(152 days)
VICRYL™ Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). VICRYL™ Mesh may be cut to the shape or size desired for each specific application.
VICRYL™ (polyglactin 910) Mesh is a synthetic absorbable sterile copolymer made from glycolide and L-lactide. The copolymer is identical in composition to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture.
VICRYL™ Knitted Mesh, which is more porous than VICRYL™ Woven Mesh, may be used in instances in which compliant and stretchable support material is desired.
The provided document is a 510(k) Premarket Notification for the VICRYL™ Mesh device. It asserts substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics.
Therefore, many of the requested categories regarding acceptance criteria, study design, ground truth, and statistical analysis are not applicable (N/A) because this type of submission focuses on demonstrating equivalence to existing devices, not on presenting novel performance data from a clinical or analytical study with defined acceptance criteria.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (N/A for 510(k) Substantial Equivalence) | Reported Device Performance (N/A for 510(k) Substantial Equivalence) |
|---|---|
| No explicit acceptance criteria based on specific performance metrics are defined in this 510(k). The submission relies on substantial equivalence to predicate devices. | No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the VICRYL™ Mesh itself, as the submission relies on substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- N/A. This 510(k) submission does not describe a test set or data provenance for a performance study. It's a regulatory submission demonstrating substantial equivalence based on technological characteristics and intended use, not clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- N/A. As no test set performance study is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. No test set performance study is described, therefore no adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is a medical device (surgical mesh), not an AI-based diagnostic tool. No MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a physical medical device (surgical mesh), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No new performance study requiring ground truth is described. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning their known safety and effectiveness serve as the "ground truth" for the category.
8. The sample size for the training set
- N/A. This 510(k) submission pertains to a physical medical device (surgical mesh) and does not involve an algorithm or an AI model with a training set.
9. How the ground truth for the training set was established
- N/A. As there is no training set for an algorithm, there's no ground truth establishment for it.
Summary of the 510(k) Submission:
The submission for VICRYL™ Mesh (K191373) focuses on demonstrating substantial equivalence to two predicate devices: VICRYL™ (Polyglactin 910) Mesh (K810428) and VICRYL™ Mesh Bag (K051701).
The core argument for equivalence is:
- Technological Characteristics: Both the subject and predicate devices are synthetic absorbable sterile copolymers made from glycolide and L-lactide.
- Intended Use: All devices are designed for temporary wound or organ support (kidney, liver, spleen) and can be cut to size.
- Manufacturing and Sterilization: The subject mesh is manufactured within existing processes for the predicate device, with no changes to manufacturing, packaging, sterilization, or shelf life.
- Differences: The only notable difference for the subject device is a revision to the Instructions for Use (IFU) to clarify indications and align with evolving regulatory expectations.
Therefore, Ethicon, Inc. did not conduct a performance study with acceptance criteria and a test set to "prove the device meets the acceptance criteria" in the manner typically expected for a novel device or AI algorithm. Instead, they demonstrated that their device is fundamentally the same as already cleared devices, making it "as safe and effective as the predicates."
§ 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.