Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L are indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images and associated identification information from various digital imaging source modalities, including but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Radiography, Digital Mammography and Nuclear Medicine.

Device Description

Fuji Medical Dry Laser Imagers models DRYPIX 7000, DRYPIX 5000 and FM-DP L are image recording devices that use laser exposure and thermal development to print on medical dry imaging films the digital image data that is sent from medical diagnostic imaging modalities. Image processing is performed on the obtained digital images, and via laser exposure, and thermal development the le perfermou on tilm. The main difference between the FM-DP L device and the DRYPIX devices are image throughput. The only difference in the DRYPIX devices is that the DRYPIX 7000 is a 220 Vac version while the DRYPIX 5000 is a 110 Vac version.

AI/ML Overview

Based on the provided document, the device in question is the Fuji Medical Dry Laser Imagers (models DRYPIX 7000, DRYPIX 5000, and FM-DP L). This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and standalone performance metrics as one might find for an AI/CADe device.

Therefore, much of the requested information (acceptance criteria table with reported performance, sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth specifics for training) is not available or applicable in this type of submission for this particular device.

Here's what can be extracted and inferred from the document:

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

This device is a Medical Image Hardcopy Device (printer). Its performance is primarily assessed through its ability to provide "diagnostic quality medical images on film for aid in physician diagnosis." The 510(k) summary does not provide specific quantitative acceptance criteria or reported performance metrics (e.g., spatial resolution, Dmax/Dmin, throughput accuracy, or specific image quality scores) that would typically be associated with software or diagnostic devices. Instead, substantial equivalence to predicate devices is the primary "acceptance criterion" for regulatory clearance in this context.

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices)	Reported Device Performance (Inferred)
Diagnostic Quality Images: Ability to produce medical images on film suitable for physician diagnosis.	Assumed to meet diagnostic quality standards, as it is considered substantially equivalent to already cleared devices (Agfa LR 5200 Laser Film Recorder and Kodak DRYVIEW 8610 Laser Imager) which are established for producing diagnostic quality images.
Image Recording Functionality: Process digital image data from various modalities and print them via laser exposure and thermal development.	Functions as described, processing digital image data from CT, MRI, Ultrasound, CR, DR, Digital Mammography, and Nuclear Medicine into film output.
Safety and Efficacy: No new safety and efficacy issues compared to predicate devices.	A hazard analysis was performed, and the device is deemed a "minor level of concern." Compliance with relevant standards (21 CFR 1040.10, UL 60601-1, IEC 60601-1-2, DICOM) is stated, indicating the device meets established safety and performance protocols for medical electrical equipment and imaging communication.
Image Throughput: Production speed of images.	The document notes differences in "image throughput" between the FM-DP L and DRYPIX devices, implying this is a design consideration, but no specific performance numbers are given.
Voltage Compatibility: Power requirements.	DRYPIX 7000 is 220 Vac, DRYPIX 5000 is 110 Vac, indicating different models meet different electrical standards/customer needs.

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

Not Applicable/Not provided. As this is a hardcopy device and the submission focuses on substantial equivalence rather than a new clinical claim based on image analysis, there is no mention of a "test set" of medical images or patient data in the context of a performance study for 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/Not provided. This information is irrelevant for a device that prints images. The "ground truth" for a printer would be its adherence to technical specifications for image reproduction, rather than expert interpretation of medical images.

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

Not Applicable/Not provided. There is no "test set" in the context of diagnostic interpretation that would require an adjudication method.

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 device is an imager (printer), not an AI/CADe system. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not Applicable. This device performs a physical function (printing images), not an algorithmic diagnostic interpretation.

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

For a medical image hardcopy device, the "ground truth" refers to its technical specifications and ability to accurately reproduce digital images onto film with diagnostic quality. The document indicates compliance with DICOM, which is a standard for handling, storing, printing, and transmitting medical imaging information, suggesting accurate reproduction of originating image data is a key aspect. The assessment relies on engineering and quality control, not medical ground truth like pathology for diagnostic accuracy. The substantial equivalence argument relies on the predicate devices having met appropriate standards for diagnostic image quality.

8. The sample size for the training set:

Not Applicable. This device does not use machine learning, so there is no "training set."

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

Not Applicable. As no training set exists, no ground truth needed to be established for it.

In summary, the provided document for the Fuji Medical Dry Laser Imagers (K033377) is a 510(k) summary demonstrating substantial equivalence to predicate devices (Agfa LR 5200 and Kodak DRYVIEW 8610). It does not contain the detailed performance study information typically associated with AI/CADe devices or new diagnostic algorithms, as the device's function is to print diagnostic quality medical images on film, rather than to interpret them.

Summary

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Image /page/0/Picture/1 description: The image shows the Fujifilm logo. The logo consists of the Fujifilm symbol on the left and the word "FUJIFILM" in bold, black letters on the right. Below the word "FUJIFILM" is the text "I&I-Imaging & Information".

K033377
Page 1 of 2

FUJIFILM MEDICAL SYSTEM

419 WEST AVENUE STAMFORD, CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926

510(K) Summary

in accordance with the requirements of the Safe Medical Device Act, FUJIFILM Medical Systems, USA, Inc. herewith submits a 510(K) summary of safety and effectiveness for the following device.

SUBMITTER NAME / ADDRESS:	FUJIFILM Medical Systems, USA, Inc.419 West AvenueStamford, CT 06902
CONTACT PERSON / TEL NO:	Frank GianelliRegulatory CoordinatorTel No: (203) 602-3774
DATE SUMMARY PREPARED:	October 17, 2003
ESTABLISHMENT NO.:	2443168
TRADE/PROPRIETARY NAME:	Fuji Medical Dry Laser Imagers, modelsDRYPIX 7000, DRYPIX 5000, FM-DP L
COMMON/USUAL NAME:	Medical Dry Laser Imager
CLASSIFICATION NAME:	Medical Image Hardcopy Device
CLASS/PANEL:	Class II, 90-LMC, 21CFR 892.2040

DEVICE DESCRIPTION:

INTENDED USE:

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Image /page/1/Picture/0 description: The image shows a handwritten note with the identifier "K033377" at the top. Below the identifier, the text "page 2 of 2" is written, indicating that this is the second page of a two-page document. The handwriting appears to be somewhat cursive and slightly messy.

Image /page/1/Picture/1 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in bold, black letters, with a smaller symbol to the left. Below the main logo, the text "I&I-Imaging & Information" is printed in a smaller, lighter font, indicating the company's focus on imaging and information technologies.

FUJIFILM MEDICAL SYSTEMS US

419 WEST AVENUE STAMFORD, CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926

PREDICATE DEVICE AND SUBSTANTIAL EQUIVALENCE INFORMATION:

Fuji Medical Dry Laser Imagers models DRYPIX 7000, DRYPIX 5000 and FM-DP L are considered comparable and substantially equivalent to the Agfa LR 5200 Laser Film Recorder (K012010) manufactured by Agfa Corporation and the Kodak DRYVIEW 8610 Laser Imager (K002146) manufactured by the Eastman Kodak Company.

SAFETY INFORMATION:

Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L introduce no new safety and efficacy issues other than those already identified with the predicate devices. The results of a hazard analysis, combined with the appropriate preventive measures taken indicate that the device is of minor level of concern as per the May 29, 1998 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L comply with the following mandatory and voluntary standards:

21 CFR 1040.10 Performance Standards for Light Emitting Products (Laser Products) .
. Medical Electrical Equipment Part 1: General Requirements for Safety UL Standard 60601-1 (IEC 60601-1-1 included)
Medical Electrical Equipment Part 1: General Requirements for Safety; Electromagnetic . Compatibility - Requirements and Tests: IEC 60601-1-2
DICOM (Digital Imaging and Communications in Medicine) Developed by the American . College of Radiology and the National Electrical Manufacturers Association.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN - 9 2004

Mr. Frank Gianelli Regulatory Coordinator FUJIFILM Medical Systems, USA, Inc. 419 West Avenue STAMFORD CT 06902

Re: K033377

Trade/Device Name: Fuji Medical Dry Laser Imagers Models; DRYPIX 7000, DRYPIX 5000, and FM-DP L Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: October 20, 2003 Received: October 22, 2003

Dear Mr. Gianelli:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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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This letter will allow you to begin marketing your device as described in your Section 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 the 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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

Enclosure

Page 2

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510(k) Number (if known): _

Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX Device Name : 5000 and FM-DP L

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 801.109

Over-The-Counter Use

Nancy C. Brogdon
(Division Sign-Off)

(Optional Format 1-2-96)

Radiological Devices
510(k) Number K033377

Division of Reproductive, Abdominal.

Page A3-2

Regulation Number and Section

§ 892.2040 Medical image hardcopy device.

(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(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). 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.