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The ATLANTIS™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

The ATLANTIS™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (locking mechanism is pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 or ISO 5832-3 and may be supplied either sterile or non-sterile.

The provided documents are a 510(k) premarket notification summary and an FDA clearance letter for the ATLANTIS™ Anterior Cervical Plate System. These documents are for a medical device (spinal implant) and do not contain information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-driven medical device.

The 510(k) summary focuses on:

• Product Description: Materials, components, and general design.
• Intended Use/Indications: For temporary stabilization of the anterior cervical spine during fusion in various conditions.
• Substantial Equivalence: The key claim in a 510(k) submission, where the device is shown to be as safe and effective as a legally marketed predicate device. In this specific case, it states the device was claimed to be substantially equivalent to itself, which is unusual phrasing but generally means a modification or rebranding of an existing device.

The FDA clearance letter confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria and study details for an AI/algorithm-driven device's performance.

The questions in your prompt (sample sizes for test/training, ground truth establishment, MRMC studies, standalone performance, etc.) are specific to the evaluation of AI/ML-based medical devices, which operate very differently from a physical implant like a cervical plate system. The safety and effectiveness of such implants are typically demonstrated through mechanical testing (e.g., fatigue, static strength), biocompatibility testing, and comparison to established designs (predicate devices), rather than through clinical studies involving expert consensus on algorithm output or multi-reader multi-case analyses.

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