(73 days)
The PROLENE™ 3D Patch is indicated for the repair of groin hernia defects that require a reinforcing material to obtain the desired surgical result.
PROLENE™ 3D Patch is a device comprised of nonabsorbable (polypropylene) components. The polymer of the polypropylene filaments is identical to the material used in PROLENETM Suture. It consists of a flat mesh onlay patch secured to a formed expandable diamond-shaped mesh patch component. The expandable patch portion of the device is a hollow diamond-shaped component that is deployed through the use of an integrated, looped, polyester thread.
I am sorry, but the provided text is a 510(k) summary for a medical device (PROLENE™ 3D Patch) seeking FDA clearance. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria and device performance results as you've requested.
The text does not include information about:
- Acceptance criteria for device performance
- A study comparing the device against these criteria
- Sample sizes for test or training sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
The core message of this document is that the PROLENE™ 3D Patch is identical to a previously cleared device (PROLENE™ (Polypropylene) 3D Patch, K010722) in terms of its technological characteristics, materials, construction, manufacturing, and sterilization. The only differences mentioned are revisions to the labeling (Instructions for Use) for clarity, to address regulatory expectations, and to add a new contraindication. The indication statement was also modified for clarity but does not introduce new indications or expand the patient population.
Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided text, as this information is not present in the document.
§ 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.