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510(k) Data Aggregation
(86 days)
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 the addition of new components to the previously cleared Hoffmann 3 Modular External Fixation System. The Hoffmann 3 Modular External Fixation System consists of Rods. Posts: Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The additional components consist of a Multiplanar Rod to Rod Coupling, Multiplanar Pin to Rod Coupling, 30° Rod Coupler, 4/5 Apex Pin, 5/6 Transfixing Pin and a Ø11mm Semi Circular Rod. 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Hoffmann 3 Modular External Fixation System
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Material Properties | Corrosion Testing | Substantially equivalent to predicate devices. |
| Mechanical Performance | Insertion Testing | Substantially equivalent to predicate devices. |
| Pullout Strength Testing | Substantially equivalent to predicate devices. | |
| Rotation Testing | Substantially equivalent to predicate devices. | |
| Static and Dynamic Cantilever Bending Testing | Substantially equivalent to predicate devices. | |
| Force and Torque Testing | Substantially equivalent to predicate devices. | |
| MR Environment Safety | Magnetic Resonance Environment Testing | Substantially equivalent to predicate devices. |
| Radio Frequency Heating Testing | Substantially equivalent to predicate devices. | |
| Artifact Testing | Substantially equivalent to predicate devices. |
Overall Conclusion: The non-clinical testing demonstrated that the Hoffmann 3 System components are substantially equivalent to devices currently cleared for marketing. No specific quantitative performance metrics beyond "substantially equivalent" are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "non-clinical laboratory testing and engineering evaluations," which implies various test samples were used for each type of mechanical and material test.
- Data Provenance: The testing was "non-clinical laboratory testing and engineering evaluations," which suggests the data was generated in a controlled laboratory environment (likely in the US, given the FDA submission). It is considered prospective testing for the purpose of this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This submission relies on engineering and laboratory testing for substantial equivalence, not clinical data or expert interpretation of clinical outcomes. Ground truth in this context refers to established engineering and material science standards.
4. Adjudication Method for the Test Set
- Not applicable. This was based on objective engineering and material testing against established predicate device performance and standards, not on subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: Clinical testing was not required for this submission." This indicates that the FDA deemed non-clinical, bench testing sufficient for this 510(k) submission, likely because it was an addition of new components to an already cleared system.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
- Not applicable. This is a medical device (external fixation system), not an AI algorithm. Its performance is inherent in its physical and mechanical properties, not in an interpretive algorithm.
7. Type of Ground Truth Used
- Engineering and Material Standards: The "ground truth" for the non-clinical testing was based on established engineering principles, material science standards, and performance characteristics demonstrated by the legally marketed predicate devices (K111786 Hoffmann 3 Modular External Fixation System, K051306 Hoffmann II MRI External Fixation System, K053472 Hoffmann II MRI Components, K001886 Apex Fixation Pins).
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm or software that requires a training set. The "training" for proving substantial equivalence came from the existing knowledge of the predicate devices and established engineering principles.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set mentioned or implied for this type of device submission.
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