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When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are 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, tumor and/or trauma (e.g. fracture or dislocation), spinal stenosis, curvatures (e.g. scoliosis, kyphosis), pseudarthrosis, and/or failed previous fusion. Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization when used for trauma (e.g., fracture or dislocation) with the usage of bone graft material left to the surgeon's discretion.

When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Coment, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) bone cement (Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion.

These implants may also serve as traditional pedicle screws when used without bone cement in patients. Please see Section IV for the complete Indications for Use.

CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert for information regarding those implants. Care should be taken so the correct components are used in the spinal construct. CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobalt-chromiummolybdenum alloy. Never use stainless steel and titanium implant components in the same construct.

To achieve best results, do not use CD Horizon™ Fenestrated Screw implants with components from any system other than the CD Horizon™ Spinal System. As with all orthopedic and neurosurgical implants, CD Horizon™ Fenestrated Screw implants should never be reused under any circumstances.

The provided text describes a 510(k) premarket notification for a medical device, the CD Horizon™ Fenestrated Screw Set, and its substantial equivalence to predicate devices. However, the document does not contain information related to an AI/ML-driven device, acceptance criteria for such a device, or any study proving an AI/ML device meets specific performance criteria.

The focus of this 510(k) is an expansion of the indications for use for an existing medical implant (spinal screws) to include trauma treatment with optional bone graft material,
and states that no changes were made to the existing devices, nor were any new components added to the system. Therefore, it explicitly states: "no additional testing was required or performed."

As such, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets these criteria from the provided text. The document describes a traditional medical device approval process, not an AI/ML product validation.

Therefore, I must state that the information requested regarding AI/ML device acceptance criteria and performance study details is not present in the provided document.

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