(108 days)
ETHICON PHYSIOMESH™ may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
ETHICON PHYSIOMESH™, Flexible Composite Mesh, is a sterile, low profile, flexible composite mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is composed of a nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh. The polypropylene component is constructed of knitted filaments of extruded polypropylene. An additional dyed polydioxanone film marker has been added for orientation purposes.
The provided document describes a 510(k) summary for the ETHICON PHYSIOMESH™, Flexible Composite Mesh. This document focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment) are not applicable to this submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Text) | Reported Device Performance (from Text) |
|---|---|
| Intended Criteria (not explicitly defined) | "ETHICON PHYSIOMESH™, Flexible Composite Mesh underwent a comprehensive bench, and animal testing program and passed all intended criteria in accordance with appropriate test protocols and standards." |
"During bench testing the device was subject to testing such as device thickness, pore size, burst strength, device weight, tensile strength, device stiffness, suture pullout strength, burst strength and tear resistance."
"Additionally, in-vitro and in-vivo testing was provided showing that the device performed as intended."
"ETHICON PHYSIOMESH™, Flexible Composite Mesh met all testing criteria, demonstrated substantial equivalence to its predicate devices and did not raise any new questions of safety or effectiveness." |
| Substantial equivalence to predicate devices: | Demonstrated substantial equivalence to: |
| - PROCEED Mesh (K031925 & K060713) for Indications for Use | - For Indications for Use and technological characteristics |
| - ULTRAPRO Hernia System (K071249) for technological characteristics related to the polyglecaprone 25 Film | - For technological characteristics related to the polyglecaprone 25 Film |
| - ULTRAPRO Mesh (K033337) for technological characteristics related to the mesh materials polyglecaprone 25 & polypropylene | - For technological characteristics related to the mesh materials polyglecaprone 25 & polypropylene |
| Safety and Effectiveness (implicitly, by not raising new questions) | "did not raise any new questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
This information is not provided. The document refers to "bench, and animal testing program" and "in-vitro and in-vivo testing," but no specific sample sizes for these tests are mentioned. As this is not an AI/ML device, concepts like "test set" and "data provenance" in the context of clinical data are not explicitly applicable in the way they are for AI/ML device studies. This submission relies on engineering and biological testing rather than clinical study data a machine learning model would use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device. The "ground truth" for the performance characteristics of the mesh would be established through standardized physical, chemical, and biological testing methods.
4. Adjudication method for the test set
Not applicable. This is not an AI/ML device.
5. If a multi-reader multicase (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, and no human readers are involved in its primary function or evaluation in the way an MRMC study would apply.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this medical device would be based on:
- Physical and Mechanical Properties: Measured values from bench testing (e.g., thickness, pore size, burst strength, weight, tensile strength, stiffness, suture pullout strength, tear resistance) against predefined specifications and industry standards.
- Biological Compatibility: Results from in-vitro and in-vivo (animal) biocompatibility and performance studies, assessing tissue response, degradation profiles (for absorbable components), and overall biological integration as per recognized standards (e.g., ISO 10993 series).
- Substantial Equivalence: Comparison of these characteristics, and the indications for use, to those of already legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.