Kuvia3D software is intended for the display and analysis of DICOM image data to facilitate 3D visualization of joint anatomy for planning surgical and non-surgical therapies.

Device Description

Kuvia3D is a software system used to display, analyze and generate three-dimensional visualizations of DICOM image data. The software is supported on an off-the-shelf personal computer system platform running the Microsoft Windows operating system. The user will transfer medical image data to the Kuvia3D system from a DICOM image system (such as a PACS) and proceed to use Kuvia3D's viewing and segmentation tools to segment the image data as desired. Once the user has completed segmenting the image data, they can convert the segmented region to a 3D rendered surface and adjust the view of the segmented anatomy as desired. Linear measurements may be taken in the 2D image as well as the 3D surface rendering. Screen captures of the 3D surface rendering window mav be saved as derivative images and appended to the imaging study, or transferred to other DICOM image systems.

AI/ML Overview

Based on the provided text, the Kuvia3D device is a software system for displaying and analyzing DICOM image data to facilitate 3D visualization of joint anatomy. The document is a 510(k) premarket notification for substantial equivalence, not a detailed study report with specific performance metrics against pre-defined acceptance criteria. Therefore, the information typically found in a clinical study report (e.g., specific sensitivity/specificity, reader study details) is not present.

However, I can extract the information related to the approach to acceptance criteria and the type of testing conducted to demonstrate substantial equivalence, based on the provided text.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document frames "acceptance criteria" in terms of compliance with standards and demonstration of substantial equivalence to predicate devices, rather than specific quantitative performance metrics. While specific performance numbers are not given, the device "meets" its acceptance criteria by demonstrating this equivalence and compliance.

Acceptance Criteria Focus	Reported Device Performance
Compliance with voluntary DICOM and JPEG standards for device performance.	Kuvia3D complies with the voluntary DICOM and JPEG standards for device performance.
Design and manufacturing according to engineering quality processes and standards.	Kuvia3D is designed and manufactured according to engineering quality processes and standards as detailed in the 510(k) submission.
Validation that Kuvia3D conforms to defined product, user requirements, and intended uses.	Verification activities were conducted on system, unit, and software component levels to validate that Kuvia3D conforms to defined product and user requirements and intended uses. Predefined acceptance criteria were met.
Demonstration of safety and effectiveness as the predicate devices.	Nonclinical software testing was conducted under simulated use conditions. Predefined acceptance criteria were met and demonstrate that the device is as safe and effective as the predicate devices. Kuvia3D is substantially equivalent to the predicate device in terms of intended use, specific features/functionality, and design. The color-coded display of anatomical feature size, similar to a reference device, does not raise any new questions of safety or effectiveness. The 510(k) Pre-Market Notification contains adequate information and data to determine that Kuvia3D is as safe and effective as the legally marketed predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified. The document mentions "nonclinical software testing" and "simulated use conditions" but does not provide a number of cases or datasets used.
Data Provenance: Not specified. The text focuses on the software itself and its compliance, not on a dataset of patient images. It refers to "DICOM image data" which is a generic format.

3. 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)

Not applicable. The document describes software verification and validation, not a study involving human reader performance comparisons or ground truth established by experts on a specific image set. It states: "A physician, providing ample opportunity for competent human intervention, reviews images, generates/corrects segmentations as necessary and reviews information generated by Kuvia3D." This refers to the clinical use case, not the V&V testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication method is described for generating ground truth for a test set, as this type of study was not performed or detailed in the document.

5. 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

No MRMC study was done or reported. The document describes a "stand-alone software package" and its substantial equivalence to predicate devices based on its features and compliance with standards, not its comparative effectiveness with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the testing described appears to be primarily standalone software testing: "Nonclinical software testing was conducted under simulated use conditions." This implies testing the algorithm's functionality and compliance as a standalone system. The document states, "Kuvia3D is a stand-alone software package."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly describe "ground truth" in the context of a diagnostic performance study. The testing focused on validating that the software conforms to defined requirements and standards. For features like segmentation accuracy or measurement accuracy, the "ground truth" would likely be based on:

Engineering specifications.
Comparison against known correct outputs for simulated data or previously validated methods.
"The basic information on which the coding is based does not change. Digital data displayed and thicknesses rendered via color coding do not raise new questions of safety and effectiveness since the underlying algorithms and libraries used to generate the segmentations are the same for each." This rather vaguely suggests that the validity of the underlying data and algorithms for segmentation is assumed.

8. The sample size for the training set

Not applicable. This is a 510(k) for a software system, not a machine learning algorithm that requires a training set in the conventional sense. The "development" and "training" for such software refer to its engineering and coding according to specified requirements and standards.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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

4QImaging, LLC Dba Qmetrics Technologies % Mr. Edward Schreyer CEO 1250 Pittsford-Victor Road Suite 110, Bldg. 200 PITTSFORD NY 14534

Re: K161559

Trade/Device Name: Kuvia3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 2, 2016 Received: June 6, 2016

Dear Mr. Schreyer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

June 23, 2016

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161559

Device Name Kuvia3D

Indications for Use (Describe)

Kuvia3D software is intended for the display and analysis of DICOM image data to facilitate 3D visualization of joint anatomy for planning surgical and non-surgical therapies.

Type of Use (Select one or both, as applicable)

Residential Use (Part 91, SFB 901, Subject Property)
On-Site Commercial Use (SFB 901, Subject Property)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Qmetrics Technologies. The logo consists of a red sun-like graphic on the left, followed by the word "Qmetrics" in red and black. Below "Qmetrics" is the word "TECHNOLOGIES" in gray.

Summary of Safety and Effectiveness

Device Name:	Kuvia3D
Date Prepared:	May 24, 2016
Submitter:	Qmetrics Technologies1250 Pittsford-Victor Rd.Suite 110, Bldg. 200Pittsford, NY 14534
Contact:	Edward SchreyerEdward.schreyer@qmetricstech.comPhone: +1 585 301-4300 x141Fax: +1 585 270-4686

Device Classification:

Trade Name	Kuvia3D®
Common Name	Picture Archiving and Communications System (PACS)
Device Classification Name	System, Image Processing, Radiological
Device Class	Class II
Regulation	892.2050
Product Code	LLZ
Classification Panel	Radiology

Predicate/Reference Devices:

	Predicate Device	Reference Device	Reference Device
Trade Name	3D-DOCTOR	ClearCanvasRIS/PACS	RTVue XR
Device Class	Class II	Class II	Class II
Common Name	System, ImageProcessing,Radiological	System, ImageProcessing,Radiological	Optical CoherenceTomography (OCT)
510(k)Submitter/Holder	Able Software5 Appletree Lane	ClearCanvas, Inc.439 University	Optovue, Inc.45531 Northport

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Image /page/4/Picture/0 description: The image is a logo for Qmetrics Technologies. The logo has a red graphic on the left side that looks like a sun with rays coming out of it. To the right of the graphic is the word "Qmetrics" in red and black lettering. Below the word "Qmetrics" is the word "TECHNOLOGIES" in smaller, gray lettering.

	Lexington, MA02420-2406	Ave., Suite 1920Toronto, ON M5G1Y8	Loop WestFremont, CA 94538
510(k) Number	K003746	K110332	K120238
Regulation Number	21 CFR 892.2050	892.2050	21 CFR 886.1570
Product Code	90 LLZ	90 LLZ	HLI
Classification Panel	Radiology	Radiology	Opthalmic

Intended Use:

Kuvia3D software is intended for the display and analysis of DICOM image data to facilitate 3D visualization of joint anatomy for planning surgical and non-surgical therapies.

Kuvia3D is indicated for Prescription Use only.

Device Description:

Major Functions performed by Kuvia3D:

. Exchange of medical image data in DICOM standard format between the Kuvia3D system and DICOM-compatible imaging systems, such as MRI or CT scanners or PACS systems.
Storage of image data
Exchange of DICOM image data with other Kuvia3D systems
. Multi-planar image display, including 3D rendering display
Segmentation of image data, including editing of object boundaries.

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Image /page/5/Picture/0 description: The image shows the logo for Qmetrics Technologies. The logo has a red graphic on the left side that looks like a sun with rays coming out of it. To the right of the graphic is the word "Qmetrics" in black font, with the "Q" in red. Below the word "Qmetrics" is the word "TECHNOLOGIES" in a smaller, gray font.

. Analysis of image data, including linear length.
. 3D display of adult articular knee cartilage as segmented, color-coded by thickness.

Technical Characteristics:

Kuvia3D is a stand-alone software package used on general-purpose hardware meeting the minimum requirements specified in the labeling/documentation. It is based upon standard Microsoft™ technology. Use of Kuvia3D does not involve patient contact, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, reviews images, generates/corrects segmentations as necessary and reviews information generated by Kuvia3D. The intended use and general technological characteristics of Kuvia3D are the same as those of the predicate device; a reference device has been included to demonstrate that certain technical characteristics absent from the predicate but present in Kuvia3D are common with a more recently cleared device in the product code LLZ.

Feature	Kuvia3D(SubjectDevice)	3D-Doctor(PredicateDevice)	ClearCanvas(ReferenceDevice)	RTVue XR(ReferenceDevice)
Intended Use
Storage and exchange of DICOMmedical images	Yes	No	Yes	No
Display and analysis of images	Yes	Yes	Yes	Yes
3D rendering and display ofimages	Yes	Yes	No	Yes
Specific Functionality
Query/import/send/receive imagedata per DICOM file transferstandards	Yes	No	Yes	No
Store image data locally	Yes	Yes	Yes	Yes
Feature	Kuvia3D(SubjectDevice)	3D-Doctor(PredicateDevice)	ClearCanvas(ReferenceDevice)	RTVue XR(ReferenceDevice)
Features to search, display andselect image data based onDICOM header tag information	Yes	No	Yes	No
Display 2D image data, includingmulti-planar views	Yes	Yes	Yes	No
Display 3D image data	Yes	Yes	No	Yes
Adjust display of image data,including zoom/scale,window/level.	Yes	Yes	Yes	Yes
Segment selected regions ofinterest	Yes	Yes	No	No
Analyze/measure images	Yes	Yes	Yes	Yes
Convert segmented regions to a3D surface-rendered display	Yes	Yes	No	Yes
Manipulate display of 3D objects(rotate, zoom, etc)	Yes	Yes	No	Yes
Color-coded thickness display ofanatomy	Yes	No	No	Yes
Design
Supported on standard, off-the-shelf Windows platform	Yes	Yes	Yes	No
Conforms to DICOM standard fordata exchange	Yes	No	Yes	No
Conforms to JPEG standard forlossless compress of digitalmedical images	Yes	No	Yes	No
System comprised of client andserver software components	Yes	No	Yes	No

The following table illustrates the comparison of specific features and functionality of Kuvia3D to the predicate devices, demonstrating substantial equivalence.

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Image /page/6/Picture/0 description: The image shows the logo for Qmetrics Technologies. The logo features a red graphic on the left that resembles a rising sun or a series of lines radiating outward. To the right of the graphic is the word "Qmetrics" in black, with the "Q" in red. Below "Qmetrics" is the word "TECHNOLOGIES" in a smaller, gray font.

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Image /page/7/Picture/0 description: The image shows the logo for Qmetrics. The logo consists of a red graphic on the left, resembling a sunrise or a series of radiating lines. To the right of the graphic is the word "Qmetrics" in bold, with the "Q" in red and the rest of the word in black. Below "Qmetrics" is the word "TECHNOLOGIES" in smaller, gray letters.

Color Coding of anatomical thickness measurements:

The color coding of cartilage thickness is equivalent to the color coding and thickness map display of corneal and ganglion cell complex structures provided by the reference device RTVue XR (K120238).

Color coding the thickness of anatomical features has also been demonstrated for more than a decade with results published in the open literature (e.g. for measuring bladder wall thickness and corneal thickness). Color coding merely provides a simplified means of rapidly assessing differences in thickness (as opposed to moving a cursor over parts of interest and reading thickness data displayed on a screen). The basic information on which the coding is based does not change. Digital data displayed and thicknesses rendered via color coding do not raise new questions of safety and effectiveness since the underlying algorithms and libraries used to generate the segmentations are the same for each.

Testing:

Kuvia3D complies with the voluntary DICOM and JPEG standards for device performance and is designed and manufactured according to engineering quality processes and standards as detailed in the 510(k) submission. Verification activities were conducted on system, unit and software component levels to validate that Kuvia3D conforms to defined product and user requirements and intended uses. Nonclinical software testing was conducted under simulated use conditions. Predefined acceptance criteria were met and demonstrate that the device is as safe and effective as the predicate devices.

Substantial Equivalence Conclusion:

Kuvia3D is substantially equivalent to the predicate device as listed in terms of intended use, specific features/functionality, and design. Color-coded display of anatomical feature size is also a feature found in reference device RTVue XR (K120238). The thickness values are presented to the user as a color-coded display, a feature similar to the predicate. This and any other difference between Kuvia3D and the predicate device do not raise any new questions of safety or effectiveness.

Conclusion:

The 510(k) Pre-Market Notification for Kuvia3D contains adequate information and data to determine that Kuvia3D is as safe and effective as the legally marketed predicate device.

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).