QMENTA Care Platform Family is a software medical imaging system used to receive DICOM images and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. QMENTA Care Platform Family consists of two components:

A Storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage.
A workflow server that allows to integrate legally marketed applications for clinical use into the OMENTA Care Platform Family. The applications are geared toward specific types of image analysis and are marketed with corresponding names.

The results may be saved to a DICOM image file and may be further visualized on an imaging workstation.

QMENTA Care Platform Family is designed to aid suitably qualified physicians, who will base their diagnoses on training and protocols that do not necessarily rely on image maps or image quantifications.

Device Description

QMENTA Care Platform Family (QMENTA Care) is a software medical imaging system that runs on standard computer hardware that may compute legally marketed applications for clinical use based on DICOM images captured via MR, CT and PET modalities.

These actions include:

Retrieval of MR, CT and PET DICOM image studies from PACS and/or OS-based file storage
. Computation of legally marketed applications for clinical use
Generation of reports summarizing the computations performed

The resulting output may be provided in a standard DICOM format as additional MR series with possible computed outputs (image overlays, numerical reports, and/or other results) that can be displayed on third-party DICOM workstations and Picture Archive and Communications Systems (PACS).

From a workflow perspective, QMENTA Care can operate as a computing appliance that is capable of supporting DICOM file transfer for input and output of results.

The legally marketed applications for clinical use can be "plugged in" into the QMENTA Care Platform Family. The applications may be geared toward specific types of image analysis and may be marketed with corresponding names.

AI/ML Overview

The provided text describes the QMENTA Care Platform Family, a software medical imaging system, and its FDA 510(k) clearance. However, it does not describe a study with specific acceptance criteria and reported device performance metrics related to the accuracy or effectiveness of an AI algorithm in performing a diagnostic task.

Instead, the document details the platform's functionality (receiving, organizing, storing, and making DICOM images and textual reports available, and integrating legally marketed applications for clinical use). The "Performance data" section focuses on software verification and validation, risk management, and usability testing as per general medical device software development standards.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance for an AI algorithm, or details about patient sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, because this information is not present in the provided document. The device described is a platform for managing and integrating other applications, not a specific AI diagnostic algorithm with performance metrics.

The document states: "The subject of this premarket submission, QMENTA Care Platform Family, did not require clinical studies to support substantial equivalence." This further confirms that it is a platform for managing data and integrated applications, rather than a device with a direct diagnostic AI component whose performance would be assessed through the metrics requested.

In summary, the provided text describes a software platform, not an AI algorithm with specific clinical performance metrics.

Summary

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June 16, 2021

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Mint Labs, Inc., d/b/a. QMENTA % Paulo Rodrigues CTO, Co-Founder QMENTA Imaging S.L. C/ Roger de Lluria 46, Pral. 1ª 08009 Barcelona. Cataluna 08009 SPAIN

Re: K202718

Trade/Device Name: QMENTA Care Platform Family Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 26, 2021 Received: April 1, 2021

Dear Paulo Rodrigues:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 medical devices and radiation-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) K202718

Device Name OMENTA Care Platform Family

Indications for Use (Describe)

A Storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage.
A workflow server that allows to integrate legally marketed applications for clinical use into the OMENTA Care Platform Family. The applications are geared toward specific types of image analysis and are marketed with corresponding names.

The results may be saved to a DICOM image file and may be further visualized on an imaging workstation.

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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Image /page/3/Picture/0 description: The image shows the word "QMENTA" in a sans-serif font. The letters are a gradient of teal to blue, with the teal being on the left side of the word and the blue being on the right side. The letters are all capitalized and evenly spaced.

SECTION 5. 510(K) SUMMARY

Submitter:

Mint Labs, Inc., d/b/a. QMENTA One International Place, Suite 3700 Boston, Massachusetts 02110, United States

QMENTA Imaging S.L. C/ Roger de Llúria 46, Pral. 1ª 08009 Barcelona, Spain Phone: +34 933 282 007 Contact Person: Paulo Rodrigues - paulo @qmenta.com Phone: +34 933 282 007 Date prepared: September, 09, 2020

Device:

Trade/Proprietary Name:	Mint Labs, Inc., d/b/a. QMENTA - QMENTA Imaging S.L.
Common Name:	QMENTA CARE PLATFORM FAMILY
Classification Name:	Picture archiving and communication systems tomedical image management and processing system21 CFR 892.2050
Classification Regulations:	Class II
Product Code:	LLZ
Review panel:	Radiology
Performance standards:	None established under Food Drug and Cosmetic Act

Predicate device:

The QMENTA Platform Product Family is one product with a predicate. The QMENTA Platform Family is a storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage; and also, a workflow server that may run image processing workflows on image studies. These

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Image /page/4/Picture/0 description: The image shows the word "QMENTA" in a stylized font. The letters are rounded and have a gradient color scheme, transitioning from a teal color on the left to a blue color on the right. The letters are all capitalized and evenly spaced.

image processing workflows can be different "plugged in" modules from different manufacturers.

Predicate

Characteristic	Predicate Device	Proposed Device	Explanation ofdifferences
Manufacturer	Blackford Analysis LTD	Mint Labs, Inc., d/b/a.QMENTA - QMENTA ImagingS.L.	-
Device Name	Blackford AnalysisRegistration Product Family	QMENTA Care PlatformFamily	-
510(k)number	K142337	N/A	-
DeviceClassification	Class II	Class II	-
Regulation Nº	892.2050	892.2050	-
Product Code	LLZ	LLZ	-
Indications foruse:	The Blackford RegistrationProduct Family consists oftwo components:1. A Workflow Server thatcalculates DICOMregistration objects fromCT and MR modality data,and also PET/CT data viausing the CT data forregistration.2. A localizer tool thatworks across studies, orseries in the same studywithin a different frame ofreference.The first intended clinicaluse, when reading studiesof the above modalities, isto aid navigation through,and comparativeinterpretation of a target	QMENTA Care PlatformFamily is a software medicalimaging system used toreceive DICOM images andtextual reports, organizeand store them in aninternal format, and tomake that informationavailable across a networkvia web and customizeduser interfaces. QMENTACare Platform Familyconsists of twocomponents:1. A Storage/archivingserver for theretrieval of DICOMimages from CT andMR modality data,and also PET/CTdata from PACS	The devices arehighly similar intheir indicationsfor use since theyboth focus on thecalculation ofDICOM objectsfrom CT and MRmodality data, andalso PET/CT data.Both devicesinclude aWorkflow Servercomponent, thatperforms theimage processingoperations of theDICOM objects.Blackford includesa localizer tool tohelp the user
	series with respect to asource series. Normally,the source series will bewithin a current study andthe target series will bewithin a prior study.However they may also bewithin the same study buthave a different frame ofreference. Aidingnavigation may include, butis not limited to, indicatingcorresponding anatomicallocations, synchronizedscrolling, matchingorientations and/orreference lines inreformatted series andfusing two images fromsource and target series.The second clinical use is toaid presentation of changebetween cross-sectionalradiographic studies toclinical colleagues andpatients.Registration-aidedinterpretation of imagesshould be carried out by asuitably qualified physician,who will base theirdiagnoses on training andprotocols that do notnecessarily rely onregistration for navigation	and/or OS-basedfile storage.2. A workflow serverthat allows tointegrate legallymarketedapplications forclinical use into theQMENTA CarePlatform Family. Theapplications aregeared towardspecific types ofimage analysis andare marketed withcorrespondingnames.The results may be saved toa DICOM image file and maybe further visualized on animaging workstation.QMENTA Care PlatformFamily is designed to aidsuitably qualified physicians,who will base theirdiagnoses on training andprotocols that do notnecessarily rely on imagemaps or imagequantifications.	navigate throughstudies, or seriesin the same study.Similarly, QMENTACare provides astorage andarchiving serverwhere the usercan navigatethrough thestudies or serieswithin a study.
Use Scenario	Registration-aidedinterpretation of imagesshould be carried out by asuitably qualified physician,who will base theirdiagnoses on training and	QMENTA Care PlatformFamily is designed to aidsuitably qualified physicians,who will base theirdiagnoses on training andprotocols that do not	Not a clinicallysignificantdifference.
	protocols that do notnecessarily rely onregistration for navigation.	necessarily rely on imagemaps orquantifications.	Not a clinicallysignificantdifference.


TechnologicalCharacteristics	Multiple applications	Multiple Applications
	Hosts and manages a	Additional legally marketed
	portfolio of Blackford® and	applications for clinical use
	Platform Partner products,	can be "plugged in" into the
	configured and managed	QMENTA Care Platform
	centrally, supporting	Family. The applications are
	automated or triggered	geared toward specific types
	processing of imaging	of image analysis and are
	applications and Al	marketed with
	algorithms.	corresponding names.
	Flexible hosting and cloud	Flexible hosting and cloud	Not a clinicallysignificantdifference -hosted usingresources in thecloud.
	deployment	deployment
	Flexible hosting allows	The "plugged in" clinical
	clinical applications to be	applications are hosted on
	locally hosted on VM or	VM or Docker containers.
	Docker containers. Cloud	Studies are routed to
	deployment enables	separate resources in the
	studies to be routed to	cloud, minimizing dataflow.
	separate resource in the
	cloud, minimizing dataflow
	Fully DICOM compliant	Fully DICOM compliant	Not a clinicallysignificantdifference.
	DICOM compliant and	DICOM image studies
	integrated with DICOM	retrieved from PACS and/or
	modality worklist to	OS-based file storage. From
	pre-fetch prior studies for	a workflow perspective,
	analysis.	QMENTA Care can operate
		as a computing appliance
		that is capable of supporting
		DICOM file transfer for input
		and output of results.
	Configurable dataflow	Configurable dataflow	Not a clinicallysignificantdifference.
	Configurable dataflow	QMENTA Care offers
	management offers	configurable dataflow
	multiple adaptable SCPs	management, where image
	that maximize data	studies can be transferred
	ingestion speed,	from multiple SCPs into the
	customizable AE titles for	Storage/Archiving server.
	manual triggering, and	Then images can be
comprehensiveconsolidationmultiple sources.	patient automatically processed byfrom the configured imageprocessing applications, andresults can be automaticallytransferred back to a thirdparty DICOM workstation orPACS.QMENTA PACS Nexus is asmall application that runson a local workstation insidethe hospital network andautomates the task ofexporting images to theQMENTA Care Platform andretrieving the results.
Relevancy EngineRelevancy enginedetermines which studiesto send each clinicalapplication and collatesdescriptor knowledge fromall deployments. Itautomates the process ofmatching incoming studyinformation with theappropriate application,processes the data, andensures results are quicklysent back to the rightsystem.	Protocol Adherence EngineThe protocol adherenceengine determines if studiesfollow the configuredrequirements for a clinicalapplication, taking intoaccount descriptionknowledge and imageparameters available inDICOM objects, e.g. numberof timepoints, consistentspacing, etc.	Not a clinicallysignificantdifference.
Blackford CuratedMarketplace™ provides avetted curated marketplaceof regulatory approvedmedical imaging analysisapplications and Alalgorithms accessed viaBlackford Platform	QMENTA SoftwareDevelopment Kit providesthe possibility of integratingcurated legally marketedthird-party applications forclinical use accessed viaQMENTA Care PlatformFamily.	Not a clinicallysignificantdifference.

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QMENTA

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Image /page/6/Picture/0 description: The image shows the word "QMENTA" in a sans-serif font. The letters are colored in a gradient, transitioning from a light teal on the left to a light blue on the right. The letters are all lowercase and have rounded edges.

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Image /page/7/Picture/0 description: The image shows the word "QMENTA" in a sans-serif font. The letters are rounded and have a gradient color scheme, transitioning from a teal color on the left to a blue color on the right. The word is centered and takes up most of the frame.

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Image /page/8/Picture/0 description: The image shows the word "QMENTA" in a sans-serif font. The letters are a gradient of blue and green, with the left side of the word being green and the right side being blue. The letters are rounded and have a soft, friendly appearance.

Substantial equivalence to the predicate

The subject and predicate device are software programs for the management of multiple imaging applications and Al algorithms, in one system in the cloud.

Both devices provide access to medical imaging analysis and artificial intelligence algorithms incorporated as software packages for use with DICOM objects from CT, MR modalities, and also PET/CT data.

While the subject device's indications for use differ slightly from the predicate device, both devices are intended to simplify the deployment and management of medical imaging applications and Al algorithms.

Both devices are intended for use by radiologists and other clinicians for the purpose of extracting actionable information from radiological medical images.

Device description:

These actions include:

Retrieval of MR, CT and PET DICOM image studies from PACS and/or OS-based file storage
. Computation of legally marketed applications for clinical use
Generation of reports summarizing the computations performed

From a workflow perspective, QMENTA Care can operate as a computing appliance that is capable of supporting DICOM file transfer for input and output of results.

Indications for use

QMENTA Care Platform Family is a software medical imaging system used to receive DICOM images and textual reports, organize and store them in an internal format, and to make that information

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available across a network via web and customized user interfaces. QMENTA Care Platform Family consists of two components:

1. A Storage/archiving server for the retrieval of DICOM images from CT and MR modality data, and also PET/CT data from PACS and/or OS-based file storage.
1. A workflow server that allows to integrate legally marketed applications for clinical use into the QMENTA Care Platform Family. The applications are geared toward specific types of image analysis and are marketed with corresponding names.

The results may be saved to a DICOM image file and may be further visualized on an imaging workstation.

Performance data

All product specifications were verified and validated. Testing was performed according to internal company procedures.

Software testing and validation were conducted according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent.

Verification and validation testing was completed in compliance with the following standards and guidance documents:

ISO 14971:2012, Medical devices – application of risk management to medical devices
AAMI ANSI IEC 62304:2006, Medical device software – Software life cycle processes
. General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January, 2002)
. AAMI ANSI IEC 62366:2007, Medical devices – Application of usability engineering to medical devices

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The following quality assurance measures were applied to the QMENTA Care Platform Family product:

Risk Analysis
Requirements Review
Design Reviews
Testing on unit level
Integration testing
Performance testing

Results from internal verification and validation testing performed in accordance with QMENTA Imaging design control processes confirm that QMENTA Care Platform Family product specifications have been met. Testing described in this 510(k) consists of verification of all design input requirements and product specifications. All clinical input requirements were validated. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device. Cybersecurity is also addressed in this submission. The subject of this submission, QMENTA Care Platform Family, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing. The subject of this premarket submission, QMENTA Care Platform Family, did not require clinical studies to support substantial equivalence.

The QMENTA Care Platform Family risk analysis was completed and risk control measures were implemented to mitigate unacceptable hazards.

Additionally, usability testing was performed as part of the HFE/Usability Validation process including a minimum of 15 participants. All the participants were selected to reflect the intended use population categories.

Conclusions:

By virtue of its intended use and physical and technological characteristics, QMENTA CARE PLATFORM FAMILY® is substantially equivalent to a device that has been approved for marketing in the United States.

The performance data shows that QMENTA CARE PLATFORM FAMILY® is as safe and effective as 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).