(241 days)
Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing
The synthetic mesh is constructed of knitted filaments of an alternative polypropylene resin. This material change does not affect the device description (or the device description on the package and instructions for use.) The proposed VitaMESH™ with the material supplier change is knitted by the same process as the predicate VitaMESH™, which interlinks each fiber junction and which provides for elasticity in both directions are.
The document describes a 510(k) summary for the VitaMESH™ Macroporous PP Surgical Mesh. The submission is based on a material supplier change for the polypropylene resin used in the mesh. The primary goal is to demonstrate that the device, with the new material, is substantially equivalent to the predicate device (VitaMESH™ Macroporous PP Surgical Mesh, K060520).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a direct "acceptance criteria" table in the form of specific numerical thresholds for each test. Instead, it states that the tests were performed to show that the device with the alternative polypropylene continues to meet specifications or that the properties are the same as the predicate device. The performance is reported as meeting these specifications or showing substantial equivalence.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Aerial density | Met specifications; same as predicate. |
| Device stiffness | Met specifications; same as predicate. | |
| Tensile strength | Met specifications; same as predicate. | |
| Suture pullout strength | Met specifications; same as predicate. | |
| Tear resistance | Met specifications; same as predicate. | |
| Burst strength | Met specifications; same as predicate. | |
| Pore size | Met specifications; same as predicate. | |
| Mesh thickness | Met specifications; same as predicate. | |
| Surface finish inspection | Met specifications; same as predicate. | |
| Shelf Life | Aging study (5 years accelerated) | Continues to meet specifications. |
| Real-time aging study (5 years) | In progress to support data. | |
| Sterilization Residuals | Ethylene Oxide Residual Analysis | Within limits specified in I.S. EN ISO 10993-7: 2008. |
| Microbiological | Bioburden testing | Met Proxy Biomedical Ltd. acceptance criteria. |
| Pyrogen testing (LAL method) | Met all acceptance criteria. | |
| Biocompatibility | Cytotoxicity | Conformance with requirements per I.S. EN ISO 10993-1: 2009. |
| Irritation | Conformance with requirements per I.S. EN ISO 10993-1: 2009. | |
| Sensitization | Conformance with requirements per I.S. EN ISO 10993-1: 2009. | |
| Chemical characterization of alternative polypropylene resin | Conformance with requirements per I.S. EN ISO 10993-1: 2009. | |
| Chemical Analysis | Chemical constitution | Comparable. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each mechanical, microbiological, or chemical test. It generally refers to "VitaMESH™ units manufactured using an alternative polypropylene resin." The provenance is implied to be from Proxy Biomedical Ltd. in Ireland, as they are the submitter and manufacturer. The studies are prospective in the sense that they were conducted specifically for this submission to assess the performance of the device with the new material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The device under review is a surgical mesh, not an AI or diagnostic imaging device that requires expert interpretation for ground truth establishment. The evaluation relies on laboratory and in-vitro testing against established international standards and internal specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As this is a physical medical device, there is no need for adjudication methods typically used in diagnostic studies involving human readers. The performance is objectively measured through standardized lab tests.
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
This section is not applicable. The device is a surgical mesh, not an AI-assisted diagnostic tool. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Industry Standards: I.S. EN ISO 10993-7: 2008 for Ethylene Oxide Sterilization Residuals and I.S. EN ISO 10993-1: 2009 for Biocompatibility.
- Internal Specifications: Proxy Biomedical Ltd.'s own established acceptance criteria for various tests (e.g., bioburden, mechanical properties).
- Comparison to Predicate Device: The primary ground truth is the performance and characteristics of the legally marketed predicate device (VitaMESH™ Macroporous PP Surgical Mesh, K060520) which the new device aims to be substantially equivalent to.
8. The sample size for the training set
This section is not applicable. There is no "training set" in the context of this traditional medical device submission. Machine learning models use training sets, but this is a physical product evaluated through laboratory testing.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
§ 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.