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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, 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 DDD, 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, 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, pseudarthosis, 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 (1.2 - 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™M 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 consists of non-sterile domino connectors, made of Titanium Alloy, that are used to provide the surgeon with an efficient construct extension as well as connection options for multi-rod spinal constructs. The subject CD HORIZON™ Spinal System includes 1. Non-sterile Domino connectors 2. Trays and lid

The provided text is a 510(k) Summary for the Medtronic CD HORIZON™ Spinal System. It describes the device, its indications for use, and a comparison to predicate devices, focusing on the substantial equivalence argument for non-sterile domino connectors.

However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic performance.

The "Performance Data" section explicitly states:

"The purpose of this submission is to take the existing sterile domino connector designs, cleared in the predicate 2, and provide them non-sterile. The subject domino connectors are being created to provide additional rod connector options for surgeon convenience. No design changes have been made to the subject devices as a result of this submission. The subject devices remain identical to the designs cleared in the predicate 2 with the same intended use, materials, and fundamental technology. As a result, the subject CD HORIZON™ Spinal System does not represent a new worst case; therefore, no new bench performance testing is warranted."

And regarding biocompatibility, it states:

"Identical to the predicate devices, the subject domino connectors are made of Titanium Alloy. This material is considered biocompatible due to its long history of clinical use in medical devices."

Based on this information, the device discussed (CD HORIZON™ Spinal System domino connectors provided non-sterile) is a physical medical device (spinal fixation system component) and not an AI/ML-driven device or a diagnostic tool that would typically have acceptance criteria presented as sensitivity, specificity, or similar performance metrics derived from a study involving ground truth established by experts.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving performance, as this type of information is not present in the provided text for this particular device submission. The submission relies on demonstrating substantial equivalence to previously cleared predicate devices due to no change in design or fundamental technology, other than the sterilization status of the component.

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