(14 days)
The Atrium C-Qur TM OVT Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.
The Atrium C-Qur" OVT Mesh is a surgical mesh used during surgical procedures. The mesh contains two layers of mesh stitched together. The second layer is cut into flaps. The intent of the addition of a second layer with flaps is to allow the surgeon to more easily position and attach the mesh to the surgical site.
The provided text describes a 510(k) premarket notification for a medical device modification, the Atrium C-Qur™ OVT Mesh. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for a novel device.
Therefore, many of the requested elements for a detailed study on device performance and acceptance criteria are not explicitly available in the provided text. The document states "Results of verification testing indicate that the product meets the established performance requirements" but does not detail what those requirements are, what performance was reported, or the methodology of the verification testing.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document refers to "established performance requirements" but does not detail them. | The document states: "Results of verification testing indicate that the product meets the established performance requirements." (Section 8) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified. The document refers to "verification testing" but does not indicate if this involved human clinical data, animal studies, or bench testing on the device. Therefore, information regarding "country of origin of the data," "retrospective or prospective" is not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The document does not describe a clinical study involving experts establishing ground truth for a test set. This is a 510(k) for a device modification, relying on substantial equivalence to a predicate device.
4. Adjudication method for the test set
- Not applicable, as no clinical test set requiring adjudication is described.
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 document pertains to a surgical mesh, not an AI-assisted diagnostic or interpretive device that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, as no clinical ground truth determination is described in the context of this 510(k). The "performance data" mentioned likely refers to bench testing to confirm physical properties or functional aspects of the modified mesh.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable, as no training set is relevant to this 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.