(207 days)
All meshes made by Hemiamesh are made of monofilament polypropylene. The meshes are designed to be used in the surgical repair of abdominal wall hernias such as primary or recurrent inguinal hernias, femoral hernias, inscisional hernias as well as thoracic wall defects.
Herniamesh products Hertra 1. 2 & 2A and Hermesh 3, 4 & 5 have the same intended uses as Trelex Mesh and Marlex Mesh. All are used in the repair of primary or recurrent inguinal hernias (particularly when facial structures are weak), primary or recurrent inscisional hernias so large that the fascial edges of the hernial ring cannot be approximated (generally one-fourth of the abdominal wall), femoral hernias, or chest wall defects where it is not possible to use autogenous tissue to prevent or correct lung herniation.
Herniamesh Plugs T1, T2 & T3 have the same intended use as the Marlex Mesh Dart which is used for the repair of hernias with a three dimensional shape i.e. femoral, inguinocrueal or large recurrent inguinal hernias.
This document is a 510(k) premarket notification for Herniamesh surgical meshes, demonstrating substantial equivalence to predicate devices (Trelex Mesh and Marlex Mesh). It doesn't report on an AI/ML device or a study with typical acceptance criteria like sensitivity, specificity, accuracy, etc. Instead, the "acceptance criteria" here are questions related to establishing substantial equivalence for a medical device submitted under a 510(k) pathway.
Therefore, the requested information elements (1-9) which are typically associated with performance studies for AI/ML devices or clinical trials, are not applicable to this document. The document focuses on demonstrating equivalence in terms of indications, intended use, and technological characteristics.
Here’s a breakdown of why each requested point isn't directly applicable in the context of this 510(k) summary:
- 1. A table of acceptance criteria and the reported device performance: This document doesn't present a study with quantitative performance metrics for the Herniamesh products as it's a submission for substantial equivalence based on material, design, and intended use, not clinical efficacy or diagnostic accuracy. The "acceptance criteria" are the four questions posed by the FDA's decision-making process for substantial equivalence.
- 2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of a performance study described here. The evaluation is a comparison against existing predicate devices.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" to establish through expert consensus in this type of submission.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as points 2 and 3.
- 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 or human reader improvement is discussed.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" is not a concept that applies to this type of substantial equivalence submission.
- 8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of the document's approach to "acceptance criteria":
The document defines "acceptance criteria" (though not explicitly called that) as the four questions from the FDA's "substantial Equivalence" Decision-Making Process:
- Does New Device Have Same Indication Statement?
- Reported performance/Finding: Yes. All indications are identical to predicate devices (repair of abdominal wall hernias, femoral hernias, chest wall defects).
- New Device Has Same Intended Use and May be "Substantially Equivalent"?
- Reported performance/Finding: Yes. Intended uses are the same as predicate devices (e.g., repair of primary/recurrent inguinal hernias, incisional hernias, femoral hernias, chest wall defects).
- Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?
- Reported performance/Finding: Yes. Made of the same material (polypropylene monofilament of various thickness). Design and structure (monofilament knitted into a mesh design, flat or three-dimensional) are the same as predicate devices.
- Are The Descriptive Characteristics Precise Enough to Ensure Equivalence?
- Reported performance/Finding: Yes. Since materials, design, and structure are the same, the descriptive characteristics applying to predicate devices also apply to Herniamesh products. Process validation will ensure properties are maintained.
Conclusion:
Based on answering "Yes" to all four questions, the Herniamesh surgical meshes are deemed "Substantially Equivalent" to the predicate devices. This is the "study" and "proof" provided within this 510(k) submission for regulatory acceptance.
§ 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.