(59 days)
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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Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 17 1998
Lars Moring Regulatory Affairs Manager Planmeca Ov Asentajankatu 6 FIN-00810 Helsinki FINLAND
Re:
Dixi, Digital Intraoral X-ray Imaging System Dated: February 5, 1998 Received: February 17, 1998 Regulatory class: II 21 CFR 892.1800/Procode: 90 EAD
Dear Mr. Moring:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, narket the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Feleral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PLANMECA OY
ENCLOSURE 12
February 5, 1998
Ref .: 510(k) Notification Extraoral source X-ray system Planmeca Dixi, Digital Intraoral X-ray Imaging System
p. 12-1
INDICATIONS FOR 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.
Lurs leef
(Signature)
Lars Moring/Regulatory Affairs Manager (Typed name/Title)
February 5, 1998 (Date)
(510(k) Number)
. .
Thomas J. Cilark
Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
§ 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.