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The SKYHAWK Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1 to L5 with the following indications:

• Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
• Spondylolisthesis;
• Spinal stenosis;
• Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• Tumor;
• Pseudoarthrosis;
• Failed previous fusion; and
• Trauma (i.e., fracture or dislocation).

The SKYHAWK Lateral Plate System consists of an assortment of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates, bone screws, and set screws. The.plates attach by means of screws to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The SKYHAWK Lateral Plate System implants and instruments are provided non-sterile. They require sterilization prior to use.

The SKYHAWK Lateral Plate System is a medical device for spinal fixation. The provided document details its mechanical testing results but lacks information on performance metrics typically associated with AI/ML-driven devices (like sensitivity, specificity, etc.) or specific acceptance criteria beyond meeting performance benchmarks of predicate devices. Therefore, some sections of your request cannot be fully addressed.

Here's an analysis based on the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical mechanical testing of the device itself, not a test set of data reflecting patient outcomes or imaging. Therefore, concepts like "sample size for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" as they relate to AI/ML studies are not applicable here. The "sample" in this context refers to the physical devices subjected to mechanical stress tests. The number of devices tested is not specified, but it would align with the requirements of ASTM F1717-13.

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

This is not applicable as the study involves mechanical testing of a physical device, not an AI/ML diagnostic or prognostic system requiring expert review of data for ground truth establishment. The "ground truth" here is the physical performance of the device under specific, standardized mechanical loads, as measured by testing equipment.

4. Adjudication Method for the Test Set

Not applicable. The "test set" is the physical device and its components, and performance is determined by mechanical measurements against established ASTM standards and predicate device performance, not by expert 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 510(k) submission for a physical medical device (spinal plate system) based on mechanical equivalency, not an AI/ML device involving human readers or comparative effectiveness studies of human performance.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this study is the physical performance of the SKYHAWK Lateral Plate System as measured through standardized mechanical testing (static and dynamic axial compression bending, and static torsion testing), compared against the established performance of legally marketed predicate devices and the requirements of ASTM F1717-13.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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