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The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:

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

The Summit OCT Spinal 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 Minipolyaxial Screws are designed to accept a 3.0mm rod and are available in various sizes and geometries.

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

Manufactured from ASTM F-136 implant grade titanium alloy.

The provided text is a 510(k) summary for a medical device (Summit OCT Spinal System Minipolyaxial Screws) and contains regulatory information, indications for use, and a description of the device. However, it does not contain any information about acceptance criteria, detailed study designs, or performance data beyond a general statement that "Performance data were submitted to characterize the modified Summit OCT Spinal System minipolyaxial screws."

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need a document that includes:

• Specific acceptance criteria (e.g., tensile strength, fatigue life, torsional stability thresholds).
• Details of mechanical or other performance studies.
• Results of those studies demonstrating compliance with the acceptance criteria.
• Information on human reader studies or ground truth establishment if this were an AI/image-based device, which it is not.

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