(41 days)
The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.
The Distal Radius Volar Rim Plating System consists of a series of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr used in bone fixation and the management of fractures and reconstructive surgeries in narrow to standard head widths.
The provided text is a 510(k) summary for a medical device (Distal Radius Volar Rim Plating System). It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies using a test set of data (clinical or otherwise) to demonstrate a specific level of performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
Specifically, the document lacks the following information required to answer your questions:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for a test set.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone algorithm performance study.
- Type of ground truth used (clinical outcomes, pathology, expert consensus, etc.).
- Sample size for a training set.
- How ground truth for a training set was established.
The "Summary of Substantial Equivalence" section only mentions "pre-clinical data including axial load construct testing, evaluation of galvanic corrosion potential, tab bending and function" to demonstrate similarity to predicate devices, but these are general engineering tests, not studies assessing diagnostic or clinical performance against acceptance criteria using patient data or expert consensus.
§ 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.