(16 days)
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The proposed sling is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a knitted polypropylene monofilament fiber mesh body implant, dilators with association loops, mesh sleeve and center tab.
The provided text is a 510(k) summary for a surgical mesh device, the Obtryx™ System and Prefyx PPSTM System. It explicitly states that no clinical testing was required or performed to prove the device meets acceptance criteria. Instead, the device's substantial equivalence to a predicate device (AdvantageTM, Advantage FitTM System & LynxTM Systems) was established through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since no clinical testing was performed, there are no specific clinical acceptance criteria or reported device performance metrics in the document. The document primarily focuses on demonstrating equivalence to a predicate device through non-clinical means.
| Acceptance Criteria (from predicate device) | Reported Device Performance |
|---|---|
| Intended Use | Identical |
| Technological Characteristics | Identical |
| Performance Characteristics | Identical (based on non-clinical testing) |
| Biocompatibility | Identical (based on non-clinical testing) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical test set was used.
- Data Provenance: Not applicable. The document refers to "testing results of the material, biocompatibility, bench testing" for the non-clinical assessment, but does not specify the origin of any data, if any external data was used for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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 device is a surgical mesh, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (surgical mesh), not an algorithm.
7. The type of ground truth used
- Not applicable in the context of clinical performance evaluation. The "ground truth" for demonstrating substantial equivalence was the performance, biocompatibility, and intended use of the legally marketed predicate device, as assessed through non-clinical testing.
8. The sample size for the training set
- Not applicable. This device is a surgical mesh and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established
- Not applicable. As noted above, there is no training set for this device.
Justification for the above responses from the text:
The key section is H. Substantial Equivalence and 1. Non-Clinical Testing:
- "The surgical mesh is identical to currently marketed surgical mesh in terms of performance characteristics, biocompatibility, and intended use. Therefore, testing was not required to be repeated on the surgical mesh."
- "Conclusion: Based on testing results of the material, biocompatibility, bench testing, and the proposed device labeling, the device is substantially equivalent to the identified predicate device in terms of intended use..."
This clearly indicates that no new clinical studies or clinical performance data specific to this device were generated or provided in the 510(k) submission. The substantial equivalence was established through non-clinical means by demonstrating its identity to a predicate 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.