CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.

CONi is not intended for use in mammography.

CONi is not intended for diagnostic use on mobile devices

Device Description

CONi (Capture Over Network Interface) is a secure cloud-based application for viewing and archiving medical images. The CONi software system is comprised of a Picture Archiving and Communication System (CONiPACS) and an image viewer (CONiView). CONi supports imaging studies from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.

AI/ML Overview

The provided submission K130624 for GlobalMedia Group, LLC. CONi™ does not contain information about explicit acceptance criteria for device performance or a detailed study proving the device meets said criteria in the way a clinical performance study would.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (ALZ Web PACS, Version 1.0, K081304) for its intended use, technological characteristics, and safety/effectiveness, without presenting specific performance metrics.

The non-clinical tests listed are related to software development and validation, rather than a performance study with specific acceptance criteria:

Establishment of Requirements
Risk Analysis (software and system)
DICOM Standard Conformance Statement
HIPAA Compliance Statement
Software Unit Testing
Software Integration Testing
Software System Testing
Software Hazard Testing

Therefore, it is not possible to fill out the requested table and answer many of the study-specific questions.

Here's an attempt to address the questions based on the available information, noting where information is explicitly absent:

1. Table of acceptance criteria and the reported device performance

A table of acceptance criteria and reported device performance cannot be provided as this information is not present in the 510(k) summary. The submission focuses on demonstrating substantial equivalence, not on specific performance metrics or clinical study results with predefined acceptance criteria. Testing focused on software validation, DICOM conformance, and HIPAA compliance.

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 in the 510(k) summary. The document does not describe a clinical performance test set or data derived from real patient cases. The testing mentioned (Unit, Integration, System, Hazard) implies internal software quality assurance.

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. No ground truth establishment for a test set of medical cases is described.

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

This information is not provided. No adjudication method is mentioned as there is no described test set requiring expert adjudication.

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

An MRMC comparative effectiveness study was not done and is not applicable to this device. CONi™ is a Picture Archiving Communication System (PACS) and image viewer, not an AI-assisted diagnostic tool designed to improve human reader performance. It does not provide AI assistance for diagnostic interpretation.

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

A standalone performance study was not done and is not applicable. CONi™ is a PACS and image viewer, which inherently involves human interaction for viewing and archiving images. It does not perform any diagnostic algorithms in a standalone capacity that would require such a study.

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

This information is not provided. No ground truth is mentioned as there are no diagnostic claims or performance analyses on medical images in the context of clinical accuracy.

8. The sample size for the training set

This information is not provided. As CONi™ is a PACS and image viewer (not an AI/CAD algorithm), it does not typically involve a "training set" in the machine learning sense. The software development process likely involved internal testing with various types of DICOM images to ensure proper functionality and rendering.

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

This information is not provided and is not applicable as there is no "training set" in the context of machine learning described for diagnostic purposes.

Summary

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K130624
Page 1 of 5

510(k) Summary GlobalMedia Group, LLC. CONi™

MAY 0 7 2013

Date Prepared: January 8, 2013

Submitter's Information:

GlobalMedia Group, LLC 15020 N. 74th St. Scottsdale, AZ 85260

Contact:	Nicholas Campbell
Phone:	(480) 398-7430
Fax:	(480) 922-1090

Trade Name, Common Name and Classification:

Trade Name: CONi®

Device Classification Regulation: 892.2050 ~ Picture Archiving Communication System Product Code: LLZ - System, Image Processing, Radiological

Predicate Device:

Trade Name: ALZ Web PACS (Version 1.0) Device Classification Regulation: 892.2050 – Picture Archiving Communication System Product Code: LLZ - System, Image Processing, Radiological Applicant: ALZ, Inc. 510(k) Number: K081304

Device Description:

Studies can be shared with a specialist at another facility quickly with a study-specific passcode. This facilitates remote consultation and expedites the study transfer process in emergency situations when a patient is being transported. No physical media such as CDs are needed because collaboration occurs entirely over an internet connection. Secondary over-triage can even be avoided.

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Intended Use:

CONi is not intended for use in mammography.

Technological Characteristics and Substantial Equivalence

The proposed and predicate devices provide a web-based system for the archiving and viewing of medical images. The proposed and predicate devices are to be used with general purpose computing hardware to acquire, transmit, or view the stored medical images. Equivalent with the predicate device, CONi consists of a software application that is installed in a hosted server environment that will communicate with the client's PCs via an internet connection. Communication between the CONi application and client's PCs utilizes DICOM protocols and encrypted browser communications. Both the proposed and predicate devices are hosted by HIPAA compliant facilities. File acquisition, sending functions, and image view and manipulation are included in the proposed and predicate devices.

	GlobalMedia Group	ALZ
	CONI	Web PACS (Version 1)
DeviceDescription	CONI (Capture Over Network Interface) isa secure cloud-based application forviewing and archiving medical images. TheCONI software system is comprised of aPicture Archiving and CommunicationSystem (CONIPACS) and an image viewer(CONIView). Images and information canbe viewed and stored via a secureInternet connection.	The ALZ Web PACS (Version 1.0) isdesigned for management, viewing, andprocessing of DICOM images. The ALZ WebPACS consists of the ALZ Web PACSsoftware application installed on a serverand the ALZ Web PACS viewer running onclient computers connecting to the servervia HTTPS protocol.
RegulationNumber	892.2050	892.2050
Product Code	LLZ	LLZ
Intended Use	CONI provides for the archiving andviewing of medical images from thefollowing DICOM modalities: ComputedTomography (CT), Magnetic Resonance(MR), X-ray (CR), Ultrasound (US), andVisible Light (External Camera (XC) andOther (OT)). Images and information canbe viewed and stored via a secureInternet connection.CONI is not intended for use in	The ALZ Web PACS (Version 1.0) is animaging software system intended to beused by trained healthcare professionals.ALZ Web PACS is used with generalpurpose computing hardware to acquire,transmit, store, view, and process DICOMimages.The device is not intended formammography.
	GlobalMedia GroupCONImammography.	ALZWeb PACS (Version 1)
TechnologicalCharacteristics(Server)	Reliable hardware platform, preconfiguredand pretestedMultiple simultaneous DICOM associationsMulti-modality, multi-vendor functionalityand compatibilityRIS incorporatedServer monitored by GlobalMed andhosting site (FireHost)Shared archiveStudies are marked as reviewed after areport is written	Reliable hardware platform, preconfiguredand pretestedMultiple simultaneous DICOM associationsMulti-modality, multi-vendor functionalityand compatibilityRIS incorporatedServer instance monitoringShared archiveStudies are marked as read after a DICOMquery (this feature is set if client requests)
TechnologicalCharacteristics(Communication)	Not a featureDICOM Worklist ClientAutomatic study routing based onadministrative routing rulesCompiles with DICOM standardsEmail notification upon arrival of newstudy or finished report	DICOM query/retrieveDICOM Print client and DICOM WorklistclientAuto forward of data setsComplies with all HL7 and DICOM,standardsEmail notification upon arrival of new study
	Not a feature	Emailing images as JPEG
TechnologicalCharacteristics(Licensing)	Supports all modalities exceptmammography	Available for all DICOM modalities
	Unlimited number of web users	Unlimited number of web users
TechnologicalCharacteristics(Web)	User-friendly web interface layoutCoherent overview of studies with searchand filter possibilitiesAutomatic browser logoutUnlimited number of users and concurrentusersDisplay of all color/grayscale imagesPDF reportsTransfer of images via web to DICOMdestinations	User-friendly web interface layoutCoherent overview of studies with searchand filter possibilitiesAutomatic browser logoutUnlimited number of users and concurrentusersDisplay of all color/grayscale imagesDisplay of structured reportsTransfer of images via web to DICOMdestinations
	Not a Feature	File attachments to images or studies
TechnologicalCharacteristics(Import)	Not a FeatureNot a Feature	Import of any DICOMDIR mediaDirectory registration of DICOM data
TechnologicalCharacteristics(Export)	Not a Feature	DICOM export function by burning theDICOM images to a CD or by using a USB
TechnologicalCharacteristics	Automatic synchronization with remoteservers	Automatic synchronization with remoteservers
	GlobalMedia GroupCONI	ALZWeb PACS (Version 1)
(Database)	Not a Feature	Configurable overflow management (highwater/low water, study date, customsettings) if setting is requested by client
TechnologicalCharacteristics(Data Access)	Admin userPredefined privileges for physicians,nurses, and techniciansUser access control	Admin userPrivilege settings for each user/group arecustomizableUser access control
TechnologicalCharacteristics(Service)	No client software updates required	Software updates/upgrades optional
TechnologicalCharacteristics(Languages)	English, Spanish, and Portuguese	English
TechnologicalCharacteristics(Web Viewer)	Available to an unlimited number ofviewers and concurrent viewersViewing of any kind of images and PDFreportsCenter/window	Available to an unlimited number ofviewers and concurrent viewersViewing of any kind of images andstructured reportsCenter/window
	Not a feature	Comparison of multiple studies
	Stack mode/cine mode	Stack mode/cine mode
	Not a Feature	Measurements (distance, ROI, angle)
	Thumbnail preview	Thumbnail preview
	Background preload	Background preload
	Supports DICOM compressions. Serverdoes not compress DICOM files.	JPEG DICOM compressions vary permodality
Typical User	Trained professionals, physicians, nurses,clinicians and technicians.	Healthcare professionals
Software Levelof Concern	Moderate	Moderate

Substantial Equivalence Table:

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Summary of Non-Clinical Tests

The following quality assurance measures were applied to the development of the CONI system:

. Establishment of Requirements
Risk Analysis (software and system) .
. DICOM Standard Conformance Statement
. HIPAA Compliance Statement
. Software Unit Testing
. Software Integration Testing
. Software System Testing
Software Hazard Testing .

Safety and Effectiveness Summary

The CONi software application provides a safe and secure location for the archiving and

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viewing of medical images. CONi does not diagnosis any medical condition and is intended to be used by trained individuals. The software utilizes DICOM communication protocols and has been designed and tested to meet HIPAA requirements. CONi does not control the function of any other medical device. GlobalMedia Group considers the CONi software application to be as safe and effective for use as the previous cleared predicate device.

Conclusion

The GlobalMedia Group CONi software application has similar functionality, intended use, technological characteristics, and typical users as the predicate device. As a result, the CapSure software application will fall under the same FDA classification number and product code as the predicate device. The GlobalMedia Group CONi software introduces no new issues or concerns of safety and effectiveness, and is substantially equivalent to the predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

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

May 7, 2013

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

Re: K130624

Trade/Device Name: CONi™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 23, 2013 Received: April 24, 2013

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Job

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Division 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Smh7)

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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Indications for Use

510(k) Number (if known): K130624

Device Name: CONi®

Indications for Use:

CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT). Magnetic Resonance (MR), X-ray (CR); Ultrasound (US), and Single Frame Visible Light Photography (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.

CONi is not intended for use in mammography.

CONi is not intended for diagnostic use on mobile devices

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 In Vitro Diagnostics and Radiological Health (OIR)

Smh. 7).

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

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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).