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510(k) Data Aggregation
(86 days)
K001886 Apex Fixation Pins
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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(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.
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