Collage is a software application intended for viewing of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. It is intended for use by doctors, clinicians, and other qualified individuals utilizing standard PC hardware. This device is not indicated for mammography use.

Device Description

Collage is an interactive imaging software used for the visualization, storage, and management of 3D medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound as well as 2D patient images, such as patient photographs, intraoral photographs, and dental x-rays. Doctors, dental clinicians, and other qualified individuals can retrieve, process, render, review, store and print images, utilizing standard PC hardware. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. The Collage software is intended as a platform bridging different sets of patient data for comprehensive studies. With Collage software, doctors can manage all of their patient images, including both 2D and 3D image data, in a single software.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Collage" device:

The provided text does not contain explicit acceptance criteria or a detailed study proving the device meets those criteria, as typically understood for AI/ML medical devices.

Instead, the document is a 510(k) premarket notification summary for a Picture Archiving and Communication System (PACS) software, "Collage." The evaluation focuses on demonstrating substantial equivalence to a predicate device (OsiriX MD, K101342) through software development quality assurance measures and bench testing.

Here's an attempt to answer your questions based on the available information, noting where information is absent:

A table of acceptance criteria and the reported device performance

The document does not specify formal, measurable "acceptance criteria" for clinical performance. The evaluation is based on demonstrating the software functions as intended and is comparable to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Software is stable and operating as designed.	"Testing confirmed that the software is stable and operating as designed."
Risk associated with the software is reduced to acceptable levels.	"Testing also confirmed that the software has been evaluated for hazards and that risk has been reduced to acceptable levels."
Ability to render and manage 2D and 3D medical images.	"Bench testing of the software with predicate software was performed by evaluation of images rendered by Collage and predicate software. This testing and evaluation included testing of rendering both 2D and 3D images... This testing confirms that Collage is as effective as its predicate in its ability to perform its essential functions of rendering and managing medical images."

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

The document mentions "Bench testing of the software with predicate software was performed by evaluation of images rendered by Collage and predicate software." It does not specify the sample size of images used for this bench testing, nor does it provide information on the provenance (country of origin, retrospective/prospective) of these images.
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)

"Bench testing... was evaluated by an expert in the field of radiology." Only one expert is mentioned. Their specific qualifications (e.g., years of experience) are not detailed beyond "an expert in the field of radiology."
Adjudication method (e.g., 2+1, 3+1, none) for the test set

Given that only "an expert" evaluated the bench testing results, there was no adjudication method mentioned or implied (like 2+1 or 3+1 consensus).
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 comparative effectiveness study was done. The device "Collage" is a PACS software for viewing and managing images, not an AI-assisted diagnostic tool. Therefore, there's no mention of how human readers improve with AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as "a software application intended for viewing...images." "Diagnosis is not performed by this software but by doctors, clinicians and other qualified individuals." It is a tool for clinicians, not a standalone diagnostic algorithm. Therefore, no standalone (algorithm-only) performance was assessed in the context of diagnostic accuracy, as it's not its intended function. The "standalone" performance assessed was its ability to render and manage images as a PACS system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench testing described, the "ground truth" was essentially the visual evaluation and comparison of rendered images by a radiology expert against images rendered by the predicate device, to ensure "Collage" performs its essential functions effectively. It's not a diagnostic "ground truth" derived from pathology or outcomes, but rather a functional ground truth for image display.
The sample size for the training set

The document describes "Collage" as an imaging software, not an AI/ML model that would typically have a distinct "training set." Therefore, no sample size for a training set is mentioned. The software development followed standard quality assurance measures, but this is different from machine learning model training.
How the ground truth for the training set was established

As there is no mention of a training set for an AI/ML model, this question is not applicable based on the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

June 4, 2015

Anatomage Inc. % Mr. Sean Xu Program Director 111 N. Market Street. #500 SAN JOSE CA 95113

Re: K150976 Trade/Device Name: Collage Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 14, 2015 Received: April 15, 2015

Dear Mr. Xu:

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.

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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,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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) K150976

Device Name Collage

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510K Summary

Submitter	Anatomage Inc.111 N. Market Street #500San Jose, CA 95113Phone: (408) 885-1474Fax: (408) 295-9786
Regulatory Contact Person	Sean Xu, Program DirectorPhone Number: (408) 885-1474 ext 108
Device Name	Collage
510(k) Preparation Date	04/08/2015
Common Name	System, Image Processing, Radiological
Classification	Class II
Classification Name	Imaging Processing System, LLZ, 21 CFR 892.2050
Product Code	LLZ, 21 CFR 892.2050
Device Description	Collage is an interactive imaging software used for thevisualization, storage, and management of 3D medical image filesfrom scanning devices, such as CT, MRI, or 3D Ultrasound aswell as 2D patient images, such as patient photographs, intraoralphotographs, and dental x-rays. Doctors, dental clinicians, andother qualified individuals can retrieve, process, render, review,store and print images, utilizing standard PC hardware. Thesoftware runs in Windows operating systems and visualizesmedical imaging data on the computer screen. The Collagesoftware is intended as a platform bridging different sets of patientdata for comprehensive studies. With Collage software, doctorscan manage all of their patient images, including both 2D and 3Dimage data, in a single software.
Intended Use	Collage is a software application intended for viewing of 3Dmedical image files from scanning devices, such as CT, MRI, or3D Ultrasound as well as 2D patient images, such as patientphotographs, intraoral photographs, and dental x-rays. Images anddata can be stored, communicated, processed and displayed withinthe system and or across computer networks at distributedlocations. It is intended for use by doctors, clinicians, and other
Equivalent Devices	K101342, OsiriX MD
Technological Characteristic	Collage is a software that handles digital medical images. Thisdevice does not contact the patient, nor does it control any lifesustaining devices. Diagnosis is not performed by this softwarebut by doctors, clinicians and other qualified individuals. Aphysician, providing ample opportunity for competent humanintervention, interprets images and information being displayedand printed.Collage is installed on standard off-the-shelf x86 processor basedcomputers running the Windows operating system.
Non-Clinical Test Results	The following quality assurance measures were applied to thedevelopment of the system:· Risk Analysis· Requirements Reviews· Design Reviews· Performance testing· Usability testing· Final acceptance testing· Bench testing to compare with predicate softwareTesting confirmed that the software is stable and operating asdesigned. Testing also confirmed that the software has beenevaluated for hazards and that risk has been reduced to acceptablelevels.Bench testing of the software with predicate software wasperformed by evaluation of images rendered by Collage andpredicate software. This testing and evaluation included testing ofrendering both 2D and 3D images in both predicate and subjectsoftware and was evaluated by an expert in the field of radiology.This testing confirms that Collage is as effective as its predicate inits ability to perform its essential functions of rendering andmanaging medical images.
Summary	Based on the intended use, product, performance, and testinginformation provided in this notification, the subject device hasbeen shown to be substantially equivalent in the area of technicalcharacteristics, general functionality, and indicated use to thecurrently marketed predicate device and does not introduce anynew potential risks.

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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).