(188 days)
The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.
AdVance™ XP Male Sling System is a sling system which treats male stress urinary incontinence by repositioning the urethra with a suburethral mesh. The AdVance XP Male Sling System is comprised of a permanently implanted monofilament polypropylene mesh sling, two needle passers used to implant the sling, and retraction system (retractor ring and stay hooks). The male sling is connected during the procedure to the needle passers through keved connectors at each end of the male sling which are removed after the male sling is positioned. The male sling reposition the bulbar urethra 2-4cms. The AdVance™ XP Male Sling System kit is composed of four primary components: Male Sling, Needle Passers, Retractor Ring, and Stay Hooks. The AdVance™ XP Male Sling and Needle Passers are the subject of this submission. The Retraction System (retractor ring and stay hooks) is purchased pre-sterilized off the shelf components and is cleared through K791665.
The provided text is a 510(k) summary for a medical device (AdVance™ XP Male Sling System). It details the device's characteristics, comparison to a predicate device, and various performance tests. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria related to an AI/ML device, as requested in the prompt. The device described here is a physical surgical implant, not an AI/ML system.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document.
The document discusses:
- Acceptance Criteria for the physical device: Primarily demonstrated through bench testing, sterilization evaluation, and shelf life testing, showing comparability to the predicate device in terms of technological characteristics and performance.
- Device Performance: Stated that "performance testing demonstrate that the technological characteristics and performance criteria of the AdVance™ XP Male Sling System are comparable to the predicate device (K182169) and functions as intended equivalent to devices currently on the market for the same intended use."
But none of the specific AI/ML-related questions (e.g., sample sizes for test/training sets, expert ground truth, MRMC study, standalone performance) can be answered from this content.
§ 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.