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The Innovasis Opteryx™ Cervical Plate System is intended for use in anterior cervical fixation for the following indications:

• Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
• Spondylolisthesis,
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis,
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• Tumor,
• Pseudoarthrosis; and
• Previous failed fusion.
  The Innovasis Opteryx™ Anterior Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.

The Innovasis 'Optervx' Anterior Cervical Plate System is a 6AI-4V ELI Titanium Alloy device comprised of an anterior cervical fixation plate and various screws. The purpose of this device is to stabilize the anatomical positioning of the cervical vertebrae after surgery. The cervical plates will be available in a variety of sizes to allow for the treatment of a wide variety of differing cases. Screws of different types will be included in the sets as well. Fixed angle screws will be included for cases when it is important to maximize stability. Variable angle screws will be included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae. Differing lengths of screws will be provided in both the fixed and variable configurations, to allow for Unicortical or bicortical purchase.

The Innovasis Opteryx™ Anterior Cervical Plate System is a medical device designed for anterior cervical fixation. It is composed of a titanium alloy plate and various screws, intended to stabilize the cervical vertebrae after surgery.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical performance testing (static and fatigue testing) and a demonstration of substantial equivalence to predicate devices based on mechanical characteristics and intended use. There is no mention of a test set involving human subjects or clinical data in this 510(k) summary. The testing focused on the physical and mechanical properties of the device itself.

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

Not applicable. As noted above, the primary testing described is non-clinical performance data and a comparison to predicate devices, not human-centered testing requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is mentioned.

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 not an AI-enabled device; it is a physical medical implant. Therefore, no MRMC study or AI-related comparative effectiveness was performed.

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

Not applicable. This is not an algorithm-only device.

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

For the non-clinical performance data, the "ground truth" would be established by engineering standards and specifications (e.g., ASTM F1717) for stiffness, strength, and fatigue life, and material composition standards (ASTM F136). For the substantial equivalence claim, the ground truth refers to the established safety and effectiveness of the identified predicate devices the new device is compared against.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore no "training set" in that context is used. The "training" for the device's design and manufacturing would come from established engineering principles and prior device knowledge.

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

Not applicable. (See point 8).

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