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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SENTINEL Spinal System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

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

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The SENTINELTM Spinal System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, and locking caps.

Based on the provided text, the document is a 510(k) Pre-market Notification for the SENTINELTM Spinal System. This type of document is for medical devices and focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, rather than presenting a study related to acceptance criteria and device performance in the way one might for an AI/ML diagnostic tool.

The information requested in the prompt (acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets) is not applicable to this type of regulatory submission. This document is for a physical implantable device (spinal system), not a software or AI/ML driven diagnostic or treatment prediction tool.

Therefore, I cannot provide the requested table and study details as they are neither present nor relevant to this 510(k) submission for a spinal system. The document instead discusses:

• Device Description: What the SENTINELTM Spinal System is made of and its components (titanium alloy, occipital plates, screws, hooks, rods, locking caps).
• Intended Use: The conditions it's designed to treat (degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, etc., for cervical spine and occipito-cervico-thoracic junction).
• Material: Titanium alloy (ASTM F136).
• Substantial Equivalence: The primary claim, stating it's substantially equivalent to predicate devices (Synthese Synapse System, Biomet Altius OCT System, Stryker Spine OASYSTM System, and Depuy SUMMITTM OCT Spinal System) in indications for use, design, function, and materials.

In summary, this document does not contain the information needed to answer your specific questions related to acceptance criteria and performance studies for an AI/ML device.

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