(109 days)
The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.
AdVance™ XP is a sling system which treats male stress urinary incontinence by repositioning the urethra with a suburethral mesh. The AdVance XP system is comprised of a permanently implanted monofilament polypropylene mesh sling, two needle passers used to implant the sling, SKW retractor and percutaneous needle. The sling is connected during the procedure to the needle passers through keyed connectors at each end of the sling which are removed after the sling is positioned. The sling repositions the bulbar urethra 2-4cms.
This is a 510(k) premarket notification for the AdVance™ XP Male Sling System, which is a surgical mesh used for treating male stress urinary incontinence (SUI). The document does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and sample sizes for AI model training/testing cannot be extracted from this document.
However, I can provide information about the general performance assessment conducted for this medical device, which is a non-AI product.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI device, there are no "acceptance criteria" for an algorithm's performance. Instead, the "performance criteria" refer to the physical and functional characteristics of the medical device. The document states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Technological Equivalence | The AdVance™ XP has the same mesh material, pore size, sling arm width, sheath, connectors, and transobturator surgical approach as the predicate device (AdVance™ Male Sling System, K053371). The technological differences are sling length, mesh weave, anchoring mechanism, and needle passer shape. Despite these differences, the device achieves its mechanism of action by repositioning the bulbar urethra 2-4 cm, which is the same as the predicate. |
| Safety and Effectiveness | Demonstrated through: |
- Bench testing: Evaluated technological characteristics and performance criteria.
- Biocompatibility testing: Assessed the material's compatibility with the body.
- Real-world complaint data: Reviewed existing data, likely from the predicate device or similar products.
- Clinical literature searches: Reviewed published clinical studies.
- Clinical evaluations: Specific details are not provided in this summary, but these would typically involve human use studies or literature reviews of previous human use.
Conclusion: "The results from this testing and other data demonstrate that the technological characteristics and performance criteria of the AdVance™ XP are comparable to the predicate device and can perform in a manner equivalent to the devices currently on the market for the same intended use." And "non-clinical and clinical performance data supports a determination that the subject device is substantially equivalent to the predicate device, and that it is at least as safe and effective for its intended use." |
The following information cannot be provided as the document describes a traditional medical device (surgical mesh), not an AI/Machine Learning diagnostic or assistive device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for a non-AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable for a non-AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a non-AI device.
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 for a non-AI device. There are no "human readers" or "AI assistance" involved in the direct assessment of this surgical mesh.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a non-AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a traditional medical device like this, "ground truth" would be related to established safety and performance standards, clinical outcomes, and successful use in target patients, often from the predicate device's history and relevant clinical literature. The document mentions "clinical evaluations" and "clinical literature searches."
8. The sample size for the training set
Not applicable for a non-AI device.
9. How the ground truth for the training set was established
Not applicable for a non-AI device.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.