(27 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 cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.
The GEMINUS Plate System is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis and fixed anale pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility.
The Skeletal Dynamics GEMINUS Plate System is comprised of:
- · Titanium alloy plates, washers and screws
- · Cannulated cobalt chrome polyaxial locking screws
- · Stainless steel k-wires (for provisional fixation not for implantation)
- · System specific instrumentation.
The provided text describes a 510(k) premarket notification for a medical device, the "Skeletal Dynamics GEMINUS Volar Distal Radius Plate System." This submission is for a mechanical device (bone fixation plate system), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (like AI performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.
The "study" described in this document is performance testing, specifically static and fatigue testing of the mechanical device. The acceptance criteria for such a device are typically established based on recognized industry standards for orthopedic implants and direct comparison to a predicate device.
Here's an attempt to answer the questions based on the provided document, noting where information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as described) |
|---|---|
| Mechanical Performance | Device passed static and fatigue testing. |
| Equivalence to Predicate | "Equivalent to the cleared Geminus Volar Distal Radius Plate System (K111620)" and "as safe and effective as the Skeletal Dynamics Volar Distal Radius Plate System (K111620) and the Synthes Titanium Alloy Volar Distal Radius Plate System (K963798)." |
| Material Properties | Titanium alloy plates, washers, screws. Cannulated cobalt chrome polyaxial locking screws. (Implies materials meet standards for biocompatibility and strength, though not explicitly detailed as acceptance criteria). |
| Intended Use | "Intended for fixation of fractures and osteotomies of the distal radius." (Matches predicate and intended use). |
| Design | "Similarities in design (fundamental scientific technology)" to predicate. Minor differences (cobalt chrome polyaxial locking screw) do not raise new safety/effectiveness concerns. |
| Sterility | "Similarities in sterility" to predicate (provided non-sterile, sterilized in user facility). |
| Packaging | "Similarities in packaging" to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of physical test units. Mechanical testing typically involves a specific number of samples to achieve statistical significance, but the exact count isn't in this summary.
- Data Provenance: Not applicable in the context of patient data. The "data" here comes from mechanical laboratory testing of the device components/system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as this is a mechanical device. "Ground truth" in this context would be engineering specifications and standards for mechanical performance, not expert medical opinion on clinical cases. The testing would be performed by qualified engineers or technicians in a laboratory setting.
4. Adjudication Method for the Test Set
- Not applicable for mechanical device testing. The results of static and fatigue tests are quantitative measurements assessed against pre-defined engineering standards or comparative data from predicate devices.
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 a mechanical orthopedic implant, not an AI or SaMD.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is a mechanical orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for evaluating this device's performance would be recognized engineering standards for orthopedic implants (e.g., ASTM standards for static and fatigue testing of bone plates) and comparative data from the legally marketed predicate devices. The goal is to demonstrate that the new device performs at least as well as, or equivalently to, the predicate devices under these standard mechanical tests.
8. The Sample Size for the Training Set
- Not applicable. This is a mechanical device, not an AI or SaMD requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is a mechanical device, not an AI or SaMD.
§ 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.