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The CD HORIZON TM Spinal System with or without SEXTANT TM 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, the CD HORIZON TM Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD HORIZON TM LEGACY TM 3.5mm rods and the CD HORIZON TM Spinal System PEEK 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, the CD HORIZON TM Spinal System 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 TM Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON TM SPIRE TM 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.
In order to achieve additional levels of fixation, the CD HORIZON TM Spinal System rods may be connected to the VERTEXT TM Reconstruction System with the VERTEX TM rod connector. Refer to the VERTEX TM Reconstruction System Package Insert for a list of the VERTEX TM indications of use.

The CD HORIZON™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.
A subset of CD HORIZON™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK™ Plates and connecting components. Similarly, to the CD HORIZON™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this Traditional 510(k) is to modify Medtronic's CD HORIZON™ Spinal System to add additional components to the system, specifically, a sterile domino connector. The subject device is made of Titanium Alloy, Cobalt Chrome and Silicone.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CD HORIZON™ Spinal System, structured according to your request.

Please note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain the detailed clinical study information often found in PMA applications or publications about AI/software as a medical device (SaMD). Therefore, many of your requested points related to AI/software performance, such as sample size for training/test sets, ground truth establishment for training, number of experts, adjudication methods, and MRMC studies, are not applicable or available from this type of regulatory submission for a spinal implant system.

The "device" in this context refers to a physical spinal implant system, not an AI/software device.

Acceptance Criteria and Device Performance for CD HORIZON™ Spinal System

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each mechanical or endotoxin test. However, "worst case subject implants" were used for endotoxin testing. For mechanical testing, standard sample sizes for such tests according to ASTM F1798 and F1717 would have been used, but specific numbers are not provided in this summary.
• Data Provenance: The studies were non-clinical (laboratory-based mechanical and biological testing) performed by the manufacturer, Medtronic Sofamor Danek USA, Inc.

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 physical implant, not an AI/software device requiring expert ground truth for image interpretation or diagnosis. The ground truth for mechanical testing is derived from the physical properties and performance under specified loads, measured by instrumentation.

4. Adjudication method

• Not applicable for the types of non-clinical tests performed.

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 not an AI/software device.

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

• Not applicable. This is not an AI/software device.

7. The type of ground truth used

• Biocompatibility: Conformance to established material standards and historical safe use.
• Mechanical Testing: Physical measurements of mechanical properties (e.g., strength, durability under load) against specified limits outlined in ASTM standards F1798 and F1717.
• Non-Pyrogenicity Endotoxin Testing: Measurement of bacterial endotoxin levels against the established limit of 20 EU/device.

8. The sample size for the training set

• Not applicable. This is a physical implant; there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering, materials science, and previous product iterations, but not "trained" in the AI sense.

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

• Not applicable. As above, there is no training set for an AI/ML context. The "ground truth" for the device's design and manufacturing is derived from engineering principles, material science, and regulatory standards.

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