(98 days)
Vertessa™ may be used for the repair of uterine or vaginal vault prolapse that requires support material. It may be used in open or laparoscopic abdominal procedures.
Vertessa™ is designed to be used in the inpatient or outpatient surgery setting in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa™ mesh will be provided sterile and is comprised of macroporous monofilament polypropylene warp knit clear mesh.
The document provided details for a 510(k) premarket notification for the "Vertessa™" surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics.
Therefore, the requested information elements related to specific acceptance criteria, a standalone study with performance metrics, MRMC studies, ground truth establishment, sample sizes for training/test sets, and expert adjudication are not applicable to this 510(k) summary. The study conducted here is a bench and validation testing to demonstrate substantial equivalence against predicate devices for various characteristics.
Here's the information that can be extracted or inferred from the provided text, structured to address your request as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, there are no explicitly stated numerical "acceptance criteria" for performance that the device must meet independently. Instead, the "acceptance criterion" is generally "demonstrates substantial equivalence" to the predicate devices in the assessed characteristics.
| Characteristic Assessed | Reported Device Performance (vs. Predicate) |
|---|---|
| Mesh thickness | Substantial equivalence to Ascend® Blue |
| Mesh knit characteristics | Substantial equivalence to Ascend® Blue |
| Pore size | Substantial equivalence to Ascend® Blue |
| Mesh density | Substantial equivalence to Ascend® Blue |
| Tensile strength | Substantial equivalence to Ascend® Blue |
| Mesh stiffness | Substantial equivalence to Ascend® Blue |
| Flexural rigidity | Substantial equivalence to Ascend® Blue |
| Tear resistance | Substantial equivalence to Ascend® Blue |
| Burst strength | Substantial equivalence to Ascend® Blue |
| Suture pullout | Substantial equivalence to Ascend® Blue |
| Pyrogen levels | Substantial equivalence to Ascend® Blue |
| Biocompatibility | Substantial equivalence to Ascend® Blue |
| Aging | Passed testing requirements (shelf life) |
| Shelf life | Passed testing requirements (shelf life) |
| Transportation | Passed testing requirements |
| Sterilization | Passed testing requirements |
| Mechanical bench and validation testing | Equivalent device function to Ascend® Blue and POPMesh™ |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided text. The testing conducted included "bench, simulated use, surgeon feedback and validation testing," for which specific sample sizes are not detailed.
- Data provenance: Not explicitly stated, but assumed to be internal testing conducted by Caldera Medical, Inc. The document does not indicate the country of origin of data or if it was retrospective or prospective in the medical sense (e.g., patient data). It refers to laboratory/bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The substantial equivalence argument relies on direct comparison of physical and mechanical properties of the device (Vertessa™) to a predicate device (Ascend® Blue) and passing of various standard tests (biocompatibility, sterility, etc.), rather than expert-established ground truth in a diagnostic or clinical context. "Surgeon feedback" is mentioned, but its role in "ground truth" or a defined test set is not detailed.
4. Adjudication method for the test set
- Not applicable and not provided. As explained above, the assessment is based on physical and mechanical properties and standard compliance, not on expert adjudication of diagnostic outcomes.
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 not an AI-enabled diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device. The "standalone" performance here relates to the physical and mechanical properties of the mesh itself, which were tested against established standards and compared to a predicate device.
7. The type of ground truth used
- Again, the concept of "ground truth" in the diagnostic sense (e.g., pathology, outcomes data) does not directly apply here. For the physical and mechanical properties, the "ground truth" or reference point is the performance of the predicate device (Ascend® Blue) and established industry standards and FDA guidance documents for testing methods and acceptable ranges (e.g., ISO-10993 for biocompatibility, ASTM F-1980-07 for accelerated aging).
8. The sample size for the training set
- Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning device.
In summary: The provided document is a 510(k) summary for a surgical mesh, which aims to demonstrate substantial equivalence to existing predicate devices. The "studies" conducted are primarily bench and validation tests conforming to FDA guidance and industry standards, comparing physical and material properties, and biological safety. The detailed elements requested are typically associated with performance studies for diagnostic devices, especially those involving AI or human interpretation, which is not the case for this product.
§ 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.