(149 days)
C-QUR Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
C-QURTM Mesh is a sterile, knitted polypropylene monofilament mesh material for tissue reinforcement with a bio-absorbable, animal derived oil coating (O3FA) composed of fatty acids, lipids and glycerides. The C-QUR Mesh family is available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.
The provided document is a 510(k) premarket notification from the FDA regarding surgical mesh devices (C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic). It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document specifically states: "This submission does not contain technological changes for subject devices. C-QUR Mesh has the same technological characteristics as previously cleared C-QUR Mesh devices (K050311, K082748, K090909, K100076, K110110 and K121070). The subject devices differ only from the predicate devices in the indications for use, contraindications, and MR compatibility in the labeling." It also states, "The mesh materials used to construct the Atrium C-QurTM Mesh have not been modified and remain the same as those described in predicate C-QUR Mesh devices."
The document focuses on demonstrating substantial equivalence based on existing, previously cleared devices and labeling changes, rather than presenting a new performance study to prove the device meets acceptance criteria. Therefore, the information required to answer the prompt directly is not available within this document. The document is essentially a regulatory filing affirming that these updated versions of the C-QUR mesh family do not represent a new device that requires a de novo performance study, but rather are equivalent to those already on the market.
Based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria, because such information is not present. This document is a regulatory approval based on substantial equivalence, not a report of a new performance study.
Therefore, I cannot populate the table or provide details about sample size, expert involvement, or ground truth establishment for a new performance study of this device. The document explicitly states that there are no technological changes and that the device characteristics are the same as previously cleared predicates.
§ 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.