(202 days)
DynaMesh®-VENTRAL serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-VENTRAL is indicated for repairing hernias in all current extraperitoneal surgical thecniques.
The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-VENTRAL is a textile structure knitted from non absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a zig-zag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates correct mesh positioning; the mesh is correctly positioned when the ziqzag-stripes are in the craniocaudal direction. The used green dye is Phtalocyanine green, CAS1328-53-6,PG7 of BASF. DvnaMesh®-VENTRAL is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-VENTRAL will be packed in a cardboard box. Within the cardboard box the device will be double-packed in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.
The provided text is a 510(k) Summary for the DynaMesh®-VENTRAL surgical mesh, which is a medical device for repairing hernias. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain the detailed study information typically found in an FDA PMA (Premarket Approval) application or a clinical trial report.
Here's a breakdown of the requested information based on the provided text, with explanations for what is not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds against which the DynaMesh®-VENTRAL was evaluated. Instead, it lists "Laboratory Bench Tests" that were conducted to "demonstrate performance to an accepted norm and/or substantial equivalence to the predicate products." The performance details for each test (e.g., specific burst strength values, tensile strength values) are not reported in this summary.
| Test Type | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not detailed in document) |
|---|---|---|
| Burst Strength Test | To meet accepted norms and/or be substantially equivalent to predicate | Performance demonstrated (details not provided) |
| Tensile Strength | To meet accepted norms and/or be substantially equivalent to predicate | Performance demonstrated (details not provided) |
| Maximum elongation | To meet accepted norms and/or be substantially equivalent to predicate | Performance demonstrated (details not provided) |
| Suture Pullout Strength Test | To meet accepted norms and/or be substantially equivalent to predicate | Performance demonstrated (details not provided) |
| Tear Resistance Testing | To meet accepted norms and/or be substantially equivalent to predicate | Performance demonstrated (details not provided) |
| Porosity Test | To meet accepted norms and/or be substantially equivalent to predicate | Performance demonstrated (details not provided) |
| Mesh stiffness | To meet accepted norms and/or be substantially equivalent to predicate | Performance demonstrated (details not provided) |
2. Sample size used for the test set and the data provenance
The document mentions "various Laboratory Bench Tests" but does not specify the sample sizes used for these tests. Data provenance (country of origin of the data, retrospective or prospective) is also not mentioned for these bench tests. Given they are bench tests on the device materials, "country of origin of the data" would likely refer to the testing facility, which is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or not provided in this type of submission. Bench tests typically involve laboratory technicians or engineers performing standardized tests, not medical experts establishing ground truth in a clinical context.
4. Adjudication method for the test set
This information is not applicable or not provided. Adjudication methods are typically used in clinical studies involving human interpretation or outcomes, not for material property bench tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done or mentioned. This document describes a 510(k) submission based on substantial equivalence to a predicate device, primarily supported by bench testing of material properties, not clinical comparative effectiveness studies involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The DynaMesh®-VENTRAL is a physical surgical mesh, not a software algorithm or AI device.
7. The type of ground truth used
For the bench tests, the "ground truth" would be the physical properties and performance of the device as measured by standardized laboratory methods. This isn't "expert consensus," "pathology," or "outcomes data" in the clinical sense. These tests aim to objectively measure the material characteristics of the mesh. The comparison is made against "accepted norms" and the performance of the predicate device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As mentioned above, this is not an AI/ML algorithm.
§ 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.