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When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput -- T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System and the Mountaineer 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 .
• atianto/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 Summit OCT Spinal System and Mountaineer OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.

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

Addition of components to the Summit OCT Spinal System and Mountaineer OCT Spinal System.

The Summit OCT Spinal System and Mountaineer OCT Spinal Systems also contain Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document is a 510(k) summary for the Summit OCT Spinal System and Mountaineer OCT Spinal System, specifically for an addition of components. It does not describe a study related to an AI/ML powered device, nor does it provide acceptance criteria or performance data in the typical sense of a clinical or performance study for such a device. Rather, it focuses on the substantial equivalence of additional components for an existing spinal fixation system.

Therefore, many of the requested elements for describing an AI/ML device study are not applicable or cannot be extracted from the provided text.

Here is an attempt to answer the questions based on the provided text, highlighting where information is not available due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

The provided document does not contain a table of acceptance criteria or reported device performance in the context of an AI/ML device study. This submission is for an addition of components to an existing spinal fixation system. The "Performance Data" section states: "Performance data were submitted to characterize the additional components of the Summit OCT Spinal System and Mountaineer OCT Spinal System." However, the details of this performance data and the specific acceptance criteria are not included in the provided 510(k) summary. These would typically involve mechanical testing, material characterization, and compliance with ASTM standards, not clinical performance metrics for an AI system.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device for which a "test set" of data would be used to evaluate algorithm performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system. The "ground truth" for such devices typically involves established engineering principles, material science, and mechanical testing standards.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system, not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is a 510(k) submission for an addition of components to a spinal fixation system.

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