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The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the 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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the 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, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis). (5) fracture, (6) pseudarthrosis. (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor.

The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw system in skeletally mature patients, the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: (1) are receiving fusion with autogenous graft only, (2) who are having the device attached to the lumbar or sacral spine, and/or (3) who are having the device removed after the development of a solid fusion mass.

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 rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The purpose of this 510(k) submission is to add modified rods to the CD HORIZON® Spinal System.

This document describes the CD HORIZON® Spinal System and its indications for use. It's a 510(k) premarket notification summary, which means it's about demonstrating substantial equivalence to a device already on the market, not necessarily proving efficacy through extensive clinical trials as would be required for a PMA (Premarket Approval) for novel devices.

Therefore, the typical acceptance criteria and study design elements you'd find for an AI/ML medical device (like accuracy thresholds, specific expert qualifications, MRMC studies, training set details) are not present in this type of submission. This document is focused on regulatory clearance for a physical medical device.

Based on the provided text, here's what can be inferred/extracted regarding the "acceptance criteria" and "study" for this device, recognizing the different context:

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

For a traditional physical medical device 510(k), "acceptance criteria" are not typically stated as numeric performance benchmarks like sensitivity/specificity. Instead, the primary acceptance criterion for the FDA is demonstrating substantial equivalence to a predicate device already legally marketed. This is a regulatory acceptance criterion, not a performance metric in the AI/ML sense.

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

• Sample Size for Test Set: Not applicable. There is no "test set" in the context of an AI/ML study. Instead, the "device" here refers to physical spinal system components. The substantial equivalence was likely demonstrated through comparative analysis of design, materials, manufacturing processes, and potentially mechanical testing data against the predicate devices.
• Data Provenance: Not applicable.

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

• Not applicable. There is no ground truth, expert consensus, or expert review process described for performance validation in the AI/ML sense. The "ground truth" for substantial equivalence is the existing regulatory clearance of predicate devices, and the assessment is performed by the FDA based on the submission.

4. Adjudication method for the test set

• Not applicable.

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 physical spinal implant system, not an AI/ML diagnostic or assistive device.

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

• Not applicable.

7. The type of ground truth used

• Not applicable in the context of an AI/ML device. For a 510(k) submission, the "ground truth" for clearance is the regulatory determination that the new device shares fundamental characteristics and indications for use with existing legally marketed devices, and raises no new questions of safety or effectiveness.

8. The sample size for the training set

• Not applicable. There is no AI model or "training set" for this physical device.

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

• Not applicable.

In summary: The provided text is a 510(k) summary for a physical medical device (spinal implant system). The "study" described is a demonstration of substantial equivalence to previously cleared predicate devices, confirmed through a regulatory review process by the FDA, not a performance study of an AI/ML algorithm. Therefore, most of the requested points related to AI/ML device evaluation are not applicable to this document.

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