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K Number
K071902
Device Name
AMS MINIARC SLING SYSTEM
Manufacturer
AMERICAN MEDICAL SYSTEMS, INC.
Date Cleared
2007-08-24

(45 days)

Product Code
PAH
Regulation Number
878.3300
Type
Traditional
Panel
GU
Reference & Predicate Devices
K070065
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AMS MiniArc Sling System is intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The AMS MiniArc Sling System is a modification of Single Incision Sling System consisting of a sling and a surgical instrument (called a "Needle Passer") for suburethral sling placement. The slings are made from polymeric mesh.

AI/ML Overview

The provided text describes a 510(k) submission for the AMS MiniArc™ Sling System, a surgical mesh device for treating female stress urinary incontinence. However, it does not contain any information about acceptance criteria, device performance metrics, or a study to prove these criteria.

The document is primarily focused on:

  • Identifying the submitter, contact person, device name, classification, and predicate device.
  • Stating the intended use of the device.
  • Briefly describing the device as a modification of a previous system.
  • Confirming that the device components were tested for biocompatibility and performance requirements and found "substantially equivalent to the predicate device."
  • Communicating the FDA's decision regarding substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document does not discuss:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance. The text only states "The components...have been tested," but gives no details.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance. This is a surgical mesh, not an AI-assisted diagnostic device.
  6. Standalone (i.e., algorithm only) performance. Again, this is a surgical mesh.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.