(71 days)
The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation, where:
DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation, stabilization and reconstruction of:
- Rib fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
- Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilization and reconstruction of: - Rib and sternum fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
- Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for fixation, stabilization and reconstruction of: - Sternum fractures, fusions, and/or osteotomies
- Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
The DePuy Synthes MatrixRIB intramedullary splints and the universal plate are indicated for the fixation and stabilization of ribs.
The devices subject to this notification are proposed for addition to the MatrixRIB Fixation System.
The subject devices consist of self-drilling screws and screw guides designed to be used with the previously cleared MatrixRIB 1.5mm plates and the splints.
The MatrixRIB Self-Drilling Screws are available as
• locking screws, for permanent fixation,
• and non-locking screws, for temporary fixation only.
The subject screws are manufactured from Titanium Alloy (Ti-6Al-7Nb). They are provided in a range of lengths
• locking: 13 lengths from 8mm to 20mm, with 1mm increments;
• non-locking: 2 lengths from 10mm to 12 mm, with 2 mm increments).
The MatrixRIB Screw Guides are to be used with the subject self-drilling screws to facilitate their fixation on patient's ribs and sternum. The subject screw guides are manufactured from Stainless Steel and are provided in 2 designs,
• one for the 1.5mm MatrixRIB plates,
• and one for the MatrixRIB IM splints.
The provided text does not contain information about the acceptance criteria or study details for a device that involves performance metrics such as reader studies or algorithm performance. The document describes a 510(k) premarket notification for the "MatrixRIB Fixation System" which is a metallic bone fixation appliance. The acceptance criteria and performance data discussed are related to the mechanical properties of the screws within the system, not diagnostic or AI-driven performance.
Therefore, I cannot fulfill the request for information on acceptance criteria, a table of acceptance criteria and reported device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, or how training set ground truth was established, as this information is not present in the provided document.
The document does mention:
- Non-clinical performance data: "Non-clinical testing and analyses conducted as part of this submission include: Screw Pull-Out Testing per ASTM F543-17, Screw Failure Torque Testing per ASTM F543-17, Screw Cantilever Load Testing, Construct Dynamic Testing. The non-clinical performance data demonstrates that the mechanical performance of the proposed MatrixRIB Self-Drilling Screws met all acceptance criteria and is comparable to that of the predicates."
- Clinical testing: "Clinical testing was not necessary for the determination of substantial equivalence."
This indicates that the "acceptance criteria" referred to in the document are mechanical and material-specific, not related to diagnostic accuracy or AI performance.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.