(90 days)
PROLENE™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.
The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).
PROLENE™ Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device 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, LLC). This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.
PROLENE™ 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 fiber junctions are not subject to the same work fatigue exhibited by more rigid metallic meshes. This bi-directional, elastic property allows adaptation to various stresses encountered in the body.
PROLENE™ Hernia System is a sterile, pre-shaped, three-dimensional device designed for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). It is constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material is undyed PROLENE™ (Polypropylene) Mesh constructed of knitted nonabsorbable polypropylene filaments.
This document describes a 510(k) premarket notification for PROLENE™ Polypropylene Mesh and PROLENE™ (Polypropylene) Hernia System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI or diagnostic device might.
Therefore, many of the typical questions regarding acceptance criteria and a study proving performance are not applicable in this context. The core of this submission is about demonstrating that the revised labeling does not change the fundamental safety and effectiveness of a device that is already legally marketed.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. For a 510(k) submission concerning a change to labeling for an existing surgical mesh, typical acceptance criteria would relate to demonstrating that the change itself does not adversely affect the device's safety or effectiveness, or create new risks. This is usually shown through a comparison to the predicate device and an explanation of why the updated labeling (including the new contraindication and reworded sections) does not alter the fundamental characteristics or performance of the device. Performance is implicitly understood to be equivalent to the predicate device, which has already been deemed safe and effective.
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 applicable/provided. This 510(k) does not describe a clinical performance study with a test set. The submission focuses on demonstrating equivalence to predicate devices based on technological characteristics and a labeling change.
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 applicable/provided. No performance study is described that would require a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No test set and subsequent adjudication would be relevant for this type of submission.
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 information is not applicable/provided. This is a surgical mesh device, not an AI or diagnostic imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. The concept of "ground truth" as it applies to performance studies for new diagnostic or AI devices is not relevant here. The "truth" in this context is that the device, with its updated labeling, remains substantially equivalent to already cleared predicate devices.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This information is not applicable/provided. As there is no training set, there is no ground truth to establish for it.
Summary of the Document's Approach to Acceptance Criteria:
Instead of demonstrating performance against specific numerical acceptance criteria through a clinical study, this 510(k) submission for the PROLENE™ devices relies on the concept of substantial equivalence to predicate devices (K962530 and K984220).
The "acceptance criteria" here are implicitly met by demonstrating that:
- The intended use of the devices remains the same.
- The fundamental scientific technology, design, materials, and construction are unchanged from the predicate devices.
- The performance characteristics are equivalent to the predicate devices.
- The labeling changes (addition of a new contraindication, reworded/reformatted sections) do not introduce any new indications or expand the patient population, nor do they negatively impact the device's safety or effectiveness as established by the predicate.
The document explicitly states:
- "PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (K962530) predicate device with respect to technological characteristics." (Page 5)
- "PROLENE™ (Polypropylene) Hernia System. Nonabsorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh (K984220) predicate device with respect to technological characteristics." (Page 5)
- The conclusion further reiterates that based on intended use, technology, and characteristics, the devices "are considered to be substantially equivalent to their predicate devices". (Page 7)
Therefore, the "study" proving the device meets acceptance criteria is the 510(k) submission itself, which provides a comparative analysis to already cleared predicate devices, demonstrating that the current devices, even with updated labeling, remain safe and effective for their intended use. It is a regulatory demonstration of equivalence, not a clinical performance study.
§ 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.