KODAK DIGITAL SCIENCE Distributed Medical Imagers are computer peripheral printing devices used to make hard copy of medical images and reports on paper and/or film.

Device Description

KODAK DIGITAL SCIENCE 3600 Distributed Medical Imager is designed for mid to high end desktop Referral Imaging and Distributed Medical Imaging applications printing color or monochrome images on Medical Paper and/or Film Media up to 11x14 inch, with dual media supply trays and optional network interfacing.

KODAK DIGITAL SCIENCE 1200 Distributed Medical Imager is designed for low end to mid range desktop Referral Imaging and Distributed Medical Imaging applications printing color or monochrome images on Medical paper and/or film up to 8.5x11 inch, with a single media supply tray.

AI/ML Overview

Here's an analysis of the provided text regarding the Eastman Kodak Company KODAK DIGITAL SCIENCE Distributed Medical Imagers (K983905), focusing on the acceptance criteria and the study to prove device performance.

Important Note: The provided document is a 510(k) summary for a medical device that acts as a printer. Therefore, the "acceptance criteria" and "study" are not related to diagnostic accuracy or clinical outcomes as one might expect for a diagnostic AI device. Instead, they focus on the device's technical specifications and substantial equivalence to a predicate device. The information provided is primarily about comparing the new device's features and performance parameters to an already approved device.

Acceptance Criteria and Reported Device Performance

The core of the "acceptance criteria" for these devices is demonstrating substantial equivalence to a predicate device, the KODAK EKTASCAN Medical Color Imager 2000PS (KEMCI 2000PS) (K951948). The performance is reported by comparing the specifications of the new devices to the predicate.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	KODAK DIGITAL SCIENCE 3600 DMI Performance	KODAK DIGITAL SCIENCE 1200 DMI Performance
Purpose and Functionality: Computer peripheral printing device for hard copy of medical images and reports on paper/film.	Yes (Inkjet printing)	Yes (Inkjet printing)
Printing Method: Produce monochrome or color images.	Inkjet	Inkjet
Interfaces: Similar connectivity options.	Parallel: IEEE 1284, Optional: Ethernet	Parallel: IEEE 1284
Standards Compliance: Meet relevant safety and regulatory standards.	UL, CSA, FCC, EN50082, etc.	UL, CSA, FCC, EN50082, etc.
Print Media Types: Printing on coated paper, transparency, plain paper, card stock.	Coated Paper, Transparency (blue), Plain Paper, Card Stock	Coated Paper, Transparency (blue), Plain Paper, Card Stock
Monochrome Printing: Capability to print in black and white.	Yes	Yes
Color Printing: Capability to print in color.	Yes	Yes
Output Print Quality: The new devices' output is "similar" to the predicate. (Detailed resolution improvement noted)	1200 dots per inch	1200 dots per inch

Explanation of Substantial Equivalence: The document asserts that the new devices' purpose and functionality are "substantially equivalent" to the predicate. The basis for this is that all devices are computer peripheral printing devices printing monochrome or color images on paper or transparency media. The key technological difference is the printing method (Inkjet for new devices vs. Thermal Dye Sublimation for the predicate). However, the submission concludes that, despite this difference, "the function and output of the SE devices is similar to that of the predicate device" and that they are "as safe and effective as the predicate device."

Study Details:

Given that this is a 510(k) submission for a printer, and not a diagnostic AI device, the concepts of "test set," "ground truth," and "multi-reader multi-case (MRMC) studies" are not directly applicable in the conventional sense. The "study" here is essentially the comparison of specifications and technical performance to demonstrate substantial equivalence to the predicate device.

Sample size used for the test set and the data provenance:
- Test Set Description / Sample Size: Not applicable in the context of a "test set" for diagnostic performance. The evaluation is based on comparing the published specifications and performance characteristics of the new devices against those of the predicate device.
- Data Provenance: The data provenance is from the manufacturer's own specifications and testing, likely internal engineering and quality assurance tests performed during the development of these printers. The document does not specify the country of origin for this data or if it was retrospective or prospective, but it would inherently be prospective testing of the newly manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" in the diagnostic sense for a printer. The "truth" is whether the printer meets its mechanical and output specifications (e.g., resolution, media handling, color accuracy, interface compatibility), which would be verified by engineering tests against predetermined design specifications.
Adjudication method for the test set:
- Not applicable. There is no adjudication method described because there isn't a diagnostic ground truth or expert interpretation involved.
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 MRMC study was done. This type of study is irrelevant for a medical image printer. The device's purpose is to produce physical copies of images/reports, not to aid in interpretation or diagnosis.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a peripheral output device, not a standalone diagnostic algorithm. Its performance is evaluated based on its ability to accurately reproduce digital images on physical media.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For a printer, the "ground truth" would be related to engineering specifications, e.g., "does the printer accurately reproduce colors according to color calibration standards," or "does it print at 1200 DPI as specified." These are objective, measurable technical parameters, not clinical "ground truth."
The sample size for the training set:
- Not applicable. This device is a printer, not an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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K983905

JAN 25 1999

Appendix G -- Summary of Safety and Effectiveness

I. Date Prepared

October 30, 1998

II. Submitter

Eastman Kodak Company Health Imaging Division 343 State Street Rochester, New York 14650

III. Contact Person

Judith A. Wallace Regulatory Affairs (716) 724-2314

IV. Device Names

Trade Names: KODAK DIGITAL SCIENCE 3600 Distributed Medical Imager KODAK DIGITAL SCIENCE 1200 Distributed Medical Imager

Common Names: 3600 DMI; 3600 Imager 1200 DMI; 1200 Imager

V. Device Classification

FDA has classified the predicate device as Regulatory Class II under CFR 892.1750

VI. Predicate Device

KODAK EKTASCAN Medical Color Imager 2000PS ('KEMCI 2000'); 510(k) number K951948

VII. Description of Devices

KODAK DIGITAL SCIENCE 1200 Distributed Medical Imager is designed for low end to mid range desktop Referral Imaging and Distributed Medical

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Imaging applications printing color or monochrome images on Medical paper and/or film up to 8.5x11 inch, with a single media supply tray.

Accessories: Media & Inks

KODAK DIGITAL SCIENCE Distributed Medical Imaging Paper / 8.5x11 in.
· KODAK DIGITAL SCIENCE Distributed Medical Imaging Paper / A4
KODAK DIGITAL SCIENCE Distributed Medical Imaging Paper / 4x6 in.
KODAK DIGITAL SCIENCE Distributed Medical Imaging Film / 8x10 in.
KODAK DIGITAL SCIENCE Distributed Medical Imaging Film / 11x14 in.
KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Black 1
KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Black 2
KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Color 1
KODAK DIGITAL SCIENCE Distributed Medical Imaging Cartridge / Color 2

VIII. Indications for Use

KODAK DIGITAL SCIENCE Distributed Medical Imagers are computer peripheral printing devices used to make hard copy of medical images and reports on paper and/or film.

IX. Substantial Equivalence:

The purpose and functionality of the KODAK DIGITAL SCIENCE Distributed Medical Imagers is substantially equivalent to the KODAK EKTASCAN Medical Color Imager 2000PS. The basis for the equivalence is that the 3600 and 1200 Imagers, like the KEMCI 2000PS, are computer peripheral printing devices which print monochrome or color images on paper or transparency media. The primary difference is that the 3600 and 1200 Imagers directly deposit black or color inks onto the receiving media to render the image whereas the KEMCI 2000PS uses heat to transfer black or color dyes from a substrate material onto the receiving media.

Although technologically different, the function and output of the SE devices is similar to that of the predicate device and we conclude that the SE devices are as safe and effective as the predicate device.

Specification	KODAK DIGITAL SCIENCE3600 Distributed MedicalImager	KODAK DIGITAL SCIENCE1200 Distributed MedicalImager	KODAK EKTASCANMedical Color Imager2000PS
Printing Method	Inkjet	Inkjet	Thermal Dye Sublimation
Interfaces	Parallel: IEEE 1284Optional: Ethernet,10Base2 RJ45	Parallel: IEEE 1284	Parallel: IEEE 1284Optional: Ethernet,10Base2 RJ45SCSI (2 ports)
Standards	UL, CSA, FCC, EN50082,CISPR 22, VCCI, CE Mark,C-Tick, Energy Star, SETIMark, SEMKO	UL, CSA, FCC, EN50082,CISPR 22, VCCI, CE Mark,C-Tick, Energy Star	UL, CSA, TUV-GS, FCC,ICES, EN500, VCCI, CEMark
Sheet Sizes	A3 (11.69x16.54 in.)Tabloid (11x17 in.)11x14 in.8x10 in.	8x10 in.LetterLegalA4	8.5x11.0 in.8.5x11.7 in.8.5x14.0 in.9.5x14.0 in.

Tabular Comparison of Features and Specifications of the Devices:

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	LetterLegalA4ExecutiveB5A5Custom:3x5 in. min.12.6x22 in. max.	ExecutiveB5A5A6
Print Media	Coated PaperTransparency (blue)Plain PaperCard Stock	Coated PaperTransparency (blue)Plain PaperCard Stock	Coated PaperTransparency (clear)
Media Supplies	1 or 2	1	1
Monochrome Printing	Yes	Yes	Yes
Color Printing	Yes	Yes	Yes
Print Resolution	1200 dots per inch	1200 dots per inch	300 pixels per inch
Hard Drive	optional	none	none
Memory	8-64 MB RAM	n/a	48 MB RAM

$$\begin{array}{c} \text{G}^{\text{'}} \text{3} \ \text{10/30/98} \end{array}$$

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is black and the background is white. The text is centered in the image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 25 1999

Judith A. Wallace Regulatory Affairs Associate Eastman Kodak Company Health Imaging Division 901 Elmgrove Road Rochester. NY 14653

Re:

K983905 Kodak Digital Science 1200 & 3600 Distributed Medical Imagers Dated: October 30, 1998 Received: November 3, 1998 Regulatory class: II 21 CFR 892.2040/Procode: 90 LMC

Dear Ms. Wallace:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation 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 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,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Facsimile of CDRH's "Indication for Use" Page 3.

510(k) Number (if known): K983905

Device Name:

KODAK DIGITAL SCIENCE 3600 Distributed Medical Imager KODAK DIGITAL SCIENCE 1200 Distributed Medical Imager

Indication of Use:

KODAK DIGITAL SCIENCE Distributed Medical Imagers are computer peripheral printing devices used to make hard copy of medical images and reports on paper and/or film.

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
Concurrence of CDRH, Office of Device Evaluation
and Radiological Devices
510(k) Number K983905

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter _

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.