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The CD HORIZON® Spinal System with or without SEXT ANT® instrumentation is intended for posted on noncervical fixation as an adjunct to 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.

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 With the exception of degatered.ro also 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 When implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. 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 (TI-SI) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinoves 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.

The CD HORIZON SPIRE™ Z Spinal System (subject device) is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI) as an adjunct to fusion in skeletally mature patients. The CD HORIZON SPIRE™ Z Spinal System is a subset of the CD HORIZON® Spinal System.

The provided text is related to a 510(k) premarket notification for a medical device called the MEDTRONIC Sofamor Danek CD HORIZON SPIRE™ Z SPINAL SYSTEM. It outlines the device's description, indications for use, and a comparison to a predicate device for substantial equivalence.

Crucially, this document describes a traditional medical device (spinal fixation system) and not an AI/ML-driven device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., specific metrics like accuracy, sensitivity, specificity, or human-in-the-loop studies) are not applicable to this submission.

The "studies" mentioned in the document are non-clinical and relate to the physical and functional aspects of the updated system, specifically:

• Assessment of modifications: Ensuring the changes to the inserter/compressor instrument align with internal Medtronic procedures.
• Cleaning and sterilization assessments: Verifying the implants and instruments can be adequately cleaned and sterilized.
• Ship testing: Performed according to ASTM 4169-09 to ensure packaging prevents damage during shipping.

The "acceptance criteria" for this device would revolve around these non-clinical tests demonstrating that the modified device (with the new inserter/compressor and updated packaging) performs equivalently to the predicate device and is safe and effective for its intended use. This is achieved by demonstrating substantial equivalence to an already legally marketed device rather than proving novel clinical performance through trials with human patients or AI/ML model validation metrics.

Therefore, I cannot populate the table or answer the specific questions about AI/ML study design, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not present or relevant in the provided 510(k) summary for a spinal implant.

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