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The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities in the thoracic and lumbar spine such as scoliosis, kyphosis, lordosis and thoracolumbar spinal instability caused by fracture.

The principal components of the Micomed Halm Zielke Instrumentation System, which is a low profile spinal fixation system, are as follows: Halm and HC plates, screws, threaded rods, standard hex nuts for threaded rods, fluted rods, and vertebral clamps (double and single hole). Additional instrumentation includes: awls, wrenches, insertion instruments for rods and screws, vertebral and end vertebra screws, top loading screws and set screws, rod pushers and rod benders, grip and compression tongs, rod cutter and distraction instrument. The principal components of the Micomed Halm Zielke Instrumentation are used in the following manner: First, the most cranial and caudal Halm plates are each attached to the lateral aspect of the vertebral body with two screws (countersunk, Zielke), and then additional plates are attached as needed. The threaded rod is then connected to the top of the Zielke screws and anchored with the standard hex nuts. Once the threaded rod is properly connected to the Halm plates, partial correction of the scoliotic deformity is performed before attaching the pre-bent fluted rod by closing the lid of the Halm plate and securing with the head screws. The secured fluted rod can then be rotated around its longitudinal axis to achieve and appropriate level of derotation and relordosation. If this system is used in the thoracic spine, rod rotation is performed in reverse to produce or enhance physiological kyphosis. Additionally, segmental compression or distraction can be used to increase or decrease lordosis or kyphosis, as desired.

This is a summary of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria.

Note: The provided document is a 510(k) summary for a spinal instrumentation system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics against specific acceptance criteria as might be found in a clinical trial for a novel AI device. Therefore, some requested information, particularly regarding AI-specific details like training data and expert consensus for ground truth, is not applicable or available in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as this is a mechanical device study, not a data-driven AI study. The "test set" likely refers to samples of the device components subjected to biomechanical testing per ASTM F1717-96. The number of samples tested is not specified in this summary.
• Data Provenance: Not applicable in the context of a 510(k) for a mechanical device. The testing is laboratory-based mechanical testing, not retrospective or prospective clinical data from a specific country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of AI, refers to expert-annotated data. For this mechanical spinal instrumentation system, the "truth" is determined by established engineering standards and biomechanical testing parameters.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically relevant for human review of data or images, especially in clinical studies or AI evaluations. For mechanical testing, results are quantitative and based on instrument readings and engineering standards.

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

Not applicable. This device is a mechanical instrumentation system for spinal surgery, not an AI-assisted diagnostic or predictive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device. The "performance" refers to the mechanical integrity and function of the physical spinal implants.

7. The type of ground truth used

For the biomechanical performance, the "ground truth" is defined by the ASTM F1717-96 standard and the physical properties and performance characteristics of the predicate devices. The system is considered to meet the criteria if its biomechanical performance is equivalent to, or better than, the predicate devices when tested according to this standard.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a mechanical device.

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