The Kodak Color Medical Imager 1000 series medical printers are thermal print engines intended to produce continuous tone photographic quality hard copy output with integrated color management that adjusts printed colors to accurately match medical image monitors or user specified color profiles. The hardcopy output includes, however is not limited to, nuclear medicine, ultrasound, CT (especially 3-D reconstruction), MRI and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. Digital images can be acquired from, but not limited to local area networks (LAN), Internet, medical image storage devices, or directly from digital medical image capture modalities. The system of printer and physical image is not a high-resolution device and is not intended for use with FFDM systems.

Device Description

The KODAK Color Medical Imager 1000 is intended for use as a hard copy device for output from imaging source modalities used in medical imaging diagnosis and referral. Electronic image information signals are managed in the KODAK Color Medical Imager 1000 and transformed to heat a color donor ribbon and drive color dyes to a receptor sheet using thermal dye sublimation technology.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria related to device performance in terms of diagnostic accuracy, nor does it describe a study that quantitatively proves the device meets such criteria through a clinical trial or performance evaluation with human readers.

Instead, the document focuses on regulatory compliance, safety, and substantial equivalence to a predicate device based on technical characteristics and adherence to voluntary standards.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria Type	Acceptance Criteria (Stated)	Reported Device Performance
Regulatory & Safety	Meeting voluntary standards: DICOM, SMPTE, UL 60950, IEC 60601-1-1, ISO 12207, ISO 14971.	Not explicitly quantified, but the conclusion states "Safety and effectiveness are assured via meeting voluntary standards," and the device is deemed "as safe and effective as the predicate device."
Intended Use	Produce continuous tone photographic quality hard copy output with integrated color management that adjusts printed colors to accurately match medical image monitors or user specified color profiles. Suitable for medical image diagnosis use and referral. Not a high-resolution device, not for FFDM systems.	Not explicitly quantified. Implicitly met by the device's design and intended use statement. The device is intended to perform this function, and substantial equivalence implies it does so comparably to the predicate.
Technological Basis	Use same technical design base as predicate (Codonics EP-1000). Receive image data from modality. User control via modality/host control. KODAK DRYVIEW media.	Stated that "The subject device and predicate devices use the same technical design base." and describes the operational flow, suggesting these characteristics are met by design.
Patient Contact	No patient contact.	Stated: "The subject device, like the predicate, has no patient contact."
Control of other devices	Does not control, monitor or otherwise affect any devices directly connected to or affecting the patient.	Stated: "The devices also do not control, monitor or otherwise affect any devices directly connected to or affecting the patient."

Missing Information (based on the provided text):

The document does not provide information on:

Sample size used for the test set and the data provenance: There is no mention of a test set for performance evaluation in terms of diagnostic accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no diagnostic performance study, there's no ground truth establishment for a test set.
Adjudication method for the test set: Not applicable as no diagnostic performance study is described.
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: This is a non-AI device (a medical imager/printer), so an MRMC study with AI assistance is not relevant or described. The document mentions "Medical personnel review images displayed by the subject device and its predicates. This offers ample opportunity for competent human intervention in case of a malfunction or other failure," which refers to the human role in the diagnostic process after the image is printed, not as part of an AI-assisted interpretation study of the device itself.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for this type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no diagnostic performance study is described.
The sample size for the training set: Not applicable, as this is not an AI/algorithm-based diagnostic device requiring a training set in that context.
How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the document):

The document describes a substantial equivalence determination study rather than a clinical performance study. The core "study" is a comparison of the KODAK Color Medical Imager 1000 to a predicate device, the Codonics EP-1000 Medical Color dry imager (K030690). The "proof" that the device meets acceptance criteria primarily relies on:

Similarity in Intended Use: The intended uses are stated to be similar.
Technological Characteristics: The subject device is stated to use the "same technical design base" as the predicate device.
Adherence to Voluntary Standards: The device meets recognized safety and performance standards (DICOM, SMPTE, UL 60950, IEC 60601-1-1, ISO 12207, and ISO 14971).
Safety Profile: Both devices have no patient contact and do not control other patient-affecting devices. The document highlights the role of human medical personnel in reviewing images as a safeguard.

In essence, the "study" is a regulatory submission process demonstrating that the new device is "as safe and effective" as a legally marketed predicate device based on direct comparison of its design, intended use, and compliance with general safety and performance standards, rather than a clinical trial measuring diagnostic accuracy using a test set and ground truth.

Summary

{0}------------------------------------------------

K042/59

SEP 2 4 2004

Section B1

510(k) Summary

September 14, 2004

Eastman Kodak Company 343 State Street Rochester NY 14650

Contact: Stephen Slavens 1 Imation Way, 304-3B-61 Oakdale, MN 55128 Phone: 651-393-1395 FAX: 651-393-1440

Device:

Trade name: Common name: Classification name: KODAK Color Medical Imager 1000 KPRO 8500 Color Printer Medical Image Hardcopy Device 21 CFR 892.2040

Predicate device:

Codonics EP-1000 Medical Color dry imager (K030690)

Description And Intended Use of Device:

The Intended Use of the Kodak Color Medical Imager 1000 series medical printers is as thermal print engines intended to produce continuous tone photographic quality hard copy output with integrated color management that adjusts printed colors to accurately match medical image monitors or user specified color profiles. The hardcopy output includes, however is not limited to, nuclear medicine, ultrasound, CT (especially 3-D reconstruction), MRI and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. Digital images can be acquired from, but not limited to local area networks (LAN), Internet, medical image storage devices, or directly from digital medical image capture modalities.

Technological Characteristics:

The subject device and predicate devices use the same technical design base. The printers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK DRYVIEW imaging media is removed from a daylight cartridge and transported to the laser imaging station. Image data and media merge at the laser station and the film is scanned. The exposed media is transported through the integrated processor and exits the printer.

{1}------------------------------------------------

Software is used to control the image management and machine functions

Performance Data:

Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, SMPTE, UL 60950, IEC 60601-1-1, ISO 12207, and ISO 14971.

Conclusion:

The subject device, like the predicate, has no patient contact. The devices also do not control, monitor or otherwise affect any devices directly connected to or affecting the patient. Medical personnel review images displayed by the subject device and its predicates. This offers ample opportunity for competent human intervention in case of a malfunction or other failure.

The subject KODAK Color Medical Imager 1000 and predicate device, the Codonics EP-1000 Medical Color dry imager (K030690) have been designed to the equivalent safety standards.

Eastman Kodak therefore concludes that the KODAK Color Medical Imager 1000 is as safe and effective as the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of several curved lines that create the shape of the bird's wings and body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2004

Mr. Stephen Slavens Regulatory Affairs Director Eastman Kodak Company Health Imaging Group, Digital Output SPG 1 Imation Wav. 304-3B-61 OAKDALE MN 55128-3414

Re: K042159 Trade/Device Name: KODAK Color Medical Imager 1000 Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: August 5, 2004

Received: August 10, 2004

· Dear Mr. Slavens:

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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter whilanow you to ought manies. By substantial equivalence of your device to a legally premarket notification. The PPA mialing sification 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 advice to: your 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 Additionally, for questions on and please note the regulation entitled, "Misbranding Other of Othphanoo at (2001) 21 CFR Part 807.97) you may obtain. Other general of received to promarity in the Act may be obtained from the Division of Small nitormation on your responsion. 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. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Section B2

Statement of Indications for Use:

510(K) Number (if known): _

Device Name: KODAK Color Medical Imager 1000

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use \checkmark OR Over the Counter Use __

(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number __ K042159

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.