eFilm Video™ is a software application that captures video streams from analogue medical image acquisition devices with video outputs and converts these streams to DICOM compliant cine loops. These images can be sent to DICOM compliant devices for display and processing. Users may also input patient demographic information that is related to the captured images.

Device Description

eFilm Video™ is a software application that is used for capturing video streams from analogue medical image acquisition devices with video outputs and converting these streams to DICOM modiant cine loops. Users may capture single stills or consecutive images and save them as DICOM files that can be viewed and manipulated in a picture archiving and communications viewing application.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the eFilm Video™ device, focusing on acceptance criteria and study details.

Important Note: The provided 510(k) summary for eFilm Video™ (K013631) is for a "Video Capture System" that converts analog video streams into DICOM cine loops. This is a very different type of device than what is typically associated with AI-driven medical image analysis, which usually involves performance metrics like sensitivity, specificity, or AUC for detecting or classifying medical conditions.

Based on the information provided, the "acceptance criteria" for this specific device are centered around its functional capabilities and safety, rather than diagnostic performance metrics of an AI algorithm. The testing described is primarily software verification and validation.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Evidence
Functional Equivalence	Performs the same functions relating to image acquisition as the predicate device (CHILI Video/Pro Video - K000411).	Stated that "eFilm Video™ performs the same functions relating to image acquisition as the predicate device" and "eFilm Video™ operates in the same environment as the predicate device and raises no new operation risk and therefore is substantially equivalent to the predicate device."
Safety - Patient Contact	Does not contact the patient.	Explicitly stated: "eFilm Video™ does not contact the patient."
Safety - Life Support	Does not control any life-sustaining devices.	Explicitly stated: "nor does it control any life-sustaining devices."
Safety - Human Oversight	Allows for competent human intervention for interpreting displayed/printed images and information.	Explicitly stated: "competent human intervention interprets images and information being displayed and/or printed."
Software Quality	Tested according to documented specifications in a Software Test Plan, as part of the manufacturer's Product Development Process.	Stated: "eFilm Video™ is tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part of eFilm Medical Inc.'s software development process as described in the SOP-01: Product Development Process."
Hazard Analysis	All potential hazards identified and classified as minor.	Stated: "This submission contains the result of a hazard analysis and all potential hazards have been classified as minor."
Compliance	Manufactured according to voluntary standards.	Stated: "eFilm Video™ has been and will continue to be manufactured according to the voluntary standards listed in the Voluntary Standards section (4.1) of this submission." (Specific standards are not detailed in this summary excerpt but are implied to be in the full submission).

Study Details (Based on the Provided Information)

Since eFilm Video™ is a video capture system and not an AI-driven diagnostic tool, the typical "study" parameters for AI performance (like sample size for test sets, ground truth methodology for diagnostic accuracy, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this 510(k) summary. The "study" here refers to the internal software testing and verification/validation processes.

Sample size used for the test set and the data provenance:
- Test Set Size: Not specified in this summary. The testing refers to software testing against "specifications," rather than a clinical test set of patient data for diagnostic performance.
- Data Provenance: Not applicable in the context of typical diagnostic imaging studies. The device captures video streams from "analogue medical image acquisition devices," implying it processes various types of medical video.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this device is not designed to provide a diagnostic output requiring expert-established ground truth for performance evaluation. The "ground truth" for this device would be whether it accurately converts analog video to DICOM cine loops according to its specifications. This would be verified through technical testing, not expert clinical interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used to establish consensus ground truth in diagnostic studies. This summary focuses on functional and safety verification.
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, as this device is a foundational video capture and DICOM conversion tool, not an AI-assisted diagnostic aid.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The term "standalone performance" isn't directly applicable in the AI sense. However, the device's core function (capturing and converting video) is an "algorithm only" type of process. Its performance is evaluated against its technical specifications, which are implicitly standalone. The summary states there is "opportunity for competent human intervention [who] interprets images and information being displayed and/or printed," which speaks to its place in a clinical workflow, not its standalone diagnostic capability.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for diagnostic ground truth. The "ground truth" for this device's performance would be successful conversion of analog video to DICOM-compliant cine loops as per technical specifications, verified by software testing and potentially visual inspection of the output for fidelity.
The sample size for the training set:
- Not applicable. This device is a software application for video capture and conversion, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no machine learning model or training set involved.

Summary

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K01363/

NOV 2 0 2001

510(k) Summary of Safety and Effectiveness

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

Date Prepared:	Oct 26, 2001
Submitted By:	eFilm™ Medical Inc.500 University Ave, Suite 300,Toronto, OntarioCanada M5G 1V7
Contact Name:	Joseph A. Thomas
Contact Email:	joseph.thomas@efilm.ca
Contact Telephone:	(416) 204 9664 ext 291
Contact Fax:	(416) 204 9442
Device Trade Name:	eFilm Video™
Device Common Name:	Video Capture System
Regulation Number:	892.2030
Device Classification:	Class II
Name:	Medical Image Digitizer
Predicate Device:	CHILI Video/Pro Video
Predicate Device Manufacturer:	STEINBEIS-TRANSFERZENTRUM MEDIZINISCHEINFORMATIK
Predicate Device 510(k) Number:	K000411
Date Received:	02/08/2000
Decision Date:	04/14/2000
Decision:	Substantially Equivalent
Panel Code Device Reviewed by:	Radiology
Panel Code Device Classified by:	Radiology
Product Code:	LMA
Regulation Number	892.2030
Classification:	Class II

Device Description

Indications For Use

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

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Technological Characteristics

eFilm Video™ performs the same functions relating to image acquisition as the predicate device. of ilm Video™ operates in the same environment as the predicate device and raises no new er inf 11000 ** operation risk and therefore is substantially equivalent to the predicate device.

eFilm Video™ does not contact the patient, nor does it control any life-sustaining devices. A el inf 'ndoo' video mot opportunity for competent human intervention interprets images and information being displayed and/or printed.

Testing

eFilm Video™ is tested according to the specifications that are documented in a Software Test Plan. 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 Video™ contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.

1. eFilm Video™ 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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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol resembling an eagle or bird, composed of three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

EFilm Medical Inc.™ % Mr. Ned Devine Program Manager Entela Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548 Re: K013631 Trade/Device Name: eFilm Video™ Video Capture System Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: October 26, 2001 Received: November 5, 2001

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection 310(t) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regars) to regars the Medical Device Amendments, or to conninered prior to May 20, 1978, als casordance with the provisions of the Federal Food, Drug, de necs mat have boon recuire approval of a premarket approval application (PMA). and Cosmetic Trol (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, mercerore, manel and net, include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is elassified (500 a00 70) . 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 r lease be advisou that I Dr viewan that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any i vith 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 (21 CFR Part 607), laboring (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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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 noutication. The I Drivinating sification 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 If you desire spooline active at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Compinated at (2007 oation" (21 CFR Part 807.97). Other general information on of relection to promation the Act may be obtained from the Division of Small Manufacturers, your responsional and Consumer 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. Snogdon

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 Statement

510(k) Number: K: 13631

NOV 2 0 2001

Device Name: eFilm Video™

Indications for Use:

eFilm Video™ is a software application that captures video streams from analogue medical image eFilm Video™ is a software application nat capares these streams to DICOM compliant cine
acquisition devices with video outputs and converts these streams to DCOM c acquisition devices with Video outputs and conveliant to Libertis (1) Users
loops. These images can be sent to DICOM compliant devices (1) List (1) Locked loops. These images can be sent to Broom complain as near and the captured images.

Typical users of eFilm Video™ 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): _______________________________________________________________________________________________________________________________

Nancy C. Beagdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013631

Regulation Number and Section

§ 892.2030 Medical image digitizer.

(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.