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The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput – T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:

. ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
. spondylolisthesis
. spinal stenosis
. fracture/dislocation
. atlanto/axial fracture with instability
. occipitocervical dislocation
revision of previous cervical spine surgery
tumors

The occipital bone screws are limited to occipital fixation only.

The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.

The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TIMX™, MONARCH™, EXPEDIUM™ and MOSS® MIAMI™ Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Expansion of the size offering of MOUNTAINEER OCT Spinal System Minipolyaxial Screws. The MOUNTAINEER OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

The provided text does not describe an AI/ML device, nor does it contain information about acceptance criteria and studies that prove a device meets those criteria in the context of AI/ML.

Instead, the document is a 510(k) summary for a medical device called the "MOUNTAINEER OCT Spinal System" (specifically, an expansion of its size offering). A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.

The "Performance Data" section explicitly states: "Performance data were submitted to characterize the additional components of the MOUNTAINEER OCT Spinal System." This refers to mechanical performance data for the physical spinal implant components, not performance data for an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth related to an AI/ML device from this document.

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