AMS MALE TRANSOBTURATOR SLING SYSTEM

• K Number: K053371
• Device Name: AMS MALE TRANSOBTURATOR SLING SYSTEM
• Manufacturer: AMERICAN MEDICAL SYSTEMS, INC.
• Date Cleared: 2006-02-03 ( 60 days)
• Product Code: OTM , FTL
• Regulation Number: 878.3300
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: K982155 , K023516 , K011251 , K040537 , K040623

Intended Use

The AMS Male Transobturator Sling System is indicated for a sub-urethral sling implant for the treatment of male stress urinary incontinence (SUI).

Device Description

The AMS Male Transobturator Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement using a transobturator approach. The slings are made from polymeric mesh and have resorbable sutures.

AI/ML Overview

The provided text is a 510(k) summary for the AMS Male Transobturator Sling System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than reporting on a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML device evaluations.

Therefore, I cannot extract the requested information because the document does not contain:

• A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm.
• Information about sample sizes for test sets, data provenance, or ground truth establishment relevant to an AI/ML study.
• Details on expert involvement, adjudication methods, or MRMC studies for AI/ML performance.
• Separate standalone performance data for an algorithm.
• Training set information for an AI/ML device.

The study described is focused on demonstrating substantial equivalence of a surgical device and its components to existing, legally marketed predicate devices through:

• Bench testing (previously cleared and new)
• Biocompatibility testing
• Cadaver studies
• Clinical data (likely for predicate devices and potentially limited comparative data for the new device, but not detailed as an AI/ML performance study)
• A literature review

The "Supporting Information" section on page 0 mentions "clinical data," but this is not presented in a format that would allow for the detailed answers requested for an AI/ML device's acceptance criteria and study design.

Regulation Number and Section

§ 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.