(24 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 Sling 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 and sutures to assist the surgeon in placement of the device. The sleeves and sutures are removed after placement of the device.
The provided text describes a 510(k) summary for the Desara Mesh Sling, a surgical mesh device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance in the way one might expect for a diagnostic or AI-driven device.
Here's a breakdown based on the information provided, highlighting what is not available in the given text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the given text in a tabular format as you've requested. The document states:
"The biocompatibility tests conducted for the new Desara mesh were selected in accordance to ISO 10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing standards and all test results were passing."
And, "In accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, the results of bench, cadaver lab and validation testing has shown the new Desara Mesh device to be substantially equivalent to the predicate device."
This indicates that acceptance criteria would have been defined by ISO 10993 for biocompatibility and specific unstated criteria for bench, cadaver lab, and validation testing, with the general reported performance being "passing" and "substantially equivalent." No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or defined physical properties with numerical targets) are given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text mentions "bench, cadaver lab and validation testing," but no details on sample sizes for these tests are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable/provided. The device is a surgical mesh, not a diagnostic tool requiring expert interpretation for ground truth establishment. The testing mentioned (biocompatibility, bench, cadaver lab, validation) would involve engineering and biological assessments, not expert image/data review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the primary focus of this device's performance evaluation for 510(k) submission.
5. 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 information is not applicable. The Desara Mesh Sling is a surgical implant, not an AI-driven diagnostic device. Therefore, no MRMC study or AI-assisted human reader improvement analysis would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, this is a surgical mesh, not an algorithm, so standalone performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For biocompatibility, the ground truth would be established by standardized biological responses as defined by ISO 10993. For bench and cadaver lab testing, the "ground truth" would relate to physical properties, mechanical performance, and surgical handling characteristics compared against engineering specifications and potentially against the predicate device. Outcomes data would typically come from clinical trials, which are not detailed here beyond the general statement of substantial equivalence.
8. The sample size for the training set:
This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/provided, as there is no training set for this type of device.
Summary of available information regarding acceptance criteria and study:
The provided document details a 510(k) submission for the Desara Mesh Sling. The core of its performance data revolves around demonstrating substantial equivalence to a predicate device.
- Acceptance Criteria (Implicit):
- Biocompatibility: Meet ISO 10993 standards.
- Bench Testing: Meet unstated physical and mechanical property specifications, and demonstrate equivalence to the predicate device.
- Cadaver Lab Testing: Demonstrate equivalence in handling and placement characteristics in a simulated surgical environment.
- Validation Testing: General phrase indicating further testing to confirm design outputs meet design inputs, likely encompassing performance and safety benchmarks comparable to the predicate.
- Reported Device Performance:
- "all [biocompatibility] test results were passing."
- "the results of bench, cadaver lab and validation testing has shown the new Desara Mesh device to be substantially equivalent to the predicate device."
The document lacks the specific quantitative metrics, detailed study parameters, and expert-based evaluations that would be present for a diagnostic or AI-driven medical device. Its focus is on demonstrating that the modified surgical mesh is as safe and effective as its predecessor through a series of engineering and biological tests.
§ 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.