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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 and Align® TO Urethral Support System (Align® System) include a sterile, single use permanent implant that provides support for the urethra in female patients with stress urinary incontinence. The mesh consists of a knitted, open porosity, monofilament, polypropylene mesh strip, which is self-anchoring. The open porosity of the mesh design and large pore sizes allow for macrophage penetration and the creation of an inert scaffold for tissue ingrowth to create a permanent support for the urethra. The knitted polypropylene mesh is made from a small diameter fiber which creates a soft and pliable material. The mesh sling is encased in a removable, protective sheath assembly. The sheath assembly consists of a PTFE tube with a Peel-Away tab that is used to separate the two sections of the sheath for removal of the sheath assembly after the implant has been placed. At the ends of the sheath are flexible green polyurethane tubes to aid in placing the device and for easy visualization during cystoscopy. The sheath incorporates a stainless steel dilator that smoothes the transition from the green tubing to the protective sheath to aid in sheath removal. Push on polypropylene connectors at each end of the green tubes are used to connect the device to the introducers. Because of the different surgical approaches that may be used to place the device, the same implant is offered in several kit configurations depending on the surgical approach (retropybic, suprapubic, or transobturator) to be used for placement of the mesh implant.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

• Sheath removal is easy. | - Demonstrated ability of the sheath to easily glide through tissue during implantation.
• Demonstrated ease of sheath removal. |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The text mentions a "cadaver study" but does not specify the number of cadavers (i.e., the sample size) used for this test.
• Data Provenance: The cadaver study is a type of prospective non-clinical study, as it involves physical testing performed specifically for the device evaluation. The country of origin is not specified, but given the submission is to the FDA, it is likely that the study was conducted under U.S. or internationally recognized standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Experts: The text does not explicitly mention the use of experts to establish ground truth for the cadaver study in the way one might for a diagnostic imaging device. Instead, the "ground truth" for the non-clinical tests (dimensional, tensile, insertion force, cadaver study) would be based on engineering specifications and direct observation/measurement. For the cadaver study, the assessment of "ease of glide" and "ease of removal" would likely be subjective evaluations by the operators performing the study (e.g., surgeons or medical device engineers experienced with such procedures). No specific number or qualifications are provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable in the context of these non-clinical performance studies. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical studies or for diagnostic evaluations where multiple human readers interpret data. For mechanical and cadaveric testing, the results are typically objectively measured or observed, and consensus among experts for subjective assessments (like "ease of use") would be part of the testing protocol rather than a formal adjudication process described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data is not necessary to determine substantial equivalence." The comparison for effectiveness is primarily based on non-clinical performance against predicate devices' characteristics and performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Standalone Performance: Not applicable. This device is a surgical implant system, not an AI algorithm or a diagnostic tool that would have a "standalone" or "human-in-the-loop" performance metric. The performance is related to its physical and functional characteristics.

7. The Type of Ground Truth Used:

• Ground Truth: For the non-clinical tests (dimensional, tensile, insertion force), the ground truth is based on engineering specifications and direct measurements. For the cadaver study, the ground truth for "ease of glide" and "ease of removal" is based on direct observation and subjective assessment during the simulation of the surgical procedure.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is a medical device (a surgical mesh system), not an AI algorithm that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices, not machine learning.

9. How the Ground Truth for the Training Set Was Established:

• Training Set Ground Truth: Not applicable, as there is no training set for this type of medical device.

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