(223 days)
The Biomerix Ventral Hernia Repair Mesh is intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.
The Biomerix Ventral Hernia Repair Mesh is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film. The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of a tissue attachment to the device during the wound healing period. The Biomerix Ventral Hernia Repair Mesh is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes.
The Biomerix Ventral Hernia Repair Mesh is a medical device, and the provided text describes its acceptance criteria and the studies performed to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria as would be typical for an AI/software device. Therefore, a direct mapping to the requested table and sections for AI/software is not fully possible. However, I will extract the relevant information from the document as best as the content allows.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Bench Testing | Device meets performance specifications of surgical meshes (as per FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, issued March 2, 1999). | "Test results demonstrate that the device meets the specifications, performs comparably to predicate devices and is acceptable for clinical use." |
| Biocompatibility | Device is biocompatible according to ISO 10993-1 standards. | "Biocompatibility testing in accordance ISO 10993-1 standards was conducted, and results demonstrate that the device is biocompatible according to these standards." |
| Animal Testing | Device performs equivalently to a predicate device regarding minimization of tissue attachment and histological response. | "Animal testing demonstrates that the Biomerix Ventral Hernia Repair Mesh performs equivalently to a predicate device in terms of minimization of tissue attachment to the device and histological response." |
| Overall Conclusion | Substantial equivalence to identified predicate devices in terms of intended use, safety, and effectiveness. | "Based on the material, biocompatibility, bench, and animal testing, and the proposed device labeling, the Biomerix Ventral Hernia Repair Mesh is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of data for an AI/software device. The studies mentioned are:
- Bench testing: Involves physical testing of the mesh material. No data provenance or sample size for a "test set" is applicable in the AI sense.
- Biocompatibility testing: Involves evaluating the biological response to the material. No data provenance or sample size for a "test set" is applicable in the AI sense.
- Animal testing: Used to assess tissue attachment and histological response. The sample size for the animal study is not specified, nor is the "provenance" in the geographical sense. It is a prospective study using animal models.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the device is a physical surgical mesh, not an AI/software device that relies on expert interpretation for its ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for a physical medical device. The "ground truth" for the performance of this device is established through objective physical, chemical, biological, and animal model testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This is not applicable as the device is a physical surgical mesh, not an AI/software device intended to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical surgical mesh, not an AI algorithm. Its performance is inherent to the material and design.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" for its performance is established by:
- Bench test specifications: Objective engineering and material properties.
- ISO 10993-1 standards: Objective biological safety criteria.
- Comparative animal study results: Histological and tissue attachment observations in animal models, compared to a predicate device.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical surgical mesh and does not involve AI model training.
9. How the Ground Truth for the Training Set was Established
This is not applicable as the device is a physical surgical mesh and does not involve AI model training.
§ 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.