(107 days)
- Bone fracture fixation; .
- . Osteotomy;
- . Arthodesis;
- . Correction of deformity;
- Revision procedures where other treatments or devices have been unsuccessful; .
- . Bone reconstruction procedures.
This submission is a line extension to the Hoffmann® II External Fixation System. The components of the Hoffmann® Light System will be based on the component designs of the Hoffmann® II External Fixation System.
The Hoffmann® Light System is an external fixation system that is a line extension to the Hoffmann® II External Fixation System. The device is indicated for use in bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures.
The acceptance criteria for the Hoffmann® Light System are based on its substantial equivalence to the Hoffmann® II External Fixation System in terms of intended use, design, materials, and operational principles. The study that proves the device meets the acceptance criteria demonstrates that the subject components of the Hoffmann® Light System are substantially equivalent in strength to the predicate components of the Hoffmann® II External Fixation System.
Here's the detailed breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent to Hoffmann® II External Fixation System in intended use, design, materials, and operational principles. | The Hoffmann® Light System's components are based on the designs of the Hoffmann® II External Fixation System, indicating equivalence in design and operational principles. Its intended uses are identical to the predicate. |
| Substantially equivalent in strength to the predicate components (Hoffmann® II External Fixation System components). | The test results demonstrate that the subject components (Hoffmann® Light System) are substantially equivalent in strength to the predicate components (Hoffmann® II External Fixation System). |
2. Sample size used for the test set and the data provenance
The provided document does not specify the exact sample size used for the strength testing or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "The test results demonstrate that the subject components are substantially equivalent in strength to the predicate components."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The acceptance criteria are based on direct physical properties (strength) and design/material equivalence, rather than a clinical ground truth established by medical experts for a diagnostic or AI device.
4. Adjudication method for the test set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for clinical evaluations involving human interpretation (e.g., image reading) where ground truth might be ambiguous and require expert consensus. The testing here appears to be mechanical/physical.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI) where human readers interpret medical images or data. The Hoffmann® Light System is an external fixation device, not a diagnostic tool, and does not involve human readers interpreting data for diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study, as understood for AI algorithms, was not done. The device is a mechanical orthopedic device, not an AI algorithm. Its performance is measured through physical and mechanical testing, not algorithmic accuracy.
7. The type of ground truth used
The "ground truth" for this device's acceptance is based on mechanical testing results (demonstrating equivalent strength) and engineering assessment of design, materials, and operational principles against a legally marketed predicate device. This is a comparison against established engineering standards and the performance of an existing, approved device, rather than a clinical ground truth from pathology or patient outcomes.
8. The sample size for the training set
This information is not applicable and not provided. The Hoffmann® Light System is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, the device is not an AI model with a 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.