(20 days)
The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are indicated for fixation of long long fractures including but not limited to fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.
This Special 510(k) submission is intended to address modifications to the predicate Stryker Plating System. The subject and predicate devices are internal fixation plates, screws and accessories of the r no basyon attryker Locked Plating System is intended for use in long bone fracture fixation. The byeten. The Bujates are indicated for fixation of long bone fractures including but not limited to fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia and the distal femur.
The provided text describes a Special 510(k) submission for the Stryker Locked Plating System, which is a medical device. This submission focuses on modifications to an existing predicate device and demonstrates substantial equivalence rather than presenting a study to prove acceptance criteria for a novel device or an AI/software component.
Therefore, the information requested in your prompt (e.g., acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth, MRMC study, standalone performance) is not applicable to this document as it pertains to a mechanical medical device seeking clearance based on substantial equivalence to a predicate device, not on clinical performance or AI/software validation.
The "study that proves the device meets the acceptance criteria" in this context is a mechanical testing comparison to the predicate device to demonstrate comparable mechanical properties.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparable mechanical properties to predicate components | Mechanical testing demonstrated comparable mechanical properties to the predicate components. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified (refers to mechanical components, not human data).
- Data Provenance: Not applicable for mechanical testing.
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 as this involves mechanical testing, not a clinical study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for mechanical testing would be established engineering standards or the performance of the predicate device.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.