(192 days)
PROCEED Ventral Patch is intended for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
PROCEED Ventral Patch is also indicated for the repair of tissue deficiencies caused by trocar use.
The proposed PROCEED* Ventral Patch (PVP) is a self-expanding, partially absorbable, laminate mesh device that is designed for the repair of hernias and other fascial deficiencies such as those caused by trocar use. The mesh device is comprised of several layers: an absorbable fabric of oxidized regenerated cellulose (ORC), PROLENE* Soft Mesh, two absorbable polydioxanone polymer rings, VICRYL* Mesh, polydioxanone polymer film, and polyester suture.
This submission, K061533, describes the PROCEED Ventral Patch, a surgical mesh device. The review of the provided text reveals that the submission focuses on substantial equivalence to predicate devices rather than establishing novel performance criteria through extensive clinical studies with specific acceptance criteria and ground truth.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not applicable in this context. The provided information centers on demonstrating that the new device has similar technological characteristics and performs comparably to already marketed devices.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biological Reactivity (Biocompatibility): Acceptable for intended use as per ISO Standard 10993-1. | Acceptable: "Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use." |
| Functional Performance (Bench and Animal Testing): Meets or exceeds all functional requirements. | Meets or Exceeds: "Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements." |
| Substantial Equivalence to Predicate Devices: Similar technological characteristics and intended use. | Substantially Equivalent: "Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated for functional or biological testing. The text only mentions "bench and animal testing" and assessment using "ISO Standard 10993-1." Specific sample sizes, details of animal models, or the location/type of these tests are not provided. This suggests standard-based testing rather than a large-scale clinical trial with a defined "test set" in the context of AI/diagnostic device evaluation.
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)
- Not applicable. This submission does not involve expert-adjudicated ground truth as would be relevant for a diagnostic or AI-driven device. The "ground truth" for this surgical mesh is established through compliance with biological and functional standards, and comparison to predicate devices, rather than expert consensus on diagnostic images or clinical outcomes in a comparative trial setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "adjudication method" in the sense of resolving discrepancies among experts for a test set, as this is not a diagnostic device relying on human interpretation of complex data for ground truth establishment.
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. An MRMC comparative effectiveness study is relevant for diagnostic devices, particularly those involving AI assistance to human readers (e.g., radiologists interpreting images). This submission is for a surgical mesh, which is a physical implant, not a diagnostic or AI-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI algorithms or diagnostic systems. The PROCEED Ventral Patch is a surgical implant and does not operate as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance and safety is established through:
- Compliance with ISO Standard 10993-1 for biological reactivity.
- Meeting/exceeding functional requirements as determined by "bench and animal testing."
- Comparison of technological characteristics and intended use to predicate devices to establish substantial equivalence.
- Safety track record of the materials (PROLENE, VICRYL, ORC, polydioxanone polymer) which are identical to those in currently marketed devices.
8. The sample size for the training set
- Not applicable. A "training set" is a concept used in machine learning for AI model development. This submission is for a medical device (surgical mesh) and does not involve AI.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI component, there is no training set or ground truth established in that context.
§ 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.