(54 days)
The Digora Optime imaging system is indicated for capturing, digitization and The Digora Optime Images stored in imaging plate recording media.
A digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Spatial Resolution (Predicate Device: Digora) | 8 lp/mm |
| Spatial Resolution (Subject Device: Digora Optime) | 10 lp/mm |
| Dose required for a certain pixel-value (compared to Digora) | Equivalent |
| Bit Depth (Predicate Device: Digora) | 8 bits |
| Bit Depth (Subject Device: Digora Optime) | 14 bits |
| Ability to read imaging plates of sizes: 0, 1, 2, 3 intraoral films | Confirmed |
| Diagnostic capability (compared to Digora) | Equivalent or slightly better |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for a test set. It mentions a "comparison between a pixel-value of a known object and the spatial resolution," which suggests some form of testing, but details on the number of images or cases are absent.
The data provenance is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The statement about "diagnostic capability" implies some form of assessment, but the methodology is not detailed.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not mention an MRMC comparative effectiveness study. It states that "Digora Optime has also been shown to be able to provide images of equivalent or slightly better diagnostic capability to the predicate device Digora." However, it does not elaborate on the study design or report any effect size.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device described is an "imaging plate reader" that processes digital electronic signals and relies on "auxiliary software (such as Digora for Windows K983267), a PC" for further image processing, display, and archiving. While the device itself is a piece of hardware, the term "standalone" in the context of an algorithm or AI typically refers to the performance of the software processing. The document focuses on the technical performance of the imaging plate reader and its output quality, rather than the standalone performance of an AI algorithm in isolation. Therefore, a standalone algorithm-only performance study as typically understood in AI is not described. The performance described is of the entire system as an image acquisition and digitization device.
7. The Type of Ground Truth Used
The ground truth appears to be based on:
- Known object characteristics: For spatial resolution and pixel-value.
- Comparison to a predicate device's performance: For dose and diagnostic capability.
There is no mention of pathology, expert consensus, or outcomes data being explicitly used as ground truth.
8. The Sample Size for the Training Set
The document does not mention any "training set" or "training data" as
this is not an AI/ML device per se but a medical device for image acquisition.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned in the context of this device.
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KOH i 050
Image /page/0/Picture/1 description: The image shows the logo for Soredex. The logo consists of the word "SOREDEX" in a bold, italicized font. Above the word is a black, triangular shape with a curved top edge. A thin, vertical line connects the triangle to the top of the word "SOREDEX".
JUN 1 5 2004
510(k) Summary
Date April 19, 2004
Submitters Information
Soredex Instrumentarium Corporation Elimaenkatu 22 00510 Helsinki Finland Phone: Contact:
Trade Name Digora Optime (or Ontime)
Common Name Imaging plate reader
Classification
Solid state x-ray imager
Predicate Device Digora
510(k): K934949
Product Description
A digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.
Further image processing, display and achieving are carried out with an auxiliary software (such as Digora for Windows K983267), a PC.
510(k) Diaora Optime
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Intended Use
Intentied USC
The Digora Optime imaging system is indicated for capturing, digitization and The Digord Optime Images stored in imaging plate recording media.
Technological Characteristics
Technological onaracter.org to spability of reading imaging plates, which in size correspond to the number 0,1,2 and 3 intra oral films.
conespond to the number of , = sheate device is 8 bits and correspondingly in the subject device 14 bits.
Performance data
r errormanoc data A companion botwoon bigenalue of a known object and the spatial resolution. The dose required to for a certain pixel-value was equivalent of that required for Digora. Spatial resolution for Digora is 8 lp/mm, and 10 lp/mm for Digora Optime.
Conclusion
Digora Optime has found to have substantially equivalent physical performance as the predicate device Digora.
Digora Optime has also be shown to be able to provide images of equivalent or slightly better diagnostic capability to the predicate device Digora.
Digora Optime is as safe and effective as the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2004
Mr. Kai Lanér Director Soredex Instrumentarium Corporation Elimaenkatu 22 B Helsinki FINLAND
Re: K041050 Trade/Device Name: Digora Optime (or Digora Ontime) Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: 90 MQB Dated: April 19, 2004
Received: April 22, 2004
Dear Mr. Lanér:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endobard) vo vogany - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 continer & proct to may 20, 1973) in accordance with the provisions of the Federal Food, DNIg, devices that have been resulted to require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mantes of the Act include requirements for annual registration, listing of general controls provisions of tractice, 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 If your device is classinod (600 a0010) ads. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a Pr may be subject to save additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obancements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a device complies with other requirements of the Act that FDA has made a decemination may Juinistered by other Federal agencies. You must comply of ally I edelal statures and regalanced as but not limited to: registration and listing (21 CFR Part with an the Ace 3 requirements, mere and manufacturing practice requirements as set forth in the 807), laboling (21 OF R Far 807), govern 820); and if applicable, the electronic product quality Systems (QD) regalation (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) I ms letter will anow you to ocgin manieting your device of your device to a legally premarket notification. The I DA micing of basification 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 If you desire specific advice for your device 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 Additionally, for questions on the prosses note the regulation entitled, "Misbranding Other of Compinance at (201) 37 . or (21CFR Part 807.97) you may obtain. Other general by relerence to premation (21 the Act may be obtained from the Division of Small mormation on your responsionities and creation at its toll-free number (800) 638-2041 or Manufacturers, International and Golless http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Bugden
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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Page 1 of 1
510 (k) NUMBER : K041050
DEVICE NAME :
DIGORA OPTIME (or DIGORA ONTIME)
INDICATIONS FOR USE :
The Digora Optime imaging system is indicated for capturing, digitization The Digora Optime Imaging System is inalities in imaging plate recording media.
Daniel L. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041050
Prescription Use
§ 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.