MiPACS HTML5 Web Viewer, is a software device, that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MIPACS HTML5 Web Viewer requires no installation on the client's behalf and is compatible with any HTML5compliant web browser (e.g. Google Chrome. Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox, MacOS). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy, compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

MiPACS HTML5 Web Viewer, is not intended for diagnostic image review on mobile devices.

Device Description

MiPACS HTML5 is a medical software with a Moderate level of concern.

MiPACS HTML5 Web Viewer uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access the device and RIS systems. Whether on-site or from another location, physicians and trained professionals can manage, edit, view and move diagnostic exams quickly and efficiently. As part of the MiPACS HTML5 Web Viewer support, Medicor Imaging, performs virtually all the system maintenance.

The MiPACS HTML5 Web Viewer is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:

. To store and retrieve various kinds of DICOM Objects such as:
- -Images from multiple modalities,
- -Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
- -Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note,
- -Structured Reports [SR].

The MiPACS HTML5 Web Viewer, is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.

AI/ML Overview

The provided document is a 510(k) summary for the MiPACS HTML5 Web Viewer, which is a medical image management and processing system. The summary describes the device, its intended use, and a comparison to a predicate device, but it explicitly states that clinical testing was not necessary to show substantial equivalence. Therefore, there is no study provided that proves the device meets specific acceptance criteria in a clinical context with human readers or standalone algorithm performance.

The document mainly focuses on nonclinical testing and compliance with recognized standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a specific table of quantitative acceptance criteria for image viewing performance or associated reported device performance metrics like sensitivity, specificity, or AUC, as these would typically come from clinical studies. The "acceptance criteria" mentioned refer to predetermined testing criteria met during nonclinical validation testing.

Acceptance Criteria (Nonclinical)	Reported Device Performance (Nonclinical)
All predetermined testing criteria for output functions and actions	"The MiPACS HTML5 Web Viewer has been assessed and tested at the company's facility and has passed all predetermined testing criteria."
All requirements listed in the specified standards (DICOM, IEC 60812, ANSI AAMI IEC 62304, FDA Guidance on Cybersecurity, FDA Guidance for Software Contained in Medical Devices)	"The Validation Test Plan was designed to evaluate output functions, and actions performed by Medicor Imaging, and followed the process documented in the Validation Test Plan.""Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

Acceptance Criteria (Nonclinical)

Reported Device Performance (Nonclinical)

All predetermined testing criteria for output functions and actions

"The MiPACS HTML5 Web Viewer has been assessed and tested at the company's facility and has passed all predetermined testing criteria."

All requirements listed in the specified standards (DICOM, IEC 60812, ANSI AAMI IEC 62304, FDA Guidance on Cybersecurity, FDA Guidance for Software Contained in Medical Devices)

"The Validation Test Plan was designed to evaluate output functions, and actions performed by Medicor Imaging, and followed the process documented in the Validation Test Plan.""Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

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

Sample Size for Test Set: Not applicable for a clinical test set. The document refers to "validation testing" which is nonclinical. The sample size of test cases (e.g., DICOM objects, images) used in this nonclinical testing is not specified.
Data Provenance: Not applicable for a clinical test set.

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

Not applicable. No clinical ground truth was established by experts as clinical testing was not performed.

4. Adjudication method for the test set:

Not applicable. No clinical test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states, "Clinical testing is not necessary to show substantial equivalence for the subject device." The device is a "Medical Image Management and Processing System" (viewer), not an AI-powered diagnostic aid that would typically undergo an MRMC study to compare reader performance with and without AI assistance.

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

No, not in the sense of a diagnostic algorithm. The device is a viewer. "Standalone performance" in this context refers to its functionality as a software system in handling and displaying medical images, which was assessed through nonclinical validation testing. The summary states: "Based on the performance as documented in the Validation Testing, MiPACS HTML5 Web Viewer was found to have a safe and effectiveness profile that is similar to the predicate device."

7. The type of ground truth used:

For the nonclinical testing, the "ground truth" would likely be the expected functional behavior and output of the software according to its design specifications and compliance with DICOM and other relevant standards. For example, if a DICOM image is loaded, the ground truth for its display would be that it renders correctly, with accurate window/level manipulations, zoom, measurements, etc., as per DICOM standards and the device's functional design. This is a form of design specification compliance.

8. The sample size for the training set:

Not applicable. This device is a medical image viewer and does not involve a machine learning algorithm that requires a training set.

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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

LEAD Technologies Inc. % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive McKINNEY TX 75071

November 12, 2021

Re: K212984

Trade/Device Name: MiPACS HTML5 Web Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 5, 2021 Received: September 17, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212984

Device Name MiPACS HTML5 Web Viewer

Indications for Use (Describe)

MiPACS HTML5 Web Viewer, is not intended for diagnostic image review on mobile devices.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Medicor Imaging. The word "medicor" is in gray, with the word "imaging" in a smaller font below it. To the right of the word "medicor" is a blue triangle pointing downwards.

Submission number: K212984

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER

Mr. William Little, FDA Project Manager Medicor Imaging, a division of LEAD Technologies Inc. 1927 S. Tryon Street, Suite 200 Charlotte, NC, 28203 Tel: 704-332-5532 x 760 Fax: 704-372-8161 Email: will.little@leadtools.com

Date Prepared: November 3, 2021

II. DEVICE

Name of Device: MiPACS HTML5 Web Viewer Regulation Name: Medical Image Management and Processing System Classification Name: system, image processing, radiological (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ

III. PREDICATE DEVICES

The predicate device is: InstaRISPACS / InstaZFP / InstaMobi V5.0 (K182572), Class II, requlation number; 892.2050, product code LLZ.

IV. DEVICE DESCRIPTION

MiPACS HTML5 is a medical software with a Moderate level of concern.

The MiPACS HTML5 Web Viewer is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:

. To store and retrieve various kinds of DICOM Objects such as:
- -Images from multiple modalities,
- -Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
- -Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note,
- -Structured Reports [SR].

The MiPACS HTML5 Web Viewer, is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.

Key Feature List

. Web-based technology for access from anywhere
Integration with any modality, RIS, HIS or EMR, desktop Integration, and custom integration
. Turnkey installations including all PACS professional services

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Image /page/4/Picture/0 description: The image shows the text "510(k) Summary" in bold, black font. The text is centered on a white background. The text appears to be a title or heading for a document or section.

Image /page/4/Picture/1 description: The image shows the logo for Medicor Imaging. The word "medicor" is in gray, with the word "imaging" in a smaller font below it. To the right of the word "medicor" is a blue triangle pointing downwards.

Submission number: K212984

Off-site disaster recovery service ●
. Automatic management reports
. Detailed HIPAA log of PACS transactions
Diagnostic viewer

The MiPACS HTML5 Web Viewer device does not intend to replace the skills and judgment of a qualified physician/radiologist and must be used only by people who are properly trained in the system's functions and capabilities.

The User must be aware of the accuracy and precision limitations of the data displayed, printed or exported from The MiPACS HTML5 Web Viewer. The quality of the data depends on the information received, user interaction, and the features in the display device and printer, among others.

Warning: When an app viewer is being used, the medical images are only for consultation; and must not be viewed for diagnostic purpose.

V. INDICATIONS FOR USE

The MiPACS HTML5 Web Viewer is a software device that enables Users to view and manipulate medical images. Patient images/studies can be accessed by Users locally within the system or across a wide-area network at distributed locations. The MiPACS HTML5 Web Viewer requires no installation on the client's behalf and is compatible with any HTML5compliant web browser (e.q., Google Chrome, Microsoft Internet Explorer 10, Microsoft Edge, Mozilla Firefox, MacOS). Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy, compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. The MiPACS HTML5 Web Viewer, is not intended for diagnostic image review on mobile devices.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The subject and predicate devices are both web-based viewers which are indicated for medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use.

Any differences between the subject and predicate devices have no negative impact on the device safety or efficacy and do not raise any new potential or increased safety risks and are equivalent in performance to existing legally marketed devices.

Feature/Functions	Subject Device –MiPACS HTML5 WebViewer	PredicateInstaRISPACS/InstaZFP/ InstaMobiK182572
System	Indications for Use	Medical image management and processing system	Medical image management and processing system
	Processor	8 core Xeon Processor (or more)	Core i7 / Quad Core Xeon
Feature/Functions	Subject Device –MiPACS HTML5 WebViewer	PredicateInstaRISPACS/InstaZFP/InstaMobiK182572
Workstation ClientHardware(recommended)	Operating System	Any Operating System(Windows, MacOS, Linux,Firefox)	Windows 8.1 (64 bit)
	Display	Medical Grade Monitor isrecommended. Resolutiondepends on the modalitytype.	Medical Grade Monitor isrecommended. Resolutiondepends on the modalitytype.
	RAM	Minimum 8GB RAM	Minimum 8GB RAM
	Hard Disk	500 GB minimum	750GB minimum
	Server features	System Architecture	Web based
Hardware		Vendor Agnostic	Vendor Agnostic
Security		Log-on user ID &password	Log-on user ID &password
Remote monitoring		Yes	Yes
Database		SQL Server	MySQLv5.7
Viewer Features:	Image Viewing Layout	Customer Layout or Std.formats (up to 4*4)	Std. formats (up to 4*4)
	WW/WL	Yes	Yes
	Zoom in/Zoom out	yes	yes
	HounsfieldMeasurement	Yes	Yes
	Linear and anglemeasurements	Yes	Yes
	Series Comparison	Yes	Yes
	Scout line display	Yes	Yes
	MPR/MIP capabilities	Yes	Yes
	Stack mode	Yes	Yes
	Gray scale invert	Yes	Yes
	Filters	Yes	Yes
	Rotate	Yes	Yes
	Key Image selection	Yes	Yes
	DICOM Print	Yes	Yes
	Windows print	Yes	Yes
	Query/Retrieve	Yes	Yes
Image compression	Lossless streaming	Lossless streaming
Feature/Functions	Subject Device –MiPACS HTML5 WebViewer	PredicateInstaRISPACS/InstaZFP/ InstaMobiK182572
Selection tools	Thumbnails	Thumbnails
Other features	Link to HospitalInformation System(HIS)	Yes
	HIPAA	Compliant
	PACS Server	Yes
Configurations	Radiology Workstation	Yes
	Basic Image Viewer	Yes

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Image /page/5/Picture/0 description: The image shows the Medicor Imaging logo. The word "medicor" is in gray, with the word "imaging" in a smaller font below it. A blue triangle is located above and to the right of the word "medicor."

Submission number: K212984

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Image /page/6/Picture/0 description: The image shows the logo for Medicor Imaging. The word "medicor" is in gray, with the word "imaging" in a smaller font below it. To the right of the word "medicor" is a blue triangle pointing downwards, with a trademark symbol next to it.

Submission number: K212984

VII. PERFORMANCE DATA

Clinical testing is not necessary to show substantial equivalence for the subject device. Successful Bench Testing should be sufficient in demonstrating substantial equivalence.

Nonclinical Testing:

The MiPACS HTML5 Web Viewer has been assessed and tested at the company's facility and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions, and actions performed by Medicor Imaging, and followed the process documented in the Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

Summary:

Based on the performance as documented in the Validation Testing, MiPACS HTML5 Web Viewer was found to have a safe and effectiveness profile that is similar to the predicate device.

The following Standards were used to develop the MiPACS HTML5 Web Viewer, and the device has met all the requirements listed in the Standards except for inapplicable requirements:

Title of Standard	Date OfRecognition	SpecialtyTaskGroup Area	FDARecognitionNumber	StandardDevelopingOrganization	StandardDesignationNumber andDate
Digital ImagingandCommunicationsin Medicine(DICOM) Set	06/27/2016	Radiology	12-300	NEMA	PS 3.1 - 3.20(2016)
Analysistechniques forsystem reliability -Procedure forfailure mode and	01/14/2019	Radiology	5-120	IEC	60812 Edition3.0 2018-08,

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Image /page/7/Picture/0 description: The image shows the logo for Medicor Imaging. The word "medicor" is written in gray, with the word "imaging" written in a smaller font size below it. To the right of the word "medicor" is a blue triangle pointing downwards, with a trademark symbol next to it. The logo is simple and professional, and it is likely used to represent the company's brand.

Submission number: K212984

Title of Standard	Date OfRecognition	SpecialtyTaskGroup Area	FDARecognitionNumber	StandardDevelopingOrganization	StandardDesignationNumber andDate
effects analysis(FMEA)
Medical devicesoftware -Software life cycleprocesses[IncludingAmendment 1(2016)]	01/14/2019	Software/Informatics	13-79	ANSI AAMIIEC	62304:2006/A1:2016

. FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Document Issued on: October 2, 2014
. FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005

VIII. CONCLUSIONS

The 510(k) Pre-Market Notification for the MiPACS HTML5 Web Viewer contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, and intended use. The MiPACS HTML5 Web Viewer do not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs comparably to the predicate devices.

Regulation Number and Section

N/A