(86 days)
PROLENE™ Soft Mesh is indicated for the repair of abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
PROLENE™ Soft Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device is composed of knitted filaments of extruded polypropylene. Blue PROLENE™ monofilaments have been integrated to produce contrast striping in the mesh.
PROLENE™ Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE™ Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). Blue PROLENE™ monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE™ Mesh. Polypropylene material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.
PROLENE™ Soft Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling.
This document is a 510(k) premarket notification for a medical device called PROLENE™ Soft Polypropylene Mesh. It is a submission to the FDA demonstrating substantial equivalence to previously cleared devices. Therefore, it does not describe a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance characterization study that would establish specific performance metrics against an established ground truth.
Instead, the core of this document is to demonstrate that the new device is "substantially equivalent" to existing, legally marketed predicate devices. This means that the acceptance criteria are essentially met if the new device is shown to be as safe and effective as the predicates, based on having the same technological characteristics and intended use, or different characteristics that do not raise new questions of safety and effectiveness.
Here's an breakdown based on your request, with the understanding that the context is a 510(k) submission for substantial equivalence rather than a de novo performance study:
1. Table of acceptance criteria and the reported device performance
The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device, as opposed to meeting specific numerical performance thresholds.
| Acceptance Criterion (for 510(k) Substantial Equivalence) | Reported Device Performance (PROLENE™ Soft Polypropylene Mesh) |
|---|---|
| Same intended use as predicate device(s) | Indications for Use are for "repair of abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result," which is consistent with the predicate devices. The indication statement was modified for clarity but does not introduce new indications or expand the patient population. |
| Same technological characteristics as predicate device(s) | "Identical to the PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene). Nonabsorbabale Synthetic Surgical Mesh (K001122) marketed mesh with respect to technological characteristics." This includes material (knitted filaments of extruded polypropylene), construction, specification, manufacturing, and sterilization process. |
| Does not raise new questions of safety or effectiveness | No material, construction, specification, manufacturing, or sterilization process changes. Changes are limited to labeling (Instructions for Use) to add a new Contraindication and reword/reformat for clarity. These changes do not introduce new safety or effectiveness concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of an AI/algorithm performance study. A 510(k) submission for substantial equivalence primarily relies on existing data and characteristics of the predicate devices. No new clinical or performance data from a specific test set is presented.
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)
Not applicable. The ground truth in this context is the regulatory clearance and established safety and effectiveness of the predicate devices. There is no new "ground truth" establishment for a test set described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described.
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
Not applicable. This device is a surgical mesh, not an AI-powered diagnostic tool, so an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established safety and effectiveness of the predicate devices (PROLENE™ Soft Polypropylene Mesh K163152 and PROLENE™ Soft (Polypropylene) Nonabsorbabale Synthetic Surgical Mesh K001122), as determined through their previous FDA clearances based on their own data and clinical history. The current submission's "ground truth" is that these predicate devices are already shown to be safe and effective.
8. The sample size for the training set
Not applicable. This document does not describe a training set as it's not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This document does not describe a training set.
§ 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.