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510(k) Data Aggregation
(12 days)
The URETEX® SUP device is indicated for the treatment of stress urinary incontinence in women.
The URETEX® TO Trans-Obturator Urethral Support System is indicated for the treatment of stress urinary incontinence from urethral hyper mobility 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.
The provided text describes the URETEX® SUP Pubourethral Sling, a medical device for treating stress urinary incontinence in women. The submission to the FDA focuses on establishing substantial equivalence to predicate devices rather than proving specific clinical effectiveness through a standalone study with defined acceptance criteria and performance metrics typically associated with AI/ML devices.
Therefore, the requested information elements (1, 2, 3, 4, 5, 6, 7, 8, 9) related to acceptance criteria, ground truth, and specific study designs for AI/ML performance are not applicable or available in this document. This device is a traditional medical device, not an AI/ML device.
However, I can provide information based on the performance testing mentioned in the document, framed as demonstrating substantial equivalence to predicate devices:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds that the URETEX® SUP device had to meet to be deemed effective or safe. Instead, the performance testing aimed to show that the URETEX® SUP device's characteristics were similar to those of its predicate devices. The "acceptance" was therefore based on demonstrating substantial equivalence, meaning the performance characteristics were not meaningfully different from existing, legally marketed devices.
| Characteristic | Acceptance Criteria (Demonstrates similarity to predicate devices) | Reported Device Performance (URETEX® SUP vs. Predicates) |
|---|---|---|
| Density | Similar to predicate devices (Ethicon Prolene®, Sofradim Parietene®) | Showed similarity to predicate devices (specific values not provided) |
| Thickness | Similar to predicate devices | Showed similarity to predicate devices |
| Elongation | Similar to predicate devices | Showed similarity to predicate devices |
| Breaking Strength | Similar to predicate devices | Showed similarity to predicate devices |
| Tear Resistance | Similar to predicate devices | Showed similarity to predicate devices |
| Burst Resistance | Similar to predicate devices | Showed similarity to predicate devices |
| Tensile Strength | Similar to predicate devices | Showed similarity to predicate devices |
Study Proving Device Meets Acceptance Criteria:
The study referenced is "Performance Testing r." (Section 7 of the 510(k) summary).
- Study Type: Comparative physical and mechanical property testing.
- Objective: To determine that the URETEX® SUP Sling has similar performance characteristics to its predicate devices (Ethicon Prolene®, Sofradim Parietene®).
- Methodology: Testing was performed in accordance with ISO standards. Various physical and mechanical properties of the URETEX® SUP Sling were evaluated and compared against the selected predicate devices.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the document. The text mentions "All of the testing was performed using the URETEX® SUP Sling, the Ethicon Prolene®, and the Solradim Parietene® prodicate devices for comparative purposes," implying samples of each device were tested. The specific number of samples for each test (density, thickness, etc.) is not provided.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by or for Sofradim Production, likely in France (country of origin of the sponsor). This was not a clinical study; it was laboratory/bench testing of materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was physical materials testing, not a study requiring expert clinical ground truth assessment.
4. Adjudication method for the test set:
- Not applicable. Material properties (e.g., density, tensile strength) are objectively measured, not adjudicated.
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:
- Not applicable. This is a traditional medical device (surgical mesh), not an AI/ML device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a traditional medical device, not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for the performance testing was the measured physical and mechanical properties of the predicate devices, against which the URETEX® SUP's properties were compared.
8. The sample size for the training set:
- Not applicable. This is a traditional medical device; there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device.
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