(373 days)
Desara Mini is intended to be used in females to position a suburethral mesh sling for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence resulting from urethral hypermobility. The mesh is placed transvaginally using a reusable introducer (sold separately)
The Desara Mini is a sterile, single-use pubourethral sling. The device is comprised of monofilament polypropylene yarn, which is knitted into a mesh, two self-fixating tips and two guiding suture loops at each end of the device. The device contains a visible midline marker to assist the surgeon in placement of the device.
The Desara Mini is available in one configuration and a reusable introducer is available separately.
The provided 510(k) summary for the Caldera Medical Desara Mini surgical mesh primarily focuses on establishing substantial equivalence to predicate devices through technical and performance characteristic comparisons, rather than presenting a study to prove acceptance criteria for a new, unique performance claim. As such, the information needed to fully respond to your request regarding acceptance criteria and a study proving device performance in the context of an AI/human reader study is not present in this document.
However, I can extract the available information regarding performance data and testing methods used to demonstrate substantial equivalence, which serves a similar purpose in the medical device approval process:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable way for novel performance endpoints. Instead, it demonstrates that the Desara Mini meets the established characteristics and performance benchmarks of its predicate devices. The "reported device performance" is essentially that the Desara Mini's characteristics are "substantially equivalent" to the predicate devices.
Here's an interpretation of the performance data in relation to the predicate devices:
| Performance Characteristic/Test | Acceptance Criteria (Implied by Predicate Device Equivalence) | Reported Device Performance |
|---|---|---|
| Mesh Characteristics | ||
| Mesh Thickness | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Mesh Weave Characteristics | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Pore Size | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Mesh Density | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Tensile Strength | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Mesh Stiffness | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Flexural Rigidity | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Tear Resistance | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Burst Strength | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Suture Pullout | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Pyrogen Levels | Equivalent to Desara Mesh (K110169) | Substantially equivalent |
| Biocompatibility | Meets FDA guidance for biocompatibility (as per Desara Mesh) | Passed all testing requirements; substantially equivalent |
| Sterility/Packaging | Meets FDA guidance for sterility, aging, shelf life, transportation, sterilization (as per Desara Mesh) | Passed all testing requirements; substantially equivalent |
| Mechanical/Functional | ||
| Junction Strength | Equivalent to MiniArc (K073703) | Demonstrates equivalent |
| Device Function (Fixation Tips, Polypropylene Mesh, Suture Loops, Introducer) | Equivalent to MiniArc (K073703) | Demonstrates equivalent |
| Device Performance | Equivalent to MiniArc (K073703) | Demonstrates equivalent |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of human data or clinical studies for performance evaluation. The testing described involves bench testing for material properties and mechanical performance, and cadaver lab testing for functional performance. No sample sizes for these tests are provided. Data provenance is not specified beyond being "bench" and "cadaver lab" testing. This is common for a 510(k) submission where substantial equivalence is primarily based on material and design similarities, rather than new clinical effectiveness.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This document describes a medical device submission based on substantial equivalence through material and functional testing, not a study requiring expert readers to establish ground truth for image interpretation or diagnosis.
4. Adjudication Method:
Not applicable, as no expert consensus or ground truth establishment process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The submission is for a surgical mesh and its performance relies on physical and mechanical properties, not on diagnostic accuracy enhanced by AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The Desara Mini is a physical surgical device, not a software algorithm.
7. Type of Ground Truth Used:
The "ground truth" for the performance claims in this submission is the established performance characteristics and safety profile of the predicate devices (Desara Mesh and MiniArc), as well as established industry standards and FDA guidance for surgical mesh testing. For instance, the mesh characteristics were assessed against standards, and biocompatibility was assessed against ISO-10993.
8. Sample Size for the Training Set:
Not applicable. This document describes a medical device submission where the relevant "training" would be the historical data and performance of the predicate devices and general knowledge of surgical mesh properties, not a machine learning training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See #8).
§ 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.