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Blackstone™ III° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) spondylolisthesis;
c) fracture:
d) spinal stenosis;
e) deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) tumor;
g) pseudarthrosis;
h) revision of previous surgery

The Plate Washer addition for the Blackstone™ III° Anterior Cervical Plating System is a titanium alloy (6AL-4V ELI, per ASTM F136) device which is a non-sterile, single use component. When used with the Blackstone™ III° Anterior Cervical Plating System a surgeon can build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space.

The given text describes a medical device, the "Blackstone™ III° Anterior Cervical Plating System Plate Washer (System Addition)," and its premarket notification to the FDA. However, the provided document does not contain any information regarding acceptance criteria, device performance metrics, or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K012184 and K974885) for the purpose of FDA clearance. It describes the device, its intended use, and indicates that it is substantially equivalent to existing devices through its nature, implying that similar performance would be expected.

Therefore, I cannot provide the requested information in a table format or answer the specific questions about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this data is entirely absent from the provided text.

The closest relevant information, regarding the basis of substantial equivalence, is stated in Section 1 of the provided text:

"The Plate Washer addition for the Blackstone™ III° Anterior Cervical Plating System by its very nature is substantially equivalent to the predicate devices listed below:
Blackstone™ III° Anterior Cervical Plating System (K012184)
Blackstone™ Anterior Cervical Plate System (K974885)
The FDA has cleared each of these devices, for anterior fixation to the cervical spine from C2 to C7."

This indicates that the device's equivalence is based on its similarity in design and intended use to already cleared devices, rather than a new study with specific performance criteria.

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