IMPAX® Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information.

They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.

MPR and 3D functions allow the user to view 3D image data from perspectives different from that in which it was acquired. Digital subtraction allows a user viewing time series studies to remove densities not enhanced by a contrast medium, highlighting vascular structures.

Device Description

The predicate devices and IMPAX® Workstations with MPR, Digital Subtraction and 3D options are medical image management devices.

Workstation configurations include a general purpose diagnostic workstation (DS3000) and analogous versions for cardiologists (Cardio3000) and orthopedists (OT3000). A review workstation (CS5000) is available for use by persons other than the interpreting physicians; and a quality control workstation (QC3000) provides administrative functions and the ability to view and correct improper operator entries.

The multi-planar reconstruction, digital subtraction and 3D features described in this notification will be offered as options, either separately or combined on multiple workstation configurations.

AI/ML Overview

This 510(k) summary (K022292) is for Agfa Corporation's IMPAX® Workstations with MPR, Digital Subtraction and 3D options. This device is a Picture Archiving and Communications System (PACS) and the submission details its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or an analytical study proving that the device meets those criteria.

Here's an analysis based on the provided text, highlighting what is present and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) summary focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided. The document mentions various types of testing (Unit, System, Integration, Field, Beta tests) but does not detail sample sizes for any test sets or the origin/type of data used.

3. 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):

This information is not provided. As detailed above, there's no mention of a test set with an established ground truth in the context of human expert review.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. No adjudication method is mentioned.

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:

This information is not provided. The document describes workstations that aid in diagnosis, but it does not describe an AI system or an MRMC study to compare human readers with and without AI assistance. The device is a PACS workstation with advanced visualization features (MPR, 3D, Digital Subtraction), not an AI-powered diagnostic tool in the modern sense.

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

This information is not provided. This device is described as a "Workstation" intended for "use by the physician to aid in diagnosis" and by "medical professionals." This clearly indicates a human-in-the-loop system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided. The document does not describe the use of any specific ground truth for performance evaluation.

8. The sample size for the training set:

This information is not provided. The device is not described as an AI/ML device that would typically involve a "training set" in the context of algorithm development for diagnostic performance.

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

This information is not provided. As above, there's no mention of a training set for an AI/ML algorithm.

Summary of Device and Testing Mentioned in the Document:

Device Name: IMPAX® Workstations with MPR, Digital Subtraction and 3D options
Intended Use: Acquisition, display, digital processing, review, transfer, storage, archiving, and printing of medical images and patient demographic information. Indicated for use by physicians to aid in diagnosis and by medical professionals for access to medical images and patient demographic information.
Key Features: Multi-planar reconstruction (MPR), Digital Subtraction, and 3D visualization.
Substantial Equivalence: Claimed based on having the same intended use and comparable image manipulation tools as predicate devices (Philips EasyVision workstations with Endo-3D option K973983 and Quantitative Analysis option K971965).
Testing Mentioned:
- Unit tests (single component/module, by development personnel)
- System tests (multiple components/modules, entire system, by independent personnel)
- Integration tests (Agfa performance under simulated use)
- Field tests (complete system in user setting, direct control of Agfa)
- Beta tests (system in user setting, without immediate/direct control of Agfa)

Conclusion regarding your request:

The provided 510(k) summary for K022292 details the device's intended use, technological characteristics, and a general overview of testing procedures to ensure functionality and safety. However, it does not include any of the specific information requested regarding acceptance criteria, quantitative device performance against those criteria, details about test or training sets, ground truth establishment, expert involvement, or MRMC studies. This is typical for 510(k) submissions of this era for PACS workstations, which focused on demonstrating substantial equivalence in function and safety, rather than providing detailed diagnostic performance metrics as might be expected for AI-powered diagnostic devices today.

Summary

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K022292
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SEP 1 2 2002

510(k) Summary

IMPAX® Workstations with MPR, Digital Subtraction and 3D options

Common/Classifications Name: Picture Archiving and Communications System, 21 CFR 892.2050

Agfa Corporation 10 South Academy Street Greenville SC 29602-9048 Contact: Jeff Jedlicka, Prepared July 10, 2002

Legally Marketed Predicate Devices A.

The legally marketed predicate devices are the Philips EasyVision workstations with Endo-3D option (cleared on January 8, 1998 as K973983) and Quantitative Analysis option (cleared on January 30, 1998 as K971965).

Device Description в.

The predicate devices and IMPAX® Workstations with MPR, Digital Subtraction and 3D options are medical image management devices.

The multi-planar reconstruction, digital subtraction and 3D features described in this notification will be offered as options, either separately or combined on multiple workstation configurations.

C. Intended Use

They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.

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Substantial Equivalence Summary D.

Impax® Workstations with MPR, Digital Subtraction and 3D options have the same intended use as the predicate devices. The differences in indications statements do not alter the intended diagnostic effect. Both the IMPAX® Workstations with MPR, Digital Subtraction and 3D, and the predicate devices are intended for use by the physician to assist in diagnosis.

The image manipulation tools are comparable. Each tool gives the user an ability to view image data from a perspective different from the one in which it was acquired.

Both IMPAX® workstations and Philips EasyVision workstation (Endo-3D, K973983) allow the user to choose optional planes from which to view three dimensional image data, and to create and view three dimensional representations.

Both IMPAX® workstations and Philips EasyVision workstation (Quantitative Analysis, K971965) allow the user viewing time series studies to remove image densities not enhanced by a contrast medium.

E. Technological Characteristics

The workstations have the same technological characteristics. All are of similar design and constructed of similar materials.

All products operate on commercially available computer systems.

All comply with the DICOM standard for communications with other imaging system components.

ட் Testing

IMPAX Workstations with MPR, Digital Subtraction and 3D options are subject to testing according to established procedures by both Agfa and the software developer. No product will be released for distribution or sale until all required tests and validation activities have been successfully combleted.

Tests are conducted according to documented test plans. Records of test results are maintained.

The following types of tests are conducted:

Unit tests - Tests of a single component or module, usually conducted by or

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under the direction of development personnel.

System tests - Tests of multiple components or modules, up to and including the entire system. System tests are conducted by persons independent of the development personnel.

Integration tests – Tests by Agfa of system performance under simulated use conditions.

Field tests - Tests of a complete system in a user setting, but under the direct control of Agfa.

Beta tests - Tests of a system in a user setting, but without the immediate or direct control of Agfa.

G. Conclusions

This premarket notification has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

ﺑﺘﺼﺪ

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract image of an eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2002

Re: K022292

Agfa Corporation HealthCare Division % Mr. David D. Ledwig Principal Consultant Practical Compliance, LLC P.O. Box 1927 BREVARD NC 28712

Trade/Device Name: IMPAX® workstations with MPR, Digital Subtraction and 3D Options Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: July 10, 2002 Received: July 15, 2002

Dear Mr. Ledwig:

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 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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of 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/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

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: IMPAX® Workstations with MPR, Digital Subtraction and 3D options

Indications For Use:

They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K022292
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Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

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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).