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The URETEX® SUP device is intended to be used as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The URETEX® SUP Pubourethral Sling is used in gynecological procedures for the treatment of stress incontinence. The URETEX® SUP device is made from polypropylene sealed monofilament stitches (tape). It is composed of an insertion instrument, connector, sheath, and the pubourethral implant. The insertion instrument consists of a stainless steel needle with PVC tubing.

This document describes the 510(k) submission for the Sofradim Production URETEX SUP® Pubourethral Sling and Instruments (K012949), which is intended for the treatment of stress urinary incontinence in women. The study proving the device meets acceptance criteria is primarily a performance testing study to demonstrate substantial equivalence to predicate devices, rather than a clinical trial with specific acceptance criteria in terms of clinical outcomes or a standalone algorithm-only study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicit in the comparison to predicate devices, meaning the URETEX SUP® device must perform similarly to the legally marketed predicates in the specified tests to be considered substantially equivalent. The document does not provide specific numerical acceptance thresholds but rather states that the "test results showed that the Sofradim and predicate devices were similar in performance characteristics."

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

The document does not specify a distinct "test set" in the context of a clinical study with patients. Instead, the "test set" for this type of submission refers to the samples of the URETEX® SUP Sling, Ethicon Prolene®, and Sofradim Parietene® predicate devices that were subjected to mechanical and material property testing.

• Sample Size: Not explicitly stated as a number of units or material swatches. The testing was performed on "the URETEX® SUP Sling, the Ethicon Prolene®, and the Sofradim Parietene® predicate devices." This implies that a sufficient number of each device type were tested to obtain reliable measurements for the physical properties.
• Data Provenance: The testing was "performed in accordance with ISO standards" by Sofradim Production (based in Trevoux, France). This is likely retrospective in the sense that the devices already existed and were tested for this submission, rather than a prospective clinical trial. The location of the testing would be France.

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

This type of information is not applicable to this 510(k) submission. The ground truth for this submission is based on objective physical and mechanical property measurements performed in a laboratory setting, not on expert clinical assessment or interpretation.

4. Adjudication Method for the Test Set

This is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert assessments or clinical outcomes, which is not the nature of the performance testing described here.

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 is not applicable. This submission is for a medical device (surgical mesh), not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI-related comparative effectiveness was performed or reported.

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

This is not applicable. This document describes a physical medical device, not an algorithm, so a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used

The ground truth used for this submission is objective, measurable physical and mechanical properties of the materials, measured against established engineering and material science standards (ISO standards). It is not based on expert consensus, pathology, or outcomes data in a clinical sense for determining device performance in this specific submission section. The "ground truth" for substantial equivalence is the performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this 510(k) submission, as it's not a machine learning or AI-driven device. Device development and testing for this product would follow engineering and manufacturing processes, not a machine learning pipeline.

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

This is not applicable as there is no training set.

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