(74 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 either distal or volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. The Skeletal Dynamics 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 and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility. The Skeletal Dynamics Geminus Volar Distal Radius Plate System is comprised of: titanium alloy plates, washers and screws; stainless steel K-wires (for provisional fixation not for implantation); system specific instrumentation.
This is a 510(k) premarket notification for a medical device (Skeletal Dynamics Geminus Volar Distal Radius Plate System), not an AI/ML device. Therefore, the questions related to AI/ML device performance (acceptance criteria, training/test set details, expert ground truth, MRMC studies, standalone performance) are not applicable.
The provided document describes the safety and effectiveness of a bone plate system by demonstrating its substantial equivalence to a predicate device already on the market.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in the way one would for an AI/ML model (e.g., specific thresholds for accuracy, sensitivity, specificity). Instead, the "acceptance criteria" for this conventional medical device revolve around demonstrating substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (Synthes Titanium Alloy Volar Distal Radius Plate System K963798) in: | The Skeletal Dynamics Geminus Volar Distal Radius Plate System demonstrated substantial equivalence by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility, and packaging. |
| - Intended Use | Similarities demonstrated |
| - Indications for Use | Similarities demonstrated |
| - Materials | Similarities demonstrated |
| - Design (fundamental scientific technology) | Similarities demonstrated |
| - Performance | Preclinical analysis and cadaveric testing, including static, fatigue, and dynamic mechanical testing, established equivalency. |
| - Sterility | Similarities demonstrated |
| - Packaging | Similarities demonstrated |
| Safe and Effective | Concluded to be as safe and effective as legally marketed predicate devices based on equivalence. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of numerical count. The testing involved "preclinical analysis and cadaveric testing."
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by Skeletal Dynamics, LLC. It's prospective in the sense that the testing was performed for this 510(k) submission to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to a conventional medical device like a bone plate system. The "truth" is established through mechanical and cadaveric testing against established engineering principles and medical device standards, not through expert consensus on interpretations of data.
4. Adjudication method for the test set:
Not applicable. There's no "ground truth" to adjudicate in the context of expert review for this type of device. Performance is determined by objective mechanical testing and cadaveric studies.
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. This is not an AI/ML device, and no human reader studies are mentioned or relevant for demonstrating equivalence of a bone plate system.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- For the performance testing (mechanical and cadaveric testing), the "ground truth" is based on:
- Mechanical properties and performance standards: The device's ability to withstand static, fatigue, and dynamic loads as expected for bone fixation, likely compared against established benchmarks or the predicate device's performance.
- Cadaveric testing: Demonstrating the surgical implantation characteristics and initial biomechanical stability in a simulated human environment.
- Comparison to predicate device: The ultimate "ground truth" for substantial equivalence is demonstrating that its performance is comparable to an already approved device.
8. The sample size for the training set:
Not applicable. There is no AI/ML model to train for this device.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML model to train for this device.
§ 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.