(91 days)
The Hoffmann 3 Modular External Fixation System 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.
The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, 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 rods, casts or other means of internal fixation.
The indications for use of external fixation devices include:
- Bone fracture fixation .
- Osteotomy ' .
- . Arthrodesis
- . Correction of deformity
- . Revision procedure where other treatments or devices have been unsuccessful
- . Bone reconstruction procedures
This Traditional 510(k) submission is intended to address a sterilization modification to the previously cleared Hoffmann 3 Modular External Fixation System and the addition of a new Apex Fixation Pin. The Hoffmann 3 Modular External Fixation System consists of Rods, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The additional component will be a new Apex Fixation Pin manufactured from stainless steel. The modification is to provide the previously cleared components and the additional Apex Fixation Pin as part of a sterile kit. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems and in conjunction with other commercially available Apex Pins.
This submission describes the Hoffmann 3 Modular External Fixation System, a medical device used for stabilizing fractures and other bone conditions. The submission focuses on a sterilization modification to previously cleared components and the addition of a new Apex Fixation Pin.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The provided document describes a Non-Clinical Testing approach to demonstrate substantial equivalence, rather than specific acceptance criteria for a new device's efficacy. The acceptance criteria essentially boil down to demonstrating that the modified device and new component meet safety and performance standards comparable to an existing, cleared predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material/Corrosion | Corrosion Testing performed. |
| Mechanical Performance | Insertion Testing performed. Pullout Strength Testing performed. Static and Dynamic Cantilever Bending Testing performed. Force and Torque Testing performed. |
| MR Compatibility | Radio Frequency Heating Testing performed. Artifact Testing performed. |
| Overall Equivalence | "Testing demonstrated that the subject Hoffmann 3 System components are substantially equivalent to devices currently cleared for marketing." |
No specific quantitative or statistical acceptance criteria (e.g., minimum tensile strength, maximum corrosion rate) are provided in the summary. The phrase "substantially equivalent" is the overarching criteria, validated through the non-clinical tests listed.
Study Information
The document explicitly states: "Clinical Testing: Clinical testing was not required for this submission." This means that the device's acceptance was based solely on non-clinical (laboratory and engineering) testing, not on studies involving human subjects or the evaluation of diagnostic performance as would be typical for AI/imaging devices.
Given the nature of the device (an external fixation system), the study focuses on engineering and material characteristics, not diagnostic or predictive performance. Therefore, many of the requested categories are not applicable.
Here's an breakdown based on the provided text:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" consists of physical Hoffmann 3 Modular External Fixation System components and the new Apex Fixation Pin. The provenance is the manufacturing process of these components.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and material properties is established by engineering standards and measurements, not expert consensus.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is relevant for subjective evaluations, not objective engineering tests.
- 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 a mechanical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
- The type of ground truth used:
- Mechanical Properties: Established by standard engineering test methodologies and equipment, measuring parameters like strength, pullout force, bending resistance, and torque.
- Material Properties: Established by corrosion testing and material analysis.
- MR Compatibility: Established by specific protocols for radio frequency heating and artifact generation in an MRI environment.
- The sample size for the training set: Not applicable. There is no "training set" in the context of this type of non-clinical engineering evaluation.
- How the ground truth for the training set was established: Not applicable.
In summary, the Hoffmann 3 Modular External Fixation System received clearance based on non-clinical bench testing and engineering evaluations demonstrating substantial equivalence to previously cleared predicate devices. This type of submission relies on objective measurements against established engineering and material standards, rather than clinical studies or methodologies typically associated with AI-driven diagnostic tools.
§ 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.