The Minray dental x-ray system is intended to be used for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intraoral digital or film image receptor media.

The Minray dental x-ray system is indicated for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intra oral film or digital image receptor media.

Device Description

Minray is an extraoral source dental x-ray system, which produces dental images on intraoral digital or film image receptors. The x-ray generator operates on high frequency and has an DC output. There are two selectable anode voltages 60 kV and 70 kV. Anode current is constant 7 mA. Exposure time can be selected from 20 ms to 3.2 s.

AI/ML Overview

The provided text is a 510(k) summary for the Minray Dental X-ray System. It describes the device, its intended use, and states that "Verification and validation testing was successfully performed to confirm that Minrav corresponds with the intended use."

However, this document does not contain the detailed performance data, acceptance criteria, sample sizes, ground truth establishment methods, or information about expert involvement that your request asks for. The document is a regulatory submission summary, not a study report.

Therefore, I cannot fulfill your request with the information provided because:

Acceptance Criteria and Reported Device Performance: No specific acceptance criteria or quantitative performance metrics (like sensitivity, specificity, accuracy) are mentioned in the document. It only states that verification and validation were "successfully performed."
Sample Size and Data Provenance: No sample size for test sets or data provenance (country, retrospective/prospective) is provided.
Number and Qualifications of Experts: There is no mention of experts being used to establish ground truth.
Adjudication Method: No adjudication method is described.
MRMC Comparative Effectiveness Study: There is no indication of an MRMC study or an effect size for human readers.
Standalone Performance: While the device is an X-ray system, the document doesn't present an "algorithm only" standalone performance if AI were involved. It's a hardware device.
Type of Ground Truth: The document does not specify the type of ground truth used for any testing.
Training Set Sample Size and Ground Truth Establishment: No information on a training set or how its ground truth was established is provided, as this device is an X-ray generator, not an AI/ML algorithm.

To answer your questions, I would need a different type of document, such as a detailed study report or clinical trial results, which are not present in this 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image shows the word "SOREDEX" in a stylized font. To the left of the word is the date "APR 2 9 2004". The text is black and the background is white. The image appears to be a logo or heading from a document.

510(k) Summary

KO33755

Date November 27, 2003

Submitters Information

Soredex Instrumentarium Corporation Elimaenkatu 22 00510 Helsinki Finland Phone: +358 10 394820 Fax .: +358 9 7015261 Contact: Kai Lanér

Trade Name Minray

Common Name Dental X-ray System

Classification

Unit, X-ray, Extraoral with Timer / EHD

Predicate Device

We consider that Minray is substantially equivalent in design, composition and function with Heliodent DS (K960819).

Product Description

Intended Use

Performance data

Verification and validation testing was successfully performed to confirm that Minrav corresponds with the intended use.

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Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2004

Mr. Kai Lanér Soredex Instrumentarium Corporation Elimäenkatu 22 B, Helsinki P.O. Box 250 00031 Sordex FINLAND

Re: K033755 Trade/Device Name: Minray Dental X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II

Product Code: 90 EHD Dated: March 10, 2004 Received: March 12, 2004

Dear Mr. Lanér

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), You may, therefore, market 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, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K033755 510 (k) NUMBER :

MINRAY DEVICE NAME :

INDICATIONS FOR USE :

Prescription Use
(Per 21 CFR 801.109)

Daniel A. Lynn

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .

Regulation Number and Section

§ 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.