(97 days)
The Upsylon Y mesh is intended for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Upsylon Mesh is a preformed Y shaped lightweight polypropylene mesh consisting of two vaginal mesh arms and one sacral mesh arm. The Upsylon mesh is blue in color with a non-colored centering line.
The provided text describes a 510(k) premarket notification for the Upsylon Y mesh. This is a traditional medical device submission seeking substantial equivalence to existing devices, primarily relying on bench testing and qualitative assessments rather than clinical studies with explicit acceptance criteria related to device performance in a living system.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert involvement, and multi-reader multi-case studies, which are typical for AI/CADe submissions, is not applicable to this 510(k) submission for a surgical mesh.
However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence to the predicate devices.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format for specific performance metrics the way a diagnostic device might. Instead, it states that the performance testing "demonstrate equivalence of the Upsylon Y mesh to the predicate meshes." This implies the performance fell within a range considered acceptable for substantial equivalence to the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | "demonstrate equivalence of the Upsylon Y mesh to the predicate meshes." Implies performance comparable to predicate devices for safe and effective use. |
| Y mesh leg tensile | Performance completed with samples aged at T=0 and T=7 months accelerated aging. Results supported the Upsylon Y mesh configuration and demonstrated equivalence. |
| Y mesh leg elongation | Performance completed with samples aged at T=0 and T=7 months accelerated aging. Results supported the Upsylon Y mesh configuration and demonstrated equivalence. |
| Y mesh attachment strength | Performance completed with samples aged at T=0 and T=7 months accelerated aging. Results supported the Upsylon Y mesh configuration and demonstrated equivalence. |
| Biocompatibility | Performance data provided in K103426 for LITE Pelvic Floor Repair Kits supports the Upsylon Y mesh. |
| Mesh Characterization | Performance data provided in K103426 for LITE Pelvic Floor Repair Kits supports the Upsylon Y mesh. |
| User Evaluation | "conducted a user evaluation in cadavers which evaluated placement of the mesh." (This is a qualitative user evaluation, not a quantitative performance acceptance criterion). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a number of devices or cases in the provided text. The performance testing was carried out on "samples" of the Upsylon Y mesh, aged at T=0 and T=7 months accelerated aging.
- Data Provenance: The testing was "bench and user evaluation" conducted by Boston Scientific. This indicates in-house testing. The "user evaluation in cadavers" is a laboratory-based assessment, not a clinical trial on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission focuses on material and mechanical properties, as well as a cadaver-based user usability assessment, not diagnostic accuracy or expert consensus on clinical findings. Therefore, "ground truth" in the diagnostic sense is not relevant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical trials or studies where expert disagreement on a finding needs to be resolved for ground truth establishment. This was a bench and cadaver-based study.
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/CADe system. Therefore, an MRMC study and AI assistance evaluation are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware; it does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the traditional sense of diagnostic ground truth. For the mechanical and material testing, the "ground truth" would be established by validated test methods and engineering standards, comparing the results statistically or comparatively to the predicate devices. For the user evaluation, the "ground truth" would be the successful placement and evaluation of the mesh by the users in a cadaver model.
8. The sample size for the training set:
- Not applicable. There is no "training set" for this type of medical device submission.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this type of medical device submission.
In summary: K122794 for the Upsylon Y mesh is a 510(k) submission based on substantial equivalence, primarily supported by bench performance testing (mechanical properties) and a user evaluation in cadavers. It is not a submission for a diagnostic AI/CADe device, and therefore, many of the requested criteria related to clinical studies, human readers, and AI performance are not relevant or present in the provided document. The "acceptance criteria" were qualitative, focused on demonstrating equivalence to predicate devices through engineering and simulated-use testing.
§ 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.