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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 Caldera Desara Mesh is 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 sleeve and sutures to assist the surgeon in placement of the device. The sleeve and sutures are removed after placement of the device.

Here's the analysis of the provided text regarding the CALDERA DESARA 510(K) SUMMARY.

The provided text does NOT contain information about any acceptance criteria, device performance studies, or clinical trial data. It is a regulatory submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical effectiveness data.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, or ground truth details.

The document primarily describes:

• Device Name: Desara Mesh
• Applicant: Caldera Medical, Inc.
• Intended Use: In females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence.
• Predicate Device: Caldera T-Sling (K050516)
• Technological Characteristics: States the Desara device has the same materials and design as the Caldera T-Sling, with minor changes related to suppliers and mesh configuration.
• Regulatory Status: 510(k) clearance (K072456) as a Class II device (Surgical Mesh, Product Code OTN).

To answer your prompt fully, I would need a different type of document, such as a clinical study report or a more detailed summary of clinical data that would typically be associated with a PMA (Premarket Approval) application or a 510(k) that included specific performance testing.

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