(114 days)
The Universal Surgical Mesh is intended for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Universal Surgical Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (ETHICON, INC). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue in-growth. Universal Surgical Mesh in knitted by a process that interlinks each fiber junction and 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 adaptation to various stresses encountered in the body.
This document describes a 510(k) submission for the Universal Surgical Mesh. As such, it does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria.
This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through a detailed study.
Here's why the requested information is not available in the provided text:
- Acceptance Criteria and Reported Device Performance: This device is a surgical mesh. The submission asserts that it is "identical in composition" and has the "same intended use and same technological characteristics" as a predicate device (PROLENE Polypropylene Mesh). There are no specific performance metrics or acceptance criteria for things like sensitivity, specificity, or accuracy that would be relevant for an AI/software device.
- Clinical/Non-Clinical Studies: The document explicitly states: "The company did not conduct, nor depend on, clinical studies or non-clinical laboratory studies in order to establish substantial equivalence as there is no change to the clinical intended use as compared to the two predicate devices." This means there was no study performed to evaluate the device's performance against any set criteria.
- Ground Truth, Training Sets, Adjudication, MRMC studies, Standalone performance: These concepts are relevant for studies evaluating the performance of diagnostic or AI-driven devices. They do not apply to the Universal Surgical Mesh, which is a physical implant with a demonstrated equivalence to a previously approved device.
In summary, the provided text is for a traditional medical device (surgical mesh) seeking 510(k) clearance based on substantial equivalence, not the type of device (e.g., AI/diagnostic software) that would involve the extensive performance study details you've asked for.
§ 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.