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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated 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
• atlantoaxial 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 Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.

The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.

The Summit OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws and Songer Cables. For occipitocervicothoracic fusion, the transition rod is bent and cut to the appropriate length. The occipital plate is fixed to the occiput with bone screws and the transition rod is attached to the plate by a locking mechanism. This locking mechanism consists of a bolt and a washer which are free to rotate and translate along a slot in the occipital plates. The rod loads from the top and is fixed and locked into place with a mini outer nut. Sub-axially, cable connectors are fixed to the transition rod and attached to the spine via sublaminar cabling looped through the cable connectors. The end of the construct is stabilized with polyaxial screws and mini outer nuts to the upper thoracic spine, as required.

The Summit OCT System can also be linked to the ISOLA, TiMX. Monarch and MOSS Miami Systems using the dual wedding bands and axial connectors, and via dual diameter rods.

The provided text describes a medical device, the Summit Occipito-Cervico-Thoracic (OCT) Spinal System, and its submission for 510(k) clearance. It does not contain information about software, AI, or performance criteria typically associated with such technologies. Therefore, I cannot generate the requested table and study details.

The document focuses on the intended use, device description, and a general statement about "Biomechanical testing, including static and dynamic cantilever beam testing and axial slip testing" as performance data. This type of testing is standard for mechanical medical devices to establish their structural integrity and biocompatibility, not for assessing diagnostic accuracy or algorithmic performance.

Specifically, the document lacks information on:

• Acceptance Criteria for an AI/Software Device: There are no metrics like sensitivity, specificity, accuracy, F1-score, or any other performance thresholds typical for AI or software.
• Reported Device Performance of an AI/Software Device: No numerical results are provided that would correspond to the acceptance criteria.
• Sample Size for Test Set: There is no mention of a test set, only biomechanical testing performed on the physical device.
• Data Provenance: Not applicable as there's no data in the context of AI.
• Number of Experts & Qualifications for Ground Truth: Not applicable, as there's no algorithmic ground truth being established.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not mentioned.
• Standalone Performance: Not applicable for a mechanical device.
• Type of Ground Truth: Not applicable for a mechanical device.
• Training Set Size and Ground Truth Establishment: Not applicable for a mechanical device.

The FDA letter confirms the device's substantial equivalence to predicate devices based on the information provided by the submitter, DePuy AcroMed, Inc. This 510(k) clearance process is for traditional medical devices, not for AI-enabled software.

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