LogoFDA 510(k) Search
K Number
K101440
Device Name
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
Manufacturer
GENERIC MEDICAL DEVICES, INC.
Date Cleared
2010-06-18

(25 days)

Product Code
OTN
Regulation Number
878.3300
Type
Special
Panel
GU
Reference & Predicate Devices
K083471,K072456
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The GMD Universal Urinary Incontinence Sling™-1012 is indicated for use in women as a suburethral sling for the treatment of Stress Urinary Incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The GMD Universal Urinary Incontinence Sling™-1012 is a sterile, single use device for the treatment of female Stress Urinary Incontinence. The Universal Urinary Incontinence Sling™ 1012 is comprised of a polypropylene knitted mesh protected by a disposable polypropylene sheath with a surgical suture loop at each end for attachment of the sling to GMD's reusable T-slot trocars (sold separately). The surgical suture loop is used for inside-out / bottom-up and outside-in / top-down approaches. The method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.

AI/ML Overview

The provided text describes a medical device, the GMD Universal Urinary Incontinence Sling™-1012, and its submission for 510(k) clearance rather than a study proving its performance against specific acceptance criteria in the context of a diagnostic or AI-enabled device.

There is no mention of a clinical study, acceptance criteria, or an AI device/algorithm in the provided text. The submission is for a physical medical device (a surgical mesh).

Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance using the provided text. The document focuses on regulatory clearance based on substantial equivalence to predicate devices, not on a detailed performance study with defined metrics.

Here's a breakdown of why I cannot fulfill each requested point:

  1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "nonclinical testing" (bench and animal studies) on a previous version of the device (K083471) and "additional nonclinical testing" on the modification using cadavers. It concludes that "the data demonstrates that the GMD Universal Urinary Incontinence Sling™-1012 is substantially equivalent to the predicate. device(s) and that there is no change in the safety and effectiveness due to the modification." This indicates a comparison to a predicate, not a set of specific objective acceptance criteria for performance metrics.
  2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set is mentioned. The "cadavers" are mentioned for "additional nonclinical testing," but no sample size or details of this testing are provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a test set with ground truth established by experts.
  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is mentioned.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-enabled device; no MRMC study or human reader performance is mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is discussed in the context of a performance study.
  8. The sample size for the training set: Not applicable. This is not an AI device; no training set is mentioned.
  9. How the ground truth for the training set was established: Not applicable. This is not an AI device; no training set or ground truth for it is mentioned.

§ 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.