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The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The Curiteva Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary. All system components are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.

The provided document is a 510(k) summary for a spinal implant device (Curiteva Laminoplasty System), not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML device.

Specifically, the document discusses:

• Acceptance Criteria & Performance: The performance data section (page 4, section F) states that "Non-clinical testing performed on the Curiteva Laminoplasty System supports substantial equivalence to predicate devices." The tests performed are:
  • Static four-point bending per ASTM F2193
  • Dynamic four-point bending per ASTM F2193
  • Axial screw pullout per ASTM F543
    It concludes that the strength and performance are sufficient for intended use and substantially equivalent to the primary predicate device (K032534). However, this refers to mechanical testing of a physical implant, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the following information which is relevant to AI/ML device studies:

1. Table of acceptance criteria and reported device performance (for AI/ML): Not applicable.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth establishment for training set: None of this information is present as the document describes a physical medical device, not an AI/ML algorithm.

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