The Quality Control Workstation allows radiologist technicians to enter patient information and/or correct erroneous patient information, exam information, and if necessary, the image look and/or image orientation. It allows them to route it to different locations to give greater flexibility to physicians in analyzing patient images.

Device Description

Kodak's Quality Control Workstation is a Sun Microsystems based workstation for the display, printing, and manipulation of medical images. The Quality Control Workstation is designed with an ethernet interface to interface with other Kodak products or digital systems using ACR/NEMA compatible interfaces and or DICOM.

AI/ML Overview

The provided text describes a 510(k) submission for the KODAK Digital Science Quality Control Workstation, primarily focusing on its features and how it compares to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria.

The purpose of this 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a specific performance claim against predefined acceptance criteria through a formal study with detailed statistical analysis.

Therefore, many of the requested details, such as sample size, ground truth establishment for a test set, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are not present in the provided document.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the sense of quantitative performance thresholds for a clinical study. Instead, it focuses on demonstrating that the new device's features are comparable to the predicate device and that its functionality is safe and effective for its stated indications for use.

The "device performance" reported is primarily a feature comparison, showing that the new device either matches or improves upon the predicate device's capabilities.

Acceptance Criteria (Implied)	Reported Device Performance
General Functionality: Image enhancement, productivity improvement, proper display for diagnostic purposes, elimination of film cassettes/darkroom processing/sterilization need.	KODAK Digital Science Quality Control Workstation: - Image enhancement for proper display for diagnostic purposes. - Productivity improvement, eliminates film cassettes and darkroom processing, eliminates the need to sterilize film cassettes. - New Image Processing Library.
Hardware/Environmental Compatibility: Power, environmental conditions, acquisition unit, disk storage, network, video inputs, image capture/store time.	KODAK Digital Science Quality Control Workstation: - Power: 90-132vac/47-63Hz, 180-264vac/47-63Hz (matches predicate). - Environmental: 4-45 degrees C/15-90% RH non-condensing (matches predicate). - Acquisition Unit: 2.5" Hard Drive (matches predicate). - Disk Storage: 2.0GB Boot Disk, 4GB, 8GB, 12GB, 16GB Removable Disk (Exceeds predicate's 30, 60 Mbytes). - Network: Ethernet (matches predicate), DICOM v3.0 format (ACR NEMA) (matches predicate). - Video Inputs: Monochrome: RS-170/CCIR; Red, Green, Blue (RGB) (matches predicate). - Image Capture Time: Less than 1 second (Faster than predicate's 1/30 second). - Image Store Time: Less than 1 second (Faster than predicate's 1/30 second).
Image Presentation Capabilities: Number of images per frame.	KODAK Digital Science Quality Control Workstation: - 1,2,4,6,8,9,12,15,16,24,35 images per frame, plus slides (matches predicate).
Safety: Patient isolation, non-manipulation of primary diagnosis data, human intervention for hard copy output.	KODAK Digital Science Quality Control Workstation: - Patient is electrically isolated from the workstation. - Does not manipulate data for primary diagnosis except to enhance portions of images for a clearer view. - Images displayed are not for primary diagnosis; hard copy output or images on other workstations are for primary diagnosis, allowing for "adequate opportunity for competent human intervention." - Primary function: display with no corruption; level of concern is minor, as failures would not result in patient injury.
Image Processing: Non-destructive modification, raw data preservation, multiple enhanced versions.	KODAK Digital Science Quality Control Workstation: - Adaptive unsharp masking and tonescaling (non-destructive). - Copy of original data kept until approved. - Raw data is never changed. - Generates at least one enhanced version; user can create more.
Interoperability: Network support, image format.	KODAK Digital Science Quality Control Workstation: - ACR/NEMA and/or DICOM format over TCP/IP.

Details of the Study (or lack thereof)

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device, not on presenting a detailed clinical or performance study with quantified acceptance criteria. Therefore, most of the following requested information is not available in the provided text.

Sample size used for the test set and the data provenance: Not mentioned. The submission relies on a comparison of features and intended use, not a performance study on a specific test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. No test set requiring expert ground truth is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
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 workstation for image display and manipulation, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a workstation for human use, and explicitly states that displayed images are not for primary diagnosis and that "competent human intervention" is part of the diagnostic process for hard copies.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no mention of a ground truth established for a performance study. Its primary function is "to display with no corruption of the image information."
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set. The "image processing routines" (adaptive unsharp masking and tonescaling) are described as using "computed or user-specified values," implying traditional algorithms rather than trained models.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a 510(k) premarket notification focusing on substantial equivalence through feature comparison and intended use rather than a detailed performance study with explicit acceptance criteria and supporting data for algorithmic performance.

Summary

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K974107 PAGE 1 of 4

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

DATE PREPARED: October 28, 1997 I.

SUBMITTER: II.

JAN 21 1998

Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas, Texas 75252-8026

CONTACT PERSON: III.

Nancy Butcher Regulatory Affairs (214) 454--1417

DEVICE NAME: IV

KODAK Digital Science Quality Control Workstation Trade Name Picture Archiving and Communications Systems (PACS) Common Name Components

V DEVICE CLASSIFICATION

FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750.

VI. PREDICATE DEVICE:

KODAK Ektascan Imagelink Quality Control Workstation

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K974107 2/4

COMPARISON OF FEATURES: VII.

KODAK Ektascan Characteristics KODAK Digital Science Imagelink Quality Control Quality Control Workstation Workstation K923270 this submission Knumber GENERAL Image enhancement which Productivity improvement, Advertised use eliminate film cassettes and allows for the proper display of darkroom processing, eliminate the images for diagnostic purposes need to sterilize film cassettes New Image Processing Library 90-132vac/47-63Hz 90-132vac/47-63Hz Hardware requirements 180-264vac/47-63Hz 180-264vac/47-63Hz 4-45 degrees C/15-90% RH 4-45 degrees C/15-90% RH Environmental non-condensing non-condensing Acquisition Unit 2.5" Hard Drive 2.0GB Boot Disk Removable Disk 4GB, 8GB, 12GB, 16GB 30, 60 Mbytes Disk Storage Capacity Ethernet Network Capability Ethernet Monochrome: RS-170/CCIR; Monochrome: RS-170/CCIR; Video Inputs Red, Green, Blue (RGB) Red, Green, Blue (RGB) 1/30 second 1/30 second Image Capture Time Less than 1 second Less than 1 Second Image Store Time Printer Interface Unit Removable Disk Cartridge, Removable Disk Cartridge, Inputs Ethernet, DICOM v3.0 format Ethernet, DICOM v3.0 format (ACR NEMA) (ACR_NEMA) SCSI, Video, RS-485, RS-422, SCSI, Video, RS-485, RS-Outputs RS-232 422, RS-232 1,2,4,6,8,9,12,15,16,24,35 1,2,4,6,8,9,12,15,16,24,35 Image Presentation images per frame, plus slides images per frame, plus slides

SIDE-BY-SIDE COMPARISON TABLE

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K974107 3/4

DESCRIPTION OF DEVICE: VIII.

The patient is not connected to a Quality Control Workstation. The Quality Control Workstation does not control, monitor or affect any equipment that is directly involved with a patient.

The Quality Control Workstation is attached via a SCSI cable to a KODAK Digital Science Storage Phosphor Reader (K913354). The KDSSPR is not in direct contact with a patient. Therefore, the patient is electrically isolated from the Quality Control Workstation equipment and any conceivable electrical failure would not affect the patient.

The Quality Control Workstation does not manipulate data on which a primary diagnosis or finding may be based except to enhance portions of images for a clearer view.

Images displayed on the Quality Control Workstation will not be used for primary diagnosis. Images outputted from the Quality Control Workstation to a laser printer or workstations on the ethernet will be used for primary diagnosis. The evaluation of the hard copy output provides adequate opportunity for competent human intervention.

The primary function of the Quality Control Workstation is to display with no corruption of the image information. The level of concern associated with the function is minor, as failures or latent design flaws would not be expected to result in injury to the patient.

IX. The Device

The general hardware configuration of the Quality Control Workstation contains the following major components:

Sun Microsystems Desktop Workstation with

SCSI (Small Computer System Interface)
ethernet interface
Floppy disk drive/ CD ROM drive

Gray Scale Display

External Hard Disk Multipack

Tape Drive

Bar code printer

Uninterrupted Power Supply (UPS)

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K974107 4/4

X. Indication for Use

XI. Methodology

The Quality Control Workstation acquires images from phosphor readers and attaches patient records for transmission to other systems.

The Quality Control Workstation can be use in two modes: pass through or manual mode. In pass through mode, an exam is processed at the Quality Control Workstation and then routed directly to its destination. In manual mode, a user must verify the image and Patient and exam information before releasing it to its destination.

The image enhancement which allows for the proper display of the images for diagnostic purposes is performed by adaptive unsharp masking processing and tonescaling.

It uses computed or user-specified values. This is a non-destructive image processing routine to the raw image. Because this routine modifies the original data, a copy of the original data is kept until the image has been approved and forwarded to a destination. The data remains at the Quality Control Workstation for a hospital configurable time before it is deleted.

For each raw image, the Quality Control Workstation generates at least one enhanced version. The number of enhanced versions is dependent on the type of exam and the user can create versions as needed. The raw data is never changed.

The Quality Control Workstation is a network-orientated workstation supporting the ACR/NEMA and or DICOM format over TCP/IP.

Images may be manipulated using a mouse/trackball for such functions as rotating and flipping.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/4/Picture/4 description: The image shows the text "JAN 21 1993". The text is in a bold, sans-serif font. The month is abbreviated to "JAN". The day is "21" and the year is "1993".

Nancy Butcher Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas, Texas 75252-8206 Re:

K974107

Kodak Digital Science Quality Control Workstation (QCV) Dated: October 30, 1997 Received: October 31, 1997 Regulatory class: Unclassified Procode: 90 LMD

Dear Ms. Butcher:

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 interstate 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). You may, therefore, 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 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 requirement, 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. 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 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 question 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" (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/dsmamain.html".

Sincerely vours.

William Yu

Lillian Yin, Ph.D. 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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K974107 510(k) Number (if known): Device Name: KODAK Digital Science Quality Control Workstation

INDICATION FOR USE:

The Quality Control Workstation (QCW) is a networked-oriented workstation supporting the KODAK Digital Science System standard network (ACR/NEMA and/or DICOM over TCP/IP).

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

Concurrence of CDR., Office of Device Evaluation (ODE)

Prescription Use (Per 21 CRF 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

David L. Dickson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number

Regulation Number and Section

§ 892.2020 Medical image communications device.

(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.