(14 days)
The Ventralight ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
The Ventralight ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.
The provided text describes a 510(k) summary for the Ventralight ST Mesh, a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on quantitative performance metrics like sensitivity, specificity, or F-score often associated with AI/ML-based devices.
Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable in this context.
Here's an analysis based on the information provided, highlighting the aspects that are relevant to this type of medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of traditional surgical mesh device, "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device, focusing on similar safety and effectiveness. The performance is assessed through non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Properties Comparability: Device should maintain appropriate mechanical characteristics for its intended use and be comparable to the predicate device. | Bench Testing Results: |
- PGA pullout strength testing completed.
- Burst strength testing completed.
- Tear strength testing completed.
- Suture retention strength testing completed.
- Dry bond strength testing completed.
- Hydrogel disruption testing after laparoscopic deployment completed.
Conclusion: "Results of testing demonstrate that the Ventralight ST Mesh design meets product specifications and intended uses." |
| Biocompatibility: Device materials should be biocompatible and comparable to the predicate device. | Biocompatibility Testing: Completed (similar to predicate device, as there were no material changes). |
| Tissue Interaction (reduced attachment, ingrowth): The device should demonstrate similar tissue ingrowth and minimal tissue attachment as the predicate device. | Animal Study Results (4-week post-implantation porcine model, comparative): Evaluated:
- Tissue attachment
- Mesh contracture
- Tissue in-growth
- Host inflammatory and fibrotic response
Conclusion: Results indicated similar performance to the predicate device ("performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device."). |
| Sterilization: Device sterilization method should be effective and comparable to the predicate. | Sterilization: Stated as "the same as the predicate device." |
| Packaging: Device packaging should maintain integrity and sterility. | Packaging: Stated as "the same as the predicate device." Tested seal strength and package qualification. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated with specific numbers, but the document mentions a "4 week post-implantation study in a porcine model." This implies a limited number of animal subjects. Bench testing also does not specify the number of samples tested for each metric, but these are typically standardized tests performed on multiple samples.
- Data Provenance: The animal study was conducted in a "porcine model," indicating an animal study rather than human clinical data. Bench testing is laboratory-based. This is prospective testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable here because "ground truth" in this context would refer to objective measurements from bench tests or histological evaluations from the animal study. These would typically be performed and interpreted by laboratory technicians or veterinary pathologists, not "experts" in the sense of clinical reviewers establishing diagnostic truth for AI.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are used when multiple human readers interpret an image or clinical case and their interpretations need to be reconciled to establish a ground truth. For bench tests and animal studies, results are typically quantitative measurements or pathological findings with established protocols.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices, not for a surgical mesh.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study: Pathology/Histology (e.g., evaluating tissue attachment, ingrowth, inflammatory response) and observational data from the porcine model.
- For bench testing: Objective physical measurements (e.g., strength values, disruption levels) using laboratory equipment and established test methods.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set in the computational sense. The "training" for the device's development would be through design iterations, material science knowledge, and manufacturing processes.
9. How the ground truth for the training set was established
- Not applicable. Since there is no training set in the AI/ML context, there is no "ground truth" to establish for a training set. The device design and materials are based on established engineering principles and prior knowledge from the predicate 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.