MULTIPICS(ME-977) by MERLIN ENGINEERING WORKS, INC.

The use of MultiPics is indicated whenever multiple images (2, 3, or 4) are required to be shown together in a single image/display, and a high-line rate (e.g., 1049 lines @ 30 frames/sec or 1249 lines @ 25 fps) video signal is required. Examples include conversion/combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and/or ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, disk, or other apparatus requiring a high-line rate video signal.

Device Description

MultiPics (Multiple Picture Scan Converter) is a digital image processing system that can display 2, 3, or 4 pictures on a single video monitor. Additionally, MultiPics has provisions for video scan conversion. MultiPics provides up to three modes of operation: DuoPics operation (Model ME-977-2), TriPics operation (Model ME-977-3), and QuadPics operation (Model ME-977-4).

AI/ML Overview

The provided text describes the Merlin MultiPics device, a digital image processing system that can display 2, 3, or 4 pictures on a single video monitor and provides video scan conversion.

Here's an analysis based on your requested points:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functionality: Display 2, 3, or 4 images on one monitor.	The device provides "DuoPics operation (Model ME-977-2)", "TriPics operation (Model ME-977-3)", and "QuadPics operation (Model ME-977-4)", which accept 2, 3, or 4 input signals respectively and output images as one-quarter of their original size, arranged on a single video frame without cropping.
Video Scan Conversion: Ability to convert video signals.	MultiPics has "provisions for video scan conversion." It is a "real-time video processing system designed to convert monochrome video images from one format to another (e.g., low line-rate to high line-rate, or visa versa)."
Standard Compliance (RS-170 and RS-343A): Meet appropriate requirements of these video standards.	"MultiPics was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that MultiPics meets these standards, as appropriate to the specific signal, as is the case for the predicate devices."
Standard Compliance (SMPTE RP-133): Correct compensation for aspect ratio changes.	"In addition, MultiPics was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes in accordance with the requirements of the particular scan conversion selected."
Low-Contrast Imaging Resolution: Achieves 1% level.	"In addition, the system permits low-contrast imaging resolution at the 1% level."
Electrical Compatibility: Electrically compatible with industry-standard monochrome video signals.	"MultiPics is electrically compatible with industry standard monochrome video signals."
Image Quality Preservation: Preserved within limits of standard video technology and line rates.	"The image quality is preserved (within the limits of standard video technology and the line rates selected)."

Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" in terms of patient data or a specific dataset. The performance tests ("nonclinical performance tests") were conducted on the device itself against established video and image processing standards (RS-170, RS-343A, SMPTE RP-133). The data provenance is implied to be from internal testing by Merlin Engineering Works.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a video signal processing and display system, not an AI or diagnostic tool that requires expert-established ground truth on medical images. The "ground truth" for its performance is defined by adherence to engineering standards (RS-170, RS-343A, SMPTE RP-133) for video signals, which are objectively measurable. No experts are mentioned as establishing ground truth in a clinical sense.
Adjudication method for the test set:
Not applicable. The tests are against engineering standards, not subjective assessments requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This device is a display and conversion system for medical images, not an AI diagnostic tool that assists human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the performance tests described (adherence to RS-170, RS-343A, SMPTE RP-133) represent a standalone evaluation of the device's technical specifications and capabilities, independent of human interaction beyond operating the device for testing purposes.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is adherence to industry-standard specifications for video signals and image processing (RS-170, RS-343A, SMPTE RP-133). This is a technical, objective ground truth, not a clinical one based on expert consensus, pathology, or outcomes data.
The sample size for the training set:
Not applicable. This device is a hardware/software system for video signal processing, 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 training set for this type of device.

Summary

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Merlin Engineering Works 1888 Embarcadero Road. Palo Alto, CA 94303 Tel (415) 856-0900 Fax (415) 8

Summary of Safety and Effectiveness 2.

Submitter:	Merlin Engineering Works, Inc.1888 Embarcadero RoadPalo Alto, California 94303JUN 25 1997
	Telephone:Facsimile:	(415) 856-0900(415) 858-2302
	Contact:	Gerald Engbretson,Operations Manager / Director, Regulatory Affairs
Device identification:	Trade Name:		MultiPics
	Model Number(s):		ME-977
	Common Name:		Multiple Picture Digital Scan Converter.
	ClassificationName:		(A component of) stationary x-ray system, per 21CFR 892.1680 (or equivalent)
Device(s) to whichsubstantial equivalenceis claimed:	K953398	UniScan(a.k.a. Model ME-959)	Merlin EngineeringWorks, Inc.
	K920550	IDP-5100 InterventionalDisplay Processor	Perkins ManufacturingCo.
	K904447	SME-3500 Cine Video System		Sony MedicalElectronics
Description of thedevice:	MultiPics (Multiple Picture Scan Converter) is a digital image processingsystem that can display 2, 3, or 4 pictures on a single video monitor.Additionally, MultiPics has provisions for video scan conversion.
	MultiPics provides up to three modes of operation:
	DuoPics operation (Model ME-977-2)
	In the DuoPics mode, MultiPics accepts two input signals, each atvarious scan rates, and it outputs high-line video. At the output, eachimage is one-quarter of its original size with the two images locatedone beside the other (horizontally spaced), centered vertically, thusfitting into the video frame with no cropping. Each "quarter" picturecontains the same information as would be found in a full size,standard rate picture.
	TriPics operation (Model ME-977-3)
	In the TriPics mode, MultiPics accepts three input signals, each atvarious scan rates, and it outputs high-line video. At the output, eachimage is one-quarter of its original size with two of them located onebeside the other (horizontally spaced) in the bottom half of thepicture, and the other located above the two, thus fitting into thevideo frame with no cropping. Each "quarter" picture contains thesame information as would be found in a full size, standard ratepicture.

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Intended use of the device:

Summary of how the technological characteristics compare to predicate device(s):

Summary of (nonclinical) performance tests and how their results support a determination of substantial equivalence:

Conclusions drawn from the performance tests:

QuadPics operation (Model ME-977-4)

In the QuadPics mode, MultiPics accepts four input signals, each at various scan rates, and it outputs high-line video. At the output, each image is one-quarter of its original size with two of them located one beside the other (horizontally spaced) in the bottom half of the picture, and the other two located one beside the other (horizontally spaced) in the top half of the picture, thus fitting into the video frame with no cropping. Each "quarter" picture contains the same information as would be found in a full size, standard rate picture.
When used in conjunction with a Video Scan Converter capable of converting from high-line to low-line, such as Merlin's UniScan (submission K953398), the resulting MultiPics image can be recorded on standard VHS, S-VHS, and other readily available recorder formats, and can be viewed with standard video monitors.

The intended use for MultiPics is conversion and combining of X-ray (stationary, C-arm, angiography, etc.), nuclear medicine, magnetic resonance, and ultrasound images either directly from their source, or from an intermediate storage device (like a video tape or video disk), for use on display monitors, optical, tape, disk, or other apparatus requiring a video signal. MultiPics is not intended to have any patient contact.

The use of MultiPics is indicated whenever multiple images (2, 3, or 4) are required to be shown together in a single image/display, and a highline rate (e.g., 1049 lines @ 30 frames/sec or 1249 lines @ 25 fps) video signal is required.

MultiPics and the predicate devices are real-time video processing systems designed to convert monochrome video images from one format to another (e.g., low line-rate to high line-rate, or visa versa) and/or to convert from full size images to quarter size images. MultiPics and at least two of the predicate devices (Merlin UniScan) utilize similar technology to perform the scan conversion. These systems both convert the incoming analog video signal to digital form using 8-bit analog-todigital converters, process the signals in the digital domain, and convert back to analog video using 8-bit digital-to-analog converters for the output. MultiPics and (applicable portions of) the other predicate devices (Perkins IDP-5100 and Sony SME-3500) both reduce one or more full size images to smaller images, and combine them in one full size picture using digital processing.

MultiPics was tested to ensure that it meets the appropriate requirements of RS-170 and RS-343A. The data demonstrates that MultiPics meets these standards, as appropriate to the specific signal, as is the case for the predicate devices.

In addition, MultiPics was tested in accordance with SMPTE RP-133. The system correctly compensates for aspect ratio changes in accordance with the requirements of the particular scan conversion selected. In addition, the system permits low-contrast imaging resolution at the 1% level.

MultiPics is electrically compatible with industry standard monochrome video signals. The image quality is preserved (within the limits of standard video technology and the line rates selected).

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QuadPics operation (Model ME-977-4)

In the QuadPics mode, MultiPics accepts four input signals, each at various scan rates, and it outputs high-line video. At the output, each image is one-quarter of its original size with two of them located one beside the other (horizontally spaced) in the bottom half of the picture, and the other two located one beside the other (horizontally spaced) in the top half of the picture, thus fitting into the video frame with no cropping. Each "quarter" picture contains the same information as would be found in a full size, standard rate picture.

When used in conjunction with a Video Scan Converter capable of converting from high-line to low-line, such as Merlin's UniScan (submission K953398), the resulting MultiPics image can be recorded on standard VHS, S-VHS, and other readily available recorder formats, and can be viewed with standard video monitors.

MultiPics is electrically compatible with industry standard monochrome video signals. The image quality is preserved (within the limits of standard video technology and the line rates selected).

Intended use of the device:

Summary of how the technological characteristics compare to predicate device(s):

Summary of (nonclinical) performance tests and how their results support a determination of substantial equivalence:

Conclusions drawn from the performance tests:

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food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gerald C. Engbretson Operations Manager and Director of Regulatory Affairs Merlin Engineering Works ... ... .... 1888 Embarcadero Road Palo Alto, CA 94303 JUN 2 5 1007

Re: K971154 Merlin MultiPics Dated: March 27, 1997 Received: March 28, 1997 .... Regulatory class: II 21 CFR 892.1680/Procode: 90 LMD

Dear Mr. Engbretson:

We have reviewed your Section 510%) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enaction the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmers Acl (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrancing and adulteration.

If your device is classified (see above) into either class III (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 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 510(k) premarket noufication. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please of the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrl/dsmamain.html".

Sincerely yours,

William Fox

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: MultiPics

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices,
510(k) Number K971154

Prescription Use
X
(per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2020 Medical image communications device.

(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.