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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 fusion 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar 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 fusion 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 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 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.

IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC® POWEREASE® System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASET™ 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 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 in this submission include:
Additions to the existing CD HORIZON® SOLERA® Ø5.5/6.0 Spinal System
● Ø5.5/6.0 Awl Tap Screws (ATS)
● Ø5.5 Capped Rods
● Ø5.5 Percutaneous Rods
Additions to the existing CD HORIZON® SOLERA® VOYAGER™ Ø4.75 Spinal System
. Ø4.75 Awl Tap Screws (ATS)
Creating the new CD HORIZON® SOLERA® VOYAGER™ Ø5.5/6.0 Spinal System
● Cannulated Multi-Axial Screws (MAS)
● Awl Tap Screws (ATS)
● Capped Rods
Percutaneous Rods
● ● Tab Extenders
Extender Cap
● . Taps and Driver compatible with IPC® POWEREASE® System
. Navigated Driver compatible with STEALTHSTATION® and IPC® POWEREASE® Systems
. System specific cases and trays

Medtronic Reusable Instruments Only Compatible with the IPC® POWEREASE® System
The subject Medtronic Reusable taps and driver are spine preparation instruments made of high grade stainless steel. The subject taps and driver are compatible with Medtronic's IPC® POWEREASE® System and may be connected to the IPC® POWEREASE® handpiece. The subject taps and driver can be used manually using existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece.

Medtronic Reusable Instruments Compatible with the STEALTHSTATION® System and IPC® POWEREASE® Systems
The subject Medtronic Navigated Reusable driver is a spine preparation instrument made of high grade stainless steel. This instrument was specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The subject driver is also compatible with Medtronic's IPC® POWEREASE™ System when connected to the POWEREASE™ handpiece or may be used manually with existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece or the NavLock™ tracker.

The provided text is a 510(k) summary for a medical device (CD HORIZON® Spinal System and associated instruments). It describes the device, its indications for use, comparison to predicate devices, and performance data. However, it does not contain any information about an AI/ML-based medical device, its acceptance criteria, or a study proving its performance.

The document primarily focuses on the substantial equivalence of the subject devices (spinal system implants and instruments) to established predicate devices through mechanical testing and validation activities in cadaver models. It explicitly states:

• "Medtronic believes that testing is not warranted for the subject implants, subject instruments compatible with IPC® POWEREASE® System and subject Tab Extenders and Extender Cap as they do not present a new worst case when compared to the predicate devices."
• "For the subject instruments compatible with STEALTHSTATION® System and IPC® POWEREASE™ Systems, software verification testing and activities were performed that demonstrated that the subject instruments performed as intended."

This indicates that the "software verification testing" mentioned is likely for deterministic software functionality related to navigation and system compatibility, not for an AI/ML algorithm that would require the detailed breakdown of acceptance criteria and study methodology requested in the prompt (e.g., sample size, expert ground truth, MRMC study, etc.).

Therefore, I cannot fulfill the request as the necessary information for an AI/ML device is not present in the provided text.

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