FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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 FRAME™ External Fixation System is compatible with the SIDEKICK® FREEDOM External Fixation System (K043289) components, and these components provide additional fixation options in the system.

AI/ML Overview

The provided documentation describes a 510(k) submission for the SIDEKICK® EZ FRAME™ External Fixation System, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical studies to prove effectiveness against predefined acceptance criteria for a novel device.

Therefore, many of the requested details regarding acceptance criteria, extensive study design, ground truth, and reader studies are not applicable or explicitly stated in this type of submission for this device.

Here's an analysis based on the information provided:

Analysis of Acceptance Criteria and Study for SIDEKICK® EZ FRAME™ External Fixation System

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for an external fixation system, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a predicate device through mechanical and design comparisons, rather than clinical performance metrics like sensitivity, specificity, or accuracy.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Equivalence: Does the new device perform mechanically at least as well as the predicate device, without representing a new worst-case scenario?	The submission states: "Through mechanical component analysis and comparison the subject system does not represent a new worst-case." This indicates that mechanical performance was evaluated against the predicate and deemed equivalent or better.
Design and Materials Equivalence: Are the design characteristics, materials, and method of operation similar enough to the predicate device?	The submission states: "The subject device operates in the same method as the predicate" and "The design characteristics of the subject system do not raise new types of questions of safety or effectiveness." This implies that the design and method of operation are demonstrably similar to the predicate.
Intended Use Equivalence: Does the new device have the same or similar intended uses as the predicate device?	The intended uses listed for the SIDEKICK® EZ FRAME™ (Triple arthrodesis, Isolated rearfoot arthrodesis, Midfoot arthrodesis, Comminuted trauma, Diabetic Charcot reconstruction, Most foot pathology not requiring fixation above the ankle) are implicitly considered equivalent or acceptable in scope compared to the predicate device, as FDA cleared the device for these indications.
Safety and Effectiveness: Does the device perform at least as well as the predicate systems without raising new questions of safety or effectiveness?	The submission concludes: "From the evidence submitted in this 510(k), the subject device system can be expected to perform at least as well as the predicate systems." The FDA's clearance letter confirms this conclusion regarding substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance:

Not Applicable. This submission relies on substantial equivalence through mechanical and design comparison, not a "test set" of patient data in the typical sense of a clinical trial for a novel diagnostic or therapeutic device. The "test set" would primarily consist of the device components themselves undergoing mechanical testing. The document does not specify a sample size for such mechanical tests, nor does it detail data provenance in terms of patient population or origin.

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 the context of clinical studies involving expert interpretation, is not relevant here. The evaluation is against the performance and characteristics of a predicate device, which itself has established safety and effectiveness.

4. Adjudication Method for the Test Set:

Not Applicable. As there is no "test set" involving human interpretation or clinical endpoints requiring adjudication, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No. This device is an external fixation system (a hardware medical device), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant and was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This is a physical medical device, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used:

Not Applicable / Predicate Device Performance. For this type of submission, the "ground truth" is effectively the established safety and effectiveness profile, mechanical performance, and design characteristics of the legally marketed predicate device. The new device's performance is gauged against this established benchmark.

8. The Sample Size for the Training Set:

Not Applicable. As this is not an AI/ML device, there is no "training set" of data as understood in that context. The device's design and manufacturing rely on established engineering principles and materials science, not machine learning algorithms trained on data.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. Since there is no training set, there is no ground truth to establish for it.

Summary

Regulation Number and Section

§ 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.