The DSA 2000ex device is used in vascular imaging applications. During X-ray exposures, the DSA 2000ex is used to acquire video images from the video display chain provided by the X-ray manufacturer's system. The images are stored in the DSA 2000ex solid state memory, and written to the hard disk medium. Images are processed in real-time to provide increased image usability. The processing is primarily subtraction, but also includes window and level adjustments, as well as optional noise reduction, landscaping, image rotation and pixel shifting. The Eigen DSA 2000ex device is used in X-ray cardiology and radiology labs to enhance diagnostic capabilities of radiologists, and cardiologists, with minimal intervention required by users to perform basic capture, playback, and archiving functions. Additional functions include allowing measurements to be made for quantizing stenosis and guidance of catheters in the Roadmapping mode.

Device Description

The DSA 2000ex device is used in vascular imaging applications. During X-ray exposures, the DSA 2000ex is used to acquire video images from the video display chain provided by the X-ray manufacturer's system. The images are stored in the DSA 2000ex solid state memory, and written to the hard disk medium. Images are processed in real-time to provide increased image usability. The processing is primarily subtraction, but also includes window and level adjustments, as well as optional noise reduction, landscaping, image rotation and pixel shifting. The Eigen DSA 2000ex device is used in X-ray cardiology and radiology labs to enhance diagnostic capabilities of radiologists, with minimal intervention required by users to perform basic capture, playback, and archiving functions. Additional functions include allowing measurements to be made for quantizing stenosis and guidance of catheters in the Roadmapping mode.

AI/ML Overview

The provided text describes the Eigen DSA 2000ex, a Digital Subtraction Angiography device, and its substantial equivalence to predicate devices. However, the document does not contain a detailed study with specific acceptance criteria, reported device performance metrics, or information about sample sizes, ground truth establishment, expert involvement, or MRMC studies that are typically associated with AI/ML device evaluations.

The relevant section, "Testing and Performance Data," states: "All product and engineering specifications were verified and validated. Test images as well as test phantoms incorporating simulated stenosis were developed and used to verify system performance through verification, validation and benchmarking." This is a very high-level statement and lacks the specificity required to answer the questions thoroughly.

Therefore, for aspects related to detailed performance studies and acceptance criteria as you've requested, the information is not available in the provided document.

Here's a breakdown of what can be extracted and what is not available:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not Available	Not Available (beyond general statement of "system performance through verification, validation and benchmarking")

The document mentions "product and engineering specifications were verified and validated," and "Test images as well as test phantoms incorporating simulated stenosis were developed and used to verify system performance." However, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds for stenosis detection) and the corresponding measured performance values are not provided.

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

Sample Size (test set): Not Available. The document mentions "test images" and "test phantoms incorporating simulated stenosis" but does not specify the number of these.
Data Provenance: Not Available. Given the nature of "test images" and "test phantoms," these are likely internally generated or simulated, not clinical patient data from a specific country or retrospective/prospective study.

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

Number of experts: Not Available.
Qualifications of experts: Not Available.

The document does not describe the establishment of ground truth by human experts for the test set.

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

Adjudication Method: Not Available. No information on expert review or adjudication is provided.

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

MRMC Study: No. This is not an AI/ML device in the modern sense; it's an image processing system. Therefore, an MRMC study comparing human readers with and without AI assistance is not described or relevant for this type of device according to the provided text. The device "enhances diagnostic capabilities of radiologists, and cardiologists" by improving image usability, but this is through image processing, not an AI-driven diagnostic aid.
Effect Size: Not Applicable/Not Available.

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

Standalone Study: Not explicitly described. The device itself is an image processing system, which operates in a "standalone" fashion to process images. However, a formal "standalone performance study" with metrics like sensitivity/specificity for a diagnostic task, as would be expected for an AI algorithm, is not detailed. The system's "performance" is verified against engineering specifications and test phantoms, implying system-level functional performance rather than diagnostic accuracy.

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

Type of Ground Truth: "Test phantoms incorporating simulated stenosis." This suggests an engineered, known truth set for evaluating the device's ability to process and visualize specific features. It's not clinical ground truth derived from pathology or patient outcomes.

8. The sample size for the training set

Sample Size (training set): Not Applicable/Not Available. This device is an image processing system, not an AI/ML device that undergoes "training" in the contemporary sense. It's built based on established algorithms for image subtraction, noise reduction, etc., not trained on a dataset.

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

Ground Truth Establishment (training set): Not Applicable/Not Available. As it's not an AI/ML device that requires training, the concept of a training set ground truth does not apply. The algorithms are predefined based on image processing principles rather than learned from data.

Summary

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510(k) Summary

AUG 2 9 2008

1082341

Submitter's Name:	Eigen Inc.
Submitter's Address:	13366 Grass Valley Avenue, Grass Valley, CA 95945
Submitter's Telephone:	530-274-1240
Contact Name:	Animesh Khemka
Date Summary was Prepared:	July 23, 2008
Trade or Proprietary Name:	DSA 2000ex
Common or Usual Name:	Digital Subtraction Angiography
Classification Name:	System, Image Processing, Radiological, LLZPicture Archiving and Communications, 21CFR 892.2050
Predicate Devices:	Device Name	510(k) Number
	Digital 8	K901956
	DSA 2000	K063846

Description of the Device and Summary of the Technological Characteristics

The DSA 2000ex device is used in vascular imaging applications. During X-ray exposures, the DSA 2000ex is used to acquire video images from the video display chain provided by the X-ray manufacturer's system. The images are stored in the DSA 2000ex solid state memory, and written to the hard disk medium. Images are processed in real-time to provide increased image usability. The processing is primarily subtraction, but also includes window and level adjustments, as well as optional noise reduction, landscaping, image rotation and pixel shifting. The Eigen DSA 2000ex device is used in X-ray cardiology and radiology labs to enhance diagnostic capabilities of radiologists, with minimal intervention required by users to perform basic capture, playback, and archiving functions. Additional functions include allowing measurements to be made for quantizing stenosis and guidance of catheters in the Roadmapping mode.

Substantial Equivalence

The Eigen DSA 2000ex is substantially equivalent to other Eigen imaging devices: the Digital 8 and DSA 2000. The DSA 2000ex is a modification of Eigen's DSA 2000 cleared under special 510(k) # K063846 and Eigen's Digital 8, which was cleared under 510(k) # K901956. The modifications made to the DSA 2000 and Digital 8 do not alter the intended use or the fundamental scientific technology of the device.

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The DSA 2000ex and its predicates (the Digital 8 and DSA 2000) enhance and process images by performing the following functions:

E Noise Reduction
I Window/Level Feature
트 Edge Enhancement
Image Subtraction l
트 Still Image Display
X-ray Lab Command Interface I
트 X-ray Lab Video Interface
Data Archiving l
Data and Space Management l
Study Information (e.g., patient, site, and date) 트
L Configuration Menu
Still Image Acquisition and Display I
I Sequence Image Acquisition and Display
i Automated Contrast
트 Landscaping
I Pixel Shifting
Modality Work-List Support 트
I Mix (also called Roadmapping)
Quantification (also called Quantitative Coronary Angiography 트 (QCA))

The DSA 2000ex device also offers the additional feature of image rotation which is not in the predicate devices.

Testing and Performance Data

All product and engineering specifications were verified and validated. Test images as well as test phantoms incorporating simulated stenosis were developed and used to verify system performance through verification, validation and benchmarking.

Conclusion

The results of comparing the intended use, function, technological characteristics, mode of

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operation and specifications of the DSA 2000ex with those of the predicate devices demonstrate that the DSA 2000ex is substantially equivalent to existing products in the market today.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2008

Eigen, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K082341

Trade/Device Name: DSA 2000ex Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: LLZ Dated: August 14, 2008 Received: August 15, 2008

Dear Mr. Job:

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, Insting 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.

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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.

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR
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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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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K082341

Indications for Use

510(k) Number (if known): pending

Device Name: "DSA 2000ex"

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
Division of Reproductive, Abdominal and
Radiological Devices EIGEN INC.	K082341
510(k) Number	SPECIAL 510(K) - DSA 2000ex
	July 23, 2008

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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).