Search Results
Found 1 results
510(k) Data Aggregation
(38 days)
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:
| Characteristic | Acceptance Criteria (inferred by predicate) | Relimesh Performance | Predicate 1: Hermesh 7 (K070625) Performance | Predicate 2: Composite Mesh (K971745) Performance |
|---|---|---|---|---|
| Material/Design | Monofilament Polypropylene & ePTFE | Polypropylene & ePTFE | 100% Polypropylene | Polypropylene & ePTFE |
| Mesh Weight (g/sq. m) | Within historical range of predicates | 78 ± 6% | 19 | 214 |
| Filament Diameter (μ) | Within historical range of predicates | 120 | 80 | 160 |
| Thickness Mesh (mm) | Within historical range of predicates | 0.5 ± 10% | 0.27 mm | 1.5 mm |
| % Porosity | Within historical range of predicates | 86.8 | 91.9 | 83 |
| Suture Retention (N) | Comparable to or better than predicates | 24.60 | 8.75 | 26 ± 7.56 |
| Burst Strength (Kpa) | Comparable to or better than predicates | 378 | 359 | 1316 ± 3.8 |
| Tensile Strength (N/cm) | Comparable to or better than predicates | 24 ± 6 | 17.7 | N/A |
| Biocompatibility | Compliant with ISO 10993 | Compliant | - | - |
| Sterility | SAL 10^-6, EtO Residual <1 ppm | Compliant | - | - |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical studies for acceptance criteria. The evaluation is based on pre-clinical bench testing and material characterization. The provided data originates from Herniamesh SRL (Italy) and C.R. Bard Inc. for their respective predicate devices. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission. No human biological samples are mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The ground truth for this medical device submission is established through objective engineering and material science standards and biocompatibility testing, rather than expert medical interpretation of images or clinical outcomes from a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical data or expert interpretation. The evaluation relies on direct measurement and compliance with established standards.
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 submission is for a physical surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device. Performance is evaluated based on the physical and material properties of the mesh itself.
7. The Type of Ground Truth Used
The ground truth used for this submission is:
- Bench Testing Data: Objective measurements of physical properties like suture retention, burst strength, and tensile strength.
- Material Characterization: Analysis of material composition (Polypropylene, ePTFE), mesh weight, filament diameter, thickness, and porosity.
- Biocompatibility Standards: Compliance with ISO 10993 for biological evaluation of medical devices.
- Sterilization Standards: Compliance with Ethylene Oxide Residual (<1 ppm), Sterility Assurance Level 10^-6, and Ethylene Chlorohydrin Level (<2ppm).
- Predicate Device Data: Performance characteristics of legally marketed predicate devices serve as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device. The "ground truth" for demonstrating substantial equivalence is established through the comprehensive testing and characterization of the Relimesh device in comparison to established predicate devices and recognized industry standards (e.g., ISO 10993).
Ask a specific question about this device
Page 1 of 1