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This system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.

Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.

The Life Spine Cam Lock Anterior Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.

The Life Spine Cam Lock Anterior Cervical Plating System implant components are made from titanium alloy described by ASTM F136. Stainless steel and titanium implant components must not be used together in a construct.

Do not use any of The Life Spine Cam Lock Anterior Cervical Plating System components with the components from any other system or manufacturer.

This looks like a 510(k) premarket notification for a medical device called the "Cam Lock Plating System." The provided document does not contain information about acceptance criteria and study data in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC, or reader studies).

The document is for a spinal intervertebral body fixation orthosis and focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, sizing, and mechanical performance.

Therefore, I cannot provide the requested information as it pertains to AI/ML device performance metrics and studies.

Here's an explanation of why the requested information is not present in the provided text:

• Type of Device: The "Cam Lock Plating System" is a physical implant (spinal plating system) used for spinal fixation. It's not an AI/ML-driven diagnostic or prognostic software device.
• Regulatory Pathway: The document describes a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device. For mechanical devices like this, substantial equivalence is typically shown through:
  • Indications for Use comparison.
  • Technological characteristics comparison (materials, design, sizing).
  • Performance data (which for this device are mechanical tests, not clinical performance metrics related to diagnostic accuracy).
• Acceptance Criteria & Study: The "acceptance criteria" for this type of device would generally revolve around meeting established mechanical performance standards (e.g., ASTM F1717 for spinal implants) and demonstrating that the device performs as intended in terms of its structural integrity and fixation capabilities. The study mentioned ("Mechanical testing was included to demonstrate the substantial equivalency... The testing included static compression, dynamic compression and static torsion testing per ASTM F1717 in addition to a benchtop screw push-out test") is accordingly focused on these mechanical aspects.

In summary, there is no information in the provided document about:

• AI/ML performance metrics (sensitivity, specificity, etc.)
• Test set sample size or provenance for AI/ML evaluation
• Experts used to establish ground truth for AI/ML evaluation
• Adjudication methods for AI/ML evaluation
• Multi-reader multi-case (MRMC) studies with AI assistance
• Standalone AI algorithm performance
• Ground truth type, training set size, or ground truth establishment for an AI/ML model.

The document is entirely focused on the mechanical and material equivalence of a physical medical implant.

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