(82 days)
Desara® and Desara® Blue 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 and Desara® Blue 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® and Desara® Blue 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.
The provided document is a 510(k) summary for the Desara® and Desara® Blue surgical mesh devices, which are used to treat Stress Urinary Incontinence (SUI) in females. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study for a new device with novel technology that would typically involve the comprehensive details requested in your prompt.
Therefore, many of the requested details (like sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of submission. This 510(k) relies on demonstrating that the new devices are substantially equivalent to already approved predicate devices by showing similar technological characteristics and performance in bench and validation testing.
Here's an breakdown based on the information available:
Acceptance Criteria and Reported Device Performance
The document states that the Desara® and Desara® Blue devices were assessed against various mesh characteristics, and the results demonstrated "equivalent device function based upon its intended use to the predicate device, Desara® Mesh, (#K112609)." The acceptance criteria were therefore implicitly that the new devices perform comparably to the predicate and reference devices across these specified characteristics.
| Acceptance Criteria (Measured Characteristics) | Reported Device Performance (Relative to Predicate/Reference) |
|---|---|
| Material Composition | Comprised of the same polypropylene mesh resin as the reference device, Ascend® Blue (#K101462). The same mesh knit and limited contact raw materials as Desara® Mesh (#K112609) were used. |
| Mesh Thickness | Assessed (Specific values not provided, but evaluated for equivalence). |
| Mesh Knit Characteristics | Assessed (Specific values not provided, but evaluated for equivalence). |
| Pore Size | Assessed (Specific values not provided, but evaluated for equivalence). |
| Mesh Density | Assessed (Specific values not provided, but evaluated for equivalence). |
| Tensile Strength | Assessed (Specific values not provided, but evaluated for equivalence). |
| Mesh Stiffness | Assessed (Specific values not provided, but evaluated for equivalence). |
| Flexural Rigidity | Assessed (Specific values not provided, but evaluated for equivalence). |
| Tear Resistance | Assessed (Specific values not provided, but evaluated for equivalence). |
| Burst Strength | Assessed (Specific values not provided, but evaluated for equivalence). |
| Suture Pullout | Assessed (Specific values not provided, but evaluated for equivalence). |
| Pyrogen Levels | Assessed (Specific values not provided, but evaluated for equivalence). |
| Biocompatibility | Supported by the predicate devices Desara® Mesh (#K112609) and Ascend® Blue (#K101462), which passed all biocompatibility testing (same materials). |
| Aging, Shelf Life, Transportation, Sterilization | Supported by the predicate device Desara® Mesh (#K112609) and Ascend® Blue (#K101462) documentation (same or similar materials, packaging, manufacturing, and sterilization processes). |
| Device Function | "Results of both mechanical bench and validation testing demonstrate equivalent device function based upon its intended use to the predicate device, Desara® Mesh, (#K112609)." |
Study Details (Based on available 510(k) information)
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Sample size used for the test set and the data provenance:
- The document describes mechanical bench and validation testing, not typically a "test set" in the context of an AI/algorithm study with patient data. The sample sizes for these engineering tests are not explicitly provided in this summary but would be part of the underlying test reports.
- Data Provenance: The testing appears to be primarily laboratory-based (mechanical bench and validation testing). There is no mention of patient data or its country of origin.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as there is no "ground truth" derived from expert review of patient data. The "truth" or reference for performance is established by comparing to the predicate device and relevant standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as there is no "test set" involving expert review of patient data that would require adjudication.
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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:
- This is not applicable. The device is a surgical mesh for SUI treatment, not an AI diagnostic or interpretive tool that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is a medical device (surgical mesh), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference for comparison in this substantial equivalence determination is the performance characteristics of the predicate device (Desara® Mesh #K112609) and reference device (Ascend® Blue #K101462), as well as compliance with established FDA guidance documents and international standards for mesh characteristics and biocompatibility.
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The sample size for the training set:
- This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
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How the ground truth for the training set was established:
- This is not applicable.
§ 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.