FiatLux Visualize™ is a medical diagnosis software application that allows physicians, radiologists, medical technicians, nurses, and other trained medical professionals to select, review and analyze DICOM images acquired from CT and MR devices. It provides a suite of tools for 2D/3D reconstruction based on the input image dataset.

FiatLux Visualize™ software must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Mammographic and compressed images are not supported for viewing.

Device Description

FiatLux Visualize™ is a medical device software application that provides multidimensional visualization of CT and MR medical images. FiatLux Visualize allows the user to select and retrieve a patient series, display and view the images and data, interactively manipulate the images to visualize anatomy and pathology, and analyze the images using a set of tools. It reads DICOM CT and MR images transferred using removable media or Microsoft Windows networking.

AI/ML Overview

This 510(k) summary for the FiatLux Visualize™ device, a medical diagnosis software application for viewing and analyzing CT and MR images, does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics, rather than on detailed performance metrics from a specific study.

However, I can extract and infer some information based on the provided text.

Inferences and Missing Information:

The document explicitly states: "Software development for the FiatLux Visualize™ software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of medical device." This indicates that verification and validation activities were performed, which would typically involve testing against acceptance criteria, but the specific criteria and study details are not provided in this 510(k) summary.

Here's what can be extracted/inferred and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Equivalence:
- Ability to select patient series	Yes, device allows user to select and retrieve a patient series.
- Ability to display/view images and data	Yes, device displays and views images and data.
- Ability to interactively manipulate images (2D/3D reconstruction)	Yes, device allows interactive manipulation for anatomy/pathology visualization and provides a suite of tools for 2D/3D reconstruction.
- Ability to analyze images using a set of tools	Yes, device allows image analysis using a set of tools.
- DICOM CT and MR image compatibility	Reads DICOM CT and MR images.
- Image transfer via removable media or Microsoft Windows networking	Supports image transfer via removable media or Microsoft Windows networking.
Safety and Risk Mitigation:
- Adherence to software development processes	Follows documented processes for software design, verification, and validation testing.
- Risk assessment completed and identified risks controlled	Risk assessment completed; appropriate steps taken to control all identified risks.
Exclusions/Limitations:
- No support for Mammographic images	Mammographic images are not supported for viewing.
- No support for compressed images	Compressed images are not supported for viewing.

Important Note: The acceptance criteria listed are primarily inferred from the "Device Description" and "Substantially Equivalent Device Comparison" sections, which highlight the device's intended functionalities and operational scope. The document does not provide quantitative performance metrics (e.g., specific accuracy, speed, or measurement precision values) that would typically be associated with a detailed performance study.

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: The document does not indicate that an MRMC comparative effectiveness study was performed. The device is a viewer/analysis tool, and the submission focuses on its equivalence in functionality to existing products to aid human interpretation, rather than a quantifiable improvement in human reader performance with the AI.
Effect Size of Human Reader Improvement: Not applicable, as no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: The document does not describe a standalone performance study. The device is described as a "medical diagnosis software application" that "allows physicians, radiologists... to select, review and analyze DICOM images." It's an assistive tool for human interpretation, not an automated diagnostic algorithm acting independently. The text also states, "A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed."

7. Type of Ground Truth Used

Type of Ground Truth: Not specified. Given the nature of the device (image viewer and analysis tool), the "ground truth" for its verification and validation would likely be focused on the accuracy of its display, reconstruction, and measurement tools against known DICOM standards and image processing algorithms, rather than diagnostic outcomes.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is described as an "Image Processing System, Radiology" and a "medical diagnosis software application that provides multidimensional visualization of CT and MR medical images." It is a software tool for display and analysis, not an AI/Machine Learning algorithm that typically requires a distinct "training set" in the sense of learning from labeled data to make predictions. Its development would involve software engineering and testing, not AI model training.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as this is not an AI/ML device that uses a training set in the typical sense. Its "ground truth" for development would relate to accurate implementation of image processing algorithms and display functionalities.

Summary

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K08204)

5. 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is being submitted in accordance with 21CFR Part 807, Subpart E, Section 807.92.

Submitter's name and contact information

Quentin Dewolf, President and Chief Technology Officer FiatLux Imaging, Inc. 8430 - 154th Ave NE Redmond, WA 98052 Telephone: (425) 605-0902 Fax: (425) 605-4539 E-mail: Quentin.dewolf@fiatlux3d.com

AUG - 1 2008

Date prepared 30 June 2008

Trade Name, Common Name and Classification Trade Name: FiatLux Visualize™ Common Name: Image Processing System, Radiology Classification: Picture Archiving and Communications System, Class II

Substantially Equivalent Devices

FiatLux Imaging believes that FiatLux Visualize™ is substantially equivalent to other commercially available products, specifically:

avcan Workstation OsiriX (K063470) .
. BarcoView Voxar 3D (K060505)

Device Description

Intended Use:

FiatLux Visualize software must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient

510(k) Premarket Notification FiatLux Visualize™

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light conditions are consistent with the clinical applications. Mammographic and compressed images are not supported for viewing.

Substantially Equivalent Device Comparison

FiatLux Visualize™ and its substantially equivalent, commercially available devices allow for the media interchange and analysis of digital images acquired from CT and MR imaging devices. All devices support the DICOM protocol for reading images from the medical device data source.

Software

Software development for the FiatLux Visualize™ software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of medical device.

Technological Characteristics

FiatLux Visualize™ is software that is used with computer hardware to read, render and analyze diagnostic medical images in a user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed.

Conclusions

The FiatLux Visualize™ software has similar intended uses as the substantially equivalent devices and has very similar technological characteristics to those devices. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, FiatLux Visualize™ is substantially equivalent to the commercially available devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FaitLux Imaging, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

AUG - 1 2008

Re: K082041

Trade/Device Name: FiatLux Visualize™M Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 17, 2008 Received: July 18, 2008

Dear Mr. Job:

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 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.

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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 ed econic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliarry proge of the following numbers, based on the regulation number 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Beportio (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may copyrin 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html .

Sincerely vours.

Nancy 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): K082041

Device Name: FiatLux Visualize TM

Indications for Use:

Prescription Use X (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 Device Evaluation (ODE)

Lom M. Mhy
(Division Sign-Off)

Division of Reproductive, Abdominal an Radiological Devices 510(k) Number

510(k) Premarket Notification FiatLux Visualize TM

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).