(170 days)
The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.
The 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 Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis, fixed angle pegs are used for distal bone fragments. The titanium Hook Plate Extension locks to the plate by a means of titanium screw. 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
- · Cannulated cobalt chrome polyaxial locking screws
- · Titanium alloy hook plate extension
- · Stainless steel k-wires (for provisional fixation not for implantation)
- · System specific instrumentation.
The provided text describes a medical device, the Skeletal Dynamics GEMINUS Volar Distal Radius Plate System, and its clearance through the 510(k) pathway. This pathway relies on demonstrating substantial equivalence to predicate devices, rather than performing clinical studies to establish specific acceptance criteria and performance metrics for the device itself in terms of diagnostic accuracy or clinical outcomes.
Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them are not applicable in this context. The 510(k) summary focuses on preclinical performance testing to demonstrate equivalence, not clinical performance.
Here's an analysis based on the provided text, addressing elements that are applicable and explaining why others are not:
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility, and packaging to predicate devices. No new issues of safety or effectiveness. | The device demonstrates substantial equivalence to the predicate devices (Skeletal Dynamics GEMINUS Volar Distal Radius Plate K111620, K122737; Synthes Distal Radius Plate K963798; Medpac SFC K951303) based on these characteristics. The minor difference in the hook plate extension does not raise new questions of safety or effectiveness. Performance data demonstrates it is as safe and effective as the predicate devices. |
| Preclinical Mechanical Performance | Meets static and dynamic mechanical testing standards sufficient to demonstrate equivalence to predicate devices. | Mechanical testing, including static and dynamic testing, was conducted and established equivalency to the predicate devices. This implies the device performed within acceptable bounds comparable to the predicate devices, though specific numerical criteria or results are not detailed in this summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The text describes preclinical mechanical testing rather than testing on a clinical "test set" of patients or data. Mechanical tests typically involve a specific number of manufactured units or samples for laboratory testing. The sample size for these mechanical tests is not specified, nor is data provenance in the clinical sense (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: This device is a bone fixation plate, not a diagnostic imaging device or AI algorithm that requires expert ground truth for interpretation. Mechanical testing typically involves engineers and quality assurance personnel, but "ground truth" in the clinical imaging sense is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are used for resolving disagreements in expert interpretations, primarily in clinical studies or evaluations of diagnostic performance. This is irrelevant for mechanical testing of a medical implant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic tasks. This device is a surgical implant and does not involve AI or human reading tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a metallic bone fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: For mechanical testing, the "ground truth" would be established engineering principles, material specifications, and regulatory standards for device performance, against which the device's mechanical behavior is measured. No clinical "ground truth" type (like pathology or outcomes data) is identified as this is not a clinical study.
8. The sample size for the training set
- Not Applicable: This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable: As stated above, there is no training set for this device.
Summary of the 510(k) for the GEMINUS Volar Distal Radius Plate System:
The 510(k) clearance for the Skeletal Dynamics GEMINUS Volar Distal Radius Plate System relies on demonstrating substantial equivalence to existing predicate devices already on the market. This means the device met acceptance criteria related to having the same intended use, indications for use, materials, fundamental scientific design, performance characteristics (including preclinical mechanical testing), sterility, and packaging as its predicates. The key finding is that the device does not present any new issues of safety or effectiveness compared to the predicate devices. The performance testing conducted was preclinical mechanical testing (static and dynamic), which was deemed sufficient to establish this equivalency. No clinical studies involving human subjects, diagnostic performance evaluation, or AI algorithms were part of this 510(k) submission.
§ 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.