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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.

The AMS MiniArc Sling System is a modification of MiniArc 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.

The provided text is a 510(k) summary statement and related FDA correspondence for a medical device called the "AMS MiniArc™ Sling System." It describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies involving test sets, expert ground truth, or statistical analyses typically associated with proving a device meets specific acceptance criteria for a new AI/software-based medical device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document indicates "Summary of Testing: The components of the AMS MiniArc Sling System have been tested for performance requirements and found to be substantially equivalent to the predicate device," but it does not detail what those performance requirements were or how they were tested.

To be explicitly clear, the provided text does not contain any of the following information:

• A table of acceptance criteria and reported device performance: This information is not present. The document focuses on regulatory approval (510(k)) and substantial equivalence, not detailed performance metrics and acceptance thresholds.
• Sample size used for the test set and data provenance: No test set is mentioned in the context of performance evaluation.
• Number of experts used to establish ground truth and their qualifications: No experts or ground truth establishment are discussed in relation to device performance testing.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm-only) performance: Not applicable as this is a physical medical device (surgical mesh), not an AI/software algorithm.
• Type of ground truth used: Not applicable for device performance testing in this context.
• Sample size for the training set: Not applicable as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

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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.

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.

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.

Ask a specific question about this device