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The SKYHAWK Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The SKYHAWK Interbody Fusion System is designed for use with autogenous bone graft to facilitate fusion. The system is also intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the SK YHAWK Interbody Fusion System.

The SKYHAWK Interbody Fusion System consists of implants, trials, and instruments. The SKYHAWK Interbody Fusion System is comprised of a variety of implants fabricated and manufactured from polyetheretherketone (PEEK Optima LT1) as described by ASTM F2026 with tantalum markers as described by ASTM F560. PEEK is utilized due to its radiolucent properties, which aids the surgeon in determining if fusion in the operative site has occurred. Since PEEK is transparent in xrays, tantalum marker pins are inserted into the implants in order to give surgeons a visual aid in determining the location of the implants, both intra and postoperatively. The SK YHAWK Interbody Fusion System implants are offered in parallel and lordotic profiles to restore the natural curvature of the spine; the device mav be implanted using a lateral or anterolateral approach. The SKYHAWK Interbody Fusion System implants, trials and instruments are provided non-sterile. They require sterilization prior to use.

This document describes the SKYHAWK™ Interbody Fusion System, a medical device, and its acceptance criteria for regulatory approval. It does not describe an AI/ML powered device, therefore, many of the requested fields are not applicable.

Here's a breakdown of the provided information, focusing on the mechanical testing rather than AI/ML performance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. The document refers to "mechanical testing" but does not specify the number of units tested or any specific test data beyond the general conclusion of substantial equivalence.

3. Number of Experts and Qualifications for Ground Truth

This is not applicable as the study is a mechanical engineering test of a physical device, not an evaluation of an AI system's diagnostic accuracy. Ground truth here refers to the physical properties and performance measured by standardized tests.

4. Adjudication Method for Test Set

This is not applicable as the study involves mechanical testing and compliance with engineering standards, not human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable as this is a mechanical medical device, not an AI/ML diagnostic or assistive tool.

6. Standalone Algorithm Performance

This is not applicable as this is a mechanical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth for this device's acceptance is based on established engineering standards and measurement protocols. Specifically, the tests were conducted "in accordance with ASTM F2077-11 'Test Methods for Intervertebral Body Fusion Devices' and ASTM F2267-04 'Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression'." The "ground truth" is that the device performs within the acceptable parameters defined by these ASTM standards and is demonstrably similar to predicate devices.

8. Sample Size for Training Set

This is not applicable as this is a mechanical medical device, not an AI/ML system that requires a training set.

9. How Ground Truth for Training Set Was Established

This is not applicable as this device does not use a training set in the context of AI/ML. The "ground truth" for the device's design and manufacturing is based on established engineering principles, materials science (PEEK Optima LT1, ASTM F2026, tantalum markers, ASTM F560), and the specified intended use and indications.

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