Cedara WebAccess 2.4 is a software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.

Cedara WebAccess 2.4 is capable of being configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

Cedara WebAccess 2.4 provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

With no application-specific installation required on the user's computer, qualified medical professionals can use Cedara WebAccess 2.4 with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Imaging Series and file attachments.

Cedara WebAccess 2.4 was designed with an easy and convenient workflow providing image viewing tools including zoom, pan, contrast, series/layout change, toggle on/off image text, MPR, CINE, reset and measurement.

The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.

AI/ML Overview

The provided document is a 510(k) summary for Cedara WebAccess 2.4. It discusses the device description, indications for use, comparison to predicate devices, and a summary of testing. However, it does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report.

The "Summary of Testing" section (page 3) generally states:
"Nonclinical verification and validation test results established that the device meets its design requirements and intended use, and that it is as safe, as effective, and performs as well as the predicate devices and that no new issues of safety and effectiveness were raised. The results also demonstrated that the device complies with industry standards for medical data: the NEMA DICOM 3.0 standard for Digital Imaging and Communications in Medicine, the JPEG standard ISO/IEC 10918-1 for the Digital Compression and Coding of Continuous-Tone Still Images, and the ISO/IEC 15948 standard for Portable Networks Graphics (PNG)."

This statement indicates that verification and validation testing was performed to demonstrate compliance with design requirements, intended use, and industry standards, and to establish substantial equivalence to predicate devices. However, it does not provide specific quantitative acceptance criteria or detailed results of a study that would typically be used to "prove" meeting those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Therefore, based only on the provided document, I cannot fill out the requested table and information about acceptance criteria and a specific study proving device performance in the way you've outlined for a typical diagnostic AI device. The document describes a general medical image processing software (PACS-like) rather than a diagnostic AI algorithm. Its "performance" is more related to its functionality, interoperability, and safe display of images rather than diagnostic accuracy.

Here's what I can extract and what is missing, based on your request and the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional/Technical Requirements:	Device "meets its design requirements and intended use"
Compliance with industry standards:	Device "complies with industry standards for medical data: the NEMA DICOM 3.0 standard... the JPEG standard ISO/IEC 10918-1... and the ISO/IEC 15948 standard for Portable Networks Graphics (PNG)."
Substantial Equivalence to Predicate Devices:	Device "is as safe, as effective, and performs as well as the predicate devices and that no new issues of safety and effectiveness were raised."
Lossless/Lossy Compression Capability:	"capable of being configured to provide either lossless or lossy compressed images for display."
Display Monitor Requirements (for diagnostic use):	"Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements..."
Mammographic Image Interpretation:	"Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution..."
No Diagnostic Interpretation:	"does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user."
Safety & Effectiveness (general):	"no new issues of safety and effectiveness were raised."

Missing Information based on the prompt (as it pertains to a diagnostic AI algorithm):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned. The testing focused on functional verification and validation, not diagnostic accuracy on a clinical test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic test set with ground truth in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is an image viewer, not an AI diagnostic aid.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a viewing interface, not a standalone algorithm with diagnostic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no diagnostic ground truth established for performance evaluation of the device itself. The device facilitates viewing images where a human establishes the ground truth (diagnosis).
The sample size for the training set: Not applicable. This is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

In conclusion, the document describes the functional and technical compliance of an image viewing software (PACS) with industry standards and its substantial equivalence to predicate devices, rather than presenting a performance study for a diagnostic AI algorithm with specific clinical acceptance criteria like sensitivity or specificity.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for Merge Healthcare. The logo consists of the word "MERGE" in large, bold, sans-serif font, with a trademark symbol next to the "E". Below the word "MERGE" is the word "Healthcare" in a smaller, sans-serif font. The text is black against a white background.

510(k) SUMMARY

Submitter:	Merge OEM, a division of Merge Healthcare6303 Airport Road, Suite 500Mississauga, OntarioCanada L4V 1R8	JUN 2 3 2010
Contact:	Carol NakagawaDirector, Quality and Regulatory AffairsTel: 905.364.8000Fax: 905.364.8100
Date:	June 21, 2010
Trade Names:	Cedara WebAccess™ Model 2.4
Common Name:	Medical image processing software
Classification Name:	Picture Archiving and Communications System (PACS)
Product Code:	LLZ
Device Class:	Class II
Regulation No.:	21 CFR §892.2050

Predicate Devices:

Trade Name	510(k) Submitter/Manufacturer	510(k) Number
Cedara I-SoftView	Cedara Software Corp.	K022881
WebPax	Heart Imaging Technologies, LLC	K051325

Device Description:

Cedara WebAccess 2.4 provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Merge Healthcare. The word "MERGE" is in large, bold, sans-serif font, with a trademark symbol in the upper right corner. Below the word "MERGE" is the word "Healthcare" in a smaller, sans-serif font.

The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.

Indications for Use:

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Comparison to Predicate:

The intended use and technological characteristics of the Cedara WebAccess 2.4 software are substantially equivalent, in the opinion of Merge OEM, to those of the predicate devices and do not pose any new issues of safety and effectiveness.

Category	Cedara WebAccess	Cedara I-SoftView(predicate device)	WebPax(predicate device)
Annotation andMeasurement Tools	Line, Rectangle,Ellipse, ROI, Angle,Cobb Angle, ParallelLines, RatioMeasurement, Text	Line, rectangle,curve, parallel line,mid point, angle andCobb angle, pixelstatistics	Line, ROI
Category	Cedara WebAccess	Cedara I-SoftView	WebPax
		(predicate device)	(predicate device)
User InstallationRequirements	Thin ClientNo installationrequired on usersmachine – runswithin browser	Thick ClientFiles installed onuser's machine.	Thin ClientNo installationrequired on usersmachine – runswithin browser
Cross-EnterpriseDocument Sharing(XDS) functionalityXDS is an IHEinitiative that provides aframework that enablesthe sharing ofdocuments betweenvarious healthcareenterprises such asprivate physicians'offices, clinics, acutecare in-patient facilitiesand electronic healthrecord systems.	Yes	No	No
Data Types Supported	DICOM, Non-DICOM	DICOM	DICOM, Non-DICOM
ImageView/Manipulation	Zoom, Pan, WindowLevel, Auto WindowLevel, Reset, ScoutLines, Image Rotate,Image Flip, Magnify,Image Invert Image,Mirror, Cine, MPR,MRA, Tag Images.	Zoom, Pan, WindowLevel, Auto WindowLevel, Reset, ScoutLines, ImageRotate/Flip, Magnify,Image Invert, Cine,MPR, Flip, Mirror,Tag Images, 3DCorrelation, MRA.	Zoom, Pan, ImageInvert, WindowLevel, Cine,Add/EditAnnotations
Data Encryption	HTTPS	No data encryptionon transmission	HTTPS
User and Password	Can either use built inaccess control or	No access control.Uses Microsoft	Uses built in
Category	Cedara WebAccess	Cedara I-SoftView(predicate device)	WebPax(predicate device)
Control	when launched fromparent applicationutilize its accesscontrol	Windows UserManagement	access control
Data Security	Stored on server	Stored on workstation	Stored on server
Audit Trails	Audit trail logged	Audit trail logged	Audit trail logged
User Management	Provides grouping ofusers into domains.	No advanced usermanagement	Not enoughinformation todetermine usermanagement.
Transmission Modes	Via the web withInternet browsers	Standalone	Via the web withInternet browsers
File Types Used	JPEG for Lossy Data,PNG for Losslessdata	DICOM	GIF(WebPaxpotentially utilizesother file types)

Table - Comparison of Cedara WebAccess vs Predicate Devices

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Merge Healthcare. The logo consists of the word "MERGE" in large, bold, sans-serif font, with the letters slightly spaced apart. To the right of the "E" in "MERGE", there is a small "TM" symbol, indicating a trademark. Below the word "MERGE", there is the word "Healthcare" in a smaller, sans-serif font.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for MERGE Healthcare. The word "MERGE" is in large, bold, black letters, with the letters connected to each other. The letters are in all caps, and there is a trademark symbol after the letter E. Below the word "MERGE" is the word "Healthcare" in a smaller, thinner font.

Summary of Testing:

Nonclinical verification and validation test results established that the device meets its design requirements and intended use, and that it is as safe, as effective, and performs as well as the predicate devices and that no new issues of safety and effectiveness were raised. The results also demonstrated that the device complies with industry standards for medical data: the NEMA DICOM 3.0 standard for Digital Imaging and Communications in Medicine, the JPEG standard ISO/IEC 10918-1 for the Digital Compression and Coding of Continuous-Tone Still Images, and the ISO/IEC 15948 standard for Portable Networks Graphics (PNG).

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol, with three curved lines representing the bird's body and wings. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Carol Nakagawa Director, Quality and Regulatory Affairs Merge OEM, a division of Merge Healthcare 6303 Airport Road, Suite 500 Mississauge, Ontario, L4V 1R8 CANADA

JUN 2 3 2010

Re: K092915

Trade/Device Name: Cedara WebAccess 2.4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 7, 2010 Received: June 9, 2010

Dear Ms. Nakagawa:

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 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

{5}------------------------------------------------

Page 2

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/cdrh/industry/support/index.html.

Sincerely yours.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure .

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K092915

Device Name:

Cedara WebAccess 2.4

Indications for Use:

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Prescription Use Yes (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 IF NEEDED)

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

Robert M. Becker
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K0929/5

Page 1 of 1

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).