(7 days)
The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex" Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX " External Fixation System.
This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation.
This Special 510(k) submission is a line extension intended to add an alternate style of coupler to the Hoffmann® II External Fixation System.
The provided text describes a Special 510(k) submission for the Hoffmann® II Rod to Wire Coupling, a line extension to an existing external fixation system. The submission aims to demonstrate substantial equivalence to predicate devices through mechanical testing.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties Comparable to Predicate Devices | "Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices." |
| Same Intended Use | "The subject Hoffmann® II Rod to Wire Coupling shares the same intended use... as that of the currently available Hoffmann® II External Fixation System and Hoffmann® II Hybrid Frame System." |
| Basic Design Concepts | "The subject Hoffmann® II Rod to Wire Coupling shares... basic design concepts as that of the currently available Hoffmann® II External Fixation System and Hoffmann® II Hybrid Frame System." |
Study Proving Device Meets Acceptance Criteria:
A study involving "Mechanical testing" was conducted to demonstrate comparable mechanical properties to the predicate components. This testing was used to support the claim of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the mechanical testing (i.e., the "test set"). It also does not provide details about data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "experts" to establish ground truth is generally applicable to studies involving human interpretation (e.g., medical imaging). For mechanical testing, the "ground truth" would be established by the physical properties and performance metrics determined through the testing methodology. The document does not mention any human experts establishing ground truth for the mechanical testing.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human readers to resolve discrepancies in assessments. This is not relevant to the mechanical testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is a mechanical testing comparison to predicate devices, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a physical medical device (an external fixation component), not an algorithm or AI system. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable.
7. The Type of Ground Truth Used
The ground truth used for the study was established through mechanical testing. This involves objective measurement of physical properties (e.g., strength, stiffness, fatigue resistance) according to established engineering standards or protocols.
8. The Sample Size for the Training Set
The document does not describe a "training set" as this is a mechanical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device and study.
§ 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.