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The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spondylolisthesis, 3) trauma (including fractures), 4) Spinal Stenosis, 5) tumors, 6) deformity (defined as kyphosis, lordosis, or scoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions.

The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior cervical intervertebral body screw fixation from C2 to T1. Rigid fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. Implant components consist of a variety of shapes and sizes of plates, bone screws and associated instruments. Locking caps are pre- assembled to the plates. They cover the heads of the bone screws to reduce the potential for screw back-out. With this locking mechanism, implant components can be rigidly locked into many different configurations to suit the individual pathology and anatomical conditions of the mature patient. They are made of titanium alloy (Ti-6AI-4V ELI) per ASTM F136. Implants must not be used with the components from any other system or manufacturer in a construct.

This FDA document is a 510(k) clearance letter for a medical device called the "4CIS® Pinehurst Anterior Cervical Plate System". It addresses the regulatory approval of the device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. The "Performance Data" section (page 4) mentions mechanical testing according to ASTM F1717 but does not provide details on specific acceptance criteria or results. It explicitly states that "Above non-clinical performance data in the form of a comprehensive literature review was provided".

Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from this document. The provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance (as it's not an AI/ML study).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about standalone (algorithm-only) performance.
7. The type of ground truth used (other than mechanical testing standards).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is for a physical orthopedic implant, not a software device, and thus the requested AI/ML specific information is not relevant or present.

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