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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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The Micomed Posterior Doublerod System is a pedicle screw system indicated for the treatment of severe spondyloisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Micomed Posterior Doublerod System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic deformities such as scoliosis, Scheuermann's disease, degernerative disk disease defined as back pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.

The Micomed Posterior Doublerod System is a low profile, top loading spinal fixation system available in titanium and stainless steel. The system consists of pedicle screws, polyaxial screws*, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod System. * polyaxial screws are only available in titanium

The provided text describes a 510(k) submission for a medical device, specifically the Micomed Posterior Doublerod System. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and performance.

However, the document primarily outlines the regulatory approval process and device specifications, and does not contain detailed information about a study proving the device meets specific acceptance criteria in the way a clinical or even a detailed standalone performance study would. The "Testing and Performance" section is brief and refers to biomechanical performance as per an ASTM standard, rather than a comprehensive study with specific acceptance criteria that one would typically associate with AI/software performance.

Therefore, many of the requested elements for describing an acceptance criteria study, especially those related to AI/software performance (e.g., sample sizes for test sets, expert ground truth, MRMC studies, training sets), cannot be extracted from the provided text.

Here is the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document refers to biomechanical testing, which typically involves a set number of test specimens (e.g., screws, rods) rather than patient data.
• Data Provenance: Not specified, but given the nature of biomechanical testing, it would involve engineered test samples rather than patient data. The company is based in Germany, so if there were any clinical aspects not detailed, it might have European origin.

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

• Not applicable. Biomechanical testing adherence to ASTM standards does not involve expert-established ground truth in the way clinical or image-based AI studies do. The "ground truth" is typically defined by the test parameters and failure modes according to the ASTM standard.

4. Adjudication method for the test set

• Not applicable. Biomechanical testing results are typically objective measurements against a standard, not subject to adjudication by multiple human experts.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/software in diagnostic or interpretive tasks, not for physical medical devices undergoing biomechanical testing.

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

• Not applicable. This device is a physical spinal fixation system, not an algorithm. The reported "standalone" performance is the biomechanical performance of the device's components.

7. The type of ground truth used

• Ground Truth: Adherence to defined biomechanical performance standards and metrics outlined in ASTM F1717-96.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not a machine learning algorithm.

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

• Not applicable. This device is a physical medical device, not a machine learning algorithm.

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