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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 (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, 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 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™ Spinal 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™ 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™ 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, nonpedicle supplemental fixation device intended for use in the noncervical 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: DDDD (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 VertexTM Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.

Medtronic Reusable Instruments Compatible with the IPCTM POWEREASE™ System

IPCT™ 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 IPCT™ 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 Reusable Instruments Compatible with the StealthStation™ System and IPC™ POWEREASE™ System

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 IPCT™ POWEREASE™ System.

The CD Horizon™ Spinal System consists of a variety of shapes and size of rods, hooks, screws, CROSSLINK(R) Plates, staples, and connecting components, and 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 CD Horizon™ Modular 5.5/6.0 Spinal System devices consisting of implants, instruments and cases and trays to include:

1. Modular Screws consisting of: Modular Screw Shanks (bone screws) Modular Screw Heads Modular Universal Set Screw
2. Instruments compatible with IPCTM POWEREASE™ System
3. Navigated Driver and Sleeves compatible with STEALTHSTATION ™ and IPCTM POWEREASE™ Systems
4. Cases and trays

The provided text is a 510(k) summary for the Medtronic CD Horizon™ Spinal System, Medtronic Navigated Reusable Instruments, and Medtronic Reusable Instruments Compatible with the IPC® POWEREASE® System. It describes the devices, their indications for use, and a comparison to predicate devices, focusing on the substantial equivalence based on mechanical testing and software verification.

However, the document does not contain information typically found in a study proving an AI/ML device meets acceptance criteria. Specifically, it does not describe:

• Acceptance criteria for an AI/ML model's performance (e.g., sensitivity, specificity, AUC).
• A test set (sample size, provenance).
• Expert consensus for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes for AI assistance.
• Standalone AI performance.
• Training set details.

The performance data mentioned is for mechanical testing of the spinal system and software verification of the instruments, not for an AI/ML algorithm that interprets medical images or other data to provide diagnostic or prognostic information.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to an AI/ML device, nor answer most of the specific questions about such a study, because the provided text does not describe an AI/ML device or its associated performance study.

The "Performance Data" section states: "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 refers to verifying the proper functioning of the software-controlled instruments, not the performance of an AI algorithm making medical diagnoses or predictions.

In summary, the provided document is not relevant to the request as it describes a spinal implant system and surgical instruments, not an AI/ML device.

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