(339 days)
The T-Sling 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, and vaginal vault prolapse.
The T-sling is intended to be used in females to position a polypropylene mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The T-Sling is made of monofilament polypropylene warp knitted into composite mesh construction. The T-Sling is a sterile, single-use pubourethral sling for the treatment of stress urinary incontinence (SUI).
The provided text is a 510(k) Summary for the Caldera Medical T-Sling, a surgical mesh device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of design, materials, and intended use, rather than presenting clinical study data with acceptance criteria and performance metrics typically seen for AI/ML-based medical devices or devices that require extensive clinical efficacy studies.
Therefore, many of the requested items (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for this specific device.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy, or other clinical outcomes) in the way a clinical study report for an AI/ML device would. The "acceptance" for this type of device in a 510(k) submission primarily revolves around demonstrating substantial equivalence to legally marketed predicate devices, meaning it has the same intended use, fundamental technological characteristics, or, if different, those differences do not raise new questions of safety and effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) Summary for a surgical mesh device, not an AI/ML device, and it does not present a clinical study with a "test set" in that context. The evaluation is based on material properties, design, and comparison to predicates.
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)
Not applicable. Ground truth establishment by experts is not a component of this type of regulatory submission for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not described as this is not a study involving human review of data.
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
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Clinical ground truth, in the sense of a diagnostic or predictive algorithm, is not directly discussed. The "truth" in this context is the safety and effectiveness profile established by the predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and no training set is mentioned.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary regarding the device and its regulatory pathway:
The Caldera Medical T-Sling is a surgical mesh made of monofilament polypropylene, warp knitted into a composite mesh. It is intended as a sterile, single-use pubourethral sling for the treatment of:
- Genuine Stress Urinary Incontinence (SUI) in females.
- Mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
- Vaginal vault prolapse.
The 510(k) submission (K050516) sought to demonstrate substantial equivalence to existing legally marketed predicate devices. The listed predicate devices are:
The FDA's review concluded that the T-Sling is substantially equivalent to these predicate devices for its stated indications for use. This means that based on comparison of materials, design, intended use, and potentially bench testing data (which is not detailed in this summary), the FDA determined the device is as safe and effective as a legally marketed device.
§ 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.