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The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - Hyper C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scollosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies at up to two contiguous levels from C2 - T1.

The EVOL® ha – Hyper C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

The EVOL® ha – Hyper C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and lordotic and lordotic ande. All sizes have a central window for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The provided FDA 510(k) Clearance Letter for the EVOL® ha - Hyper C Cervical Interbody Fusion System does not contain details about acceptance criteria or specific studies proving device performance against such criteria in the way you've described (e.g., related to AI/ML device performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment).

This document is a marketing clearance for a traditional medical device (an intervertebral body fusion system, which is a physical implant) and not a software-as-a-medical-device (SaMD) or an AI/ML powered device. The "acceptance criteria" and "studies" you're asking about are typically associated with the rigorous validation of diagnostic accuracy or clinical utility for AI/ML systems.

Instead, for this physical medical device, "acceptance criteria" would primarily relate to its mechanical and material performance to ensure it is substantially equivalent to a predicate device and safe/effective for its intended use. The "studies" mentioned are non-clinical (benchtop) tests to demonstrate this.

Here’s a breakdown based on the information provided, adapted to the context of a physical implant:

1. A table of acceptance criteria and the reported device performance:

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

• Sample Size: Not specified in the document. For benchtop mechanical testing (like ASTM F2077 and expulsion testing), sample sizes are typically determined by the specific ASTM standard or internal quality protocols to achieve statistical significance for engineering parameters, but they are generally small (e.g., 5-10 devices per test condition depending on variability).
• Data Provenance: The tests are non-clinical, meaning they are laboratory/benchtop studies. There is no patient data involved (retrospective or prospective) for this type of device validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. For a physical interbody fusion device, "ground truth" in the diagnostic AI sense does not apply. The "ground truth" for mechanical testing is established by the engineering specifications and performance standards defined in ASTM or similar bodies. Expert interpretation might be involved in initial design and test protocol development (e.g., biomechanical engineers), but not in establishing a diagnostic "ground truth" for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. Adjudication methods are used to establish a consensus "ground truth" for diagnostic labels in medical imaging or pathology, often in the context of human reader studies for AI/ML devices. This is not relevant for the mechanical testing of a physical implant.

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. This type of study (MRMC for AI assistance) is not applicable to a physical intervertebral body fusion system.

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

• No. This is

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