The Virtue software receives image data from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication, printing and quantification of images.

Device Description

The Diagnosoft Virtue is software that runs on Windows-based operating systems to view and analyze MR images of the heart in DICOM format.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Diagnosoft, Inc. Virtue device:

Based on the provided K111833 510(k) summary, the device Virtue is a software for viewing and analyzing MR images of the heart. The document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to predicate devices for its intended use as a "Picture archiving and communications system" that performs viewing, image manipulation, communication, printing, and quantification of images.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
The K111833 submission document does not explicitly state specific acceptance criteria in terms of diagnostic accuracy, sensitivity, specificity, or other performance metrics for the Virtue software. This is common for PACS-like devices where the focus is on functional equivalence and safety for image display and manipulation, rather than a diagnostic algorithm.	The document states: "Testing of the Virtue software has demonstrated that the device fulfills prospective defined performance criteria and that the device meets the user needs." However, no specific performance data or metrics are provided.

Study Information

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not provide any details about a test set, its sample size, or the provenance of any data used for testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The document does not mention any test set, experts, or ground truth establishment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not mention any test set or adjudication method.
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:
- A MRMC study was not conducted or reported. The Virtue device is described as software for viewing and analysis, not an AI-assisted diagnostic tool in the sense of providing an interpretation or assisting a reader in making a diagnosis beyond image manipulation and quantification.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This document does not describe a standalone performance study. The device is a "Picture archiving and communications system" designed for human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not describe the use of any ground truth, as no clinical performance study for diagnostic accuracy is detailed.
The sample size for the training set:
- The document does not mention any training set, as it's not describing an AI/machine learning model in the context of diagnostic assistance.
How the ground truth for the training set was established:
- The document does not mention a training set or ground truth establishment for it.

Summary of what the document focuses on:

The K111833 submission for Diagnosoft, Inc. Virtue is a "traditional 510(k)" for a Picture Archiving and Communications System (PACS) software. The evidence provided and accepted by the FDA for this type of device typically revolves around demonstrating "substantial equivalence" to existing legally marketed predicate devices in terms of:

Intended Use: The Virtue's intended use is broad, covering viewing, image manipulation, communication, printing, and quantification of images from CT or MRI.
Technological Characteristics: Its operational and fundamental characteristics are compared to predicate devices like the Philips Easy Vision Workstation and Harp 2.06.
Safety and Effectiveness: The conclusion is that "any differences do not affect the product's safety or effectiveness." This often relies on software verification and validation activities (V&V) to ensure functions work as designed, adhere to software engineering best practices, and don't introduce new risks, rather than a clinical performance study with diagnostic endpoints.

Therefore, for this specific device and submission type, the absence of detailed clinical study performance data, acceptance criteria, and ground truth information is expected as it falls under a different regulatory pathway than novel diagnostic AI algorithms.

Summary

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K111833

5. 510(K) SUMMARY

Diagnosoft, Inc. Virtue (per 21CFR 807.92)

SEP 2 1 2011

1. SUBMITTER/510(K) HOLDER

Diagnosoft, Inc. 6501 Weston Parkway Suite 125 Cary, NC 27513

Contact Person:	Firas BenAchour
Telephone:	919-677-8100
Fax:	919-882-1815

June 23, 2011 Date Prepared:

2. DEVICE NAME

Proprietary Name: Virtue Classification Name: Picture archiving and communications system

3. PREDICATE DEVICE

· Philips Easy Vision Workstation Release 6 marketed by Philips Medical Systems, K023137
· Harp 2.06 marketed by Diagnosoft, Inc., K100352

4. DEVICE DESCRIPTION

The Diagnosoft Virtue is software that runs on Windows-based operating systems to view and analyze MR images of the heart in DICOM format.

5. INTENDED USE

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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The characteristics of the Virtue are substantially equivalent to the following current legally marketed predicate devices based on intended use, typical clinical use, and operational and fundamental technological characteristics.

· Philips Easy Vision Workstation Release 6 marketed by Philips Medical Systems, K023137
· Harp 2.06 marketed by Diagnosoft, Inc., K100352

A detailed side-by-side comparison of the Virtue with the identified predicate device is provided in the substantial equivalence discussion in this premarket notification.

7. PERFORMANCE TESTING

Testing of the Virtue software has demonstrated that the device fulfills prospective defined performance criteria and that the device meets the user needs.

8. CONCLUSION

Based on the similarities in indication for use, design, functional, and operational features the Virtue has demonstrated substantial equivalence to the listed legally marketed predicate device and any differences do not affect the product's safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is a stylized representation, with three lines forming its body and wings.

Public Health Service

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

Diagnosoft, Inc. % Mr. Jeffrey Roberts Medical Device Consultants 40 Plain Street NORTH ATTLEBORO MA 02760

SEP 2 1 2011

Re: K111833

Trade/Device Name: Virtue Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: H Product Code: LLZ Dated: June 23, 2011 Received: June 28, 2011

Dear Mr. Roberts:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

ff 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 (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/ReportalProblem/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/cdrl/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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INDICATIONS FOR USE 4.

510(k) Number (if known): Not yet assigned

Device Name: Virtue

Indications for Use:

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devic Office of In Vitro Diagnostic Device Evaluation and

510K K111833

Diagnosoft, Inc. Virtue, Traditional 510(k)

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).