ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.

ADAS 3D is indicated for patients with myocardial scar produced by ischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.

ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, radiologists, radiologists, or trained technicians) for the calculation quantification of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.

The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.

Device Description

ADAS 3D is a stand-alone software tool designed for post-processing cardiovascular enhanced Magnetic Resonance (MR) images and Computed Tomography Angiography (CTA) images that are formatted in the Digital Imaging and Communication in Medicine (DICOM) standard. ADAS 3D software aids in the non-invasive calculation, quantification and visualization of cardiac imaging data to support a comprehensive diagnostic decisionmaking process for understanding cardiovascular disease.

ADAS 3D exports information to multiple industry standard file formats suitable for documentation and information sharing purposes. The 3D data is exported into industry standard file formats supported by catheter navigation systems.

ADAS 3D analyses the enhancement of myocardial fibrosis from DICOM MR images to support:

Visualization of the distribution of the enhancement in a three-dimensional (3D) chamber of the heart.
Quantification of the total volume of the enhancement within the Left Ventricle (LV) and the visualization of the enhancement area in multiple layers through the cardiac structure.
Calculation, quantification and visualization of corridors of intermediate, signal intensity enhancement in the LV.
Quantification and visualization of the total area and distribution of the enhancement within the left Atrium (LA).

Additionally, ADAS 3D imports DICOM CTA images to support:

Quantification of LV wall thickness.
Identification and Visualization of other 3D anatomical structures.
Quantification and visualization of LA wall thickness.
Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures.

It is designed to be used by qualified medical professionals (cardiologists, radiologists or trained technicians) experienced in examining and evaluating cardiovascular MR and CTA images as part of the comprehensive diagnostic decision-making process.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the ADAS 3D device based on the provided text:

Important Note: The provided document is a 510(k) summary for a modified device, ADAS 3D, that adds two new functional features compared to a predicate device (K210850). The summary primarily focuses on demonstrating substantial equivalence of the new features and therefore might not contain all the detailed clinical study information typically found for an initial device clearance.

Description of Acceptance Criteria and Study Proving Device Meets Them

The document describes the modified ADAS 3D device as a software tool for post-processing cardiovascular MR and CTA images to aid in diagnosis and pre-planning for electrophysiology procedures. The two new features are:

Quantification and visualization of LA wall thickness.
Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures.

The device's acceptance criteria, for these new features, are centered around the validation of the software's ability to accurately measure and visualize these anatomical parameters.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Software fully satisfies system requirements for new features.	Assessed using synthetic phantoms to validate software.
Accurate quantification of Left Atrial (LA) wall thickness.	Successfully validated as per system requirements.
Accurate quantification of distances from LA epicardium to other 3D anatomical structures.	Successfully validated as per system requirements.
Safety and effectiveness of modified device demonstrated.	Implemented design control activities (design review, risk analyses, design verification/validation testing).

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The two new features (Left Atrial wall thickness and Left Atrial distances measurements) were assessed using synthetic phantoms to validate that the software fully satisfies system requirements."

Sample Size: Not explicitly stated, as "synthetic phantoms" usually implies a set of simulated data rather than a specific number of patient cases. The number of phantoms used is not provided.
Data Provenance: Synthetic/simulated data. No specific country of origin is applicable as these are not real patient cases. This was a prospective simulation/validation study of the software's performance on engineered data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document for the new features' validation. Since synthetic phantoms were used, the "ground truth" would likely be the known, precisely engineered dimensions within the phantoms themselves, rather than requiring expert consensus on clinical images.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. This aligns with the use of synthetic phantoms where the ground truth is inherently known and does not require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for these new features, nor is any such study mentioned in the context of human readers improving with AI vs. without AI assistance for these specific functionalities. The validation focused on the software's technical accuracy using synthetic data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, implicitly. The validation was conducted using "synthetic phantoms to validate that the software fully satisfies system requirements." This indicates a standalone assessment of the algorithm's performance in measuring the specified parameters without human-in-the-loop interaction for these specific validation steps.

7. The Type of Ground Truth Used

The ground truth for the validation of the new features was based on known, engineered measurements within synthetic phantoms.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. This 510(k) summary is for a modification to an already cleared device (K210850) and focuses on the validation of new features, not the creation or re-training of the entire underlying model.

9. How the Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for the training set was established. This information would likely have been part of the original K210850 submission for the predicate device. For the validation of the new features, the ground truth was inherent in the design of the synthetic phantoms.

Summary

{0}------------------------------------------------

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Adas3D Medical S.L % Antonio Riu General Manager c/ Paris 179, 2°-2° Barcelona, Barcelona 08036 SPAIN

September 3, 2021

Re: K212421

Trade/Device Name: ADAS 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 30, 2021 Received: August 4, 2021

Dear Antonio Riu:

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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K212421

Device Name

ADAS 3D

Indications for Use (Describe)

ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.

The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the

time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K212421

510(K) SUMMARY

DATE PREPARED:	July 30, 2021
SUBMITTER NAME:	ADAS3D MEDICAL S.L
SUBMITTER ADDRESS:	C/ Paris 179, 2°-2°
	08036 Barcelona
	BARCELONA
	SPAIN
CONTACT:	Antoni Riu
TELEPHONE:	+34 93 328 3964
e-mail:	Antoni.riu@adas3d.com
DEVICE TRADE NAME:	ADAS 3D
COMMON NAME:	Radiological Image Processing System
CLASSIFICATION NAME:	Radiological Image Processing System (21 CFR 892.2050)
PRODUCT CODE:	LLZ
REGULATION DESCRIPTION:	Picture archiving and communications system

Medical image management and processing system

PREDICATE DEVICE: ADAS 3D (K210850)

DEVICE DESCRIPTION

ADAS 3D analyses the enhancement of myocardial fibrosis from DICOM MR images to support:

Visualization of the distribution of the enhancement in a three-dimensional (3D) chamber of the heart.
Quantification of the total volume of the enhancement within the Left Ventricle (LV) and the visualization of the enhancement area in multiple layers through the cardiac structure.

{4}------------------------------------------------

Calculation, quantification and visualization of corridors of intermediate, signal intensity enhancement in the LV.
Quantification and visualization of the total area and distribution of the enhancement within the left Atrium (LA).

Additionally, ADAS 3D imports DICOM CTA images to support:

-Quantification of LV wall thickness.
Identification and Visualization of other 3D anatomical structures. -
Quantification and visualization of LA wall thickness. -
Quantification and visualization of distances from the LA epicardium to other 3D anatomical structures.

2. INDICATIONS FOR USE

ADAS 3D is indicated for use in clinical settings to support the visualization and analysis of MR and CT images of the heart for use on individual patients with cardiovascular disease.

ADAS 3D is indicated for patients with myocardial scar produced by ischemic or nonischemic heart disease. ADAS 3D processes MR and CT images. The quality and the resolution of the medical images determines the accuracy of the data produced by ADAS 3D.

ADAS 3D is indicated to be used only by qualified medical professionals (cardiologists, electrophysiologists, radiologists or trained technicians) for the calculation, quantification and visualization of cardiac images and intended to be used for pre-planning and during electrophysiology procedures. The data produced by ADAS 3D must not be used as an irrefutable basis or a source of medical advice for clinical diagnosis or patient treatment. The data produced by ADAS 3D is intended to be used to support qualified medical professionals for clinical decision making.

The clinical significance of using ADAS 3D to identify arrhythmia substrates for the treatment of cardiac arrhythmias (e.g., ventricular tachycardia) or risk stratification has not been established.

3. COMPARISON WITH PREDICATE DEVICE

The ADAS 3D device that is the subject of this Special 510(k) contains two new functional features compared to the previous version of the ADAS 3D cleared under K210850. The two

{5}------------------------------------------------

new functional features are denoted in bold text in the right-hand column in the table below.

Elements ofComparison	Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K210850	Modified DeviceADAS 3D(ADAS3D MEDICAL S.L)
Regulatory Data
RegulatoryClass	Class II	Class II
Classificationname	Radiological Image processing system	Radiological Image processing system
RegulationNumber	21 CFR 892.2050	21 CFR 892.2050
Product Code	LLZ	LLZ
510(k)Number	K210850	To be assigned
Use
Indications forUse	ADAS 3D is indicated for use in clinicalsettings to support the visualization andanalysis of MR and CT images of the heartfor use on individual patients withcardiovascular disease.ADAS 3D is indicated for patients withmyocardial scar produced by ischemic ornon-ischemic heart disease. ADAS 3Dprocesses MR and CT images. The qualityand the resolution of the medical imagesdetermines the accuracy of the data producedby ADAS 3D.ADAS 3D is indicated to be used only byqualified medical professionals(cardiologists, electrophysiologists,radiologists or trained technicians) for thecalculation, quantification and visualizationof cardiac images and intended to be used forpre-planning and during electrophysiologyprocedures. The data produced by ADAS 3Dmust not be used as an irrefutable basis or asource of medical advice for clinicaldiagnosis or patient treatment. The data	No change
Elements ofComparison	Predicate DeviceADAS 3D(ADAS3D MEDICAL S.L)K210850	Modified DeviceADAS 3D(ADAS3D MEDICAL S.L)
	used to support qualified medicalprofessionals for clinical decision making.The clinical significance of using ADAS 3Dto identify arrhythmia substrates for thetreatment of cardiac arrhythmias (e.g.,ventricular tachycardia) or risk stratificationhas not been established.
DeviceDescriptionIncludingFunctional andTechnologicalCharacteristics	ADAS 3D is a software tool intended to beused for post-processing cardiovascularenhanced Magnetic Resonance (MR) imagesand Computed Tomography Angiography(CTA) images that are formatted in theDigital Imaging and Communication inMedicine (DICOM) standard. ADAS 3D isintended for the non-invasive calculation,quantification and visualization of cardiacimaging data to support a comprehensivediagnostic decision-making process forunderstanding cardiovascular disease.ADAS 3D exports information to multipleindustry standard file formats suitable fordocumentation and information sharingpurposes. The 3D data is exported intoindustry standard file formats supported bycatheter navigation systems.ADAS 3D analyses the enhancement ofmyocardial fibrosis from DICOM MRimages to support:- Visualization of the distribution ofthe enhancement in a three-dimensional (3D) chamber of theheart.- Quantification of the total volume ofthe enhancement within the LeftVentricle (LV) and the visualizationof the enhancement area in multiple	ADAS 3D is a stand-alone software tooldesigned for post-processing cardiovascularenhanced Magnetic Resonance (MR) imagesand Computed Tomography Angiography(CTA) images that are formatted in theDigital Imaging and Communication inMedicine (DICOM) standard. ADAS 3Dsoftware aids in the non-invasive calculation,quantification and visualization of cardiacimaging data to support a comprehensivediagnostic decision-making process forunderstanding cardiovascular disease.ADAS 3D exports information to multipleindustry standard file formats suitable fordocumentation and information sharingpurposes. The 3D data is exported intoindustry standard file formats supported bycatheter navigation systems.ADAS 3D analyses the enhancement ofmyocardial fibrosis from DICOM MRimages to support:- Visualization of the distribution ofthe enhancement in a three-dimensional (3D) chamber of theheart.- Quantification of the total volume ofthe enhancement within the LeftVentricle (LV) and the visualizationof the enhancement area in multiple
Elements ofComparison	Predicate Device	Modified Device
	ADAS 3D	ADAS 3D
	(ADAS3D MEDICAL S.L)	(ADAS3D MEDICAL S.L)
	K210850
	- layers through the cardiac structure.- Calculation, quantification andvisualization of corridors ofintermediate, signal intensityenhancement in the LV.- Quantification and visualization ofthe total area and distribution of theenhancement within the left Atrium(LA).Additionally, ADAS 3D imports DICOMCTA images to support:- Quantification of LV wall thickness.- Identification and Visualization ofother 3D anatomical structures.	- layers through the cardiac structure.- Calculation, quantification andvisualization of corridors ofintermediate, signal intensityenhancement in the LV.- Quantification and visualization ofthe total area and distribution of theenhancement within the left Atrium(LA).Additionally, ADAS 3D imports DICOMCTA images to support:- Quantification of LV wall thickness.- Identification and Visualization ofother 3D anatomical structures.- Quantification and visualization ofLA wall thickness.- Quantification and visualization ofdistances from the LA epicardiumto other 3D anatomical structures.
	It is intended to be used by qualified medicalprofessionals (cardiologists, radiologists ortrained technicians) experienced inexamining and evaluating cardiovascular MRand CTA images as part of thecomprehensive diagnostic decision-makingprocess	It is designed to be used by qualified medicalprofessionals (cardiologists, radiologists ortrained technicians) experienced inexamining and evaluating cardiovascular MRand CTA images as part of thecomprehensive diagnostic decision-makingprocess

{6}------------------------------------------------

{7}------------------------------------------------

4. SUMMARY OF NON-CLINICAL TESTING

The modified ADAS 3D device has been subject to design controls including design review, risk analyses, design verification / validation testing in order to ensure its safety and effectiveness. The two new features (Left Atrial wall thickness and Left Atrial distances measurements) were assessed using synthetic phantoms to validate that the software fully satisfies system requirements.

{8}------------------------------------------------

5. CONCLUSION

The implemented design control activities demonstrate the safety and effectiveness of the modified device. Therefore, Adas3D Medical believes the modified ADAS 3D software device should be found substantially equivalent to the predicate ADAS 3D device (K210850).

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).