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The CD Horizon™ 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, tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the 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, the 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, the CD Horizon™ 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™ 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. Pediatric 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.

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 subject CD Horizon™ Spinal System is a multiple component device to allow the surgeon to build an implant system to fit the patients' anatomical and physiological requirements. The subject CD Horizon PEEK Rods consist of polyetheretherketone (PEEK) rods, multi-axial bone screws (MAS) and set screws to create a variety of semirigid configurations. The purpose of this traditional 510(k) is to modify the indications for the CD Horizon™ Spinal System.

The provided text describes the CD Horizon™ Spinal System and details its various components and indications for use. It also mentions non-clinical and clinical performance data used to demonstrate substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or reported device performance in a numerical format.

However, based on the information provided, here's a breakdown of the requested information, focusing on what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states that "mechanical testing was performed on the subject and predicate devices in accordance with ASTM F1717, Standard test Methods for Spinal Implant Constructs in a Vertebrectomy Model and ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Sub-assemblies Used in Spinal Arthrodesis Implants." It also mentions "Biomechanical cadaver testing was also performed." However, the specific acceptance criteria (e.g., minimum load to failure, fatigue cycles survived) and the reported device performance metrics against those criteria are not detailed.

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

From the provided text:

• Clinical Performance Study: "A retrospective study was conducted..."
• Sample Size: The sample size for the retrospective clinical study is not explicitly stated in the provided text.
• Data Provenance: The text states, "A retrospective study was conducted and demonstrated that CD Horizon™ Spinal System PEEK Rod constructs are substantially equivalent when used to provide supplemental fixation in interbody fusion procedures for the treatment of DDD." The country of origin is not specified, but given the US FDA submission context, it is likely that the data pertains to a US patient population or has relevance to the US market. The study is explicitly stated as retrospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. For a retrospective clinical study, ground truth for diagnoses like DDD, spondylolisthesis, etc., would typically be established based on existing patient medical records, imaging reports, and potentially physician-recorded outcomes. The number and qualifications of experts involved in the initial diagnosis or in reviewing the retrospective data for the study are not mentioned.

4. Adjudication Method

This information is not provided in the document. It's likely that for a retrospective study using existing medical records, the "ground truth" was established by the original treating physicians or based on the documented diagnostic criteria in the medical charts, rather than a separate adjudication process for the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

This information is not provided in the document. The study mentioned is a retrospective clinical study for the device itself, not a comparative effectiveness study involving human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable to the described device. The CD Horizon™ Spinal System is a medical implant (a hardware device), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Based on the description of the retrospective clinical study:

• The ground truth would likely be based on clinical diagnoses (e.g., degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, failed previous fusion, progressive spinal deformities, etc.) as recorded in patient medical records.
• It would also involve radiographic studies for DDD, and potentially surgical outcomes (e.g., fusion success, complication rates) and patient-reported outcomes to demonstrate the clinical effectiveness of the device as supplemental fixation.
• For the non-clinical mechanical testing, the ground truth would be the physical properties and performance characteristics of the device measured against established ASTM standards.

8. The Sample Size for the Training Set

This question is not applicable to the described device. As the CD Horizon™ Spinal System is a medical implant, it does not involve a "training set" in the context of machine learning algorithms.

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

This question is not applicable to the described device, as there is no "training set" for a hardware medical implant.

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