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The GS Medical QUASAR Stand-alone 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 QUASAR Stand-alone ACIF System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. When the GS Medical QUASAR Standalone ACIF System is used with all the titanium alloy screws for which the implant is designed it does not require supplemental fixation. When used with fewer screws the implant should be used in conjunction with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

The subject device, the QUASAR 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 QUASAR 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 supplementary fixation screws are used along with the subject device cage and plate.

The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with Titanium alloy plates (Ti-6Al-4V) and supplementary screws made up of Titanium alloy (Ti-6Al-4V).

The provided text describes a medical device, the "QUASAR Standalone ACIF System," and its clearance by the FDA. However, it does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) clearance letter for an intervertebral body fusion device, which is a physical implant used in spinal surgery, not an AI/ML diagnostic or therapeutic system. The "Performance Data" section (F) describes mechanical testing of the implant (e.g., static and dynamic axial compression, shear, torsion, expulsion, and subsidence testing) against ASTM standards, which are physical engineering standards for device performance, not clinical performance metrics for AI.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the given input because the input describes a non-AI/ML medical device.

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