(29 days)
Proxy Biomedical VITAMESH™ 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.
The VITAMESH TM is a non-absorbable, synthetic mesh, constructed of knitted filaments of Polyproylene. The VITAMESH™ is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the patient's needs. The mesh is approximately 0.010" thick, and exhibits high burst strength and tensibe strength The VITAMESH™ is knitted by a process which provides for elasticity in both digetions. Use of VITAMESH™ allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.
The provided text describes a 510(k) submission for a surgical mesh device, VITAMESH™, and not a diagnostic AI device. Therefore, the questions related to acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies, which are standard for AI/ML device evaluations, are not directly applicable to this document.
However, I can extract the information relevant to the device's performance assessment and substantial equivalence claim as presented in the document.
Here's a summary based on the provided text, adapted to the context of a medical device submission rather than an AI/ML diagnostic:
Acceptance Criteria and Study for VITAMESH™ Surgical Mesh
VITAMESH™ is a non-absorbable, synthetic surgical mesh made of knitted polypropylene filaments. Its acceptance criteria and proof of meeting them are based on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility assessments, rather than diagnostic performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Mechanical Properties | High Burst Strength | Demonstrated high burst strength (stated as substantially equivalent). |
| Tensile Strength | Demonstrated high tensile strength (stated as substantially equivalent). | |
| Elasticity in both directions | Knitted by a process providing elasticity in both directions. | |
| Material Characterization | Thickness | Approximately 0.010" thick. |
| Substantially equivalent to predicate mechanics and materials | Bench test data demonstrate mechanical and material characterization values are substantially equivalent to predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh). | |
| Biocompatibility | Non-toxic | Biocompatibility test results show the material is non-toxic. |
| Non-sensitizing to biological tissues | Biocompatibility test results show the material is non-sensitizing to biological tissues. | |
| Consistent with intended use | Biocompatibility results are consistent with the intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of a numerical count of devices or test samples. The document refers to "Bench test data" and "biocompatibility test results" generally.
- Data Provenance: Not explicitly stated, but assumed to be laboratory testing conducted by or for Proxy Biomedical, Ltd. No information about country of origin, retrospective or prospective nature of data collection, as these are not relevant for bench testing of medical devices in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This question is not applicable as the evaluation is not based on interpreting diagnostic images or clinical scenarios requiring expert ground truth in the traditional sense. The "ground truth" here is the established scientific and engineering principles for material and mechanical performance, and biological response to materials.
4. Adjudication Method for the Test Set
- This question is not applicable as there is no human interpretation or adjudication of diagnostic outputs involved. The "adjudication" is through standardized test methods and comparison to predicate device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic devices (often imaging-based) where human readers interpret cases, and an AI's impact on their performance is assessed. This is not relevant for a surgical mesh device's pre-market submission for mechanical and biocompatibility properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. VITAMESH™ is a physical surgical implant, not an algorithm or AI device. Its performance is inherent in its physical properties, not in a standalone algorithm's output.
7. The Type of Ground Truth Used
- The "ground truth" for VITAMESH™'s evaluation is primarily based on:
- Validated laboratory test methods: For mechanical properties (burst strength, tensile strength, elasticity) and material characterization.
- Established biocompatibility standards: For assessing non-toxicity and non-sensitizing properties to biological tissues, likely following ISO 10993 standards.
- Predicate device specifications: The performance of legally marketed predicate devices (Bard PTFE Mesh, Mersilene Mesh, Bard Mesh) serves as a benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
- This question is not applicable. This device is not an AI/ML algorithm that requires a "training set." The polypropylene material and knitting process are engineered and manufactured, not "trained."
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable, as there is no training set for a physical surgical mesh 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.