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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 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 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 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, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (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 and cobalt chrome per ASTM 1537. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

The purpose of this submission is to add an additional cross connector component.

Based on the provided text, the document is a 510(k) premarket notification for the Nautilus Spinal System. The text describes the device, its intended use, and states that it has been determined to be substantially equivalent to predicate devices. However, the document does not contain any information about a study proving the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or F1 score, nor does it discuss AI or algorithm performance data.

The "Performance Data" section in the 510(k) Summary only states: "Engineering analysis was presented to demonstrate the substantial equivalency of the Nautilus Spinal System." This indicates that the performance data submitted for this device relates to its mechanical performance and substantial equivalence, not to the type of statistical performance metrics typically associated with AI/ML devices.

Therefore, for your request, I cannot provide the detailed information about acceptance criteria and a study proving device performance as it pertains to AI/ML devices, because the document describes a traditional medical device (a spinal implant system) and uses a "substantial equivalence" pathway for clearance, not a pathway that would involve performance metrics like sensitivity or specificity.

I cannot create the requested table or answer most of the questions because the provided text is for a physical medical device (spinal system) and does not discuss AI/ML device performance, acceptance criteria in the context of diagnostic accuracy, or studies involving test sets, ground truth, or expert review for AI algorithms.

The document states that the device is "substantially equivalent" to predicate devices based on design, materials, indications for use, sizing, and mechanical performance (engineering analysis). This is a different type of assessment than what is typically performed for AI/ML devices where specific performance metrics like sensitivity and specificity against a ground truth would be established.

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