AXIS Image Management System is a browser-based ophthalmic image management system designed for storage, retrieval, and review of images, videos, and reports originating from ophthalmic imaging devices.

AXIS Image Management System and the predicate device are software systems that work on standard network infrastructure provided by the user. Such infrastructure may include a server, network, and computing devices.

AXIS Image Management System provides a central database of patient information and exam image history. The AXIS software resides on a server provided by the user and interfaces with networked imaging instruments. Users utilize their existing browser to access the AXIS software to review images, videos, and reports.

Images can be obtained from diagnostic devices in a variety of industry-standard formats including PDF, JPEG, DCM, and AVI.

AI/ML Overview

This document is a 510(k) premarket notification for the AXIS Image Management System. It primarily outlines the substantial equivalence to a predicate device and does not contain detailed acceptance criteria and study results in the typical format for performance studies of AI-powered medical devices.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) because the device is an Image Management System, not a diagnostic or AI-powered analytical tool. Its performance is assessed functionally and through its compliance with standards.

The closest equivalent to "acceptance criteria" are the functional characteristics and compliance with industry standards, which are met by the device.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Software-only system	Must be software-only	Yes
Patient database	Must have a patient database	Yes
Imaging review capability	Must allow imaging review	Yes
Image annotation and measurement capability	Must allow image annotation and measurement	Yes
Application access method	Must provide user access to the system	Browser on reviewing device accesses server (no special software installed on reviewing device). This is a difference from the predicate but is presented as an advantage (simpler to maintain/use and device agnostic), not a failure of a criterion.
Secure Login	Must have secure login	Yes
Interface with electronic medical records (EMR)	Must interface with EMR	Yes
Connects to imaging instruments via DICOM and non-DICOM methods	Must connect to imaging instruments (DICOM and non-DICOM)	Yes
DICOM Compliance	Must be DICOM-compliant	AXIS is DICOM-compliant as stipulated in its DICOM Conformity Statement.
Functional Performance (Software Verification & Validation)	Must perform as intended	Performance testing was conducted on AXIS Image Management System as part of the software verification and validation and was found to perform as intended.
Safety and Effectiveness Equivalence to Predicate	Must be as safe, as effective, and perform as well as predicate.	Based upon the results of the data as summarized, AXIS Image Management System has demonstrated that it is as safe, as effective, and performs as well as or better than the predicate device. Furthermore, based on the comparison with the predicate device...AXIS Image Management System is deemed to be substantially equivalent to the predicate device.

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

Not applicable. This device is an image management system, not one that performs analysis on a dataset of patient images requiring performance metrics like sensitivity/specificity. The "test set" would refer to the testing done during software verification and validation, which is typically a functional and system-level test, not a clinical data test set. The document does not specify details of the samples used in such testing.

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

Not applicable. As this device is not performing a diagnostic task, there is no "ground truth" to be established by experts in the context of clinical performance like disease detection. The "ground truth" for its functionality would be whether it performs its stated functions (storage, retrieval, display, etc.) correctly according to its design specifications.

4. Adjudication method

Not applicable, for the same reasons as points 2 and 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data: None required or submitted." As this is an image management system, its primary function is to store, manage, and display data, not to interpret or diagnose, and therefore, it does not involve human readers interpreting cases with or without AI assistance in the way a diagnostic AI would.

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

This refers to the performance of a diagnostic or analytical algorithm. The AXIS Image Management System is not such an algorithm; it is an infrastructure system. Its "standalone" performance refers to its ability to perform its specified functions (e.g., DICOM compliance, data storage, retrieval) without human intervention in the data processing flow, but this is a functional test, not a diagnostic performance test. The document states that "Performance testing was conducted on AXIS Image Management System as part of the software verification and validation and was found to perform as intended," which implies standalone functional testing.

7. The type of ground truth used

For an image management system, the "ground truth" is typically its functional correctness and adherence to standards. For example, a successful ground truth for a storage function would be that data stored can be retrieved accurately and completely. For DICOM compliance, the ground truth is successful interoperability as per the standard. The document states it is "DICOM-compliant as stipulated in its DICOM Conformity Statement" and that it "was found to perform as intended" through software verification and validation.

8. The sample size for the training set

Not applicable. The AXIS Image Management System is not an AI/ML device that requires training data.

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

Not applicable, as there is no training set for this type of device.

Summary

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

May 2, 2017

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

Re: K171098

Trade/Device Name: AXIS Image Management System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: NFJ Dated: April 11, 2017 Received: April 13, 2017

Dear Mr. Mark 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Division of Industry and Consumer Education 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,

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171098

Device Name

AXIS Image Management System

Indications for Use (Describe)

Storage, management, and display of patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 1: 510(k) Summary

Submitted By

Sonomed, Inc. 1979 Marcus Avenue C105 Lake Success, NY 11042 Tel: 516-354-0900 Fax: 516-354-5902

Establishment Registration Number

2433682

Contact Person

Mark Wallace Chief Operating Officer 414-745-7870 mwallace@escalonmed.com

Date Prepared

August 9, 2016

Submission Type

Traditional 510(k)

Trade Name

AXIS Image Management System

Common Name

System, Image Management, Ophthalmic

Classification Name

Picture Archiving and Communications Systems

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CFR Number: 892.2050 Product Code: NFJ

Intended Use

Storage, management, and display of patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.

Legally-Marketed Equivalent Devices

Carl Zeiss Surgical GmbH FORUM (K090439)

Description of the Device

Images can be obtained from diagnostic devices in a variety of industry-standard formats including PDF, JPEG, DCM, and AVI.

Comparison to Predicate Device

It is the opinion of Sonomed, Inc. that AXIS Image Management System is substantially equivalent to the predicate device, FORUM from Carl Zeiss Surgical GmbH (K090439), as they share similar fundamental technological characteristics. Both systems are comprised of a central database to store diagnostic documents (such as retinal images from other ophthalmic diagnostic devices). These documents are imported from the diagnostic devices via a networked connection.

Both AXIS Image Management System and the predicate device are software systems that work on standard network infrastructure provided by the user. Such infrastructure may include a server, network, and computing devices.

Both AXIS Image Management System and the predicate device allow a user to search the database for patients and their respective documents and to display multiple documents for comparison

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purposes. In both cases, the software can be used to access the database from a remote location via web-based access.

AXIS Image Management System and the predicate device serve the same principal purpose of clinical usage and provide a wide range of comparable functionality; the table below provides a comparison of technological characteristics with the predicate device.

Characteristic	AXIS	FORUM (K090439)
Software-only system	Yes	Yes
Patient database	Yes	Yes
Imaging review capability	Yes	Yes
Image annotation andmeasurement capability	Yes	Yes
Application	Browser on reviewing deviceaccesses server (no specialsoftware installed on reviewingdevice)	Client software installed onreviewing device, whichaccesses server
Secure Login	Yes	Yes
Interface with electronicmedical records (EMR)	Yes	Yes
Connects to imaginginstruments via DICOM andnon-DICOM methods	Yes	Yes

The only characteristic difference shown is the manner in which the applications are provided to users. In the case of FORUM, a client application software is installed onto each reviewing device, which then connects to the database software residing on the server. In the case of AXIS Imaging Management System, the database software residing on the server is accessed through an Internet browser program on the reviewing device. The particular program used is the choice of the user (e.g. Microsoft Internet Explorer, Apple Safari, etc.). In this manner, the use of AXIS Image Management System is review device agnostic, and is simpler for the user facility to maintain and use.

The indication for use of AXIS and the predicate device is identical. Evaluation performed on AXIS supports the indications for use statement, demonstrates that the device is substantially equivalent to the predicate device, and does not raise new questions regarding safety and effectiveness.

Non-Clinical Performance Data

Performance testing was conducted on AXIS Image Management System as part of the software verification and validation and was found to perform as intended. AXIS is DICOM-compliant as stipulated in its DICOM Conformity Statement. There is no stated shelf-life since AXIS is a software device only.

Clinical Performance Data

None required or submitted.

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Conclusions from Non-Clinical (and Clinical) Data

Based upon the results of the data as summarized above, AXIS Image Management System has demonstrated that it is as safe, as effective, and performs as well as or better than the predicate device. Furthermore, based on the comparison with the predicate device as shown in the discussion above, as well as guidance provided by FDA 510(k) Substantial Equivalence Decision-Making Process Flowchart, AXIS Image Management System is deemed to be substantially equivalent to the predicate device.

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).