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neon3™ is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic 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.

neon?™ 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.

neon 3™ is a modular, posterior system used for the surgical stabilization and fixation of the cervical and thoracic regions of the spine. The system components include longitudinal members, anchors and interconnection devices.

The acceptance criteria and study proving the device meets the criteria are described below:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. This study primarily involved mechanical testing of the device components, not human subject data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical testing is established by industry standards (ASTM F1717) and engineering principles rather than expert consensus.

3. Adjudication method for the test set: Not applicable. This was a mechanical testing study, not a clinical study requiring adjudication of expert opinions.

4. 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 spinal fixation system, not an AI software or imaging device that would involve human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware medical device, not an algorithm.

6. The type of ground truth used:

   • Mechanical performance: Established by adherence to ASTM F1717 (standard specification for spinal implant constructs) and engineering design principles.
   • Substantial Equivalence: Demonstrated by comparing the mechanical test results of neon3™ to those of the predicate devices.

7. The sample size for the training set: Not applicable. This refers to a medical device's mechanical performance evaluation, not a machine learning model.

8. How the ground truth for the training set was established: Not applicable.

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The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 - T3). The intended indications are as follows:

• Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Spinal Stenosis
• Fracture/Dislocation
• Tumors
• Pseudoarthrosis
• Revision of previous cervical and upper thoracic spine surgery

The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Atoll Cervico-Thoracic System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

The Atoll Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology.

The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3.

To achieve the best results, unless otherwise specifically described in another Theken Spine document, do not use Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer.

The purpose of this submission is to add transition rods and rod connectors

This document is a 510(k) summary for a medical device called the Atoll Cervico-Thoracic System. It is a premarket notification to the FDA to demonstrate substantial equivalence to existing legally marketed devices.

It describes a spinal implant system and its intended use, rather than a diagnostic device or AI software. Therefore, the questions related to studies proving acceptance criteria for device performance, ground truth, expert involvement, and AI specific metrics (like MRMC studies) are not applicable in this context. These questions typically apply to diagnostic devices, particularly those involving image analysis or AI algorithms, where performance relies on measurable metrics against a 'ground truth'.

For this device, "acceptance criteria" are related to mechanical and material properties, and "substantially equivalent" claims. The study proving acceptance is typically mechanical testing and material characterization, not clinical studies with patients for diagnostic accuracy.

Here's an attempt to answer the relevant aspects based on the provided text, while explicitly stating where information is not applicable:

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

Note: The acceptance criteria for this type of medical device are typically defined by engineering standards for mechanical strength, biocompatibility, and manufacturing quality, and by demonstrating that the device is "substantially equivalent" to legally marketed predicate devices in terms of intended use, design, and materials.

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

This information is not applicable as this is a 510(k) submission for a spinal implant, not a diagnostic device or AI algorithm that would typically involve a "test set" of data for performance evaluation in the way described. The "test" for this device would involve mechanical testing and material characterization, the specifics of which are not detailed in this summary.

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)

This information is not applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic accuracy studies of image-based or clinical data, which is not the nature of this device submission.

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

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not relevant to this device's submission.

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 information is not applicable. MRMC studies are specifically for evaluating diagnostic performance of imaging systems, often with AI assistance. This device is a surgical implant.

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

This information is not applicable. This device is a physical implant, not an algorithm.

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

This information is not applicable in the context of data-driven performance evaluation. For this device, the "ground truth" would be related to established engineering standards for material properties and mechanical performance, and the clinical outcomes for the predicate devices that established their safety and effectiveness.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this device submission.

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

This information is not applicable. There is no "training set" in the context of this device submission.

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