aycan mobile provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.

This device is not to be used for mammography.

Device Description

aycan mobile is an App for the Apple iPad. It can be used for receiving and visualization of medical images.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, where available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the clinical studies. Instead, it generally states that the device "passed all testing criteria" and that radiologists "confirmed" its capability for diagnostic reading.

Acceptance Criteria Category	Reported Device Performance
Nonclinical Testing
Verification & Validation	All verification and validation activities performed by designated individuals demonstrated that the predetermined acceptance criteria were met. The system passed all testing criteria.
Display and Technical Aspects Tests	Extensive performance tests conducted regarding display and other technical aspects. Display tests leveraged capabilities regarding IEC 62563-1 and TG18 guideline. All tests had been passed successfully.
Clinical Testing
Diagnostic Reading Capability	Series of studies performed by qualified radiologists reading different CT and MRI studies under different environmental lighting conditions. The capability of aycan mobile as a device for diagnostic reading – when used within the indications for use – was confirmed by the results of these studies.
Safety and Effectiveness	All radiologists came to the conclusion that the devices is safe and effective when used within its defined Intended Use, leading to the conclusion that aycan mobile is safe and effective when used as labeled.
Substantial Equivalence	The device was determined to be substantially equivalent to the predicate device (MOBILE MIM, K103785) based on the comparison of technological characteristics, intended use, and performance data. The reduction of functionality and modalities compared to the predicate device did not negatively affect safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document mentions "different CT and MRI studies," but does not specify the exact number of cases or images used in the clinical studies.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: "Qualified radiologists" performed the studies, but the exact number is not specified.
Qualifications of Experts: They were "qualified radiologists." No further details on their experience (e.g., years of experience) are provided.

4. Adjudication Method for the Test Set

The document implies that radiologists individually confirmed the diagnostic capability. There is no mention of a specific adjudication method like 2+1 or 3+1 consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document describes a clinical study where "qualified radiologists" read "different CT and MRI studies" using aycan mobile. However, it does not describe an MRMC comparative effectiveness study that assesses human readers' improvement with AI vs. without AI assistance. The study described focuses on confirming the diagnostic capability and safety/effectiveness of the aycan mobile device itself.

6. Standalone (Algorithm Only) Performance

The aycan mobile device is described as an application for displaying medical images for diagnosis. It does not appear to be an AI algorithm in the traditional sense that performs automated detection or analysis. Therefore, a standalone (algorithm only) performance metric would not be applicable, as it's a viewing device used by a human for diagnosis.

7. Type of Ground Truth Used

The ground truth for the clinical studies was based on the "conclusion" of "qualified radiologists" regarding the diagnostic capability, safety, and effectiveness of the device when reading CT and MRI studies. This suggests expert consensus/opinion as the basis for ground truth. There's no mention of pathology or outcomes data.

8. Sample Size for the Training Set

Since aycan mobile is a viewing and communication system and not an AI algorithm that requires training, there is no mention of a training set sample size.

9. How the Ground Truth for the Training Set Was Established

As aycan mobile is not an AI algorithm requiring a training set, this information is not applicable and therefore not provided in the document.

Summary

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K122260 Page 1 of 4

PACS tor PA

510(k) Summary of Safety and Effectiveness

The following information is in conformance with 21 CFR 807.92.

Submitter's Information: 21 CFR 807.92(a)(1)

aycan Digitalsysteme GmbHInnere Aumuehlstr. 597076 WuerzburgGermany
Phone:Fax:	+49 - 931 - 270 40 90+49 - 931 - 270 40 91
Contact Person:	Mr. Matthias Broenner
Date Prepared:	July 23th, 2012

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

Trade Name:	aycan mobile
Common Name:	Picture Archiving Communications System
Classification Name:	system, image processing, radiological
Product code:	LLZ
Regulation Number:	21 CFR 892.2050

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

FDA has classified the predicate device (K103785) as Class II, CFR 892.2050, LLZ. It is our understanding that aycan mobile 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:	K103785
Regulation Number:	892.2050
Device Name:	MOBILE MIM
Applicant:	MIM SOFTWARE INC.25200 Chagrin Blvd.Suite 200Cleveland, OH 44122
Classification Product Code:	LLZ
Decision Date:	02/04/2011
Classification Advisory Committee:	Radiology

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

aycan mobile is an App for the Apple iPad. It can be used for receiving and visualization of medical images.

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

"The avcan mobile software program is used to display medical images for diagnosis from CT and MRI modalities only.

aycan mobile provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.

This device is not to be used for mammography."

The Indications for Use of aycan mobile are a subset of the Indications for Use of the predicate device. The predicate device additionally covers registration and fusion of images and it includes the handling of SPECT and PET images. See also the Device Comparison Table below.

The reduction of the Indications for Use (compared to the predicate device) doesn't negatively affect the safety and effectiveness of the devices when used as labeled.

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

aycan mobile is a software for a mobile device (Apple iPad) that receives and visualizes 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 interprets images and information being displayed.

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Device Comparison Table between new device and predicate:

Topic	aycan mobile	MOBILE MIM
Intended Use /Indications for Use	The aycan mobile softwareprogram is used to displaymedical images for diagnosisfrom CT and MRI modalitiesonly.aycan mobile provides wirelessand portable access to medicalimages. This device is notintended to replace fullworkstations and should beused only when there is noaccess to a workstation.This device is not to be usedfor mammography.	The Mobile MIM softwareprogram is used for theregistration, fusion, and/ordisplay for diagnosis of medicalimages from only the followingmodalities: SPECT, PET, CT,and MM.Mobile MIM provides wirelessand portable access to medicalimages. This device is notintended to replace fullworkstations and should beused only when there is noaccess to a workstation.This device is not to be usedfor mammography.
Receive, Store, Retrieve,Display, and Process DigitalMedical Images	Yes	Yes
Display of Clinical Patient DataWhen No Access to aWorkstation	Yes	Yes
Image Fusion	No	Yes
Standardized Uptake Value(SUV)	No	Yes
Distance Calculation	Yes	Yes
Window / Level	Yes	Yes
Zoom, Pan	Yes	Yes
User Authentication	Yes	Yes
Modalities	CT, MRI	SPECT, PET, CT, MRI
Remote Handheld ViewingDevice	Yes	Yes
Operating Platform	Apple (R) iOS	Apple (R) iOS
Hardware Requirements	Apple (R) iPad	Apple (R) iOS handhelddevices

The comparison table shows that – besides a reduction of functionality regarding the application on The sompanson images - both Apps are substantially equivalent.

Regarding the hardware aycan mobile is limited to iPad devices compared to MOBILE MIM which can be used on the wider range of all Apple (R) iOS handheld devices.

The differences at the Indications for Use Statement are also based on the fact that MOBILE MIM handles SPECT and PET images additionally.

All these facts provide evidence to facilitate the substantial equivalence determination between aycan mobile and the predicate device, MOBILE MIM (K103785).

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Performance Data from nonclinical Testing: 21 CFR 807 92(b)(1) ·

Designated individuals performed all verification and validation activities and results demonstrated that the predetermined acceptance criteria were met. The system passed all testing criteria.

Extensive performance tests had been conducted regarding the display and other technical aspects. Display tests leveraged capabilities regarding IEC 62563-1 and TG18 guideline. All tests had been passed successfully.

Performance Data from clinical Testing: 21 CFR 807 92(b)(2)

Furthermore a series of studies had been performed by qualified radiologists reading different CT and MRI studies under different environmental lightning conditions. The capability of aycan mobile as a device for diagnostic reading – when used within the indications for use – was confirmed by the results of these studies.

All radiologists came to the conclusion that the devices is safe and effective when used within its defined Intended Use.

Conclusion: 21 CFR 807 92(b)(3)

According to all evidence collected, we come to the conclusion, that aycan mobile is substantially equivalent to the predicate device and it is safe and effective, when used as labeled.

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

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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Matthias Broenner Quality and Regulations Manger Aycan Digitalsysteme GmbH Innere Aumuehlstr. 5 WUERZBURG 97076 GERMANY

SEP 12 2012

Re: K122260

Trade/Device Name: aycan mobile Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 23, 2012 Received: July 27, 2012

Dear Mr. Broenner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been mined 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 r ou mays arover 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 class II (Special Controls), it may be subject to such 11 your device is classified (200 regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I least be advised that I Dris issuantes arour device complies with other requirements of the Act that I DA has made a aved regulations administered by other Federal agencies. You must or any I cueral statutes and regarants, including, but not limited to: registration and listing (21 Compy with an the 71ct 5 requirements, artean and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice modical device-related develop visity systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quarny device as described in your Section 510(k) premarket will anow you to begill marketing your intil equivalence of your device to a legally marketed nonicate 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 Parts 801 and 11 you desire specific da new to: your itro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou inay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number: K122260

Device Name: aycan mobile

Indications for Use:

The aycan mobile software program is used to display medical images for diagnosis from CT and MRI modalities only.

aycan mobile provides wireless and portable access to medical images. This device is 1 not intended to replace full workstations and should be used only when there is no access to a workstation.

This device is not to be used for mammography.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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).