(44 days)
The Mentor Aris Trans-obturator Surgical Kit consists of the Mentor Aris Trans-obturator Tape, an implantable, suburethral, support tape, plus introducers. The Tape and the Surgical Kit are indicated for the surgical treatment of all types of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The Mentor Aris Trans-obturator Kit consists of two components: the Mentor Aris Transobturator Tape and a set of introducer needles.
The Mentor Aris Trans-obturator Tape is an implantable, suburethral, support tape made from knitted monofilament polypropylene fibers. This structure gives the Aris Tape resistance to traction, allows tissue colonization and facilitates positioning during surgery.
A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Surgical Kit.
The provided text describes a 510(k) submission for a medical device called the Mentor Aris Trans-obturator Tape and Surgical Kit. However, it does not contain any information about acceptance criteria, device performance metrics, or any specific studies with sample sizes, expert involvement, or adjudication methods.
The key information from the document related to "proving" the device meets acceptance criteria is simply a claim of substantial equivalence to previously cleared devices.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about a study, because that information is not present in the provided text.
The document primarily focuses on:
- Device Identification: Proprietary and common name, classification, product code.
- Device Description: Components (tape and introducer needles), material of the tape (knitted monofilament polypropylene).
- Substantial Equivalence Claim: Stating it is equivalent to Mentor ObTape Trans-Obturator Tape (cleared under K031767 and K042851) and other similar products.
- Indications for Use: Surgical treatment of all types of stress urinary incontinence.
- Summary of Testing (General): A very broad statement that "All mechanical, biological, and chemical testing specifications comply with established ISO, USP, EN and/or NF standards." This statement indicates that some testing was done to meet general standards, but provides no specific results or acceptance criteria.
- FDA Communication: The FDA's letter of acknowledgment and substantial equivalence determination.
To answer your questions fully, the 510(k) summary would need to include a section detailing performance testing, clinical studies, or engineering studies, which is absent here.
§ 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.