(17 days)
Atrium C-QUR RPM Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.
Not Found
The input provided is a 510(k) clearance letter from the FDA for a surgical mesh device, Atrium C-QUR RPM Mesh. This document is related to medical device regulation and describes the process of obtaining clearance for a physical medical device (surgical mesh), not a software-as-a-medical-device (SaMD) or an AI-based diagnostic tool.
Therefore, the concepts of "acceptance criteria," "study," "sample size for test set," "ground truth," "MRMC study," "standalone performance," and "training set" as described in the prompt are not applicable to this type of device and document. These criteria are specifically for evaluating the performance of AI algorithms or diagnostic tools, which rely on data analysis and interpretation.
The provided document simply states that the Atrium C-QUR RPM Mesh is substantially equivalent to legally marketed predicate devices. This equivalence is typically established through preclinical testing (e.g., biocompatibility, material properties) and/or sometimes clinical use data if a novel feature is introduced, but not through the type of performance study outlined in the prompt for AI/diagnostic software.
In summary, none of the requested information regarding acceptance criteria, study details, and AI-specific performance metrics can be extracted from this document because it pertains to a physical surgical mesh, not an AI 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.