(142 days)
The SIDEKICK® Circular Fixator System: Struts and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction or bony or soft tissue defonnities, and correction of segmental or nonsegmental bony or soft tissue defects. The SIDEKICK® Circular Fixator System: Struts and Hinges is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
The SIDEKICK® Circular Fixator System: Struts and Hinges is a dynamic frame that can change position or orientation from the beginning of treatment to the end of treatment for correcting deformities in soft tissue or bone. The system allows precise, controlled compression/distraction. The hinges are used to create a point of rotation and/or angulation between levels of ring fixation on the frame. The rotation/angulation of the struts is used as compressors/distractors and which provide gradual or acute movement.
This document is a 510(k) summary for the SIDEKICK® Circular Fixator System: Struts and Hinges, which is a medical device. 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device, rather than conducting extensive clinical studies with acceptance criteria for device performance. As such, the information typically requested in your prompt (e.g., sample sizes, expert qualifications, MRMC studies, ground truth details for AI/software devices) is not relevant or applicable to this type of submission.
Here's a breakdown of the available information based on your request, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Performance demonstrated to be "at least as well as" the legally marketed predicate device (R & R External Fixation (Ring Fixator)). | "The results of the test show that the subject SIDEKICK® Circular Fixator System: Struts and Hinges can be expected to perform at least as well as the legally marketed predicate R & R External. Fixation (Ring Fixator)." Specifically, this was shown through static compressive stress testing. |
| Substantially equivalent indications for use, anatomical sites, and multi-piece design compared to the predicate. | "The subject SIDEKICK® Circular Fixator System: Struts and Hinges and the legally marketed predicate R & R External Fixation (Ring Fixator) have the same indications, are used at the same anatomical sites, and are both multi-piece designs." (Note: Differences exist in number of axes of rotation, material, and type of bridge element, but these differences did not preclude a finding of substantial equivalence based on the provided evidence). |
| Safety and effectiveness supported by substantial equivalence information, materials information, and comparison of design characteristics. | "The safety and effectiveness of the SIDEKICK® Circular Fixator System: Struts and Hinges is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as this submission relies on non-clinical (mechanical) testing for comparison to a predicate, not clinical data or a "test set" in the context of an AI/software device. The nature of static compressive stress testing typically involves a set number of devices or components, but the specific quantity isn't detailed, nor is provenance in the typical data sense.
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)
This is not applicable. Ground truth, as you describe it, relates to clinical interpretation or outcome data, which is not the basis for this 510(k) submission. The "ground truth" here is the established performance of the predicate device under specific mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There was no clinical test set requiring human adjudication.
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
This is not applicable. This device is a physical medical implant, not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or more accurately, the reference standard for comparison) for demonstrating substantial equivalence was the established mechanical performance of the predicate device (R & R External Fixation (Ring Fixator)) as determined through static compressive stress testing.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" or corresponding ground truth as described for an AI/software device. The comparison is against the predicate device's known mechanical properties.
§ 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.