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The Blustone Synergy Diamond SA Cervical System are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy Diamond SA Cervical System may be used with additional supplemental fixation.

The BluStone Synergy Diamond Stand Alone (SA) Cervical System consists of the Diamond cervical interbody plate and screws to be used in conjunction with the Blustone Synergy Interbody Fusion SLATE cervical interbody fusion devices to form the Diamond Stand Alone Cervical System. The Diamond Stand Alone cervical system is designed to be used with allograft and/or autograft. Use of the Diamond SA Cervical System is intended to expedite the Anterior Cervical Device instrumentation procedure, while minimizing tissue disruption through a minimally invasive approach. The Diamond plate includes anterior nail spikes to resist rotation and two holes for insertion of the included bone screws as well as an integrated locking plate to resist bone screw backout. The Diamond cervical interbody plate and screws are manufactured from titanium alloy. Previously cleared SLATE cervical cages to be used with the Diamond plate and screws are manufactured from PEEK and include tantalum markers. All implant components are available in various sizes to accommodate varying patient anatomy.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document is an FDA 510(k) clearance letter for a medical device called the "Blustone Synergy Diamond SA Cervical System," which is an intervertebral body fusion device.

The "Performance Testing" section mentions bench performance testing conducted on the device, including:

• Static and dynamic axial compression
• Static and dynamic axial compression shear
• Static and dynamic torsion per ASTM F2077-18
• Subsidence per ASTM F2267-04 (2018)
• Expulsion

It states that "Testing shows that the subject Blustone Synergy Diamond SA Cervical System performs equivalent to or better than the 5th percentile of FDA benchmark values." This implies there are FDA benchmark values that serve as acceptance criteria for mechanical performance.

However, the document does not discuss AI/ML device performance, acceptance criteria, or studies related to AI/ML device evaluation. It primarily focuses on the substantial equivalence of a physical surgical implant based on mechanical engineering tests.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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