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K Number
K980581
Device Name
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
Manufacturer
PLANMECA OY
Date Cleared
1998-04-17

(59 days)

Product Code
EHD
Regulation Number
872.1800
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

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.

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.