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510(k) Data Aggregation
(55 days)
The Bard® 3DMAX™ Light Mesh will be indicated for use in the reinforcement of soft tissue where weakness exists, such as the repair of hernia defects.
The Proposed Bard® 3DMAX™ Light Mesh, is designed to fit the inguinal anatomy. The device is anatomically shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 0.0048 inches in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an "M" shape to designate the medial edge of the mesh and an arrow pointing to the medial aspect. Both the arrow and "M" will aid the user during positioning and placement of the device. The orientation marker is composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant.
Here's a breakdown of the acceptance criteria and the study details for the Bard® 3DMAX™ Light Mesh, based on the provided document:
This device (Bard® 3DMAX™ Light Mesh) is a surgical mesh and not an AI/ML powered device. Therefore, many of the typical questions related to AI/ML device testing (e.g., number of experts, adjudication methods, multi-reader multi-case studies, separate training/test sets, or ground truth establishment for AI) are not applicable to this submission. The device is evaluated through physical and performance testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail table format with specific ranges. Instead, it describes a comparative study showing that the Proposed Bard® 3DMAX™ Light Mesh performs similarly to predicate devices across various physical and performance characteristics. The acceptance criterion implicitly is "demonstrates substantial equivalence to predicate devices."
| Characteristic | Proposed Device (Bard® 3DMAX™ Light Mesh) Performance | Predicate Device(s) (Bard® Soft Mesh, 3DMAX™ Mesh, Mersilene Mesh) Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Physical Attributes | Substantially Equivalent | ||
| Thickness | Tested | Tested | Similar to Predicates |
| Pore Size | Larger knit construction than Bard 3D Max™ Mesh | Defined for Predicates | Considered acceptable |
| Density | Tested | Tested | Similar to Predicates |
| Material Weight | 0.0272 grams/square inch | Mersilene Mesh: 0.0274 g/sq in; Soft Mesh: 0.0282 g/sq in | Comparable to Predicates |
| Mechanical Performance | Substantially Equivalent | ||
| Stiffness | Tested | Tested | Similar to Predicates |
| Tensile Strength | Tested | Tested | Similar to Predicates |
| Percent Elongation | Tested | Tested | Similar to Predicates |
| Suture Pullout Strength | Tested | Tested | Similar to Predicates |
| Burst Strength | Tested | Tested | Similar to Predicates |
| Tear Resistance | Tested | Tested | Similar to Predicates |
| Biocompatibility | Acceptable results for polypropylene material and colorant | Acceptable results for predicate materials | Meets Biocompatibility Standards |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact numerical sample sizes for each laboratory test. It generally states that "Laboratory bench testing was performed."
- Data Provenance: The tests were conducted internally by Davol Inc. (a subsidiary of C.R. Bard, Inc.). The data is from laboratory bench testing, presumably conducted prospectively for this submission. The country of origin of the data is not specified but implicitly is the USA, given the submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. This is not an AI/ML device relying on expert interpretation for ground truth. Performance is assessed through objective, quantifiable laboratory bench tests.
4. Adjudication Method for the Test Set
- N/A. Adjudication methods are typically used for subjective assessments or when multiple experts are involved in establishing ground truth, which is not the case for material and mechanical property testing of a surgical mesh.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI/ML device that interacts with human readers for diagnostic or interpretive tasks. MRMC studies are not relevant for evaluating the physical and performance characteristics of a surgical mesh.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- N/A. This is not an algorithm. The device's performance is inherently "standalone" in that its physical and mechanical properties are measured directly.
7. The Type of Ground Truth Used
- Objective Laboratory Measurements: The "ground truth" for this device's performance relies on established engineering and materials testing standards. For example, tensile strength is measured against a standard procedure, and the result is an objective numerical value. Biocompatibility is assessed against recognized biological evaluation standards (e.g., ISO 10993 series). The comparison is then made against the measured performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
- N/A. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- N/A. There is no training set as it is not an AI/ML device.
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