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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The NAUTILUS Spinal System, when properly used. is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system. the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw. head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

The provided text describes the 510(k) Summary for the NAUTILUS Spinal System. This document is for a medical device (spinal implant system) and does not contain information about an Artificial Intelligence (AI) device or its performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document explicitly states that the device is made from titanium alloy and concerns mechanical fixation for spinal fusion.

Here's why the requested information cannot be extracted from the provided text:

• No AI Device: The NAUTILUS Spinal System is a physical medical device (implants, screws, rods) made of titanium alloy. It is not an AI-powered diagnostic or assistive device.
• Performance Data Type: The "Performance Data" section specifically mentions "Dynamic compression testing per ASTM F1717" to demonstrate substantial equivalency, which are mechanical tests for physical implants, not AI algorithm performance metrics.
• No AI-related Criteria: The document does not discuss metrics like accuracy, sensitivity, specificity, AUC, or other parameters typically used to evaluate AI device performance.
• No "Ground Truth" for Algorithms: The concept of "ground truth" (expert consensus, pathology, outcome data) as it relates to training or testing an AI algorithm is not applicable to a physical spinal implant system.

In summary, the provided content is a regulatory submission for a non-AI medical device, and thus does not contain the information necessary to answer your questions about AI device acceptance criteria and studies.

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