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The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The ViewPoint is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:

• Intra-cranial surgical procedures involving space occupying lesions or malformations . (including soft tissue, vascular and osseous)
• Spinal surgical procedures involving spinal stabilization, neural decompression, or . resection of spinal neoplasms.
• ENT procedures. .
• Orthopedic surgical procedures. .

The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

This looks like a 510(k) clearance letter for a medical device called "ViewPoint ENT/Orthopedic Option," not a study or a technical report with detailed acceptance criteria and performance data.

The provided text does not include the specific details required to complete your request, such as a table of acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document primarily states:

• Intended Use: "to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures."
• Indications for Use: Intra-cranial, spinal, ENT, and orthopedic surgical procedures where stereotactic surgery is suitable and a rigid anatomical reference exists.
• Regulatory Clearance: The device was found substantially equivalent to pre-amendment devices under a 510(k) submission. This is a regulatory pathway for market approval, not a detailed scientific study report.

Therefore, based only on the provided text, I cannot fill in the requested table and answer the study-related questions. The 510(k) summary and clearance letter typically do not contain this level of detail about specific performance studies and their methodology. These details would usually be found in a separate study report or the full 510(k) submission if it were publicly available and contained such performance data.

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