(37 days)
The AxSOS™ Plus Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur.
This submission is a line extension to the Stryker® Locked Plating System for various types of locking plates. Plates will be based on the design of the monoaxial plates in the Stryker® Locked Plating System. The subject plates have locking and non-locking holes. All screws will be available sterile and non-sterile. The plates also have holes for standard Kirschner wires to enhance primary plate and fracture fixation or they can be used as suture anchors.
The provided text describes a 510(k) summary for a medical device called the AxSOS™ Plus Locking Plate System. This summary focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a study to meet specific acceptance criteria in the way one might for a novel AI or diagnostic device.
Therefore, many of the requested categories related to AI performance studies (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Stryker® Locked Plating System) in: | Demonstrated: AxSOS™ Plus Locking Plate System is substantially equivalent to the Stryker® Locked Plating System. |
| - Intended Use | Demonstrated |
| - Design | Demonstrated |
| - Materials | Demonstrated |
| - Operational Principles | Demonstrated |
| - Strength | Demonstrated through FEA and mechanical testing, showing substantial equivalence to predicate components. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is for a medical implant (bone plates and screws), not a diagnostic or AI device that relies on a "test set" of patient data in the conventional sense. The "test set" here refers to mechanical testing and Finite Element Analysis (FEA) performed on the plates themselves, not a dataset of patient cases. The document does not specify the number of physical samples tested or the exact parameters of the FEA.
- Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering tests and analyses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context would be engineering specifications and mechanical properties, not expert clinical interpretation. The evaluation is based on engineering principles and material science.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic studies. This is an engineering evaluation.
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:
- No. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- Engineering Specifications and Mechanical Properties: The ground truth for this device's performance is based on established engineering principles, material standards, and the mechanical performance of the predicate device. The goal was to prove that the new device's strength is substantially equivalent to the predicate, implying that the predicate's established safety and effectiveness through prior regulatory clearance serves as the benchmark.
8. The sample size for the training set:
- Not applicable. This is not an AI device that uses a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI 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.