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The Planmeca Dixi is a Digital Intraoral X-ray Imaging System, which is an accessory to Intraoral X-ray devices, i.e. extraoral source x-ray systems with intraoral image receptors. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The Dixi is using intraoral x-ray sensor technique, with images displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.

The Planmeca Dixi is a Digital Intraoral X-ray Imaging System, which is an accessory to Intraoral X-ray devices, i.e. extraoral source x-ray systems with intraoral image receptors. The Dixi is using intraoral x-ray sensor technique, with images displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.

I am sorry, but the provided text from the FDA letter and the "Indications for Use" enclosure from Planmeca OY, while related to regulatory approval for a dental X-ray system, does not contain the specific information required to answer your request regarding acceptance criteria and a detailed study proving device performance.

The documents focus on:

• The FDA's decision of substantial equivalence for the Planmeca Dixi system to a predicate device.
• The general regulatory class and applicable regulations.
• The intended use of the device for dental radiographic examination and diagnosis.

There is no mention of:

• Specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Details of a study conducted to prove the device meets such criteria.
• Sample sizes, data provenance, expert qualifications, or ground truth methodologies for any performance study.
• Information about MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot generate the table or provide the detailed answers to your numbered points based on the provided text.

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