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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, and/or lordosis), (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.

This 510(k) summary for the NAUTILUS Spinal System describes a medical device and its substantial equivalence to predicate devices, rather than a study evaluating device performance against pre-defined acceptance criteria in terms of accuracy or clinical outcomes. The provided document is for a pedicle screw spinal system, which is a physical implant, not an AI/ML-driven diagnostic or prognostic device that typically involves performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories for AI/ML device evaluation (like sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of submission.

However, I can extract the relevant information regarding the performance data that was provided to demonstrate substantial equivalence for this physical device.

Acceptance Criteria and Study for NAUTILUS Spinal System

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a traditional medical device like a spinal system, "acceptance criteria" primarily relate to engineering and material standards, as well as functional performance benchmarks established by recognized industry standards (e.g., ASTM). The "study" here refers to bench-top testing.

2. Sample Size used for the test set and the data provenance

• Sample Size (Test Set): Not explicitly stated as "sample size" in the context of clinical data. For bench-top mechanical testing, the "samples" would be the physical implants tested. The number of such implants tested is not specified in this summary.
• Data Provenance: N/A. Bench-top mechanical testing is performed in a laboratory setting. There is no patient data involved for this type of submission focused on substantial equivalence of a physical implant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. This information is not relevant to the evaluation of a physical implant's mechanical properties. Ground truth, in the context of AI/ML, refers to a definitive correct answer for a diagnostic or prognostic task, typically established by clinical experts.

4. Adjudication method for the test set

• N/A. Adjudication methods are used in clinical studies or expert reviews to resolve disagreements in ground truth labeling for AI/ML models. This is not applicable to a submission focusing on the mechanical equivalence of a spinal implant.

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

• N/A. MRMC studies are used to evaluate the impact of AI on human readers' performance in diagnostic tasks. This device is a surgical implant, not an AI diagnostic tool.

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

• N/A. Standalone performance evaluation is for AI algorithms. This is a physical device.

7. The type of ground truth used

• Mechanical & Material Standards: For this device, the "ground truth" (or objective standard) for its performance is adherence to established engineering standards (e.g., ASTM F1717 for dynamic compression testing) and material specifications (e.g., ASTM F136 for titanium alloy). The comparison is against these standards and the performance of the predicate devices.

8. The sample size for the training set

• N/A. There is no "training set" in the context of a physical medical device's mechanical performance evaluation. Training sets are for AI/ML model development.

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

• N/A. As there is no training set for this type of device submission, this question is not applicable.

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