(18 days)
The Drive Rail System is intended to be used on adult or pediatric patients in the treatment of conditions of the long bones of the arms and legs including limb lengthening, acute or gradual multiplanar correction of long bone deformities, fractures and diseases which generally may result in joint contractures or loss of range of motion, fractures requiring distraction, open or closed fractures, non- unions, and infected fractures or non-unions.
The Drive Rail System is a unilateral external fixation system that consists of various components used in the management of lower extremity bone fractures and reconstructive, as well as corrective, orthopedic surgery. The system consists of 316LVM stainless steel half pins along with frame components including rail segments, pin clamps, distraction/compression devices and associated accessories made from aluminum and stainless-steel materials. These components should be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided nonsterile.
The worm gear component in the Drive Rail System is made of 17-4 stainless steel, which is ferromagnetic. Since the worm gear component is magnetic and is within each external rail construct, the Drive Rail System is MR unsafe.
Here's a summary of the acceptance criteria and study information based on the provided text:
Executive Summary:
The provided document describes a Special 510(k) submission (K220809) for the OrthoPediatrics Drive Rail System. The primary purpose of this submission is to change the device's labeling regarding its Magnetic Resonance (MR) safety status from "Safety in MR environment not evaluated" to "MR Unsafe." This change is based on a determination that a component within the Drive Rail System (the worm gear) is made of ferromagnetic material. No new performance data was generated or required to support this labeling change, as per FDA guidance for MR unsafe labeling. Therefore, traditional acceptance criteria related to a device's functional performance are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Related to MR Safety Labeling) | Reported Device Performance |
|---|---|
| Presence of ferromagnetic materials: The device contains one or more ferromagnetic materials. | Confirmed: The worm gear component in the Drive Rail System is made of 17-4 stainless steel, which is ferromagnetic. |
| MR Safety Status: Labeling states that the device is "MR Unsafe." | Proposed: The proposed labeling for the subject device is "The Drive Rail System is MR Unsafe." |
| Compliance with FDA Guidance: The determination to label as "MR Unsafe" is in accordance with FDA guidance for medical devices in the MR environment. | Confirmed: The submission explicitly references FDA guidance documents ("Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and "The Special 510(k) Program") to support that no performance data is needed for "MR Unsafe" labeling based on scientific rationale of ferromagnetic materials. |
2. Sample Size Used for the Test Set and Data Provenance:
No explicit test set with a sample size was used for this FDA submission as it was a Special 510(k) focused on a labeling change based on material composition.
- Test Set Sample Size: Not applicable. The change is based on a review of device design specifications and material composition.
- Data Provenance: The determination of ferromagnetic material was based on the "OrthoPediatrics Corp reviewed drawings and conducted test to determine of component in the system contains ferromagnetic materials and is magnetic." This implies internal material specification data and potentially simple magnetic testing. No external "data provenance" like country of origin or retrospective/prospective study is relevant here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. Ground truth for a test set is not relevant here as no traditional performance study was conducted. The determination was based on the material properties of the worm gear component. The implicit "experts" would be the engineers responsible for material selection and design at OrthoPediatrics Corp.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication was utilized for this specific submission.
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 submission is for a physical medical device (an external fixation system) and not for an AI/software device. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission is for a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the material composition of the device's worm gear, which was identified as 17-4 stainless steel, a known ferromagnetic material. This was established through design review and material testing by the manufacturer (OrthoPediatrics Corp.).
8. The Sample Size for the Training Set:
Not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set.
§ 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.