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The SureMAX-SA™ Cervical Standalone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients as an adjunct to fusion for the treatment of degenerative disc disease (DDD). DDD is defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with the device. The SureMAX-SA™ Cervical Standalone System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. When used with the fixed or variable screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one or two levels from C2-T1 and requires no additional fixation. When used with one or more helical screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one level and with supplemental fixation.

The SureMAX-SA™ Cervical Standalone System is a collection of additively manufactured interbody spacers and integrated fixation for cervical implantation The cervical spacers have basic rounded rectangular shape and an open architecture. The integrated fixation consists of three screw options. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The SureMAX-SA™ Cervical Standalone System is provided sterile.

The provided text describes a 510(k) premarket notification for the SureMAX-SA™ Cervical Standalone System, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing details about an AI-based system's acceptance criteria and a study proving its performance against those criteria.

Therefore, I cannot provide the requested information as the input document does not contain details about:

• Acceptance criteria for an AI-based device's performance.
• A study proving an AI device meets acceptance criteria.
• Sample sizes for test sets where AI performance would be evaluated.
• Data provenance, expert involvement, or adjudication methods for AI ground truth.
• MRMC studies or standalone AI performance.
• Training set details for an AI model.

The document describes the device's mechanical testing to show substantial equivalence to predicate devices, which is common for physical medical devices, but it does not involve any AI performance evaluation.

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