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The Align™ Urethral Support System is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Align™ Urethral Support System includes a sterile, single use permanent implant that provides strong, stable support for the urethra in patients with stress urinary incontinence. The mesh consists of a knitted, open porosity, monofilament, polypropylene mesh strip. The open porosity of the mesh design and large pore sizes allows for macrophage penetration and tissue ingrowth to promote the creation of a permanent support for the urethra. The knitted polypropylene mesh is made from a small fiber diameter which creates a soft and pliable material.

Several configurations of this device will be offered, including retropubic, suprapubic, and transobturator, which are used to implant the device.

The principles of operation and fundamental scientific technology have not changed from the predicate.

The provided text describes a 510(k) summary for the "Bard Align™ Urethral Support System," a surgical mesh used for treating female stress urinary incontinence. However, this document does not contain the kind of detailed performance study information that would allow me to answer your specific questions regarding acceptance criteria, sample sizes, ground truth establishment, or AI-related metrics.

The document states:

• "The appropriate testing, including guidance testing, to determine substantial equivalence of the Align™ Urethral Support System was conducted."
• It mentions "PERFORMANCE DATA SUMMARY" but then provides no actual performance data or details about specific studies conducted. Instead, it moves directly to regulatory correspondence.

Therefore, I cannot provide the requested information from the given text. The text does not describe a study that proves the device meets acceptance criteria in the way medical device AI submissions typically do.

Here's what I can extract, even though it doesn't directly answer your specific questions related to performance criteria:

1. A table of acceptance criteria and the reported device performance:

• This information is not present in the provided document. The document states that "appropriate testing... to determine substantial equivalence... was conducted," but it does not report the acceptance criteria or the specific performance metrics achieved by the device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• This information is not present in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not present in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not present in the provided document.

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:

• This device is a surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• This device is a surgical mesh, not an algorithm. Therefore, standalone algorithm performance is not applicable and not mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• This information is not present in the provided document.

8. The sample size for the training set:

• This information is not present in the provided document. This device is a surgical mesh, not a machine learning model, so the concept of a "training set" in this context is not applicable.

9. How the ground truth for the training set was established:

• This information is not present in the provided document.

In summary, the provided document is a 510(k) summary for a traditional medical device (surgical mesh) and does not contain the detailed performance study information typically required for AI/ML-based medical devices, which is what your questions are designed to elicit.

Ask a specific question about this device