(29 days)
The Digora PCT imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial and cephalometric x-ray images stored in imaging plate recording media.
A digital radiography system for imaging plates located in cassettes. The system may be used with x-ray equipment utilizing film or similar cassettes. 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 photoelectronic 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 auxilia software (such as Digora for Windows K983267), a PC and a CRT.
The provided text describes the Digora PCT, an imaging plate reader, and its performance compared to a predicate device (Digora) and a conventional film-screen combination.
Here's the information extracted and organized to answer your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Digora PCT) |
|---|---|---|
| Physical Performance | ||
| Dose required | 1/4 of Digora PCT (This is inverse, meaning Digora PCT needed less dose for the same pixel value) | 4x less dose than Digora to produce an equal pixel value of a known object |
| Spatial Resolution | 6 lp/mm (Digora) | 4 lp/mm |
| Diagnostic Capability | Equivalent to Kodak T-Mat G film/Lanex Regular intensifying screens | Substantially equivalent to Kodak T-Mat G film/Lanex Regular intensifying screens for diagnostic capability |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of images or patients) used for either the physical performance comparison or the diagnostic capability comparison.
The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin. However, the submitter is "Soredex Instrumentarium Corporation Nilsiankatu 10 - 14 00510 Helsinki Finland," suggesting the testing may have been conducted in Finland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts used or their qualifications for establishing ground truth in the diagnostic capability study. It only states that a "comparison... was made to evaluate the ability of the device to provide images of equivalent diagnostic capability."
4. Adjudication Method for the Test Set
The adjudication method is not described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
The document does not explicitly mention a multi-reader multi-case (MRMC) comparative effectiveness study. It states a "comparison... was made to evaluate the ability of the device to provide images of equivalent diagnostic capability," which could imply a human reader study, but details about its design (MRMC) and effect size are absent.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
For the Digora PCT, this device is an imaging plate reader, which is a physical device that processes images. It does not appear to be an AI algorithm in the contemporary sense. Therefore, the concept of a standalone AI performance study (without human-in-the-loop) isn't directly applicable in this context. The performance described relates to the image acquisition and processing capabilities of the hardware.
7. The Type of Ground Truth Used
- Physical Performance: For dose and spatial resolution, the "ground truth" was established based on objective measurements against the predicate device (Digora). For dose, it was "pixel value of a known object." For spatial resolution, it was "lp/mm" (line pairs per millimeter).
- Diagnostic Capability: The ground truth for diagnostic capability was based on a comparison to the diagnostic capability of a "cleared film screen combination" (Kodak T-Mat G film/Lanex Regular intensifying screens). This implies that the accepted diagnostic performance of the film-screen combination served as the benchmark. The method by which this diagnostic capability was assessed (e.g., expert interpretation of images for specific pathologies) is not detailed.
8. The Sample Size for the Training Set
The document does not refer to a "training set" as this device is not an AI/ML algorithm that undergoes a distinct training phase. It is a physical device for image acquisition and processing.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, the concept of a "training set" and associated ground truth establishment does not apply. The device's performance is characterized through physical measurements and comparisons to established imaging technologies.
{0}------------------------------------------------
AUG 1 0 2001
Image /page/0/Picture/1 description: The image shows the word "SOREDEX" in a bold, sans-serif font. To the left of the word is a graphic consisting of two partial circles, one larger than the other, both filled in black. The text and graphic are all in black against a white background. The overall impression is a simple, clean logo or brand mark.
Image /page/0/Picture/2 description: The image shows handwritten text, likely from a document. The text at the top reads "K012170". Below this, the text "page 1 of 2" is written in cursive. The image appears to be a page number indicator from a multi-page document.
510(k) Summary
Date
July 10, 2001
Submitters Information
Soredex Instrumentarium Corporation Nilsiankatu 10 - 14 00510 Helsinki Finland Phone: +358 9 39371 Fax.: Kai Lanér Contact:
Trade Name
Digora PCT
Common Name Imaging plate reader
Classification
Solid state x-ray imager
Predicate Device
On physical performance: Digora 510(k): K934949 On diagnostic performance: Conventional film screen combination
Product Description
A digital radiography system for imaging plates located in cassettes. The system may be used with x-ray equipment utilizing film or similar cassettes. 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 photoelectronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.
{1}------------------------------------------------
K012170
Page 2 of 2
Further image processing, display and achieving are carried out with an auxilia software (such as Digora for Windows K983267), a PC and a CRT.
Intended Use
The Digora PCT imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial and cephalometric x-rav images stored in imaging plate recording media.
Technological Characteristics
The subject device represents a change to the predicate device in form of reading larger imaging plates such as 15 cm x 30 cm. 18 cm x 24 cm and 24 cm x 30 cm or 8 inch x 10 inch and 10 inch x 12 inch. The image pixel bit depth in the predicate device is 8 bits and correspondingly in the subject device 16 bits.
Performance data
A comparison between Digora PCT and Digora was made to evaluate the need of dose to produce equal pixel value of a known object and the spatial resolution. The dose required to for a certain pixel-value was a ¼ of that required for Digora. Spatial resolution for Digora PCT is 4 lp/mm, and 6 lp/mm for Digora. Digora PCT was found to be substantially equivalent to Digora.
A comparison between Digora PCT and Kodak T-Mat G film/Lanex Regular intensifying screens was made to evaluate the ability of the device to provide images of equivalent diagnostic capability to those of a cleared predicate device. Digora PCT was found to be substantially equivalent to a film screen combination.
Conclusion
Digora PCT has found to have substantially equivalent physical performance as the predicate device Digora.
Digora PCT is shown to be able to provide images of equivalent diagnostic capability to those of a cleared film screen combination.
Digora PCT is as safe and effective as the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in blue and is in a sans-serif font. The text is aligned to the left and is centered vertically. There is a logo to the left of the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Kai Laner Director Soredex Instrumentarium Corporation Nilsiankatu 10 - 14 HELSINKI FIN 00510 FINLAND
AUG 2 1 2013
Re: K012170
Trade/Device Name: Digora PCT (Imaging plate reader) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD, and MOB Dated: July 10, 2001 Received: July 12, 2001
Dear Mr. Laner:
This letter corrects our substantially equivalent letter of August 10, 2001.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
{3}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page 1 of 1
4012170 510 (k) NUMBER :
DEVICE NAME :
DIGORA PCT
INDICATIONS FOR USE :
The Digora PCT imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial and cephalometric x-ray images stored in imaging plate recording media.
Prescription Use
Nancy C. Brogdon
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K01217
§ 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.