The Sony UP-DF500 FilmStation™ Digital Film Imager is a thermal printer intended for use in printing high-resolution diagnostic images from CT, MRI or other compatible medical imaging systems. The Sony UP-DF500 is intended for use by medical radiologists or other appropriately trained medical personnel.

Device Description

The Sony UP-DF500 FilmStation™ Digital Film Imager is a general purpose thermal printer and is intended for use as an accessory to a wide variety of medical imaging systems for digitally printing black and white still images with DICOM format. The Sony UP-DF500 is connected to a DICOM network and the image from a compatible medical imaging system is transmitted via the DICOM network.

AI/ML Overview

This document is a 510(k) Summary for the Sony UP-DF500 FilmStation™ Digital Film Imager, a thermal printer used for medical imaging. The 510(k) submission seeks to demonstrate substantial equivalence to existing predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria in terms of quantitative performance metrics (e.g., resolution, spatial accuracy, density range, diagnostic accuracy). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on overall purpose, function, and intended use.

The "reported device performance" is implicitly demonstrated through the claim of substantial equivalence and the device's technological characteristics aligning with the predicate devices. The core "performance" being evaluated is its ability to produce high-resolution diagnostic images comparable to other legally marketed thermal printers.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically associated with clinical performance studies, which are not detailed in this 510(k) summary for a hardcopy device. The focus here is on engineering and functional equivalence rather than diagnostic accuracy on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since no specific test set or clinical performance study is described, there's no mention of experts or their qualifications used to establish ground truth for a test set.

4. Adjudication Method:

Given the lack of a detailed clinical performance study with a test set, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

The device is a thermal printer, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted and is irrelevant to this device.

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

The device is a standalone thermal printer. Its "performance" is in printing images, not in making diagnostic interpretations. So, in a sense, its operation is "standalone" in its function of printing. However, this is not a standalone diagnostic algorithm in the context of typical AI medical device evaluations. The performance being evaluated is the quality of the hardcopy output itself, independent of human interpretation until the image is presented to a human.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Given the nature of the device as a thermal printer, the "ground truth" would likely relate to the accuracy of image reproduction – e.g., how closely the printed image matches the digital image data in terms of resolution, gray scale, and spatial fidelity, rather than a clinical ground truth like pathology for diagnostic accuracy. The document does not specify how this ground truth (for image reproduction quality) was established or evaluated.

8. The Sample Size for the Training Set:

The document does not mention a training set sample size. This type of information is pertinent to machine learning algorithms, which are not applicable to a thermal printer in this context.

9. How the Ground Truth for the Training Set was Established:

As there is no mention of a training set, there is no information on how its ground truth was established.

Summary of Acceptance Criteria and Study (Based on Inference from 510(k) Format):

Based on the nature of a 510(k) for a medical image hardcopy device, the "acceptance criteria" and "study" are not presented in the format often seen for diagnostic algorithms. Instead, acceptance is based on demonstrating substantial equivalence to already legally marketed predicate devices.

Acceptance Criteria (Inferred):
- Functionality: The device must perform the same overall function as predicate devices (printing high-resolution diagnostic images from CT, MRI, etc.).
- Intended Use: The device must share the same intended use as predicate devices (for use by medical radiologists or other appropriately trained medical personnel for diagnostic purposes).
- Technological Characteristics: The device must have technological characteristics (e.g., thermal printing technology, DICOM connectivity) that are sufficiently similar to predicate devices, or any differences do not raise new questions of safety or effectiveness.
- Image Quality: Although not explicitly quantified, the implicit acceptance criterion is that the printed image quality (resolution, gray scale, lack of artifacts) must be diagnostically acceptable and comparable to the output of predicate devices.
Study That Proves the Device Meets Acceptance Criteria (Inferred):
The "study" is the 510(k) submission process itself, which involves:
- Comparison to Predicate Devices: A detailed comparison of the Sony UP-DF500 FilmStation™ to the specified predicate devices (Agfa Drystar 4500, Codonics Horizon Series, Fuji Medical Dry Imager FM-DP 2636, Kodak Dry View 8610 Laser Imager) regarding their intended use, technological characteristics, and performance.
- Engineering and Performance Testing (not detailed in this summary): While not explicitly described in the provided sections, a 510(k) submission would typically include engineering tests and performance data to demonstrate that the device meets its design specifications and produces images equivalent in quality to predicate devices. This would cover aspects like resolution, Dmax/Dmin, uniformity, and artifact levels, likely tested against industry standards or internal specifications, rather than a clinical study with patient cases. The FDA's review and ultimate clearance (FEB 0 4 2003) signify that these factors were deemed acceptable.

In essence, for this type of device, the "study" is a technical comparison and evaluation of the device's technical specifications and output quality to ensure it is as safe and effective as existing legally marketed devices, rather than a clinical trial assessing diagnostic accuracy with expert readers.

Summary

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KO2 41 08

510(k) Summary

FEB 0 4 2003

for

Sony UP-DF500 FilmStation™ Digital Film Imager

1. Sponsor

Sony Medical Systems Division Sony Electronics Inc. 1 Sony Drive Park Ridge, NJ 07656

Contact Person: Mr. Anthony John Kefalos Phone Number: 201-358-4330

Date Prepared: December 18, 2002

2. Device Name

Proprietary Name:	UP-DF500 FilmStation™ Digital Film Imager
Common/Usual Name:	Thermal Printer/Imager
Classification Name:	Medical Image Hardcopy Device

Predicate Devices 3.

Agfa Drystar 4500 Printer . Agfa Medical Imaging K010275
Codonics Horizon Series Medical Multimedia Dry Imagers . Codonics, Inc. K021054
Fuji Medical Dry Imager FM-DP 2636 ● Fuji Medical Systems USA, Inc. K962967
KODAK DRY VIEW 8610 Laser Imager ● Eastman Kodak Company K002146

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4. Device Description

న. Intended Use

Technological Characteristics and Substantial Equivalence 6.

The Sony UP-DF500 FilmStation™ Digital Film Imager has the same overall purpose and function as the predicate devices cited above. All of the systems are intended to print a high-resolution, hard copy of an image generated by a medical imaging system. The printed images can be used for medical diagnostic purposes.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sony Electronics, Inc. % Cynthia A. Sinclair, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K024188 Trade/Device Name: Sony UP-DF500 FilmStation™ Digital Film Imager Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: December 18, 2002 Received: December 19, 2002

Dear Ms. Sinclair:

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 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.

FEB 0 4 2003

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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

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510(k) Number (if known): K 82 4188

Device Name: ___Sony UP-DF500 FilmStation™ Digital Film Imager

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Hanson

510(k) Nur

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Sony Medical Systems Division 510(k) December 18, 2002 UP-DF500 FilmStation™ Digital Film Imager

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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.