The DRYVIEW CHROMA Imaging System is intended to provide hard copy images from digital imaging source output signals. The device is intended for use with DRYVIEW CHROMA film and reflective media. The device will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging). The images are to be used for medical diagnosis and referral to physicians and their patients. The DRYVIEW CHROMA Imaging System is not intended for use with FFDM or CR Mammography systems.

Device Description

The DRYVIEW CHROMA Imaging System is an inkjet printing system. The DRYVIEW CHROMA Imaging System (CHROMA System) receives medical data including image and clinical report data from a digital modality. This data is received from medical image source devices (modalities) over a network and communicated to the CHROMA device via digital communication standard, DICOM. User control is performed directly by the modality or through the host control. The CHROMA System device prints the information received using piezoelectric inkjet technology. Tiny ink droplets are propelled from pizeoelectric nozzles in inige toenhology. " in media to form the image or report communicated by the digital modality. The CHROMA System device prints on transparent polyester based (film) as well as reflective (paper) media. Media is removed from a cartridge and transported into the CHROMA System device. Print data and media merge within the device. The CHROMA System employs the use of test patterns to verify imaging performance. A test pattern generator is incorporated to assure consistency between input signals and output density. Software is used to control the image management and machine functions. The information sent to the DICOM interface is used by the DICOM Interface to choose the correct set of printing parameters and halftone patterns for optimal image quality.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical imaging hardcopy device (an inkjet printer). Typically, for such a device, the "acceptance criteria" and "study" would focus on demonstrating that the output (the printed image) meets certain quality and consistency standards to be fit for medical diagnosis. However, the provided document focuses more on substantial equivalence to a predicate device and adherence to general safety and quality standards rather than detailed performance metrics of image quality that would be established through a clinical study.

Therefore, the information requested, particularly regarding clinical study details (sample size, ground truth, experts, MRMC studies), is largely not present in this document because this type of device (a printer) is evaluated differently than, for example, a diagnostic AI algorithm.

Here's a breakdown of what can be extracted and what is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness	Assured via meeting voluntary standards: DICOM, IEC 62304, UL 60950, IEC 60601-1-2 and ISO 14971.
Printer Functionality	Receives medical data (image and clinical report) from digital modalities over a network via DICOM. Uses piezoelectric inkjet technology to print on transparent polyester-based (film) and reflective (paper) media.
Image Consistency	Test patterns are incorporated to assure consistency between input signals and output density.
Image Management & Machine Control	Software controls image management and machine functions. DICOM interface uses information to choose correct printing parameters and halftone patterns for optimal image quality.
Substantial Equivalence	Concluded to be as safe and effective as the predicate device (Codonics Horizon Ci Medical Image Multimedia Imager - K021054) based on similar design to equivalent/comparable safety standards and absence of new safety/efficacy issues.
Patient Contact	No patient contact.
Impact on Other Devices	Does not control, monitor, or otherwise affect any devices directly connected to or affecting the patient.

2. Sample size used for the test set and the data provenance

Not explicitly stated for a "test set" in the context of clinical performance evaluation. The document describes meeting voluntary standards and substantial equivalence, which implies engineering and system-level testing, but not a patient-data-driven "test set" in the diagnostic sense.
Data Provenance: Not applicable. The "data" are digital images from various modalities (CR, DR, CT, MRI) that the printer receives. The provenance of these images themselves is not relevant to the printer's performance evaluation as described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a printer. Its performance is assessed through technical specifications and comparison to a predicate device, not by expert interpretation of printed images in a diagnostic study where ground truth would be established.

4. Adjudication method for the test set

Not applicable. See point 3.

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 is not an AI-assisted diagnostic device. It is a hardcopy printer. MRMC studies are not relevant nor mentioned.

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

Not applicable. This is a printer, not a diagnostic algorithm. Its function is to reproduce digital images on physical media. Its "performance" is about faithful reproduction and reliability, not diagnostic accuracy.

7. The type of ground truth used

Not applicable. The concept of "ground truth" for diagnostic accuracy (e.g., pathology, outcomes data) does not apply to a medical image hardcopy device like this. The closest analogous concept would be the fidelity of the printed output to the digital input, which is assessed through technical printing parameters and test patterns.

8. The sample size for the training set

Not applicable. This is a hardware device (printer) with embedded software for control and image processing. It is not an AI/machine learning model that undergoes "training" on a dataset in the conventional sense.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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Carestream Health, Inc.

Traditional 510k DRYVIEW CHROMA Imaging System

OCT - 6 2011

Section B

510(k) Summary

June 3, 2011

CARESTREAM Health, Inc. 150 Verona Street Rochester, NY 14608

Contact: Christine Ehmann

Phone: 585-627-6473 FAX: 585-323-7643

Device

Trade name:	DRYVIEW CHROMA Imaging System
Common name:	Inkjet Printer
Classification name:	Medical Image Hardcopy Device (21 CFR 892.2040)

Codonics Horizon Ci Medical Image Multimedia Imager Predicate device (K021054)

Description and Intended Use of Device

Technological Characteristics

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The CHROMA System device prints the information received using piezoelectric inkjet technology. Tiny ink droplets are propelled from pizeoelectric nozzles in inige toenhology. " in media to form the image or report communicated by the digital modality.

The CHROMA System device prints on transparent polyester based (film) as well as reflective (paper) media. Media is removed from a cartridge and transported into the CHROMA System device. Print data and media merge within the device.

The CHROMA System employs the use of test patterns to verify imaging performance. A test pattern generator is incorporated to assure consistency between input signals and output density.

Software is used to control the image management and machine functions. The information sent to the DICOM interface is used by the DICOM Interface to choose the correct set of printing parameters and halftone patterns for optimal image quality.

Performance Data

Safety and effectiveness are assured via meeting voluntary standards, including: DICOM, IEC 62304, UL 60950, IEC 60601-1-2 and ISO 14971.

Conclusion

The CHROMA System, like the predicate, has no patient contact. The CHROMA System device does not control, monitor or otherwise affect any devices directly connected to or affecting the patient. Medical personnel review images and hardcopy reports printed by the subject device and its predicate. The images or reports may be reprinted, if desired, by the end user since the original image data or report is stored on a connected modality..

As with the predicate device, a test pattern generator is incorporated to assure consistency between input signals and output density. Both are hardcopy printers that employ the use of test patterns to verify imaging performance.

The DRYVIEW CHROMA Imaging System and predicate device Codonics Horizon Ci Medical Image Multimedia Imager (Codonics Horizon Ci) have both been designed to the equivalent or comparable safety standards. The hazards associated with the DRYVIEW CHROMA Imaging System do not pose any new safety or efficacy issues compared to those associated with the predicate device as well as other medical image hardcopy devices.

Carestream Health concludes that the DRYVIEW CHROMA Imaging System is as safe and effective as the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of a stylized bird. The bird is made up of three curved lines that represent the wings and body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Christine Ehmann Regulatory Affairs Director CARESTREAM Health, Inc. 150 Verona Street ROCHESTER NY 14608

6 2011

Re: K111566

Trade/Device Name: DRYVIEW CHROMA Imaging System Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: August 10, 2011 Received: August 12, 2011

Dear Ms. Ehmann:

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.

ff your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 inean 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 Parts 801 and 809); medical device reporting (reportion of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This feter 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 (2) CFR Parts $01 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K111566

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The DRYVIEW CHROMA Imaging System is intended to provide hard copy images from digital imaging source output signals. The device is intended for use with DRY VIEW CHROMA film and reflective media. The printer will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography) and MRI (Magnetic Resonance Imaging). The images are to be (sed for medical diagnosis and referral to physicians and their patients. The DRYVIEW about of maging System is not intended for use with FFDM or CR Mammography systems.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Spottl

Office of In Vitro Diagnostic L

510K K11566

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.