(49 days)
Intended for the use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.
The proposed Ventralex Patch is a self-expanding, three laver device. Two layers consist of polypropylene mesh. The top layer of polypropylene mesh forms a positioning strap and pocket. The purpose of the strap and pocket is to facilitate placement, positioning and fixation of the device. After the device has been properly placed and attached, the positioning strap must be removed and properly discarded. The monofilament PET polymer "ring" is captured between the two layers of polypropylene mesh and adds stability to the device enabling greater simplicity and assurance in the proper placement. The third layer of the device is a single layer of expanded polytetrafluoroethylene (ePTFE) that is attached to the polypropylene mesh with an interlocking PTFE stitch pattern. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer.
This is a 510(k) premarket notification for a medical device called the Ventralex Patch, a surgical mesh for hernia repair. The request asks for details about acceptance criteria and a study proving the device meets those criteria.
However, the provided text does not describe a study with quantitative acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, which are typically associated with diagnostic or AI-driven devices. This document is for a physical surgical implant, and the performance data focuses on materials, manufacturing, and biological compatibility rather than statistical performance metrics from a clinical study comparing the device's efficacy in patients against specific thresholds.
Therefore, many of the requested details (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in this 510(k) summary.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Biocompatibility | "Biocompatibility test results show that the material used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues consistent with their intended use." |
| Bench Testing | "Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing the Ventralex Patch will meet the established specifications necessary for consistent performance during their intended use." |
| Material Equivalence | "The Ventralex Patch and the predicate Composix Kugel Mesh have a single layer of expanded polytetrafluoroethylene (ePTFE) and is attached to the polypropylene mesh with an interlocking stitch using polytetrafluoroethylene (PTFE) monofilament. The peripheral edge of the polypropylene mesh is heat sealed to the ePTFE layer." |
| "The proposed device has the same the same materials, and similar physical attributes and manufacturing methods." | |
| Manufacturing Standards | "The Ventralex Patch and the predicate Composix Kugel Mesh are both intended for the use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material... The proposed device has the same the same materials, and similar physical attributes and manufacturing methods." |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The summary refers to "biocompatibility and bench testing" but does not detail specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective clinical data) for these tests in the context of a "test set" as one would for an AI algorithm or diagnostic device. These tests would involve laboratory animals or materials testing according to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in the context of this device, refers to the scientific and regulatory standards for biocompatibility and material performance. It's not established by a panel of medical experts reviewing individual cases in the way it would be for an AI diagnostic. Certification and standard compliance are the "ground truth" here.
4. Adjudication method for the test set:
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in clinical studies, particularly for diagnostic devices. This 510(k) summary does not mention such a process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, not applicable. This is not an AI device or a diagnostic imaging device that would involve human readers interpreting output. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This is a physical surgical implant, not an algorithm.
7. The type of ground truth used:
- For biocompatibility: Established biological testing standards and regulatory guidelines.
- For bench testing: Validated engineering specifications and material science principles.
- For substantial equivalence: The performance characteristics and material composition of the legally marketed predicate device (Bard Composix Kugel Mesh).
8. The sample size for the training set:
- Not applicable / Not provided. The concept of a "training set" is relevant for machine learning algorithms, not for the regulatory approval of a physical medical device like this surgical mesh. The "training" here would be the prior research, development, and manufacturing experience of Davol, Inc.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As above, the concept of a "training set" and its associated ground truth isn't applicable to this type of device and submission.
§ 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.