Search Results

The GMD Universal Urinary Incontinence Sling-1011 is a suburethral sling indicated for use in women for treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. The mesh is placed transvaginally using reusable introducers (sold separately) either through a transobturator or retropubic approach.

The use of the device in males and children under 18 years of age is not supported by clinical studies.

The GMD Universal Urinary Incontinence Sling™-1011 is a sterile, single use device for the treatment of female Stress Urinary Incontinence. The Universal Urinary Incontinence Sling™ -1011 is comprised of the same polypropylene knitted mesh as its Model 1010 and Model 1012 predicates, protected by the same disposable polypropylene sheath as its Model 1012 predicate with a disposable low density polypropylene universal sleeve at each end made of the same material and similar in design to the sleeve of its Model 1010 predicate, for attachment of the sling to GMD's reusable trocars (sold separately). Similar to both predicates, the Universal Urinary Incontinence Sling™ -- 1011 is used for inside-out / bottom-up and outside-in / top-down approaches. Similar to both predicates, the method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.

The provided text describes a medical device, the GMD Universal Urinary Incontinence Sling™-1011, and its substantial equivalence to predicate devices based on non-clinical studies. It does not contain information about acceptance criteria for a device's performance, nor does it detail a study that defines or proves the device meets specific performance metrics in the way the requested information (e.g., sample size for test/training sets, expert qualifications, MRMC study, standalone performance) would imply for a diagnostic or AI-driven device.

Therefore, I cannot fulfill the request as the provided text pertains to a regulatory submission for a surgical mesh device, focusing on its design modifications and substantial equivalence to existing predicate devices through bench and cadaver studies, rather than performance criteria of a device with measurable output like an AI algorithm or diagnostic tool. The document is a 510(k) summary for a physical medical implant, not a study evaluating performance of a diagnostic or decision-support system.

To answer your request, the input document would need to be a study report or regulatory submission for a device that has quantifiable performance metrics and a methodology for evaluating those metrics (e.g., an AI algorithm for image analysis).

Ask a specific question about this device