties testing | Results of mechanical properties testing show that PARIETEX™ COMPOSITE Mono PM Mesh has similar performance characteristics to the predicate PARIETEX™ COMPOSITE Mesh. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for performance testing.
- Data Provenance: The document describes "bench testing" for mechanical properties and "evaluated" for biocompatibility, implying in-vitro or laboratory settings. No information on country of origin or whether it was retrospective/prospective is provided, as these typically refer to clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for expert consensus in clinical data is not relevant for bench testing of medical device materials and mechanical properties. Evaluation standards (ISO 10993-1) and comparison to predicate device characteristics serve as the "ground truth" here.
4. Adjudication method for the test set:
- Not applicable. No expert adjudication process is described for the bench testing or material evaluation.
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-powered diagnostic or assistive device. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used:
- Bench Test Results/Comparison to Predicate: For mechanical properties, the "ground truth" is the established performance characteristics of the legally marketed predicate device (PARIETEX™ COMPOSITE Mesh) and generally accepted engineering standards for such devices.
- Biocompatibility Standards: For materials, the "ground truth" is compliance with international standard ISO 10993-1.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "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.