(203 days)
TRULENE MESH, NONABSORBABLE POLYPROPYLENE SURGICAL MESH IS INDICATED FOR USE IN HERNIA REPAIR AND OTHER FASCIAL DEFICIENCIES THAT REQUIRE THE ADDITION OF A REINFORCING OR BRIDGING MATERIAL TO OBTAIN THE DESIRED SURGICAL RESULT.
Trulene Mesh is Nonabsorbable Polypropylene Surgical Mesh, produced by knitting filaments of extruded undyed Monofilament Polypropylene, a synthetic linear Poly olefin.
The provided document describes a medical device called "TRULENE MESH" and its equivalence to predicate devices. It does not contain information about an AI/ML device, nor does it address the specific criteria typically associated with testing and validation of AI/ML diagnostic tools (e.g., ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).
Therefore, I cannot provide details for most of your questions based on the provided text. The document focuses on demonstrating substantial equivalence based on material composition, design, intended use, and physical properties compared to existing devices.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison table against predicate devices for various physical and material properties. The 'acceptance criteria' are implicitly that the TRULENE MESH performs "Same" or "approximately the same" as the predicate devices, and meets or exceeds requirements.
| Comparison Item | TRULENE MESH Performance | Acceptance Criteria (Implied) |
|---|---|---|
| Raw Material used | Same | Same as predicate |
| U.S.P. Size of the Polypropylene thread (5-0) | Same | Same as predicate |
| Diameter of the raw material (0.1 to 0.149 mm) | Same | Same as predicate |
| Knot Pull Tensile Strength of raw material (NLT 0.5 Kgf) | NLT 0.5 Kgf | Same as predicate |
| Linear Tensile Strength of raw material (0.75 +/- 0.05 Kgf) | 0.75 +/- 0.05 Kgf | Same as predicate |
| Intended Use | Same | Same as predicate |
| Supplied for single use only | Same | Same as predicate |
| Sterilized by E.O. method | Same | Same as predicate |
| Packaging and Labeling | Same | Same as predicate |
| Thickness of the Trulene Mesh | 0.44 - 0.46 mm | Approximately the same |
| Density of the Trulene Mesh | 95 Gram per Sq. Meter | Approximately the same |
| Pore Size of the Trulene Mesh | 22 to 23 Pores per inch | Approximately the same |
| Tensile Strength of Trulene Mesh | 14.0 to 16.0 Kgf | Approximately the same |
| Burst Strength of Trulene Mesh | 12.0 to 13.0 Kg/S.Cm | Approximately the same |
| Tear resistance of Trulene Mesh | 5.0 to 6.5 Kgf | Approximately the same |
| Suture Pull out Strength | 6.25 to 7.5 Kgf | Approximately the same |
| Biologically compatible (as per ISO-10993) | Same | Same as predicate |
2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device (surgical mesh), not a diagnostic AI/ML system. Testing refers to physical property measurements, not evaluation on a 'test set' of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device performance relies on established physical and material testing standards and comparison to legally marketed predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Study Proving Acceptance Criteria (from the document):
The study demonstrates substantial equivalence of the TRULENE MESH to predicate devices (United States Surgicals' Nonabsorbable Polypropylene Surgical Mesh K905655 and MPathy Medical Devices Ltd's Minimesh K041632) by:
- Material Equivalence: Stating it is composed of the "same material" (undyed Monofilament Nonabsorbable polypropylene).
- Design Equivalence: Stating it has a "similar knit design" and is manufactured in a "manner typical of the industry and equivalent to that to produce the predicate devices."
- Performance Testing: Performing comparative testing for parameters such as:
- Thickness
- Density
- Pore Size
- Burst Strength
- Tensile Strength
- Tear Resistance
- Cleanliness
- Sterility requirements
- Biological compatibility (as per ISO-10993 standards)
- Conclusion: The testing "demonstrates that 'TRULENE' Polypropylene Nonabsorbable surgical suture meets or exceeds the requirements and are equivalent in terms of the above mentioned predicate devices."
The study is essentially a set of comparative physical and material property tests to show the new device is functionally identical or superior to existing, legally marketed devices.
§ 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.