(91 days)
Vertessa® Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or laparoscopic abdominal procedures.
Vertessa® Lite devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa "Lite will be available in a rectangular flat sheet mesh and rectangular strip mesh designs.
The flat sheet mesh designs are available in the following sizes: 8 x 16 cm, 8 x 18 cm, 8 x 20 cm, 8 x 22 cm, 8 x 24 cm, 8 x 26 cm, 10 x 16 cm, 10 x 18 cm, 10 x 20 cm, 10 x 22 cm, 10 x 24 cm, 10 x 26 cm, and 11 x 30 cm.
The strip mesh designs are available in the following sizes: 4 x 16 cm, 4 x 18 cm, 4 x 20 cm, 4 x 22 cm, 4 x 24 cm, 4 x 26 cm, 5 x 18 cm, 5 x 20 cm, 5 x 20 cm, 5 x 22 cm, 5 x 24 cm, 5 x 26 cm, and 6 x 30 cm.
This document is a 510(k) premarket notification for the Vertessa® Lite surgical mesh by Caldera Medical, Inc. It aims to demonstrate substantial equivalence to a predicate device, not to establish new safety and effectiveness through a traditional clinical study with acceptance criteria in the way a diagnostic AI device would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device are not applicable or not present in this document. This submission primarily focuses on physical and material characteristics and demonstrates comparability to an existing device.
Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria for a diagnostic performance metric (like sensitivity, specificity, or AUC) as expected for an AI device. Instead, it compares the physical and mechanical properties of the new Vertessa® Lite to its predicate device. The "acceptance criteria" here are implied to be "comparable to the predicate device" for the listed mesh characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable mesh thickness | Demonstrated comparability to predicate Vertessa® Lite (K123337) |
| Comparable mesh knit characteristics | Demonstrated comparability to predicate Vertessa® Lite (K123337) |
| Comparable pore size | Demonstrated comparability to predicate Vertessa® Lite (K123337) |
| Comparable mesh density | Demonstrated comparability to predicate Vertessa® Lite (K123337) |
| Comparable tensile strength | Demonstrated comparability to predicate Vertessa® Lite (K123337) |
| Comparable mesh stiffness (tensile and bending) | Demonstrated comparability to predicate Vertessa® Lite (K123337) |
| Comparable tear resistance | Demonstrated comparability to predicate Vertessa® Lite (K123337) |
| Comparable suture pullout strength | Demonstrated comparability to predicate Vertessa® Lite (K123337) |
| Biocompatibility | Demonstrated per FDA guidance (ISO-10993) |
| Sterilization validation & Shelf life | Demonstrated per FDA guidance (K90-1, ASTM F-1980-07) for a three-year shelf life |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not explicitly stated in terms of number of mesh samples tested for each characteristic. This kind of detail is typically in the test reports, which are summarized here.
- Data provenance: Not specified in the provided text. The studies would have been conducted internally or by a contracted lab.
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. This submission does not involve human expert interpretation for "ground truth" establishment in the context of a diagnostic AI device. The ground truth refers to the physical and chemical properties measured by standard test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "adjudication" necessary as this is not a diagnostic interpretation 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 is not an AI device, and therefore no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI algorithm; it's a medical device (surgical mesh).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for the performance evaluation consists of established physical, mechanical, and biological testing standards and methods for surgical mesh materials. For example, tensile strength is measured against established engineering principles, and biocompatibility is assessed against ISO 10993 standards. The comparative aspect is against the properties of the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device that requires a training set.
In summary: K150016 is a 510(k) premarket notification for a Class II surgical mesh. Approval is based on demonstrating substantial equivalence to a previously cleared predicate device (Vertessa® Lite, K123337) by showing comparable physical, mechanical, and biocompatibility characteristics, rather than meeting specific diagnostic performance acceptance criteria typical for an AI/CADe device. The "study" involves physical and biological testing of the mesh and comparison to the predicate, as outlined in FDA guidance for surgical mesh.
§ 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.