The Drystar 5500M is a free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

Device Description

The device is the new Drystar 5500 and it is a dry, B/W printer, using the direct thermal printing principle to produce continuous-tone images with medical diagnostic image quality onto plastic sheets which can be viewed on a light box. The device has two input trays. Each tray can be adjusted to five different sizes (in inches) of film, including 8x10, 10x12, 11x14, 14x14 and 14x17. Three different types of film can be used in this new device, two for general purpose radiography and a new type of film for mammography, Drystar DT 2 M. The new mammography film comes in only two sizes 8x10 and 10x12. It is thicker than the general purpose radiography film in order to provide a wider range of optical densities. The printer also handles borders for mammography images in a different manner than for regular medical images. Otherwise, the device is very similar to the cleared original Drystar 5500.

AI/ML Overview

The provided document describes the Agfa Drystar 5500 printer, a medical image hard copy device, and focuses on its substantial equivalence to previously cleared devices. It does not contain information about studies proving the device meets specific acceptance criteria related to its performance in image quality or diagnostic accuracy studies in the way a diagnostic AI device report would.

Instead, the "acceptance criteria" for this device are primarily related to its functional equivalence to predicate devices and compliance with regulatory standards for safety and electromagnetic compatibility.

Here's an analysis based on the provided text, while acknowledging that a diagnostic performance study as one might expect for an AI device is NOT present:

Acceptance Criteria and Device Performance (as inferred from the document):

Acceptance Criteria Category	Criterion Description (Inferred)	Reported Device Performance (as stated in document)
Functional Equivalence (General Printing)	Produce continuous-tone B/W images with medical diagnostic image quality on plastic sheets.	The device uses "direct thermal printing principle to produce continuous-tone images with medical diagnostic image quality onto plastic sheets."
Mammography Image Printing	Ability to print mammography images on film suitable for diagnostic viewing.	"It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable, including digital mammography."
Film Compatibility	Support use with general purpose radiography film and a new type of mammography film (Drystar DT 2 M).	"Three different types of film can be used in this new device, two for general purpose radiography and a new type of film for mammography, Drystar DT 2 M."
Film Sizes	Accommodate specific film sizes for general radiography and mammography.	"Each tray can be adjusted to five different sizes (in inches) of film, including 8x10, 10x12, 11x14, 14x14 and 14x17. The new mammography film comes in only two sizes 8x10 and 10x12."
Optical Density (Mammography)	Provide a wider range of optical densities for mammography film.	Mammography film "is thicker... in order to provide a wider range of optical densities."
Mammography Quality Standards Act (MQSA) Compliance	Meet compliance requirements of the MQSA.	"The Drystar 5500 contains an automatic QC procedure that assures compliance with the Mammography Quality Standards Act (MQSA) of the FDA."
Safety and Electromagnetic Compatibility	Compliance with relevant consensus standards for safety and electromagnetic compatibility.	"It was also tested against and met a number of consensus standards for safety and electromagnetic compatibility."
Substantial Equivalence (General)	Be substantially equivalent in intended use and technological characteristics to predicate devices (Drystar 4500M, Drystar 5500).	The document's primary conclusion is that "This pre-market submission has demonstrated Substantial Equivalence."

Study Details (Based on available information):

The document does not describe a "study" in the sense of a clinical trial or performance evaluation with human readers and ground truth data for diagnostic accuracy. Instead, it refers to regulatory compliance and functional testing.

Sample size used for the test set and the data provenance: Not applicable in the context of image quality or diagnostic accuracy studies. The testing mentioned refers to functional, safety, and regulatory compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a test set with ground truth established by experts for diagnostic performance.
Adjudication method for the test set: Not applicable. There is no mention of a test set requiring adjudication in this context.
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 a printer, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a printer, not an algorithm.
The type of ground truth used: Not applicable for diagnostic performance. The "ground truth" here would be functional specifications, regulatory standards, and physical measurements (e.g., optical density, film size, continuous tone output).
The sample size for the training set: Not applicable. This device is a printer, not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable.

Summary from the document:

The Agfa Drystar 5500 printer submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Drystar 4500M and previous Drystar 5500). The "study" aspects mentioned are internal functional testing, compliance with the Mammography Quality Standards Act (MQSA) via an automatic QC procedure, and adherence to consensus standards for safety and electromagnetic compatibility. These tests confirm the device's ability to mechanically and functionally operate as intended and meet relevant regulatory requirements for a medical image hard copy device, particularly for mammography output. It is not a study assessing diagnostic performance or AI effectiveness.

Summary

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K052251

510(k) Summary

Drystar 5500

Common/Classification Name: Medical Image Hard Copy Device 21 CFR 892.2040

Sponsor:

Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048

Contact:

Jeff Jedlicka Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048

Prepared: July 18, 2005

A. Legally Marketed Predicate Devices.

The Drystar 4500M printer is legally marketed (cleared) under 510(k) number K012941 and the original Drystar 5500 printer was cleared under K023287. The new Drystar 5500, the subject of the present 510(k), is very similar to the cleared Drystar 5500 in both hardware and software. From the point of view of the hardware and 5500 in othe Drystar 5500 is substantially equivalent to the Drystar 5500. From the soint of view of the intended use of the device, dry printing mammography images on film, the device is substantially equivalent to the Drystar 4500M.

B. Device Description.

The new mammography film comes in only two sizes 8x10 and 10x12. It is thicker than the general purpose radiography film in order to provide a wider range of

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optical densities. The printer also handles borders for mammography images in a different manner than for regular medical images.

Otherwise, the device is very similar to the cleared original Drystar 5500.

ﻥ Intended Use.

The Drystar 5500 is a free-standing dry film printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable, including digital mammography.

D. Substantial Equivalence Summary.

The new Drystar 5500 has the same indications for use as the cleared Drystar 5500, except for an additional indication for use with mammography film copying. The cleared Drystar 4500M has the same indications as the new Drystar 5500.

The new Drystar 5500 has essentially the same technological characteristics as the cleared Drystar 5500. The differences can be seen in Table 3.1 located in Section III.

This premarket notification has described the characteristics of the Drystar 5500 in sufficient detail to assure a substantial equivalence determination.

E. Technological Characteristics.

The technological characteristics of the new Drystar 5500 are identical to those of the predicate device, the Drystar 5500. The technological characteristics of the Drystar 550 are also very similar to those of the Drystar 4500M.

F. Testing

The Drystar 5500 contains an automatic QC procedure that assures compliance with the Mammography Quality Standards Act (MQSA) of the FDA. It was also tested against and met a number of consensus standards for safety and electromagnetic compatibility.

G. Conclusions.

This pre-market submission has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(l)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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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 is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AGFA Corporation % Mr. Jeffrev D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709 Re: K052251

AUG 3 1 2005

Trade/Device Name: Drystar 5500 Printer Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: August 12, 2005 Received: August 18, 2005

Dear Mr. Rongero:

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 (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 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) I ms letter will anow you to begin manage.
premarket notification. The FDA finding of substantial equivalence of your device to a legally prematication. The PDF Imanig of Cassification 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 specific active for your as the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entires, common on your responsibilities under the Act from the 807.77). Tod may oouall outer generalianal 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/industry/support/index.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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Indications for Use

510(k) Number (if known): KoszZS1

Device Name: Drystar 5500 printer

Indications for Use:

The Drystar 5500M is a free standing device used to print diagnostic conventional and The Drystar 5500M Is a tree Standing uction on a standard view box. It may
mammography images on transparent film for viewing on a standard view box. It may mammography images on transparbirt him for than image generated by a medical imaging device is required or desirable.

Prescription Use __ X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Lepson

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

Page 1 of 1.

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.