(61 days)
GYNEMESH PROLENE Soft (Polypropylene) Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
GYNEMESH 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.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. 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. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.
GYNEMESH 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. The bi-directional elastic property allows adaption to various stresses encountered in the body.
The provided text is a K013718 510(k) Summary for GYNEMESH PROLENE Soft (Polypropylene) Mesh. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states that nonclinical laboratory testing was not performed, and it relies on published clinical data on the predicate devices (PROLENE Mesh and MERSILENE mesh) to support the use of the new material.
Therefore, many of the requested sections regarding acceptance criteria and performance studies of the specific device (GYNEMESH PROLENE Soft Mesh) cannot be extracted from this document, as such studies were not conducted or reported for this device in this submission.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and the reported device performance
This information is not available within this document. The document states: "Nonclinical laboratory testing was not performed as there is no change to the clinical intended use as compared to the two predicate devices." Instead, it refers to "Sufficient bench testing...in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh.'" and "Published clinical data on the use of PROLENE Mesh and MERSILENE mesh was submitted to support the used of these materials as reinforcing or bridging materials in fascial deficiencies of the pelvic wall." No specific performance data or acceptance criteria for GYNEMESH PROLENE Soft Mesh are reported.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available for GYNEMESH PROLENE Soft Mesh as no specific clinical test set was used for this device in this submission. The document refers to "Published clinical data on the use of PROLENE Mesh and MERSILENE mesh," but does not provide details about these studies' sample sizes or provenance.
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)
This information is not available as no specific clinical test set for GYNEMESH PROLENE Soft Mesh is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available as no specific clinical test set for GYNEMESH PROLENE Soft Mesh is 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
This is not applicable. The device is a surgical mesh, not an AI or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available for GYNEMESH PROLENE Soft Mesh. The submission relies on the established clinical history of the predicate devices.
8. The sample size for the training set
This information is not applicable/available as no training set for an algorithm is relevant to this device submission.
9. How the ground truth for the training set was established
This information is not applicable/available for the same reason mentioned above.
In summary, the K013718 submission for GYNEMESH PROLENE Soft Mesh relies on showing substantial equivalence to existing predicate devices (PROLENE Soft Mesh, PROLENE Mesh, and MERSILENE Mesh) based on similar materials, construction principles, and intended use, rather than presenting new clinical study data for the device itself.
§ 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.