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The Pioneer Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Pioneer Anterior Cervical Plate System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

I am sorry. The provided text is a 510(k) summary for a medical device (Pioneer Anterior Cervical Plate System) and focuses on establishing substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've outlined for performance studies.

The document states: "Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence." This indicates that the approval was based on demonstrating similarity to an already approved device (PACP - K043066), rather than a de novo study with specific performance metrics and acceptance criteria.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information is typically found in submissions for novel devices or those with specific performance claims requiring clinical or bench testing beyond demonstrating substantial equivalence to a predicate.

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