(55 days)
The Digora PCT or Digipod imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial, cephalometric and podiatric 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Digora PCT or Digipod device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Digora PCT or Digipod) |
|---|---|
| Dose required to produce equal pixel value of a known object (compared to predicate device Fuji FCR 9000HQ) | Substantially equal to Fuji FCR 9000HQ |
| Spatial Resolution (compared to predicate device Fuji FCR 9000HQ) | Substantially identical, specifically 4 - 5 lp/mm |
| Diagnostic Capability (compared to predicate device Fuji FCR 9000HQ) | Substantially equivalent diagnostic capability |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The study described is a comparison study against a predicate device, focusing on technical performance parameters rather than a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The evaluation primarily focuses on direct technical comparisons of objective metrics (dose, spatial resolution) and a general statement about diagnostic capability, rather than an assessment of diagnostic accuracy by human readers.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there is no indication of human expert review being part of the test set evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on direct technical comparisons between the device and its predicate, not on the improvement of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The "Performance data" section describes a comparison of the Digora PCT or Digipod directly against the predicate device (Fuji FCR 9000HQ) in terms of dose requirements and spatial resolution. This is an evaluation of the device's inherent technical capabilities, independent of human interpretation.
7. The Type of Ground Truth Used
The ground truth for the technical performance study appears to be objective physical measurements rather than clinical ground truth like pathology or outcomes data.
- For dose comparison, the ground truth was a "known object" and the "equal pixel value" it produced.
- For spatial resolution, the ground truth was the objective measure of line pairs per millimeter (lp/mm).
8. The Sample Size for the Training Set
The document does not mention a training set. The device described is an imaging plate reader, not an AI or machine learning algorithm that requires a training set. The "processing" mentioned refers to conventional image processing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/machine learning model.
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TABLE OF CONTENTS
MAR 27 2007
ದ
- 1 510(k) Summary
- 2 Substantial Equivalence Comparison Chart
- 3 Clinical performance (podiatric examinations)
- 3.1 Statement
- 3.2 Demo radiographs (on CD)
- 4 Labeling and description
- 4.1 Advertising material
- 4.2 User's Guide and Set-up Instructions
- 4.3 Device labels
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- Solid state x-ray imaging device report (In accordance with the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, August 6, 1999)
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- Risk Management File for Digora PCT type DXR-80 (In accordance with IEC 601-1-4)
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Image /page/1/Picture/0 description: The image shows the word "SOREDEX" in bold, black letters. To the left of the word is a black, geometric shape that resembles a stylized "T". The font of the word is sans-serif and slightly italicized, giving it a dynamic appearance. The overall design is simple and impactful, likely representing a brand logo.
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510(k) Summary
Date
January 25, 2007
Submitters Information
Soredex Palodex Group Oy Nahkelantie 160 FIN-04300 Finland Phone: +358 45 78822000 Fax .: +358 9 7015261 Contact: Kai Lanér
Trade Name Digora PCT or Digipod
Common Name Imaging plate reader
Classification Solid state x-ray imager
Predicate Device Fuji FCR 9000HQ
510(k): K951373
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.
Further image processing, display and achieving are carried out with an auxiliary software a PC and a display.
510(k) Digora PCT or Digipod
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Intended Use
The Digora PCT imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial, cephalometric and podiatric x-ray images stored in imaging plate recording media.
Technological Characteristics
The device is capable of reading 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 plxel bit depth is 16 bits.
Performance data
A comparison between Digora PCT or Digipod and Fuji FCR 9000HQ 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 substantially equal for both devices. Spatial resolution was found to be as well substantially identical i.e. 4 - 5 lp/mm.
Conclusion
Digora PCT or Digipod has found to have substantially equivalent physical performance as the predicate device Fuji FCR 9000HQ.
Digora PCT or Digipod is shown to be able to provide images of substantially equivalent diagnostic capability with Fuji FCR 9000HQ.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features an abstract design with blue lines, and the text is written in a clear, sans-serif font, also in blue.
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 Palodex Group Ov Nahkelantie 160 TUUSULA FIN-04300 FINLAND
AUG 2 3 2013
Re: K070304
Trade/Device Name: Digora PCT or Digipod Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH, EHD, and MQB Dated: January 25. 2007 Received: January 31, 2007
Dear Mr. Laner:
This letter corrects our substantially equivalent letter of March 27, 2007. 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 of
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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
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Indications for Use
510(k) Number (if known):
Device Name:
Digora PCT or Digipod
Indications For Use:
The Digora PCT or Digipod imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial, cephalometric and podiatric X-ray images stored in imaging plate recording media.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Szyrmer
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of
§ 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.