aycan Workstation OsiriX is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware.

Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Device Description

The aycan Workstation OsiriX provides services for review and post processing of diagnostic medical images and information. It conforms to the DICOM 3.0 standard to allow the sharing of medical information with other digital imaging systems. aycan workstation OsiriX runs on Apple Mac OSX systems and provides high performance review, navigation and post processing functionality for multidimensional and multimodality images.

AI/ML Overview

The provided document is a 510(k) summary for the aycan Workstation OsiriX. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use. The document does not contain the specific details required to answer all parts of your request about acceptance criteria and a detailed study proving performance.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document states, "As required by the risk analysis, designated individuals performed all verification and validation activities and results demonstrated that the predetermined acceptance criteria were met. The system passed all testing criteria."
Reported Device Performance: The document generally states that the device "provides high performance review, navigation and post processing functionality for multidimensional and multimodality images." However, specific quantitative or qualitative performance metrics against defined acceptance criteria are not provided.

Acceptance Criteria	Reported Device Performance
"Predetermined acceptance criteria were met" (Specific criteria not detailed)	"The system passed all testing criteria."

2. Sample sized 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 in the document.

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 in the document.

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

This information is not provided in the document.

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

A MRMC study or any information about AI assistance and human reader improvement is not mentioned in the document. The device is a "Picture Archiving Communications System", not an AI-powered diagnostic tool, so such a study would not be expected.

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

The document implies human intervention, stating, "A physician, providing ample opportunity for competent human intervention interarets images and information being displayed and printed." Given that it's a PACS workstation, standalone algorithmic performance for diagnosis is not its primary function, and no such study is mentioned.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The device is a workstation, and the concept of a "training set" in the context of an AI/ML algorithm doesn't directly apply here.

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

This information is not provided in the document, as it's not relevant to the type of device described.

Summary of what the document focuses on:

The 510(k) summary primarily demonstrates the substantial equivalence of the aycan Workstation OsiriX to a predicate device (IQ-SYSTEM PACS SYSTEM K062488). This is achieved by:

Categorizing the device: As a "Picture Archiving Communications System" and "system, image processing, radiological" (Product code LLZ).
Describing intended use: For viewing, capturing, storing, communicating, processing, and displaying images from various DICOM-compliant medical imaging systems.
Highlighting technological characteristics: It's a software device conforming to DICOM 3.0, running on Apple Mac OSX, and providing review and post-processing functionality. It explicitly states it does not contact the patient or control life-sustaining devices.
Stating compliance: It notes that appropriate verification and validation activities were performed, and predetermined acceptance criteria were met.
Providing warnings/limitations: Regarding lossy compressed mammographic images, digitized film screen images, and the user's responsibility for monitor quality and ambient light.

Summary

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510(k) Summary of Safety and Effectiveness

K063470

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

November 8, 2000

JAN - 5 2007

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Stephan Lange aycan Digitalsysteme GmbH Innere Aumuehlstrasse 5 97076 Wurerzburg, Germanv

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	aycan Workstation OsiriX
Common Name:	Picture Archiving Communications System
Classification Name:	system, image processing, radiological
Product code:	LLZ

Predicate Device: 21 CFR 807. 92(a)(3)

FDA has classified the predicate device (K062488) as Class II, CFR 892.2050, LLZ. It is our understanding that aycan Workstation OsiriX device falls under the same classification as the predicate device. Predicate device details are as follows:

Device Classification Name	system, image processing, radiological
510(k) Number	K062488
Regulation Number	892.2050
Device Name	IQ-SYSTEM PACS SYSTEM
Applicant	IMAGE INFORMATION SYSTEMS, LTD.
Classification Product Code	LLZ
Decision Date	09/19/2006

Classification Advisory Committee Radiology

Device Description: 21 CFR 807 92(a)(4)

Indications for Use: 21 CFR 807 92(a)(5)

Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

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510(k) Summary of Safety and Effectiveness

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It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Technological Characteristics: 21 CFR 807 92(a)(6)

aycan Workstation OsiriX is a software device that handles and manipulates digital medical images.

The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interarets images and information being displayed and printed

Testing:

As required by the risk analysis, designated individuals performed all verification and validation activities and results demonstrated that the predetermined acceptance citerial were met. The system passed all testing criteria.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for aycan Workstation OsiriX contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The submission contains the results of a hazard analysis and the "Level of Concern" for potential hazards has been classified as "Minor".

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Acyan Digitalsystemc GmbH % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210

Re: K063470

Trade/Device Name: aycan Workstation OsiriX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 13, 2006 Received: November 21, 2006

Dear Mr. Alletto:

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.

JAN 0 5 2007

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.

Image /page/2/Picture/8 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a stylized font, with the text "Centennial" underneath. Above the letters "FDA" are the numbers "1906-2006". Below the word "Centennial" are three stars. The logo is surrounded by a dotted circle.

Protecting and Promoting Public Health

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours.

Nancy C. Hogdon

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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(Indications for Use Form)

510(k) Number: K063470

Device Name: aycan Workstation OsiriX

Indications for Use:

Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.

It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

David A. Byman
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	K063470
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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).