(27 days)
VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.
VISTADENT™ AT COMPLETE software is designed for use as an imaging database for storage and organization of orthodontic patient digital images and x-ray records. Features include resizing, cropping, and rotating of images; data and image sharing with practice management systems and digital x-ray systems; cephalometric analysis with auto-tracing capability; and virtual treatment objectives. VISTADENT™ AT COMPLETE can operate as a stand-alone software or interface with other systems software.
This 510(k) submission for VISTADENT™ AT COMPLETE is a premarket notification for an imaging database software and does not contain information related to an AI/ML medical device performance study, acceptance criteria, or an MRMC comparative effectiveness study. The device is described as software for storing, organizing, manipulating, and analyzing orthodontic patient digital images and x-ray records, including cephalometric analysis with auto-tracing and virtual treatment objectives.
Therefore, I cannot provide the requested information from the provided text, as it does not include:
- Acceptance criteria and reported device performance: The submission focuses on substantial equivalence to predicate devices based on technological characteristics and intended use, not on specific performance metrics or acceptance criteria for an AI/ML component.
- Sample size and data provenance for a test set: No test set is described.
- Number and qualifications of experts for ground truth: No ground truth establishment process is mentioned for evaluation.
- Adjudication method for the test set: Not applicable as no test set is described.
- MRMC comparative effectiveness study: This type of study is not mentioned. The features described (auto-tracing, virtual treatment objectives) suggest potential AI/ML capabilities, but no study evaluating human reader improvement with AI assistance is presented.
- Standalone performance study: No standalone performance study for an algorithm is discussed.
- Type of ground truth used: Not applicable as no performance evaluation study is detailed.
- Sample size for the training set: No training set is mentioned.
- How ground truth for the training set was established: Not applicable as no training set is described.
The document is a 510(k) summary focusing on demonstrating substantial equivalence to predicate devices for a digital imaging database and analysis software, rather than reporting on the performance of a novel AI/ML algorithm against specific acceptance criteria.
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NOV 2 2 2005
K05301D
510(k) SUMMARY
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | October 21, 2005 |
| TRADE OR PROPRIETARY NAME: | VISTADENT™ AT COMPLETE |
| CLASSIFICATION NAME: | Extraoral source x-ray system, 872.1800 |
| PREDICATE DEVICES: | KODAK Orthodontic Imaging & OMS Imaging 8.0, K043104;EagleSoft ChairSide Software Application, K982422; |
Radco DentalEye 2 Dental Image Management System, K012439
DEVICE DESCRIPTION:
VISTADENT™ AT COMPLETE software is designed for use as an imaging database for storage and organization of orthodontic patient digital images and x-ray records. Features include resizing, cropping, and rotating of images; data and image sharing with practice management systems and digital x-ray systems; cephalometric analysis with auto-tracing capability; and virtual treatment objectives. VISTADENT™ AT COMPLETE can operate as a stand-alone software or interface with other systems software.
INTENDED USE:
VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.
TECHNOLOGICAL CHARACTERISTICS:
The VISTADENT™ AT COMPLETE storing, organizing, imaging, scanning, loading, tracing, analyzing, and networking functions are similar to other legally marketed orthodontic image systems. We believe that use of VISTADENT™ AT COMPLETE and the predicate devices, the similarities to the predicates, and the performance data support the safety and effectiveness of VISTADENT™ AT COMPLETE for the indicated uses.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape and features the department's emblem in the center. The emblem is a stylized representation of a bird or eagle, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2005
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street YORK PA 07405-0872
Re: K053010
Trade/Device Name: VISTADENT™ at Complete Regulatory Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: October 21, 2005 Received: October 26, 2005
Dear Ms. Lewis:
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 (Premarket Approval), it may be subject to such 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 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 CVR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation prumber at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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INDICATIONS FOR USE
510(K) Number (if known):
16 05 2010
VISTADENT™ AT COMPLETE Device Name:
Indications for Use:
VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
9
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel H. Legum
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053010
Premarket Notification
VISTADENT™ AT COMPLETE
§ 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).