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The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD HorizonTM Spinal System rods may be connected to the VertexTM Reconstruction System with the VertexTM rod connector. Refer to the VertexTM Reconstruction System package insert for a list of the VertexTM indications of use.

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This document describes a spinal system, not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance, such as acceptance criteria for AI models, human expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable.

The provided text focuses on the substantial equivalence of the Medtronic CD Horizon™ Spinal System to predicate devices, supported by mechanical testing and rationales.

Here's an analysis of the provided text based on the request's categories, indicating where information is present and where it is not applicable for this type of device:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated in this summary. Mechanical testing usually involves a specific number of samples per test type (e.g., 5-10 samples per group).
• Data Provenance: Not applicable in the context of "data provenance" for patient data, as this is a mechanical device. The testing was conducted by Medtronic to demonstrate substantial equivalence to existing predicate devices.

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

• Not Applicable: This is a mechanical device, not an AI/ML diagnostic or therapeutic device that relies on expert interpretation for ground truth. Ground truth for mechanical performance is established through standardized testing protocols (ASTM standards) and engineering principles.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable: Adjudication methods are relevant for subjective interpretations, typically in clinical studies or AI model evaluations. For mechanical testing, the results are quantitative and directly measured against engineering specifications.

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 is a mechanical device. MRMC studies are specific to evaluating diagnostic accuracy of imaging systems, often in the context of human reader performance with or without AI assistance.

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

• Not Applicable: This is a mechanical device. "Standalone" performance refers to AI algorithm performance without human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by the specified mechanical properties (e.g., strength, durability, fatigue resistance) defined by relevant ASTM (American Society for Testing and Materials) standards (F1717, F1798, F2503). Compliance with these standards indicates the device performs as intended for its mechanical application.

8. The sample size for the training set

• Not Applicable: "Training set" refers to data used to train AI/ML models. This is a mechanical device, not an AI model.

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

• Not Applicable: As no AI training set exists, no ground truth establishment for it is relevant.

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