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Desara SL 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.

Device Description

Desara® SL is a sterile, single-use pubourethral 1.1 x 12cm silng used to provide support in the pelvic region to treat stress urinary Incontinence or mixed Incontinence. The device is manufactured out of a monofilament polypropylene yarn, which is knitted into a mesh. The device has a mid-line marker, 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.

Desara® SL Is designed to work with Caldera Medical's reusable transobturator helical, hook, and Inside-out introducers, which utilize a Universal Connection System offering surgeons the flexibility to choose their preferred surgical approach.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Desara SL device, based on the provided 510(k) summary:

This device is a surgical mesh, therefore many of the typical AI/ML-related questions (like MRMC studies, training sets, etc.) are not applicable here. The focus is on material properties, biocompatibility, and functional performance, often demonstrated through bench testing and comparison to predicate devices, rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria Assessed (Examples)	Reported Device Performance (How Criteria Were Met)
Mechanical & Material Characteristics	Mesh thickness, knit characteristics, pore size, mesh density, tensile strength, mesh stiffness, flexural rigidity, tear resistance, burst strength, suture pullout.	Assessed against these characteristics, with results demonstrating equivalent device function to the primary predicate device (Desara® Mesh) for its intended use. The Desara SL is comprised of the same mesh as the predicate device, Desara® Mesh, implying that its material characteristics are inherently equivalent.
Functional Bench Testing	Sleeve to tip pull-off force, suture loop pull-out force, device mesh break strength.	All testing met predefined acceptance criteria. Results of both mechanical bench and validation testing demonstrate equivalent device function based upon its intended use to the primary predicate device, Desara® Mesh.
Biocompatibility	Absence of adverse biological reactions.	Desara® (the mesh material used in Desara SL) has passed all biocompatibility testing as per FDA guidance documents (FDA Device Advice, Guidance Documents, Biocompatibility and FDA Blue Book Memorandum #G95-1 Entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing"). ASTM F899-09 was referenced for instrument biocompatibility.
Reprocessing & Sterilization	Validated reprocessing instructions for reusable instrumentation; validation of aging, shelf life, transportation, and sterilization.	Reprocessing instructions for Desara SL instrumentation (reusable) were validated per FDA Guidance "Draft Guidance for Industry and FDA Staff - Processing Medical Devices in Health Care Settings: Validation Methods and Labeling" (May 2, 2011) and are similar to Desara Mini instrumentation (K103418). Testing documentation from Desara was used to support aging, shelf life, transportation, and sterilization of Desara® SL, as it comprised the same materials, packaging, manufacturing, and sterilization processes as Desara®. This aligns with FDA Guidance, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry, FDA, FDA Device Advice, Guidance Documents, and ASTM F-1980-07.
Clinical Effectiveness & Safety	Comparison of clinical outcomes (e.g., efficacy, post-operative complications like groin pain).	A prospective randomized trial (de Leval, J, et al.) found that a modified inside-out transobturator tape procedure using a 12 cm sling (like Desara SL) was as safe and efficacious as the original transobturator technique at one-year follow-up, and was associated with less immediate post-operative groin pain. This study directly supports the safety and effectiveness of the surgical approach enabled by a device of this length and design.

2. Sample Size Used for the Test Set and Data Provenance

For material and functional bench testing: The specific sample sizes for each mechanical test (e.g., "sleeve to tip pull-off force") are not explicitly stated in the summary. The summary indicates that "all testing met predefined acceptance criteria."
For clinical effectiveness: The summary refers to a "prospective randomized trial by de Leval J, et al." The sample size for this trial is not explicitly stated in the 510(k) summary, although the study itself (cited as Int Urogynecol J (2011) 22:145-156) would contain this information.
Data Provenance:
- Bench Testing: Likely internal Caldera Medical testing.
- Clinical Study: The cited study by de Leval, J, et al. would be the source. The article's title "Int Urogynecol J (2011)" suggests it's a published, peer-reviewed study, likely conducted in a clinical setting (country of origin not noted in the summary). It is explicitly stated as a "prospective randomized trial."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable in the traditional sense for a medical device 510(k) for surgical mesh. Ground truth for bench testing is established by engineering specifications and objective measurements against predefined acceptance criteria.
For the clinical study: The "ground truth" would be the clinical outcomes (patient symptoms, objective measures of SUI, reported complications) as assessed by the researchers and clinicians involved in that specific published trial. The expertise would be that of the medical professionals conducting the trial and evaluating patients.

4. Adjudication Method for the Test Set

Not Applicable in the traditional sense for a medical device 510(k) for surgical mesh. Bench testing results are compared directly to engineering specifications.
For the clinical study: The methods for assessing clinical outcomes and patient follow-up within the de Leval, J, et al. study would define any adjudication process for clinical endpoints. This is not detailed in the 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was NOT done. This type of study is typically used for diagnostic imaging devices where different readers evaluate the same cases with and without AI assistance to measure improvement in diagnostic performance. The Desara SL is a surgical mesh implant, not a diagnostic device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No, a standalone performance study (in the context of an AI/ML algorithm) was NOT done. This device is a physical surgical implant, not an algorithm. Its performance is evaluated through material science, mechanical testing, and clinical outcomes, not algorithmic accuracy.

7. Type of Ground Truth Used

For material and functional bench testing: Engineering specifications, material standards, and validated mechanical test methods provide the "ground truth."
For biocompatibility: Established regulatory guidelines (ISO 10993) and historical data on the predicate mesh material (Desara®) serve as the ground truth.
For the clinical study (de Leval, J, et al.): Clinical outcomes data, including physician assessments, patient-reported symptoms, and objective measures of incontinence, as well as complication rates (e.g., groin pain), serve as the ground truth for safety and efficacy.

8. Sample Size for the Training Set

Not Applicable. This is a physical, non-AI medical device. There is no "training set" in the context of machine learning. The device's design is based on established engineering principles and the predicate device.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no "training set" for an AI/ML algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through well-defined engineering, material science, and regulatory standards.

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