(22 days)
VitaMesh™ Blue Lightweight Macroporous PP 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.
VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh, a modification of VitaMesh™ Surgical Mesh, is a non-absorbable, synthetic mesh, with a blue colorant to enhance visibility. The more open weave and reduced thickness provides a more drapeable and lighter texture.
The provided document is a 510(k) premarket notification for a medical device, VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing an extensive clinical study with specified acceptance criteria and detailed performance metrics as would be found in a clinical trial report.
Therefore, many of the requested elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this type of regulatory submission. The document primarily describes design verification and comparative testing to a predicate device.
Here's an attempt to extract relevant information based on the prompt, with clarifications where data is not present:
Acceptance Criteria and Device Performance Study (VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh)
The submission describes the VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh as a modification of a previously cleared device (VitaMesh™ surgical mesh, K060520). The primary and overall "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device. This is achieved by showing that the modifications (addition of a blue colorant and physical property adjustments for lighter/more drapeable mesh) do not introduce new risks and that the fundamental performance remains comparable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Safety: No new risks introduced by modifications. | Biocompatibility: Qualification testing included biocompatibility, showing "comparable safety performance" to the predicate product. |
| Effectiveness/Performance: Fundamental performance not affected by modifications; comparable properties to predicate. | Design Verification Tests: Performed according to 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh, March 2, 1999'. These tests "showed comparable properties to the VitaMesh" (predicate). Details of specific metrics (e.g., tensile strength, pore size, burst strength) and their comparative values are not provided in this summary. Animal Implant Comparative Study: Showed "equivalent healing properties" when compared to the predicate product. Specific outcome measures (e.g., tissue integration, adhesion formation) and quantitative results are not detailed. |
| Indications for Use: Same as predicate. | Indications for Use: Identical to the predicate device: "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." |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The submission mentions "design verification tests" and an "animal implant comparative study" but does not give specific numbers of samples or animals used.
- Data Provenance: The studies appear to be pre-market regulatory tests conducted by the manufacturer, Proxy Biomedical Ltd., located in Ireland.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable/Not specified. This type of 510(k) submission does not typically involve expert review panels to establish clinical ground truth in the way a diagnostic AI device might. The "ground truth" here is based on physical property testing and animal study observations, which would be interpreted by qualified laboratory personnel and veterinary pathologists, respectively, but their specific numbers or qualifications are not detailed.
4. Adjudication Method
- Not applicable/Not specified. Adjudication methods (e.g., 2+1) are typically used in clinical studies where multiple human readers interpret data. This submission relies on objective engineering tests and animal study observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a study assessing human reader performance with or without AI assistance. This is a submission for a surgical mesh device.
6. Standalone (Algorithm Only) Performance Study
- No. This is not an AI/algorithm-based device. It is a physical surgical mesh.
7. Type of Ground Truth Used
- For the design verification tests: Objective physical and mechanical properties measured in a laboratory setting (e.g., mesh porosity, weight, tensile strength, drapeability). The detailed metrics and their measurement methodologies would be defined in quality system documents, though not provided in this summary.
- For the animal implant study: Histopathological and macroscopic observations from animal tissue after implantation, comparing healing responses to the predicate device.
8. Sample Size for Training Set
- Not applicable. This medical device is not an AI/machine learning algorithm, so there is no "training set."
9. How Ground Truth for Training Set Was Established
- Not applicable. As there is no training set for an algorithm, this question is not relevant.
§ 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.