(28 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 add additional components to the predicate Hoffmann® II MRI External Fixation System.
This document is a 510(k) premarket notification for Hoffmann® II MRI External Fixation System components. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria in the way a clinical study for an AI/ML device would.
Here's an analysis based on the provided text, highlighting the absence of the requested information due to the nature of this submission:
1. A table of acceptance criteria and the reported device performance
No acceptance criteria or device performance metrics (e.g., sensitivity, specificity, AUC) are presented in the document. This is a 510(k) for external fixation components, not an AI/ML device, so these types of performance metrics are not applicable in this context. The closest equivalent is stating that "Mechanical testing demonstrated comparable mechanical properties to the predicate components and testing in a Magnetic Resonance Environment established that the components could be safely used in Magnetic Resonance Imaging under predetermined conditions." However, specific criteria for "comparable" or "safely used" are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. There is no test set in the context of an AI/ML device's performance evaluation. The "testing" mentioned is likely mechanical and MRI compatibility testing of the physical device components, not a dataset of patient images.
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. There is no "ground truth" in the AI/ML sense, as this is a physical medical device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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 is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth, as this is a physical medical device. The "truth" in this context would be governed by engineering standards for mechanical strength and MRI safety.
8. The sample size for the training set
Not applicable. There is no "training set" for physical medical device components.
9. How the ground truth for the training set was established
Not applicable. There is no training set or ground truth in the context of this device.
Summary based on the provided document:
The document describes a 510(k) submission for new components to an existing external fixation system. The primary "study" mentioned is mechanical testing and MRI compatibility testing. These tests were conducted to demonstrate that the new components possess "comparable mechanical properties to the predicate components" and can be "safely used in Magnetic Resonance Imaging under predetermined conditions." The document does not provide specific acceptance criteria or detailed results of these tests, which is typical for a 510(k) summary relying on substantial equivalence to a predicate device. This type of submission does not involve clinical studies with human "readers" or "ground truth" as would be required for AI/ML-driven devices.
§ 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.