(90 days)
Desara® Blue OV and Desara® Blue SS devices are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Desara® Blue OV and Desara® Blue SS devices are sterile, single-use mid-urethral slings used to provide support in the pelvic region to treat stress urinary or mixed incontinence. The devices are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices have integral sleeves, tips and sutures to assist the surgeon in placement of the mesh, which are removed after placement of the device. Desara® Blue OV and Desara® Blue SS are designed to work with Caldera Medical's reusable introducers, which utilize a Universal Connection System offering surgeons the flexibility to choose their preferred surgical approach.
Desara® Blue OV incorporates an overlapping sleeve design as an alternative to the centerline sleeve gap utilized in the predicate devices, Desara® and Desara® Blue, K132069. Desara® Blue SS incorporates a shorter suture length than that of the predicate devices. Desara® and Desara Blue, K132069.
The provided text is a 510(k) summary for medical devices, specifically surgical mesh for stress urinary incontinence. It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments, rather than clinical efficacy studies involving AI. As such, the information required for a detailed AI device study (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies) is not present.
However, I can extract the acceptance criteria and performance data for the mechanical and bench tests that were conducted to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Mesh Characteristic | Acceptance Criteria (Equivalent to predicate device) | Reported Device Performance (Relative to predicate device) |
|---|---|---|
| Mesh Thickness | Equivalent | Equivalent |
| Mesh Knit Characteristics | Equivalent | Equivalent |
| Pore Size | Equivalent | Equivalent |
| Mesh Density | Equivalent | Equivalent |
| Tensile Strength | Equivalent | Equivalent |
| Mesh Stiffness | Equivalent | Equivalent |
| Flexural Rigidity | Equivalent | Equivalent |
| Tear Resistance | Equivalent | Equivalent |
| Burst Strength | Equivalent | Equivalent |
| Suture Pullout | Equivalent | Equivalent |
| Pyrogen Levels | Equivalent | Equivalent |
| Sleeve Removal Force | Met predefined acceptance criteria | Substantially equivalent |
| Suture Detachment Force | Met predefined acceptance criteria | Substantially equivalent |
2. Sample Size for Test Set and Data Provenance:
The document does not specify exact sample sizes for the "test set" in terms of number of devices or data points for each characteristic. The testing was described as "mechanical bench and validation testing," implying laboratory-based data, not patient data. The provenance is internal to Caldera Medical, Inc.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The "ground truth" for these engineering and material characteristic tests would be the measured values themselves, compared against the predicate device's established values or industry standards. There were no human experts establishing a subjective ground truth for diagnostic accuracy.
4. Adjudication Method:
Not applicable. This type of testing does not involve adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This document describes a traditional 510(k) submission for a physical medical device, not an AI or imaging-based diagnostic tool. Therefore, a MRMC study comparing human readers with and without AI assistance was not performed.
6. Standalone (Algorithm Only) Performance:
No. This is not an AI algorithm. The performance evaluation is for a physical medical device.
7. Type of Ground Truth Used:
The ground truth used for the performance evaluation of the Desara® Blue OV and Desara® Blue SS devices was based on measured material and mechanical properties compared against those of the legally marketed predicate device, Desara® Blue (#K132069), and reference devices (Ascend® Blue, #K101462, and Desara® Mesh, #K112609). This falls under direct physical measurement and comparison to established product specifications.
8. Sample Size for the Training Set:
Not applicable. As this is not an AI device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for an AI model.
§ 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.