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The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:

• · Spondylolisthesis
• · Spondvlolysis
• · Pseudoarthrosis or failed previous fusions which are symptomatic
  · Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
  The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

The Ion 3D contains various sized facet screws with and without graft windows for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.
The purpose of this 510(k) is to add new Ion 3D Facet Screws and new instruments to the system.

The provided text is a 510(k) Pre-market Notification summary for a medical device (Ion 3D Facet Screw) and does not describe a clinical study with an AI component or detailed performance criteria in the way a diagnostic AI device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering justifications and non-clinical performance testing.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or available within this document.

Here's a breakdown of the information that can be extracted and a clear indication of what is not present:

1. Table of acceptance criteria and reported device performance:

The document doesn't provide specific numerical acceptance criteria or performance metrics in a table format as would be seen for a diagnostic AI device. Instead, it relies on demonstrating that the device's mechanical performance is not "worst-case" compared to predicates and that it meets standards for biocompatibility and sterilization.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it focuses on non-clinical testing (mechanical, biocompatibility, sterilization, cleaning) rather than a clinical performance study with test data. The "test set" here refers to the physical devices and materials tested.
• Data Provenance: Not applicable. The testing is primarily laboratory-based and simulated.

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

• Not applicable. Ground truth as typically understood for AI or diagnostic devices (e.g., expert consensus on pathology images) is not relevant to this type of mechanical and material testing. The "ground truth" for these tests would be the established scientific and engineering principles and standards (e.g., ISO 10993).

4. Adjudication method for the test set:

• Not applicable. There is no mention of adjudication, as this type of testing does not involve subjective expert review for establishing ground truth from clinical data.

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:

• No. An MRMC study was not conducted. This device is a surgical implant (facet screw) and associated instruments, not an AI-powered diagnostic or assistive tool for human readers.

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

• No. This device is a physical implant and surgical tools; there is no standalone algorithm to evaluate.

7. The type of ground truth used:

• For mechanical performance: Engineering principles and simulation models (Finite Element Analysis) as surrogate for clinical performance under defined loads.
• For biocompatibility: International standard ISO 10993.
• For sterilization and cleaning: Industry-accepted validation protocols and standards.

8. The sample size for the training set:

• Not applicable. This document refers to a physical medical device, not an AI algorithm that requires a training set.

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

• Not applicable. No training set is involved for this type of device submission.

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