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The CD HORIZON® system is intended for the following indications: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is 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® Spinal System is 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 posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is 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, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW components are intended for the following indications: When used as a pedicle screw fixation system, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW components are also 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. In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW 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., degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. The CD HORIZON® ECLIPSE™ components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is 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, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. 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. When connecting to the VERTEX™ Reconstruction System in the cervical spine, components are intended for the following indications: When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEX™ Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and Rods The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Screws/Lateral Connectors The use of screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The screws are not intended to be placed in the cervical spine. Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEX™ Reconstruction System.

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 SOFAMOR DANEK spinal systems, which 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. Please note that certain components are specifically designed to connect to φ 4.5mm, φ 5.5mm, or φ 6.35mm rods, while other components can connect to both φ 5.5mm rods and ¢ 6.35mm rods. Care should be taken so that the correct components are used in the spinal construct. 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. The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Never use stainless steel and titanium implant components in the same construct. The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium implants only. Do not use with stainless steel. To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another MEDTRONIC SOFAMOR DANEK document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.

This 510(k) summary for the CD HORIZON® Spinal System is a premarket notification for a medical device and, as such, it does not describe an AI/ML device or a study involving performance metrics for such a device. Instead, it describes a spinal implant system and its intended use, focusing on demonstrating substantial equivalence to a predicate device.

Therefore, the sections regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance for an AI/ML device are not applicable to the provided document.

The document states:

• Substantial Equivalence: "The subject Rod Connector is substantially equivalent to the Medtronic Sofamor Danek CD HORIZON® Spinal System Rod Connector/Domino (K010249). A risk analysis was provided or referenced to demonstrate substantial equivalence." (Section V)
• Purpose of Submission: "The purpose of this submission was to add a component to the CD HORIZON® Spinal System." (Section V)

The "study" or justification for the device's acceptability is the demonstration of substantial equivalence to a legally marketed predicate device (K010249). This is a regulatory pathway for medical devices that are similar to devices already on the market. It does not involve performance studies against specific acceptance criteria in the way an AI/ML device would be evaluated for accuracy, sensitivity, or specificity.

In summary, based on the provided document, I cannot fill in the requested table and information because the document describes a traditional medical implant, not an AI/ML device, and its regulatory clearance is based on substantial equivalence, not performance against acceptance criteria in a clinical study context for AI/ML.

If this were an AI/ML device submission, the requested information would typically be found in dedicated sections on performance testing, clinical validation, or software verification and validation reports.

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