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The GS Medical CYGNUS-C Standalone ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The GS Medical CYGNUS-C Standalone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. The GS Medical CYGNUS-C Standalone ACIF System is to be used with two titanium alloy screws which accompany the implant and does not require supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The CYGNUS-C Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the addition on an integrated plate. This integrated plate allows for the user to bypass using an additional plate as seen with traditional ACIF spacers. The CYGNUS-C Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Subject device also contains supplementary fixation screw. The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with a titanium alloy (Ti-6Al-4V) plate and X-ray (radioopaque) markers made of tantalum. The supplementary screws are made up of titanium alloy (Ti-6Al-4V).

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification summary for a medical device (CYGNUS-C Standalone ACIF system), which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a clinical or performance study with detailed acceptance criteria.

Therefore, I cannot provide the requested information. The document primarily discusses:

• Device Description and Intended Use: For cervical spinal fusion.
• Predicate Devices: Used for comparison to establish substantial equivalence.
• Technological Characteristics: Materials and design.
• Performance Data (Mechanical Testing): States that the device underwent testing according to ASTM standards (ASTM 2077, ASTM F2267) and "the results met all acceptance criteria." However, it does not specify what those acceptance criteria were nor the detailed results of the tests.
• Biocompatibility: Based on predicate devices.
• Conclusion: Substantial equivalence.

There is no mention of a human-in-the-loop study, MRMC study, expert ground truth establishment, or training/test set details related to AI/algorithm performance, as the device described is a physical implant, not an AI-powered diagnostic tool.

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