The Drystar 5300 is a free-standing 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.

Device Description

The Drystar 5300 is a dry process, B/W medical image printer, using the direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality. The printer has one film input tray, which can contain either 11x14 or 14x17 film. The printer is a networkonly printer.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Drystar 5300M, structured as requested:

Acceptance Criteria and Device Performance Study for Drystar 5300M

This submission is a 510(k) for a medical image hardcopy device, the Drystar 5300M. The primary method for demonstrating substantial equivalence is through comparison to predicate devices, namely the Drystar 5500 and Drystar 2000/3000. For this type of device (a printer), the "performance" is generally related to its ability to print diagnostic quality images and meet safety/EMC standards. The document primarily focuses on establishing equivalence based on shared technological characteristics and existing predicate device clearances.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Test	Reported Device Performance
Technological Equivalence	"Same technological characteristics" as predicate devices (Drystar 3000 and 5500)	Met: Drystar 5300 "has the same technological characteristics" and "All use a thermal process to produce medical images."
Electrical Safety	Compliance with EN 60601-1-1 and UL-2601	Met: Device was tested for electrical safety according to these standards, as described in the 510(k) for the Drystar 4500. Electrical systems are "the same across the different models of the Drystar family of printers."
Electromagnetic Compatibility (EMC)	Compliance with EN 60601-1-2	Met: Device was tested for EMC according to this standard, as described in the 510(k) for the Drystar 4500. Electrical systems and chassis are "the same across the models of the Drystar family of printers."
Intended Use	Printing diagnostic images on transparent film for viewing on a standard view box; hard copy of images from medical imaging devices.	Met: Drystar 5300 "has the same indications for use as the legally marketed Drystar 5500."
Image Quality (Implied)	"Medical diagnostic image quality" (mentioned in device description)	Implied Met: The device uses a "direct thermal printing principle to establish continuous-tone images with medical diagnostic image quality." The equivalence claim suggests it meets this standard, though no specific quantitative metrics or reader studies are provided in this summary to explicitly prove "diagnostic image quality" outside of the substantial equivalence framework.

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

This document describes a substantial equivalence submission, not a study with a traditional "test set" of medical images or patient data in the sense of an AI algorithm.

For electrical safety and EMC testing, the "sample" would be the Drystar 5300 device itself. The tests were performed on the device. No specific number of units tested is provided, but it's presumed to be a sufficient number for type testing.
The data provenance is related to the internal testing of the Agfa Corporation, as they would have conducted the safety and EMC evaluations. The document refers to testing "as described in the 510(k) for the Drystar 4500," suggesting a reliance on established testing protocols and potentially previous reports for analogous devices from the same family.

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

Not applicable. This is a submission for a medical image printer, not a diagnostic algorithm that requires expert ground truth establishment for a test set of medical cases. The "ground truth" for the printer's function is its ability to physically print, and for safety/EMC, it's compliance with established engineering standards.

4. Adjudication Method for the Test Set

Not applicable, for the same reasons as above.

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

No. This device is a printer, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or included.

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

Not applicable. This is a physical device (printer), not a standalone algorithm.

7. The Type of Ground Truth Used

For technical characteristics and safety/EMC, the "ground truth" is adherence to established engineering standards (EN 60601-1-1, UL-2601, EN 60601-1-2) and the demonstrated equivalence of the device's design and function to previously cleared predicate devices.
For "medical diagnostic image quality," the ground truth is implicitly defined by the ability of the predicate devices (Drystar 5500, Drystar 2000/3000) to produce images deemed acceptable for diagnostic viewing. The Drystar 5300 claims to achieve this same standard through its thermal printing process. No external pathology or outcomes data is referenced for this printer specifically in relation to image quality acceptance.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (printer), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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510(k) Summary

Drystar 5300M

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

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

Contact: Jeff Jedlicka, Prepared: August 11, 2003

LEGALLY MARKETED PREDICATE DEVICES A.

This 510(k) Premarket Notification will demonstrate that the Drystar 5300 medical printer is substantially equivalent to the Drystar 5500 and Drystar 2000/3000 printers. The 2000/3000 was cleared for marketing by FDA under K943602 on May 12, 1995, and the 5500 was cleared for marketing under K023287 on October 22, 2002.

B. DEVICE DESCRIPTION

C. INTENDED USE

SUBSTANTIAL EQUIVALENCE SUMMARY D.

The Drystar 5300 is a medical device and it has the same indications for use as the legally marketed Drystar 5500. The Drystar 5300 has the same technological characteristics to the Drystar 5500. This premarket notification will describe the characteristics of the Drystar 5300 in sufficient detail to assure substantial equivalence. For a few

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characteristics, performance data is provided to demonstrate equivalence.

ய் TECHNOLOGICAL CHARACTERISTICS

The Drystar 5300 has the "same technological characteristics" as the currently marketed Drystar 3000 and 5500 printer. All use a thermal process to produce medical images.

TESTING ட்

The device was tested for electrical safety according to EN 60601-1-1 and UL-2601, as was described in the 510(k) for the Drystar 4500. The electrical systems are the same across the different models of the Drystar family of printers.

The device was tested for electromagnetic compatibility according to EN 60601-1-2, as described in the 510(k) for the Drystar 4500. The electrical systems and chassis are the same across the models of the Drystar family of printers.

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 a black and white logo. The logo features a stylized bird with three lines forming its body and wings. The bird is facing left. Encircling the bird is text, which is difficult to read due to the image quality. The logo appears to be a seal or emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2003

Mr. Jeffery A. Jedlicka Manager of Regulatory Affairs AGFA Corporation 10 South Academy Street Mail Stop 100 GREENVILLE SC 29601

Re: K032635

Trade/Device Name: Drystar 5300 Imager Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: August 26, 2003 Received: August 26, 2003

Dear Mr. Jedlicka:

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.

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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

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

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to proceed to the market.

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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 801.109)

Over-The-Counter Use

Daniel A. Layson

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

000032

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.