KODAK PACS by EASTMAN KODAK COMPANY

The KODAK PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/distribute/retrieve and display images and data from all hospital modalities and information systems. This includes the display of structured reports from CAD systems with DICOM "for presentation" mammography images.

Device Description

The KODAK PACS is an image management system.

AI/ML Overview

The provided documents are a 510(k) clearance letter for the KODAK PACS and its Statement of Intended Use. They do not contain sufficient information to answer the detailed questions about acceptance criteria, study design, and performance metrics for a medical device's AI component. The KODAK PACS described here is an "image management system," which based on the 2006 date, likely refers to a Picture Archiving and Communication System (PACS) for storing, retrieving, distributing, and displaying medical images. It notes the display of "structured reports from CAD systems with DICOM 'for presentation' mammography images," implying it can integrate with CAD (Computer-Aided Detection) systems, but it is not itself a CAD system or an AI-based diagnostic tool.

Therefore, most of the specific questions cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

A table of acceptance criteria and the reported device performance:
- Cannot be answered. The document describes a PACS system for image management and display, not an AI diagnostic device with specific performance metrics. There are no acceptance criteria or performance data provided.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be answered. No study details are provided as this is a PACS system clearance, not a performance study for a diagnostic algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Cannot be answered. Ground truth establishment is not relevant for a PACS system's clearance as described here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be answered. Not applicable for a PACS system clearance.
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:
- Cannot be answered. No MRMC study is mentioned. The device is a PACS, not an AI assistance tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be answered. Not applicable; this is an image management system, not a standalone algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be answered. Not applicable to the clearance of a PACS system.
The sample size for the training set:
- Cannot be answered. No training set for an AI algorithm is mentioned.
How the ground truth for the training set was established:
- Cannot be answered. Not applicable.

Summary of available information:

Trade/Device Name: KODAK PACS
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: II
Product Code: LLZ
Intended Use: To provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/distribute/retrieve and display images and data from all hospital modalities and information systems. This includes the display of structured reports from CAD systems with DICOM "for presentation" mammography images. (This last part indicates its ability to integrate with CAD, not that it is a CAD system itself).

In conclusion, the provided documents pertain to the regulatory clearance of a PACS system, which is infrastructure for medical image management, and not a device that would require the kind of performance study details requested for an AI diagnostic or assistance tool.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 7 2006

Ms. Carolyn L. Wagner Regulatory Affairs Specialist, Health Group Eastman Kodak Company 343 State Street ROCHESTER NY 14650

Re: K060055

Trade/Device Name: KODAK PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 6, 2006

Received: January 9, 2006

Dear Ms. Wagner:

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 (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 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 (0S) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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

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 promaticate 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), please 11 you dobir office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allot, production other general information on your responsibilities under the Act from the 00 : 7 / - 1 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/industry/support/index.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

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

KODAK PACS

Statement of Intended Use

510(k) Number (if known):

Device Name:

KODAK PACS

Intended Use and Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(per 21 CFR 801.109)

Over-the counter use__

Nancy Bradon

(Division Sigh-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(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).