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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 following indications: degenerative disc disease (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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/umbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® 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® Spinal System implants are indicated as an adjunct 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 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® 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: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® 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. The subject devices include: Rods Extenders Sequential Reducer Inserters Modified Labeling (surgical techniques and disassembly/assembly instructions) Accessories, cases, caddies, trays, and lids which may be used to transport and sterilize the subject implants and instruments. The subject CD HORIZON® Spinal System devices will be available in similar sizes as the predicate systems.

The provided text describes specific details about a medical device (CD HORIZON® Spinal System) and its regulatory approval process, focusing on substantial equivalence to predicate devices, rather than an AI/ML device or its associated studies for performance. Therefore, I cannot extract the information requested for a device that uses AI/ML.

However, I can provide a summary based on the information available about the CD HORIZON® Spinal System's performance validation from pages 4 and 5 of the document, which pertains to medical device testing for substantial equivalence, not AI/ML performance.

Acceptance Criteria and Study for CD HORIZON® Spinal System (Non-AI/ML Device)

The provided document details the substantial equivalence review for the CD HORIZON® Spinal System, a non-AI/ML device. The "study" mentioned refers to engineering rationales and bench testing conducted to demonstrate that the new device is as safe and effective as previously approved predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Mechanical Testing: Sample size was determined based on ASTM F1717 for Static Reduction Testing. Specific numerical sample sizes are not provided in this document.
• Data Provenance: The studies were bench tests conducted by Medtronic Sofamor Danek USA, Inc. The data is generated internally to support a 510(k) submission, therefore it is prospective in nature with respect to the regulatory submission, but the tests simulate conditions. There is no information about country of origin of data as it's not a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document is about a hardware medical device and its mechanical/biocompatibility testing for substantial equivalence, not an AI/ML device requiring expert ground truth for diagnostic or prognostic purposes. The "ground truth" for mechanical tests is established by published ASTM standards.

4. Adjudication Method for the Test Set

This information is not applicable for the type of testing described (mechanical and biocompatibility bench testing). Adjudication typically refers to expert review of clinical cases. The fulfillment of acceptance criteria for bench tests is usually objective and measurable, not subject to adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The device is a spinal implant system, not an imaging or diagnostic AI/ML tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or detailed.

6. Standalone (Algorithm Only) Performance

This information is not applicable as the device is a spinal implant system and does not involve an algorithm.

7. Type of Ground Truth Used

• For Biocompatibility: The "ground truth" is established by adherence to recognized standards (ISO-10993) and the long history of safe and effective use of the materials (Cobalt Chrome, Titanium, Stainless Steel, Acetal) in spinal surgery, eliminating the need for novel biocompatibility testing.
• For Mechanical Testing: The "ground truth" or reference for acceptable performance is established by ASTM F1717 and other relevant ASTM standards for materials and mechanical properties of spinal implants.

8. Sample Size for the Training Set

This information is not applicable as there is no AI/ML algorithm or training set involved in the development or testing of this hardware device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no AI/ML algorithm or training set involved.

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