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The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

The PaX-REVE3D is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce panoramic, cephalometric and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The device is operated and used by physicians, dentists, and x-ray technologists.

The provided document pertains to a 510(k) premarket notification for the PaX-Reve3D, a Computed Tomography X-Ray System for dental use. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) studies.

The document primarily focuses on:

• Device Identification: Name (PaX-Reve3D), common name, classification, and predicate devices.
• Description: General overview, product features including input conditions, capture modes (Panoramic, Cephalometric, CT), and X-ray generator specifications.
• Intended Use/Indications for Use: Diagnostic imaging for dental examination and diagnosis of diseases of teeth, jaw, and oral structure.
• Comparison to Predicate Devices: Stating substantial equivalence based on intended use, form factor, material, performance, and safety.
• Safety, EMC, and Performance Data: General statement that testing according to relevant EN/IEC standards was performed and results were satisfactory. This is a very high-level statement and does not provide detailed acceptance criteria or study results.
• Conclusion: Claim of safety, effectiveness, and substantial equivalence.
• FDA Clearance Letter: Official communication from the FDA clearing the device for market.

Therefore, based solely on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance study details.

The document only states that "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, EN/IEC 60601-2-32 and EN/IEC 60601-1-44 was performed, and EMC testing was conducted in accordance with a standard EN/IEC 60601-1-2. All test results were satisfactory." This is not specific enough to extract acceptance criteria or performance metrics for image quality or clinical efficacy studies.

To answer your request, detailed performance report documents, which are typically referenced in a 510(k) but not always fully included in the publicly available summary, would be needed.

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