(29 days)
The Hoffmann® II MRI components are external fixation frame components for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX" External Fixation System and in conjunction with Apex® Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
This Special 510(k) submission is intended to address modifications to the predicate Hoffmann This openal J ro(is) bachines to include components, which may be used safely for Magnetic Resonance Imaging (MRI).
This document describes a Special 510(k) submission for the Hoffmann® II MRI External Fixation System. The submission addresses modifications to existing Hoffmann external fixation devices to include components that can be safely used in a Magnetic Resonance Imaging (MRI) environment.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties: Comparable to predicate components. | Mechanical testing demonstrated comparable mechanical properties to the predicate components. |
| MRI Safety: Safe for use in Magnetic Resonance Imaging under predetermined conditions. | Testing in a Magnetic Resonance Environment established that the components could be safely used in Magnetic Resonance Imaging under predetermined conditions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for either the mechanical testing or the MRI environment testing. It also does not provide information about data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This document does not provide information about the number of experts, their qualifications, or how ground truth was established for the test data. This type of information would typically be relevant for studies involving diagnostic interpretation (e.g., image analysis by radiologists). For a device like an external fixation system, "ground truth" would relate to objective measurements of mechanical properties and MRI safety parameters, rather than expert interpretation.
4. Adjudication Method for the Test Set
This document does not describe any adjudication method. As mentioned above, since this involves objective mechanical and MRI safety testing, expert adjudication in the traditional sense is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic tools to assess how AI assistance impacts human reader performance. The Hoffmann® II MRI External Fixation System is a medical device, not an AI diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, a standalone study in the context of an "algorithm only" or "AI" performance was not done. The device is a physical medical device, not a software algorithm. The "testing in a Magnetic Resonance Environment" would be considered a standalone test of the device's physical properties under MRI conditions.
7. The Type of Ground Truth Used
For the mechanical properties, the ground truth would be established through objective measurements obtained from standardized mechanical testing protocols (e.g., tensile strength, fatigue testing, torsional stiffness). The "ground truth" for MRI safety would be established by objective measurements and observations according to recognized consensus standards for MRI compatibility (e.g., assessment of B1+ transmit field mapping, specific absorption rate (SAR), heating, artifact generation, force, torque, and image quality degradation). These are not typically "expert consensus" in the way a diagnostic image is, but rather adherence to established engineering and safety standards.
8. The Sample Size for the Training Set
This document does not refer to a "training set." This term is specific to machine learning and AI algorithms. The device undergoes engineering design, prototyping, and rigorous physical testing, not a "training" phase in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" as understood in machine learning/AI, this question is not applicable. The design and validation of this physical device rely on engineering principles, material science, and adherence to relevant national and international standards for medical device safety and performance.
§ 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.