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The YUKON OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies. and degenerative disease of the facets with instability.

The YUKON OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tu mors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation. the YUKON OCT Spinal System may be connected to EVEREST, MESA and DENALI Spinal System components via the rod to rod connectors or transition rods.

The YUKON OCT Spinal System is a top-loading, multiple component, posterior (occipitalcervical-thoracic) spinal fixation system consisting of screws, hooks, rods, rod connectors, and occipital components. The purpose of this submission is to add connectors to the system.

Function: The system functions as an adjunct to provide stabilization of the posterior cervical and thoracic spine.

The provided document is a 510(k) summary for the YUKON OCT Spinal System, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It is critical to understand that this document describes a mechanical medical device (a spinal fixation system) and not an AI/ML algorithm or software device. Therefore, the questions related to AI/ML performance, such as acceptance criteria for AI algorithms, AI-assisted reader performance, ground truth for AI training and testing, and standalone algorithm performance, are not applicable to this submission.

The acceptance criteria and study information provided in this document pertain to the mechanical and physical performance of the spinal fixation system.

Here's an analysis of the provided information, focusing on what is relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For a mechanical device like the YUKON OCT Spinal System, acceptance criteria typically involve demonstrating mechanical strength and durability. The document states:

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

For mechanical testing, the "test set" refers to the number of physical samples of the device components tested. The document does not specify the exact number of samples tested for each type of mechanical test (static compression, static torsion, dynamic compression).

• Data Provenance: The testing appears to be conducted by the manufacturer as part of the regulatory submission process, implying internal laboratory testing. There is no mention of country of origin of data in terms of patient data, as this is not a clinical study based on patient outcomes but rather a mechanical performance study. It is a prospective test in the sense that new samples of the device were manufactured and then tested to demonstrate performance.

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

This question is not applicable. For mechanical performance testing of a spinal fixation system, "experts" in the sense of clinicians establishing a "ground truth" for a diagnostic task are not involved. The ground truth is defined by engineering standards (e.g., ASTM F1717) and the physical properties of the materials and design. The interpretation of test results would be performed by qualified engineers.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or AI performance evaluations to reconcile discrepancies between expert opinions on a specific outcome (e.g., diagnosis). For mechanical testing, there isn't typically an "adjudication" of results in this sense, but rather adherence to standardized testing protocols and interpretation by engineers.

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

This question is not applicable. This is a mechanical device, not an AI or software device. The concept of "human readers" and "AI assistance" does not apply.

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

This question is not applicable. This is a mechanical device, not an AI or software device.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is established by engineering standards and specifications. Specifically, the document references ASTM F1717, which is a standard specification for spinal implant constructs in a corpectomy model. The performance of the device is assessed against the requirements and methodologies outlined in this standard, and in comparison to legally marketed predicate devices.

8. The sample size for the training set

This question is not applicable. This is a premarket notification for a mechanical device; there is no "training set" in the context of machine learning or AI. The design of the device is based on engineering principles and prior experience with similar devices, not a 'training set'.

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

This question is not applicable. As there is no training set for an AI/ML algorithm for this mechanical device, there is no ground truth established for a training set in that context.

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The YUKON OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (CI to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The YUKON OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the YUKON OCT Spinal System may be connected to EVEREST Spinal System components via the rod to rod connectors or transition rods.

The YUKON OCT Spinal System is a top-loading, multiple component, posterior (occipitalcervical-thoracic) spinal fixation system consisting of screws, hooks, rods, rod connectors, and occipital components.

This document describes a 510(k) premarket notification for the YUKON OCT Spinal System. It is a medical device for spinal fixation, not an AI/ML powered device. Therefore, the information requested in the prompt regarding acceptance criteria and a study proving device performance (including details about test sets, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training sets) is not applicable to this type of device.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through:

1. Technological Comparison: Highlighting similarities in design features, materials, and sizes to existing predicate spinal fixation systems.
2. Non-clinical Performance Evaluation: Citing performance evaluation based on published literature and mechanical testing according to ASTM standards (F1717 and F2706) to demonstrate equivalent mechanical properties (static torsion, static compression, dynamic torsion, dynamic compression).

Since the device is a physical spinal fixation system and not a software or AI/ML diagnostic tool, the concept of a "test set" for performance evaluation in the context of diagnostic accuracy, human reader improvement, or algorithm-only performance does not apply. Similarly, "ground truth" for a physical implant is established through design specifications, material properties, and mechanical validation, not expert consensus on images or outcome data in the same way it would be for a diagnostic algorithm.

Ask a specific question about this device