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Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects

Relimesh prostheses are dual component meshes made of non-absorbable monofilament polypropylene mesh on one side and a layer of ePTFE on the other side.
Relimesh is warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling and will maintain excellent isotropic properties because of its knitted construction. The ePTFE layer is heat sealed to the polypropylene layer
These meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body.
The devices are supplied as sterile, single-use surgical meshes.

This document describes the premarket notification (510(k)) for the Herniamesh Relimesh, a surgical mesh intended for the reconstruction of soft tissue deficiencies. The device's acceptance criteria and the study proving it meets these criteria are established through a comparison to legally marketed predicate devices, Composite Mesh (C.R. Bard Inc.) and Hermesh 7 (Herniamesh Srl).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Relimesh device are based on demonstrating substantial equivalence to predicate devices through functional and material characteristic comparisons. The specific acceptance criteria are that the Relimesh device's performance characteristics (suture retention, burst strength, tensile strength) are comparable to or better than the predicate devices, and that its material properties and intended use are similar. The reported device performance is shown in the table below:

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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:

• Herniamesh T-Sling (K020652)
• Tyco Healthcare IVS Tunneller (K010035)
• Ethicon TVT (K012628)

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.

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