(29 days)
The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius
The Skeletal Dynamics Geminus Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.
The Geminus Volar Distal Radius Plates are available in various sizes and are made of medical grade titanium alloy. Cortical screws affix the plate to the diaphysis and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility.
The Geminus Volar Distal Radius Plate System is comprised of:
- Titanium alloy plates, washers and screws
- CoCr Cannulated Polyaxial Locking Screw (PLS)
- Stainless steel K-wires (for provisional fixation; not for implantation)
- System specific instrumentation
The provided text describes the regulatory clearance of a medical device, the "Geminus Volar Distal Radius Plate System," through a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical studies to prove safety and efficacy against predefined acceptance criteria.
Therefore, the document does not contain information about:
- Acceptance criteria and reported device performance in the context of a clinical study.
- Sample size used for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI assistance (as this is not an AI/software device).
- Standalone (algorithm only) performance.
- The type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set or how ground truth for a training set was established.
Instead, the performance testing for this device focused on demonstrating equivalence to the predicate device through engineering analysis and testing.
Key information from the text regarding performance:
- Performance Testing: "Engineering analysis and testing demonstrated that the Geminus Volar Distal Radius Plate System is substantially equivalent to predicate devices currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices."
- Technological Characteristics: "The substantial equivalence of the Geminus Volar Distal Radius Plate System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness."
In summary, the provided text describes a 510(k) clearance based on substantial equivalence, not a study evaluating a device against specific clinical acceptance criteria. The "performance testing" mentioned refers to non-clinical engineering and bench testing to show that the new device performs similarly to predicate devices.
§ 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.