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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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The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.

The SureMAX™ Family of Cervical Spacers is an additively manufactured interbody system. These cervical implants have basic keystone shape and an open architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The SureMAX™ Family of Cervical Spacers is provided sterile.

The provided text is a 510(k) Summary for a medical device (SureMAX™ Family of Cervical Spacers) and does not describe an AI/ML-based medical device. Therefore, it does not contain the information needed to answer the questions about acceptance criteria and study proving device performance for an AI/ML device.

The document discusses:

• Device: SureMAX™ Family of Cervical Spacers, an additively manufactured interbody system used for anterior intervertebral body fusion.
• Indication: Treatment of cervical disc degeneration and/or cervical spinal instability.
• Performance Data: Mechanical testing per ASTM F2077 (static and dynamic compression and torsion), ASTM F2267 (subsidence), and expulsion studies.
• Conclusion: The device's performance is substantially equivalent to a predicate device based on these mechanical tests.

The information requested in the prompt, such as acceptance criteria based on accuracy metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in this document as it pertains to AI/ML device evaluation.

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