The EL-DRY 4000 digitizes image data output from medical imaging apparatus in the form of video or digital signals, then records this printing data onto the Kodak DryView laser film by mean of semiconductor laser. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images.

Device Description

The EL-DRY 4000 is a desk top radiographic Laser Imager. The EL-DRY 4000 The EL-DN I - 1000 10 a deen top edical imaging apparatus in the form of video or digital signals, then records this printing data onto the Kodak DryView laser film by mean of semiconductor laser. Digitized image data is processed to match the film size mcall of semiconductor laser 22gitLed . and formats (1,2,4,6,9,12,15,16, 20, 24), and these processed data converted into laser out put. Three different image-processing methods are available; selection is made via the imaging pad. This system is controlled by a micro-processor, and all parameters can be set using the imaging pad. Furthermore, necessary information such as format, system status, and error indicators are all shown on an LCD readout. In addition, 15 types of LUT (characteristic of film density levels) settings are available; selection is also made using the imaging pad. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images.

AI/ML Overview

The provided 510(k) summary for the Elk Laser Imager, Model EL-DRY 4000, does not contain information related to acceptance criteria or the study that proves the device meets those criteria, as it is a device for printing medical images onto film, not an AI/ML powered diagnostic or screening device.

The document describes a medical image hard copy device (a laser imager) which digitizes and prints medical images onto film. As such, the typical "acceptance criteria" and "study" described in your prompt (which relate to the performance of diagnostic algorithms, AI/ML models, or clinical effectiveness in identifying conditions) are not applicable to this type of device.

Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (Kodak DryView 8100) by comparing technical specifications and intended use. The "performance" in this context is about printing quality and functionality, rather than diagnostic accuracy.

Here's a breakdown of why it doesn't fit your requested format and what information is provided:

1. A table of acceptance criteria and the reported device performance

Not Applicable. The document compares specifications of the EL-DRY 4000 to the Kodak DryView 8100 predicate device. These are technical specifications (e.g., exposure method, film type, pixel size, throughput), not acceptance criteria for diagnostic performance.

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

Not Applicable. This device is a printer. There is no "test set" of patient data in the context of diagnostic accuracy.

3. 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)

Not Applicable. Ground truth for diagnostic purposes is not established for this device. Its function is to reproduce existing images accurately.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable.

5. 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 is not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable.

8. The sample size for the training set

Not Applicable. This device does not use a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established

Not Applicable.

Summary of Information Provided in the 510(k) for the Elk Laser Imager, Model EL-DRY 4000:

Device Type: Medical Image Hard Copy Device (Laser Imager)
Intended Use: To produce radiological quality film copies of digital or video medical images.
Predicate Device: Kodak DryView 8100
Demonstration of Performance/Equivalence: Via comparison of technical specifications between the proposed device and the predicate device (exposure method, film type, film size, pixel size, number of pixels, formats, interface, input numbers, output grayscale, image memory, contrast table, interpolation, calibration, magazine, throughput, power source, dimensions, weight).
Software: Elk Corporation certifies that software is designed, developed, tested, and validated according to written procedures. Hazard analysis was performed.
Safety Standards Applied: UL 2601-1, CSA-C22.2 #601-1, IEC 60101+A1+A2, IEC 60825, IEC 60601-2, MDD ANNEX I.

In essence, this is a hardware device for printing, and its regulatory submission focuses on demonstrating its physical/functional equivalence and safety, not on diagnostic accuracy derived from algorithmic performance.

Summary

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510(k) Summary

1. Company Identification

K011949

Elk Corporation

2-17-4 Yushima Bunkyo, Tokyo, Japan Tel. (03) 3818-1324 Fax (03) 3818-1814 e-mail elkint@ca.mbn.or.jb

2. Official Correspondent

Gary J. Allsebrook, Consultant Regulatory Management Services 16303 Panoramic Way San Leandro CA 94578-1116 Tel: 510-276-2648 Fax: 510-276-3559 Email: regman1@home.com

3. Date of Submission

June 19, 2001

4. Device Name

Classification Name:	Medical Image Hard Copy Devices were evaluatedby the Radiology panel and are classified in Class Iper 21 CFR §892.2040. ProCode LMC
Common/Usual Name:	Laser Imager & Video Capture
Proprietary Name:	Elk Laser Imager, Model EL-DRY 4000

5. Substantial Equivalence

Kodak DryView 8100, 510(k) number unknown

6. Device Description and Intended Use

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methods are available; selection is made via the imaging pad. This system is controlled by a micro-processor, and all parameters can be set using the imaging pad. Furthermore, necessary information such as format, system status, and error indicators are all shown on an LCD readout. In addition, 15 types of LUT (characteristic of film density levels) settings are available; selection is also made using the imaging pad. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images.

7. Software

Elk Corporation certifies that the EL-DRY 4000 software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance.

8. Hazard Analysis

Hazard analysis on this product has been performed throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized:

. Identification of potential hazards, their causes, and their effects;
. Development of methodologies to control the occurrence of hazards and to constrain their effects; and
. Determine any effect on patient safety and system effectiveness.

The potential hazards associated with this software product are no different than those of other PACS components . These are primarily related to failure of computer system components, and may be variously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury.

It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".

9. Safety Concerns

Standards Applied for:

USA	UL 2601 -1
Canada	CSA-C22.2 #601-1
E.U.	IEC 60101+A1+A2
	IEC 60825
	IEC 60601-2
	MDD ANNEX I

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10. Substantial Equivalence

The following product provides functions, which are substantially equivalent to this product.

Specifications	Elk, EL-DRY 4000	Kodak, DryView 8100
Exposure Method	Infra-Red Laser Diode	Infra-Red Laser Diode
Film Type	Kodak DryView Film	Kodak DryView Film
Film Size	14"x17",14"x14"	14"x17"
Pixel Size	80x80 micron	80x80 micron
Max. Number of Pixel	4,444x5398 <14"x17">	4,361x5217 <14"x17">
Formats	1,2,4,6,9,12,15,16,20,24	1,2,4,69,12,15,16,20
Interface	Video, Digital, DICOM<w/interface>	Video, Digital, DICOM<w/interface>
Number of Inputs	Up to two	1<Up to 3 with combination of9410>
Output Grayscale	4,096 steps <12 bits>	4,096 steps <12 bits>
Image Memory	64 MB SIMM	2GB Hard Desk
Contrast Table	15 Tables	15 Tables
Interpolation	Replication, Bilinear,High-resolution Cubic Spline	Sharp, Smooth
Calibration	Automatic Calibrationby mean of Imaging Pad	Automatic Image Quality Control
Magazine	125 sheets	125 sheets
Through put	60 sheets / hour	55 sheets / hour
Power Source	100-120/200-240VAC, 50/60Hz10/5A	100VAC, 50/60 Hz, 12A
Dimensions	522x650x390mm	635x660x1168mm
Weight	70kg	188kg

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling an emblem. The emblem includes a stylized caduceus, a symbol often associated with medicine and healthcare, representing the department's focus on health-related matters.

Public Health Service

AUG 2 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elk Corporation % Mr. Gary J. Allsebrook Regulatory Affairs Consultant Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116 Re: K011949 Elk Laser Imager, Model EL-DRY 4000 Medical Image Hard Copy Device Dated: June 19, 2001 Received: June 21, 2001 Regulatory Class: II 21 CFR 892.2040/Procode: 90 LMC

Dear Mr. Allsebrook:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is we nave reviews for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in commove prot to the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to ate 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 (Special Controls) or class III (Premarket Approval), it may be subject to such 11 your de ro to to regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, 800 to 07: 1 Satonalitant's System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic as so rollar in the Quand Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may Q nisponons, all 1 oda alla 2rdg Prail. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please result it response to your premarket notification does not affect any obligation you might have under sections 531 through note: and response to your promate 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), please contact the Office of Compliance 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, 4,xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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 brogdon

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

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510(k) Number (if known):

Elk Corporation, Laser Imager, Model EL-DRY 4000 Device Name:

Indications For Use:

(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 901.109)

Over-the-Counter Use

Mamie C. Brooks
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K011949

Regulation Number and Section

N/A