The Digora for Windows 2.0 is a software device intended to using and managing dental x-ray images sent by Digora imaging plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses. The software can also innager other imaging devices such as larger size imaging plate scanners and intraoral video cameras.

Device Description

Digora for Windows 2.0 is a dental imaging, image processing and archiving software, mainly to be used with Soredex Digora scanner (K934949). With this software is is possible to scan intra oral images using the Digora scanner, perform functions like edge enhancement, 3D emboss, density and contrast manipulation, length and angulation measurement with the image. The software also archives the images in the database, from where images can be stored in image media like CD-rom's.

AI/ML Overview

The provided text describes a 510(k) submission for "Digora for Windows 2.0" dental imaging software. However, it does not contain detailed information regarding specific acceptance criteria, a comprehensive study design with sample sizes, expert qualifications, or ground truth establishment for performance evaluation.

The document focuses on establishing substantial equivalence to a predicate device ("RadWorks Medical Imaging Software") rather than presenting a detailed de novo performance study.

Based on the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance metrics (e.g., accuracy, sensitivity, specificity, F1-score) in a tabular format related to diagnostic image quality or clinical outcomes.

Instead, the acceptance criteria are implicitly tied to demonstrating safety and effectiveness and substantial equivalence to the predicate device. The performance is described in terms of its features and capabilities being "substantially equivalent" to the predicate, with the implication that these features contribute to improved diagnoses.

Acceptance Criteria (Implicit from Submission)	Reported Device Performance (Summary)
I. Safety and Effectiveness	Demonstrated through:
1. Software Verification & Validation	Procedures completed.
2. Clinical Tests	Conducted.
3. Laboratory Tests	Conducted.
4. Risk Management (IEC 601-1-4)	File and summary established.
Conclusion: Device is safe and effective when used as labeled.
II. Substantial Equivalence
1. Similar Design, Operational, and Functional Features to Predicate (RadWorks Medical Imaging Software)	"Digora for Windows 2.0" offers similar imaging procedures, but "much less and their complexity is much limited" compared to the general medical "RadWorks." Specifically, it handles scanning, manipulation (3D emboss, edge enhancement, density/contrast, length/angle measurement, zoom, color, rotate, positive/negative), image storage, video capture, external media support, and printing for dental images.

Detailed Study Information (Missing or Not Applicable)

The document alludes to "laboratory and clinical tests" but provides no details on the methodology, sample sizes, or specific results of these tests. This 510(k) summary is primarily focused on demonstrating substantial equivalence, which often relies on a comparison of features and intended use rather than a full-scale, de novo clinical performance study with detailed metrics.

Sample size used for the test set and the data provenance:
- N/A (Not provided). The document mentions "clinical tests" and "laboratory tests" but does not specify the sample size of images or patients used for performance evaluation, nor does it state the country of origin or whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A (Not provided). Ground truth establishment details are absent.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A (Not provided). Adjudication methods are not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A (Not provided). There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. This device is described as imaging software with processing capabilities, not explicitly as an AI diagnostic aid in the modern sense.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A (Not provided). No standalone performance metrics are discussed. The software is intended to allow a user to "process and examine the images in order to achieve improved diagnoses," implying human interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (Not provided). The method for establishing ground truth is not specified.
The sample size for the training set:
- N/A (Not provided). Training set information is not included, as the document doesn't detail the development or validation of machine learning algorithms requiring a distinct training phase.
How the ground truth for the training set was established:
- N/A (Not provided). As no training set is discussed, its ground truth establishment is also not detailed.

Summary

{0}------------------------------------------------

DEC 30 1998

510 (k) Summary Statement for the Digora for Windows Dental imaging Software

I General Information

Submitter:	Orion Corporation Soredex
	Nilsiänkatu 10-14
	00510, Helsinki
	Finland

Telephone: + 358-9-39371

Fax: + 358-9-7015261

Kai Lanér, V. P. Contact Person:

Summary Preparation Date: September 10, 1998

Names

Proprietary Name: Digora for Windows 2.0

Common or Usual Name: Dental imaging software

Proposed Classification Name: System, Digital image communications

III Substantial Equivalent Devices

Digora for Windows 2.0 is substantially equivalent to Radworks Medical Imaging Software (K962699)

IV Product Description

{1}------------------------------------------------

V Intended Use of the Device

The Digora for Windows 2.0 is a software intended to using and managing dental x-ray images sent by Digora imaging plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnosies. The software can also support other imaging devices such as larger size imaging plate scanners and intraoral video cameras.

VI Indications for Use/Rationale for Substantial Equivalence

"Digora for Windows 2.0" software is designed to carry out substantially equivalent imaging procedures as "RadWorks" software but the amount of them is much less and their complexity is much limited than with "Radworks". "RadWorks" is a general medical software which must be capable of satisfying the various needs of medical environment. "Digora for Windows 2.0" is a software used only with Soredex Digora scanners to scan, manipulate and archive the dental image.

VII Summary of technological characteristics

Digora for Windows 2.0 software is designed to

scan images with Digora scanner
import and export images
allow images to be manipulated
- 3D emboss
- edge enhancement
- length and angle measurement
- zooming
- density/contrast adjustment
- colour effects
- rotate images
- positive/negative image
store images in the database
support video capture and store
support external image media
printing of images, image sets and patient list
implant planning

VIII Safety and Effectiveness Information

Safety and effectiveness is demonstrated by:

laboratory and clinical tests
software verification, validation and certification procedures
risk management file and risk management summary (IEC 601-1-4)

All the above items and evaluations lead to the conclusion that Digora for Windows 2.0 is safe and effective when the device is used as labelled.

{2}------------------------------------------------

IX Conclusion

Digora for Windows 2.0 Dental imaging software is substantially equivalent to the predicate device RadWorks, Medical imaging software.

The device has similar design ,operational and functional features as the current marketed predicative device.

The device has been shown to be safe and effective when it is used as labelled.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three lines forming its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 30 1998

Kai Laner V.P. Orion Corporation Soredex P.O. Box 79 FIN-00511 Helsinki Finland

K983267

Re:

Digora for Windows 2.0 Dated: November 16, 1998 Received: November 19, 1998 Regulatory class: II 21 CFR 872.1800/Procode: 90 MUH

Dear Mr. Laner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. 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 (QS) 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 531 through 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 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"(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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

510 (k) NUMBER :

DEVICE NAME :

DIGORA FOR WINDOWS 2.0

INDICATIONS FOR USE :

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

12/29/95

Prescription Use	OR	Over-The-Counter-Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

12/29/95
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number	K983267
---------------	---------

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.