Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists.

Mirada XD is a software application intended to display and visualize 2D & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include, CT, MR, PET, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.

Mirada XD allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly.

Mirada XD provides a number of tools such as rulers and region of interests, which are intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up.

Mirada XD allows the user to define, transform and export regions of interest structures in DICOM format including RT format for use in radiation therapy planning systems.

Device Description

Mirada XD is a software application for displaying and visualizing 2D & 3D multi-modal medical image data such as CT, MR, PET, SPECT and planar NM. Mirada XD runs on a workstation with color monitor(s), keyboard, mouse and optional CD-RW. Mirada XD is designed to enable rendering, reviewing, storing, printing and distribution of DICOM 3.0 compliant datasets and reports within the system and/or across computer networks.

Mirada XD enables automatic and manual registration of combinations of anatomical and functional images that can be displayed with fused and non-fused displays to facilitate the comparison of image data by the user.

Mirada XD provides a number of tools such as rulers and region of interests through SUV calculation for the assessment of regions of an image to support a clinical workflow. Mirada XD also allows users to define, transform, store and export regions of interest structures in DICOM format including RTSS format for use in radiation therapy planning systems.

AI/ML Overview

The provided text is a 510(k) summary for the Mirada XD device. It outlines the intended use, device description, and a general statement about testing. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information (sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details).

The summary states: "Mirada XD is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that Mirada XD meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate devices."

This implies that detailed testing was performed and submitted to the FDA, but the summary itself only provides a high-level overview of the testing process and its conclusion regarding substantial equivalence to predicate devices. It specifically states "performance testing demonstrates that Mirada XD is substantially equivalent to, and performs at least as safely and effectively as the listed predicate devices," but it does not specify what those performance metrics or acceptance criteria were.

Therefore, for almost all the requested information, the answer is "Information not provided in the document."

Here is the breakdown based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Not specified. The document generally states that "Mirada XD meets the user needs and requirements of the device" and "performs at least as safely and effectively as the listed predicate devices."	Not specified. No specific metrics or performance results (e.g., accuracy, precision, sensitivity, specificity for image registration or ROI tools) are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Information not provided in the document.
Data Provenance (Country of Origin, Retrospective/Prospective): Information 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)

Number of Experts: Information not provided in the document.
Qualifications of Experts: Information not provided in the document.

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

Adjudication Method: Information 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

MRMC Comparative Effectiveness Study: The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. It focuses on the device's substantial equivalence to predicate devices, not on human-AI collaboration.
Effect Size of Human Improvement with AI: Information not provided in the document.

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

Standalone Performance Study: The document mentions "algorithmic testing" was performed, but does not provide details on whether this involved a standalone performance evaluation of the algorithms without human-in-the-loop, nor does it provide any results from such testing.

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

Type of Ground Truth: Information not provided in the document. The document refers to "user needs and requirements," implying validation against operational criteria, but it does not specify a clinical "ground truth" for algorithmic performance.

8. The sample size for the training set

Sample Size for Training Set: Information not provided in the document.

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

Ground Truth Establishment for Training Set: Information not provided in the document.

Summary

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510(k) Summary of Safety and Effectiveness

Date of summary:	23 March 2010
Submitter's name:	Mirada Medical Ltd
Submitter's address:	Innovation House, Mill Street, Oxford, OX2 0JX, United Kingdom
Submitter's contact:	Gwilym Owen
Telephone number:	+44 (0)1865 811172
Device Proprietary Name:	Mirada XD
Device Common Name(s):	XD4/ XD3 (NM)/XD3 NM Edition/XD3
Classification Name:	Class II: Picture Archiving and Communications System(892.2050) Product Code: LLZ

Mirada XD is Substantially Equivalent to the following Legally Marketed devices:

510(k) Number	Trade Name	Manufacturer
K071964	MiM 4.1 (SEASTAR)	MIMvista Corp.
K091373	Syngo TrueD Software	Siemens Medical Solutions USA, Inc
K093982	XELERIS 3 PROCESSING ANDREVIEW WORKSTATION	GE Healthcare
KO33955	RTist	Mirada Solutions Ltd

1.1.1 Intended Use

Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists.

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Image /page/1/Picture/1 description: The image shows the words "MIRADA medical" in a stylized font. The word "MIRADA" is in all caps and is larger than the word "medical", which is in lowercase. The font is blocky and has a slightly futuristic look.

image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly.

Mirada XD allows the user to define, transform and export regions of interest structures in DICOM format including RT format for use in radiation therapy planning systems.

1.1.2 Device Description

1.1.3 Testing

Mirada XD is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that Mirada XD meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate devices.

Verification and Validation for Mirada XD has been carried out in compliance with the requirements of ISO 13485:2003 and in adherence to the DICOM standard.

In conclusion, performance testing demonstrates that Mirada XD is substantially equivalent to, and performs at least as safely and effectively as the listed predicate devices. Mirada XD meets requirements for safety and effectiveness and does not introduce any new potential safety risks.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping, curved lines, possibly representing a stylized caduceus or a similar emblem associated with health and medicine.

Public Health Service

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

Mirada Medical, Ltd. Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

JUN 2 8 2010

Re: K101228

Trade/Device Name: Mirada XD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 3, 2010 Received: June 4, 2010

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major 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 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro 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/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/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Trump

Donald J. St. Pierre Acting 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

K101228 510(k) Number (if known):

Device Name: Mirada XD

Indications for Use:

Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists.

Mirada XD allows the user to define, transform and export regions of interest structures in DICOM format including RT format for use in radiation therapy planning systems.

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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert Becker

Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K101228

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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).