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The Genesys Spine Cervical Stand-Alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine Cervical Stand-Alone System is to be used with autogenous bone graft and implanted via an anterior approach.

The Genesys Spine AIS-C Cervical Stand-Alone System includes PEEK interbodies and titanium interbodies, which utilize an integrated titanium alloy locking mechanism. Both PEEK interbodies and titanium interbodies are to be anchored to patient anatomy via two (2) titanium alloy bone anchors. The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed. The PEEK interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disk space. The titanium alloy interbody devices, anchor locking mechanism, and the bone anchor components are manufactured from medical grade Ti6Al-4V ELI titanium alloy per ASTM F136.

The provided text describes the Genesys Spine AIS-C Cervical Stand-Alone System, a medical device, and its equivalency to predicate devices based on non-clinical performance data.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices or specimens) used for each mechanical test (axial compression, compressive-shear, torsion, subsidence, expulsion, cadaver testing, locking mechanism force). It only mentions that "all possible configurations of the AIS-C Cervical Stand-Alone System constructs were analyzed in order to determine the worst case to be used for testing."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the nature of mechanical testing of devices, it is inherently prospective in the sense that new samples of the device are manufactured and specifically tested for the purpose of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as this study involves non-clinical mechanical testing of a medical device, not a study evaluating human performance or diagnostic accuracy where expert ground truth would be established. The "ground truth" here is adherence to mechanical standards (ASTM F2077-11, ASTM F2267-04) and comparison to predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Mechanical testing results are objective measurements against defined standards and comparisons, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical performance of the device itself, not on the effectiveness of human readers (e.g., radiologists) with or without AI assistance.

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

This question is not applicable because the Genesys Spine AIS-C Cervical Stand-Alone System is a physical medical implant, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used

The "ground truth" in this context is defined by:

• Established ASTM standards: Specifically, ASTM F2077-11 for static and dynamic axial compression, compressive-shear, and torsion; and ASTM F2267-04 for static subsidence.
• Performance of legally marketed predicate devices: The study's acceptance criterion was that the new device's mechanical test results should be "equivalent to (or greater than) previously cleared interbody fusion systems."

8. The Sample Size for the Training Set

This information is not applicable. This is a study of a physical medical device's mechanical properties, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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