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The Black Diamond™ POCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (Cl to C7) and the upper thoracic spine (TI-T3); traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin, as confirmed by radiographic studies, and degenerative disease with instability. The Black Diamond™ POCT Spinal System is also intended to restore the integrity of the spinal column even in the absences of fusion for a limited time period in patients with advanced stage tumors in whom if e expectancy is of insufficient duration to permit achievement of fusion. To achieve additional levels offixation, the Black Diamond™ POCT Spinal System may be comected to the Osseus Black Diamond™ Pedicle Screw System using transition rods or anatomically-bent rods.

The Black Diamond™ POCT Spinal System is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and upper thoracic spine. The Black Diamond™ system contains rods in multiple shapes and sizes, polyaxial screws, set screws, rod connectors and transverse connectors. Connecting components can be locked to the rod in various configurations to accommodate individual patient anatomy.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Black Diamond™ POCT Spinal System," which is a posterior cervical screw system.

It discusses:

• The FDA's review and determination of substantial equivalence to predicate devices.
• The device's indications for use.
• A summary of its technological characteristics.
• Non-clinical testing performed (mechanical testing per ASTM F1717).

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, or ground truth establishment for software/AI performance evaluation.
• Information on expert panels, adjudication methods, or multi-reader multi-case studies, as these are typically applicable to diagnostic imaging or AI/ML-based medical devices, not to mechanical spinal implants.
• Information about a standalone (algorithm only) performance study.
• Ground truth types for software performance.
• Training set sample sizes or how training set ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

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