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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.

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:

1. 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.
2. 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.
3. 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.
4. 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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
6. 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.
7. 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.
8. 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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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 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 components for the subject device where manufactured from a variety of materials including austentic steel, titanium, and a Vectran coating. This line extension is intended to add additional components for connecting rods and fixed posts, design and material modifications to the couplings, pin clamp, rods and posts. Although the Hoffmann II MRI External Fixation System will continue to be marketed, the Hoffmann 3 Modular External Fixation System will be available with additional components for connecting rods and include design and material modifications to the couplings, pin clamp, rods and posts.

{"1. A table of acceptance criteria and the reported device performance": "The document does not explicitly state numerical acceptance criteria in a table format. Instead, it describes a comparative evaluation against a predicate device. The "reported device performance" is stated as demonstrating "comparable mechanical properties to the predicate components" and that the system "could be safely used in Magnetic Resonance Imaging under predetermined conditions."\n\nAcceptance Criteria (Implied from testing and claim of substantial equivalence):\n* Mechanical Properties: Comparable to the Hoffmann II MRI System's mechanical properties.\n* Magnetic Resonance Environment Safety: Safe for use in MRI under predetermined conditions (Radio Frequency Heating, Force and Torque, Artifact).\n\nReported Device Performance:\n* Mechanical testing demonstrated comparable mechanical properties to the predicate components.\n* Testing in a Magnetic Resonance Environment established that the Hoffmann 3 Modular External Fixation System could be safely used in Magnetic Resonance Imaging under predetermined conditions. (Specific results like % difference or specific thresholds are not provided in this summary.)", "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document refers to "Non-Clinical Testing" and lists various mechanical and MRI environment tests. However, it does not specify the sample sizes used for these tests. There is no mention of human subject data, and thus no data provenance in terms of country of origin or retrospective/prospective studies are applicable for the type of testing described.", "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "This section is not applicable. The study described is non-clinical performance testing of a medical device (external fixator system) and does not involve the establishment of ground truth by human experts in the context of diagnostic interpretation. The 'ground truth' for this type of device would relate to engineering standards and safety parameters established by regulatory bodies or industry best practices, not expert consensus on medical images or patient outcomes.", "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., medical images) by multiple experts to establish a consensus ground truth. The tests performed for this device were non-clinical mechanical and MRI compatibility tests.", "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": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an external fixation system, not a diagnostic imaging or AI-assisted device. The testing described focuses on the mechanical and MRI compatibility of the hardware components.", "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "This question is not applicable to the Hoffmann 3 Modular External Fixation System as it is a physical medical device, not an algorithm or AI system. There is no 'standalone' algorithm performance to report.", "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the non-clinical testing of this external fixation system, the 'ground truth' would be based on established engineering and material science principles, industry standards (e.g., for strength, bending, torsion, pull-out, rotation), and regulatory requirements for MRI compatibility (radio frequency heating, force and torque, artifact). It's not based on expert consensus, pathology, or outcomes data related to clinical diagnosis.", "8. The sample size for the training set": "This question is not applicable to the Hoffmann 3 Modular External Fixation System. This device is a physical medical hardware system, not a machine learning model or software that requires a 'training set.' The listed tests are non-clinical hardware performance tests.", "9. How the ground truth for the training set was established": "This question is not applicable, as there is no 'training set' for this physical medical device."}

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