eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.

Device Description

eFilm™ Workstation is one of the components of a PACS (Picture Archiving and Communications System). eFilm™ Workstation is a software application that provides image viewing and System). Chim - Wonotion 10 a setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other modioal integor that an also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. The document is a 510(k) summary for the eFilm™ Workstation, a Picture Archiving Communications System (PACS), seeking substantial equivalence to a predicate device.

Here's a breakdown of why the requested information cannot be provided from the given text:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on describing the device, its intended use, and its technological characteristics as compared to a predicate device. It briefly mentions "Testing" as an integral part of the software development process according to documented specifications but does not provide any specific performance criteria or results.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is detailed for any performance study.
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): Since no performance study or test set is described, there's no mention of experts or their qualifications for establishing ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method is mentioned.
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: An MRMC study or any comparative effectiveness study with human readers, with or without AI assistance, is not described. The eFilm™ Workstation is a PACS viewing software, not an AI-assisted diagnostic tool in the context of this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance study is indicated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no performance study is detailed, the type of ground truth used is not specified.
The sample size for the training set: There is no mention of a training set as no machine learning or AI algorithm development is described that would require one.
How the ground truth for the training set was established: No training set is mentioned, so no ground truth establishment for it is described.

In summary, the provided document is a regulatory submission for substantial equivalence based on technological characteristics and indications for use, rather than a performance study report with specific acceptance criteria and results.

Summary

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JUL 3 1 2001

K012211

510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification for eFilm™ Workstation, in accordance with SMDA 1990.

Date Prepared:	July 4, 2001
Submitted By:	eFilm™ Medical Inc.500 University Ave, Suite 300,Toronto, OntarioCanada M5G 1V7
Contact Name:	Kathy Chin
Contact Email:	kathy.chin@efilm.ca
Contact Telephone:	(416) 204 9664 ext 222
Contact Fax:	(416) 204 9442
Device Trade Name:	eFilm™ Workstation
Device Common Name:	Picture Archiving Communications System (PACS)
Device Classification:	892.2050 (Class II)
Name:	Image Processing System
Predicate Device:	RadWorks™ Medical Imaging Software with QualityControl Module
Predicate Device Manufacturer:	Applicare Medical Imaging B.V.
Predicate Device 510(k) Number:	K982862
Date Received:	08/13/1998
Decision Date:	10/21/1998
Decision:	Substantially Equivalent
Panel Code Device Reviewed by:	Radiology
Panel Code Device Classified by:	Radiology
Product Code:	LLZ
Classification:	892.2050 (Class II)

Device Description

Indications For Use

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interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be interest, and litverolori, forcation, this or RIS for a fully integrated electronic patient record.

Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Technological Characteristics

Both the eFilm™ Workstation and the Radworks™ Medical Imaging Software with Quality Control Bon the on intentioners packages which can be used on more than one hardware Moduc are other alone benefits before requirements are met, the user is free to choose his/her own hardware platform.

Both systems allow digital image processing and measurement capability. Both systems can transmit to remote viewing stations over a medical imaging network.

eFilm™ Workstation does not contact the patient, nor does it control any life-sustaining devices. e int" wontetation associety for competent human intervention interprets images and information being displayed and/or printed.

Testing

eFilm™ Workstation is tested according to the specifications that are documented in a Software of mr. Testing is an integral part of eFilm Medical Inc.'s software development process as described in the SOP-01: Product Development Process

Conclusion

The 510(k) premarket notification for eFilm™ Workstation contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.

1. eFilm™ Workstation has been and will continue to be manufactured according to the voluntary standards listed in the Voluntary Standards section (4.1) of this submission.
1. This submission contains the result of a hazard analysis and all potential hazards have been classified as minor.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2001

eFilm Medical, Inc. % Mr. N.E. Devine, Jr. Responsible Third Party Offical Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Re: K012211

eFILMTM Workstation (PACS) Dated: July 4, 2001 Received: July 16, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Devine:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We meversions your booking of or the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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). You may, that neve room recentise in about 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, to such additions of the minute the equivalent determination assumes compliance with the Current Good Manufacturing The 21, 1 at 5 oo to 093. I Fouromation (QS) for Medical Devices: General regulation (QS) for Medical Devices (21 CFR Part I have that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to comply frial also are the Federal Register. Please note: this response to your premarket notification submission does not ection any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Nancy C. Bogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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Indications For Use Statement

510(k) Number: K012211

Device Name: eFilm™ Workstation

Indications for Use:

Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109):

→

Over the Counter Use (optional Format 1-2-96): __

Ohrid L. Ingram

(Division Sign-Division of Reproductive, Abdomin and Radiological Devices 510(k) Number

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).