(59 days)
Wright's SIDEKICK® EZ FRAME™ External Fixation System is intended for:
- · Triple Arthrodesis
- · Isolated Rearfoot Arthrodesis
- · Midfoot Arthrodesis
- Comminuted Trauma
- · Diabetic Charcot Reconstruction
- · Most foot pathology not requiring fixation above the ankle
The SIDEKICK® EZ FRAME™ External Fixation System uses a series of pins and wires for compression or distraction in the foot and uses a boot to secure the tibia. The system is adjustable to accommodate variations in patient anatomy. The SIDEKICK® EZ FRAMETM External Fixation System is compatible with the SIDEKICK® FREEDOM External Fixation System (K043289) components, and these components provide additional fixation options in the system.
This document is a 510(k) premarket notification for a medical device called the SIDEKICK® EZ FRAME™ External Fixation System. It asserts substantial equivalence to a predicate device, rather than providing a study demonstrating its own performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies for the device in question cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or reported device performance in terms of metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The submission focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific performance criteria for the new device. | Not applicable. Device performance metrics against specific acceptance criteria are not presented. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission states "Substantial Equivalence - Non-Clinical Evidence" and "Through technological comparison, the subject system does not represent a new worst-case." and "Substantial Equivalence - Clinical Evidence N/A". This indicates that no clinical or performance test set was used for the sidekick EZ FRAME in this submission. The evaluation is based on technological comparison and material/design similarities to a predicate device.
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. No test set was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set was used.
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 device is a mechanical external fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical external fixation system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Ground truth is not relevant in a substantial equivalence filing for a mechanical device based on technological comparison.
8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth for it.
Summary based on the document:
The document asserts that the SIDEKICK® EZ FRAME™ External Fixation System is substantially equivalent to a legally marketed predicate device (K130044: SIDEKICK® EZ FRAME™ External Fixation System) based on technological characteristics comparison. The submission explicitly states:
- Non-Clinical Evidence: "Through technological comparison, the subject system does not represent a new worst-case."
- Clinical Evidence: "N/A" (Not Applicable)
- Conclusion: "The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device."
This means that the "study" proving the device meets criteria is primarily a comparative analysis of its design, materials, and intended use against an already approved predicate device, demonstrating that it does not introduce new safety or effectiveness concerns. No new performance studies with acceptance criteria, test sets, or ground truth establishment were conducted or reported for this 510(k) submission.
§ 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.