(35 days)
Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following:
Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection. segmentectomy, pnuemonectomy/pneumectomy, pneumoreduction) and other incision and excision of the lung and bronchus.
Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).
An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neovascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.
The provided text does not contain information about acceptance criteria or a study proving the device meets them, as would be relevant for a diagnostic or AI-powered medical device.
The document is a 510(k) summary for a Surgical Mesh (Veritas Collagen Matrix), which is a physical implant. The approval process for such a device focuses on demonstrating substantial equivalence to a previously approved predicate device, primarily based on technological characteristics and intended use, rather than performance metrics from clinical studies in the same way a diagnostic algorithm would be evaluated.
Therefore, the requested information elements (acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable and not present in the provided text for this specific type of medical device approval.
The "Technology/Device Testing" section only states: "The Veritas Collagen Matrix is substantially equivalent to the predicate device in terms of testing." This implies that the testing performed was sufficient to demonstrate substantial equivalence, but it does not detail specific performance metrics or studies in the way requested for a diagnostic AI.
§ 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.