RadioVision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images.

Device Description

RadioVision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images. Records are stored in a SQL database, searchable by any of the database table column names. The database stores basic patient information and digital image data without compression. Basic image enhancement information is also stored to the database so that the images can be re-displayed at a later time with enhancements applied, without altering the original image data. Images may be assembled into layouts which can be customized as required. RadioVision includes standard enhancements such as brightness, contrast, sharpening and false color. Additional advanced controls are also available such as histogram equalization and the CrystalView and Highlight filters. RadioVision includes an automatic backup feature that allows the database to be backed up once each day at a specific time, and will create time-stamped copies of the database so that one can return to a specific point in time. Radio Vision also includes the ability to restore a previously created database backup.

AI/ML Overview

The provided text describes a 510(k) Pre-market Notification for the RadioVision device, a Macintosh-based image management database system for dental use. However, it does not contain the detailed information required to answer all aspects of your request regarding acceptance criteria and the comprehensive study proving the device meets those criteria.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (VixWin Pro) and outlining basic safety and functionality. It lacks specific performance metrics, detailed study designs, sample sizes for test sets, expert qualifications, or comparative effectiveness results.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission states a "Hazard Analysis was performed...which led to the development of Software Requirement Specifications (SRS). The SRS was used to develop a Verification & Validation (V&V) plan executed through a series of Test Cases. The V&V testing was passed, demonstrating that RadioVision performs as indicated." However, the specific acceptance criteria (e.g., accuracy, speed, specific image quality metrics) and the quantitative results of these tests are not detailed.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document mentions "a series of Test Cases" for V&V, but there is no mention of a "test set" in the context of clinical or performance data with associated sample sizes or data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided. Without a defined test set for performance evaluation, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This type of study was not conducted or reported. The RadioVision device is an "image management database, or system," not an AI-assisted diagnostic tool. Its primary functions are image acquisition, archiving, display, enhancement, printing, emailing, and import/export. The document does not describe any AI capabilities or studies involving human readers and AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a software system for image management and enhancement, not a standalone diagnostic algorithm. Therefore, "standalone performance" in the context of diagnostic accuracy is not applicable or reported. The V&V testing would have assessed its functional performance (e.g., image display, enhancement application, data storage integrity) rather than diagnostic accuracy.

7. The Type of Ground Truth Used

Given the nature of the device (image management and enhancement), the "ground truth" for its V&V testing would likely relate to the correctness and integrity of its core functions:

Image fidelity: Ensuring that images are displayed, stored, and exported accurately without loss of information.
Enhancement correctness: Verifying that applied enhancements (brightness, contrast, sharpening, false color, histogram equalization, CrystalView, Highlight filters) function as intended and produce the expected visual changes without introducing artifacts.
Database integrity: Confirming that patient and image data is stored, retrieved, and backed up correctly.
System functionality: Ensuring features like email, print, import/export work as described.

However, the document does not explicitly state the type of "ground truth" used for its V&V, only that tests were passed. It would be based on functional verification rather than clinical outcomes or pathology.

8. The Sample Size for the Training Set

This information is not provided. As RadioVision is an image management system and not an AI/machine learning model for diagnostic interpretation, the concept of a "training set" in the context of algorithm development for clinical decision support is not applicable. Its development would involve software engineering and testing, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context you are asking about.

In summary, the provided 510(k) summary for RadioVision focuses on its intended use, device description, and comparison to a predicate device, primarily addressing software functionality and safety through a V&V process. It does not include the detailed performance study information, acceptance criteria, or ground truth methodologies typically associated with AI-powered diagnostic devices.

Summary

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510(k) SUMMARY

MAY - 5 2011

General Information

Submitted by:	Haas Software6233 Paso Los CerritosSan Jose, CA 95120Phone: (888) 245-5214
Contact Person:	Eric H Smith6233 Paso Los CerritosSan Jose, CA 95120Phone: (888) 245-5214Fax: (408) 378-5354
Date Prepared:	Dec 8, 2010

Device Information

Trade Name:	RadioVision
Common Name:	Picture archiving and communications system
Classification:	Class II
Classification Name:	System, Image Processing, Radiological
Reference:	21 CFR 892.2050

Predicate Device

Manufacturer: Gendex Dental Systems Product Name: VixWin Pro 510(k) No. K060178

Device Description

RadioVision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images.

Records are stored in a SQL database, searchable by any of the database table column names. The database stores basic patient information and digital image data without compression. Basic image enhancement information is also stored to the database so that the images can be

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re-displayed at a later time with enhancements applied, without altering the original image data. Images may be assembled into layouts which can be customized as required.

RadioVision includes standard enhancements such as brightness, contrast, sharpening and false color. Additional advanced controls are also available such as histogram equalization and the CrystalView and Highlight filters.

RadioVision includes an automatic backup feature that allows the database to be backed up once each day at a specific time, and will create time-stamped copies of the database so that one can return to a specific point in time. Radio Vision also includes the ability to restore a previously created database backup.

Intended Use

Radio Vision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images.

Safety Information, comparison to predicate device

A Hazard Analysis was performed for RadioVision, which led to the development of Software Requirement Specifications (SRS). The SRS was used to develop a Verification & Validation (V&V) plan executed through a series of Test Cases. The V&V testing was passed, demonstrating that RadioVision performs as indicated.

	Pre-Market Notification	Predicate Device
	Haas SoftwareRadioVision	VixWin Pro
General Information
510(k) Number	Not yet assigned	K060178
Regulatory Classification	Class II
Features
Implementation	Software Only	Software Only
Host Platform	Mac OS	PC
USB Support	YES	YES
X-Ray Sensor Capture	YES	YES
Enhance Images	YES	YES
Store and Recall Image	YES	YES
Intra-Oral camera capture	YES	YES

Conclusion

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The information contained in this Pre-market Notification is sufficient to demonstrate that RadioVision functions as described, and is substantially equivalent to the VixWin Pro software manufactured by Gendex Dental Systems.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a clear, sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002

Haas Software % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

MAY - 5 2011

Re: K111102

Trade/Device Name: RadioVision Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 12, 2011 Received: April 20, 2011

Dear Mr. Devine:

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 enclosedly 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 provisions of the Pederal Food, Drug,
You may, therefore, market the designed of a premarket approval application (PM 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 misting 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 including, but must
CFR Part 807); lebeling (21 CFR D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting (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 5100k) remarket 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,

Mary Patel

Mary S. Pastel, Sc.D. 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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1. Indications for Use Statement

Indications for Use Form

510(k) Number (if known):

Device Name: RadioVision

Indications for Use:

RadioVision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images.

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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Platt

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111102

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Regulation Number and Section

§ 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).