(190 days)
Indicated for acquisition, storage, display, and manipulation of Dental Images
Acquiring and handling of radiographs and color images
Viewing and manipulation for insurance claims adjudication
Viewing and manipulation for diagnostic purposes
Viewing for patient education and consultation including cosmetic imaging.
Intended uses in the dental industry include the following:
Acquiring and handling of radiographs and color images:
Viewing and manipulation for insurance claims adjudication
Viewing and manipulation for diagnostic purposes
Viewing for patient education and consultation including cosmetic imaging.
This document, K012439, describes the "DentalEye 2, Dental Image Management System," which is a dental image management system. This device is indicated for acquisition, storage, display, and manipulation of dental images for various purposes including diagnostic purposes. However, the provided text does not contain a study or data proving the device meets specific acceptance criteria in the way a clinical study would typically demonstrate. Instead, it relies on substantial equivalence to a predicate device and internal software testing.
Here's an analysis of the provided information, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a "reported device performance" in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) for diagnostic purposes. The acceptance criteria implied here are related to software functionality and conformity with internal protocols, not clinical performance metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functionality and validation | Performed according to internal company protocols. Test results support design intent. |
| Substantial Equivalence to predicate device | "DentalEye 2" Dental Image Management System is substantially equivalent to TAU TigerView, K955237, in all material respects. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "software testing and validation were done according to internal company protocols," but does not specify the type of data (dental images), the number of cases, or the origin (country, retrospective/prospective) of any test data used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Since the testing described is primarily software validation and not a clinical performance study, there's no mention of experts or ground truth establishment in this context.
4. Adjudication Method
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done or is not reported in this document. The submission focuses on substantial equivalence and software validation, not a comparison of human reader performance with and without AI assistance.
6. Standalone Performance
A standalone performance study (i.e., algorithm only without human-in-the-loop performance evaluation in a clinical context) was not done or is not reported. The device is an "Image Management System," implying human interaction is central to its intended use for diagnostic purposes. The testing described is software validation.
7. Type of Ground Truth Used
The type of ground truth is not mentioned. Given the nature of the device (image management) and the described testing (software validation), the "ground truth" for the software testing would likely be adherence to functional requirements and expected software behavior, not clinical diagnostic truth.
8. Sample Size for the Training Set
This information is not provided. The device seems to be a software system without an explicit "training set" in the machine learning sense. The "training" for the software would be its development and coding based on established specifications.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Again, the concept of a "training set" with established ground truth as in AI/ML is not applicable to the description of this device and its validation in the provided text. The "ground truth" for the software development would be its design specifications and functional requirements.
In summary, the provided document K012439 describes the "DentalEye 2" Dental Image Management System as substantially equivalent to a predicate device (TAU TigerView, K955237). The "study" proving the device meets acceptance criteria primarily refers to internal software testing and validation protocols. It does not contain information on clinical performance metrics, sample sizes of images (beyond general software testing), expert involvement in ground truth establishment, or any comparative effectiveness studies typically associated with AI-driven diagnostic devices.
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EXHIBIT 2
FEB 0 6 2002
Radco Data AB Anestagatan 29 SE-163 53 Spånga, SWEDEN Phone (011) 46 (0)8 5221 84 00 Fax (011) 46 (0) 73 920 84 10 Contact: Anders Berggren, President and CEO July 30, 2001
510(k) Summary of Safety and Effectiveness
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- Identification of the Device: Proprietary-Trade Name: "DentalEye 2" Dental Image Management System Classification Name: 90 LLZ Common/Usual Name: Dental Image Management System
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- Equivalent legally marketed device: This product is similar in design and identical in function to the TAU TigerView, K955237
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- Indications for Use (intended use): Indicated for acquisition, storage, display, and manipulation of Dental Images
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- Description of the device: Intended uses in the dental industry include the following:
Acquiring and handling of radiographs and color images:
Viewing and manipulation for insurance claims adjudication
Viewing and manipulation for diagnostic purposes
Viewing for patient education and consultation including cosmetic imaging. When used for diagnostic purposes, the patient population will be the general public, and the diseases/conditions that the device will be used to diagnose are: dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.
| Comparison Areas | TAU TigerView, K955237 | "DentalEye 2" Dental Image Management System |
|---|---|---|
| Indications for use | Indicated for acquisition, storage, display, and manipulation of Dental Images | SAME |
| Host platform | Standard PC platform with Windows NT | SAME, can also use Windows 95, 98, and 2000 |
| Video capture | Matrox Meteor II | Studio PCTV |
| Receive images from other systems | YES | SAME |
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- Safety and Effectiveness, comparison to predicate device:
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- Testing information and Conclusion
r ssting information and Ochelable: "
In all material respects, the "DentalEye 2" Dental Image Management System is In an material respocts, and Tiger View, K955237. Testing was performed substantially equirtations procedures. Software testing and validation were according to internal company protocols established before testing was conducted. done according to which by designated technical professionals before software I est results were results support the conclusion that actual device performance satisfies the design intent.
- Testing information and Conclusion
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three overlapping shapes that resemble an abstract caduceus or a bird in flight. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 6 2002
DentalEve AB % Mr. Daniel Kamm P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K012439
Trade/Device Name: DentalEye 2, Dental Image Management System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: December 11, 2001 Received: December 12, 2001
Dear Mr. Kamm:
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 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I Drice 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 If you don't the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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) , 101 questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on of relocution to promazive the Act may be obtained from the Division of Small Manufacturers, your responsibilities 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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j) Indications for Use
510(k) Number
5 ro(if) Names.
Acquiring and handling of dental radiographs and color images Viewing and manipulation for insurance claims adjudication. Viewing and manipulation for diagnostic purposes Viewing for patient education and consultation including cosmetic imaging.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻬﻢ ﻓﻲ ﺍﻟﻤﺮﺍﺟﻊ Prescription Use_
Over the Counter Use_ OR (Per 21 CFR 801.109)
David G. Leggott
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).