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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 craniocervical 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, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. neon3™ 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 of fusion.

neon3™ is a modular, posterior system used for the surgical stabilization and fixation of the occipital, cervical and thoracic regions of the spine. The system components include longitudinal rods, screw and hook anchors, and interconnecting devices such as anchor- to-rod connectors, and rod-to-rod and screw-to-screw crosslinks.

The document describes the neon3™ universal OCT spinal stabilization device, a modular posterior system for spinal stabilization and fixation.

However, the provided text does not contain details about acceptance criteria, device performance metrics, or a study comparing its performance against specific quantitative criteria for diagnostic accuracy or clinical outcomes as would be found in a study proving a device meets acceptance criteria.

Instead, the document details the device's 510(k) premarket notification for FDA clearance, focusing on substantial equivalence to predicate devices based on mechanical testing.

Here's an analysis based on the information available regarding the provided request:

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

The document does not provide a table of acceptance criteria as quantitative metrics (e.g., sensitivity, specificity, accuracy) for device performance in a clinical or diagnostic context.

The performance data section mentions:

• "Mechanical testing of worst case neon3TM craniocervical constructs included static and dynamic compression bending and static torsion according to ASTM F1717 as well as static and dynamic compression bending and static and dynamic torsion per ASTM F2706."
• "The mechanical test results demonstrate that neon3TM performance is substantially equivalent to the predicate devices."

This indicates that the "acceptance criteria" were likely related to meeting the performance specifications outlined in the ASTM standards (F1717 and F2706) for spinal implant mechanical properties, and demonstrating substantial equivalence to predicate devices (Synapse Occipital-Cervical-Thoracic (OCT) System, Halifax Interlaminar Clamp, neon3TM (K150650), and Ascent™ POCT System) in these mechanical properties. The specific numerical values or success/failure thresholds for these mechanical tests are not presented in this document.

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

Not applicable. The "test set" in this context refers to mechanical testing of device constructs, not a clinical data set. The sample size for the mechanical testing is not specified beyond "worst case neon3TM craniocervical constructs". Data provenance is the manufacturing process and materials used for the constructs.

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

Not applicable. This is a mechanical testing study, not a study requiring expert clinical assessment for ground truth.

4. Adjudication method for the test set

Not applicable. This is a mechanical testing study, not a study involving human reader adjudication.

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 is a mechanical testing study for a spinal stabilization device, not an AI-assisted diagnostic or imaging device for which an MRMC study would be relevant.

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

Not applicable. This is a mechanical testing study for a spinal stabilization device.

7. The type of ground truth used

For the mechanical testing, the "ground truth" would be established by the physical and mechanical properties of the materials and constructs themselves, as measured by standardized testing procedures (ASTM F1717 and F2706). The comparison point is the performance of predicate devices, implying that their mechanical properties served as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning study.

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

Not applicable. There is no training set mentioned.

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