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510(k) Data Aggregation
(22 days)
The Desara® Mesh is 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.
The Desara Mesh is a sterile, single-use pubourethral sling used to provide support in the pelvic region to treat stress urinary incontinence, mixed incontinence, and vaginal vault prolapse. The device is manufactured out of a monofilament polypropylene yarn, which is knitted into a mesh. The device has integral sleeves, tips and sutures to assist the surgeon in placement of the device. The sleeves, tips and sutures are removed after placement of the device.
Here's an analysis of the provided text regarding the Desara Mesh, focusing on the acceptance criteria and study details:
Device: Desara Mesh (Surgical Mesh)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for a premarket notification, not a detailed study report with specific acceptance criteria and performance metrics. Therefore, explicit, quantifiable acceptance criteria and their corresponding reported device performance values are not present in the text.
Instead, the document states:
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Passed all testing requirements | "The mesh material has passed all testing requirements for biocompatibility" |
| Performance | Passed all testing requirements | "The mesh material has passed all testing requirements for ... performance" |
| Shelf life | Passed all testing requirements | "The mesh material has passed all testing requirements for ... shelf life" |
| Sterilization | Passed all testing requirements | "The mesh material has passed all testing requirements for ... sterilization" |
| Validation Testing | Passed all testing criteria | "The Desara Mesh material has been subjected to cadaver labs, bench and validation testing and has passed all testing criteria." |
| Substantial Equivalence | Safe and effective for intended use, equivalent to predicate device | "The Desara Mesh is safe and effective for its intended use and is substantially equivalent to the predicate device, Desara Mesh, K101169" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any test sets. It mentions "cadaver labs, bench and validation testing" but provides no details on the number of cadavers, bench test units, or any other data points.
The data provenance is also not specified beyond the tests being conducted for the manufacturer (Caldera Medical, Inc.). It's unclear if the data is retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not present in the document. The type of testing mentioned (biocompatibility, performance, shelf life, sterilization, cadaver labs, bench, validation) does not typically involve expert consensus to establish a "ground truth" in the way, for example, image-based diagnostic studies do. These are primarily engineering and biological safety tests.
4. Adjudication Method for the Test Set
This information is not present as the nature of the testing described (biocompatibility, engineering tests) does not typically involve expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done or mentioned. This type of study is more relevant for diagnostic AI devices where human performance with and without AI assistance is being evaluated. The Desara Mesh is a surgical implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, a standalone (algorithm only) performance study was not done or mentioned. This is not applicable to a surgical mesh device. The performance mentioned refers to the physical and biological properties of the mesh itself, not an algorithm.
7. The Type of Ground Truth Used
Based on the types of tests described, the "ground truth" would be established by:
- Biocompatibility: Adherence to established ISO standards and testing protocols (e.g., cytotoxicity, sensitization, irritation based on biological responses).
- Performance: Measured physical properties (e.g., tensile strength, pore size, elasticity) against pre-defined engineering specifications.
- Shelf life: Stability of the material over time under simulated or real-time aging conditions, meeting pre-defined criteria.
- Sterilization: Demonstrated sterility assurance level (SAL) against established standards.
- Cadaver Labs: Likely involved successful surgical placement and observation of anatomical interaction within the cadaveric model, following predefined procedural success criteria.
- Bench Testing: Objective measurements against engineering specifications.
- Validation Testing: Confirmation that the device meets its design requirements.
These are objective, measurable outcomes rather than expert consensus on a diagnostic finding or pathology.
8. The Sample Size for the Training Set
This information is not present. The Desara Mesh is a physical medical device, not an AI or algorithmic device that requires a "training set" in the computational sense. The "development" process for such a device would involve material science, engineering design, and fabrication, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of an AI device. For a physical device like a surgical mesh, the "ground truth" during its development and testing phases would be based on established engineering principles, material science properties, biological safety standards, and predefined performance specifications.
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