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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 (T1-T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusion (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 absences 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, 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 (occipital-cervical-thoracic) spinal fixation system consisting of screws, hooks, rods, rod connectors, and occipital components. The system functions as an adjunct to fusion to provide stablilization of the posterior cervical and thoracic spine.

I apologize, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria.

The document is an FDA 510(k) clearance letter for the "Yukon OCT Spinal System." It details the device's classification, indications for use, and a summary of technological characteristics and non-clinical performance evaluation, which states:

• Non-clinical Performance Evaluation: "The subject implants were compared to the predicates using engineering rationales in addition to static compression, static torsion and dynamic compression testing (ASTM F1717) and performed equivalent to or better than the predicates."

This statement indicates that the device underwent non-clinical (mechanical) testing based on ASTM F1717 standards and demonstrated performance equivalent to or better than predicate devices. However, it does not specify:

• Quantitative acceptance criteria (e.g., specific load endurance, displacement limits).
• The raw performance data of the device against these criteria.
• Details about a clinical study, including sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC, standalone algorithm performance).

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text.

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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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K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation system, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI and EVEREST Spinal Systems.

Function: These instruments are designed to interface with the Brainlab Navigation System when used for navigation during spinal surgery.

The provided text describes the regulatory clearance of the K2M Navigation Instruments, but it does not contain information about specific acceptance criteria or a detailed study proving the device meets them in the way typically expected for an AI/ML device or a diagnostic device.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance evaluation. This means the device's safety and effectiveness are established by showing it is as safe and effective as existing legally marketed devices, rather than through a detailed clinical trial with specific performance metrics and statistical analyses.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, MRMC studies, or standalone performance for this device based on the provided text.

Here's what I can extract regarding the performance evaluation:

1. A table of acceptance criteria and the reported device performance:

   • The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific dimensional tolerances with thresholds).
   • The reported performance is qualitative: "The results of these evaluations determined that the K2M Navigation Instruments are equivalent to predicate devices."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not specified. The evaluation was "Non-clinical Performance Evaluation," which likely involved laboratory testing rather than data from human patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. As this was a non-clinical evaluation of surgical instruments, expert "ground truth" as understood in diagnostic AI studies is not relevant.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable for this type of non-clinical evaluation.

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:

   • Not applicable. This device is a manual surgical instrument intended to interface with a navigation system, not an AI or diagnostic tool that assists human readers/interpreters. There is no mention of an MRMC study.

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

   • Not applicable. This device is a physical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not explicitly stated. For "Dimensional comparisons and simulated use testing," the "ground truth" would likely be engineering specifications, physical measurements, and functional observations against defined requirements for compatibility and operation within the Brainlab Navigation System.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable. This is not an AI/ML device.

Summary of relevant information from the text regarding performance evaluation:

• Evaluation Type: Non-clinical Performance Evaluation.
• Methods: Dimensional comparisons and simulated use testing.
• Purpose: To ensure functionality and compatibility with the Brainlab Navigation System.
• Conclusion: "The results of these evaluations determined that the K2M Navigation Instruments are equivalent to predicate devices." This implies that the device met the implicit standards of functionality and compatibility demonstrated by the predicate devices.

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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.

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