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The Spinal USA Interbody Fusion Device ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Spinal USA Interbody Fusion Device ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

The Spinal USA Interbody Fusion Device ACIF System consists of implants with various heights to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone (Peek Optima, LT)). The products are supplied clean and "NON-STERILE".

The provided text is a 510(k) summary for a medical device (Spinal USA Anterior Cervical Interbody Fusion Device). This type of document focuses on demonstrating substantial equivalence to a predicate device through pre-clinical performance testing. It does not contain information about clinical studies with human subjects, AI performance, or the specific criteria requested about acceptance criteria, sample sizes, ground truth establishment, or expert evaluation related to those types of studies.

Therefore, I cannot provide the requested information from the given input. The "PERFORMANCE TESTING" section only states:

"The pre-clinical testing performed indicated that the Spinal USA Interbody Fusion Device ACIF System is substantially equivalent to the predicate devices and is adequate for the intended use."

This indicates that engineering and bench testing were conducted to show the device's mechanical and material properties are comparable to existing, legally marketed devices. It does not refer to clinical performance in patients or algorithmic performance.

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