(59 days)
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
TOMTEC-ARENA is a clinical software package for reviewing, quantifying and reporting digital medical data. The software can be integrated into third party platforms. Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes.
TTA2 consists of the following optional modules:
- IMAGE-COM
- I REPORTING
- AutoStrain LV / SAX / RV / LA I
- 2D CPA
- FETAL 2D CPA ■
- 4D LV-ANALYSIS
- . 4D RV-FUNCTION
- I 4D CARDIO-VIEW
- I 4D MV-ASSESSMENT
- I 4D SONO-SCAN
- TOMTEC DATACENTER (incl. STUDY LIST, DATA MAINTENANCE, WEB ■ REVIEW)
The purpose of this traditional 510(k) pre-market notification is to introduce semi-automated cardiac measurements based on an artificial intelligence and machine learning (AI/ML) algorithm. The Al/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach. This Al/ML algorithm enables TOMTEC-ARENA to produce semi-automated and editable echocardiographic measurements on BMODE and DOPPLER datasets. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and deployment of the algorithm: The training process begins with the model observing, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project. During the training process, the Al/ML algorithm learned to predict measurements by being presented with a large number of echocardiographic data manually generated by qualified healthcare professionals. The echocardiographic studies were randomly assigned to be either used for training (approx. 2,800 studies) or testing (approx. 500 studies). A semi-automated measurement consists of a cascade of detection steps. It starts with a rough geometric estimate, which is subsequently refined more and more: The user selects a frame on which the semi-automated measurements shall be performed in TOMTEC-ARENA. Image- & metadata, e.g. pixel spacing, are transferred to the semi-automated measurement detector. The semi-automated measurement detector predicts the position of start and end caliper in the pixel coordinate system. These co-coordinates are transferred back to the CalcEngine, which converts the received data back into real world coordinates (e.g. mm) and creates the graphical overlay. This superimposed line can be edited by the user. The end user can edit, accept, or reject the measurement(s). This feature does not introduce any new measurements, but allows the end user to perform semi-automated measurements. The end user can also still perform manual measurements and it is not mandatory to use the semi-automated measurements. The semi-automated measurements are licensed separately.
Here's an analysis of the acceptance criteria and study details for the TOMTEC-ARENA device, based on the provided FDA 510(k) summary:
The 510(k) summary describes the TOMTEC-ARENA software, which introduces semi-automated cardiac measurements based on an AI/ML algorithm. The primary focus of the non-clinical performance data is on software verification, risk analysis, and usability evaluation, as no clinical testing was conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for the AI/ML algorithm's performance in terms of accuracy or precision of the semi-automated measurements. Instead, it states that "Completion of all verification activities demonstrated that the subject device meets all design and performance requirements." and "Testing performed demonstrated that the proposed TOMTEC-ARENA (TTA2.50) meets defined requirements and performance claims." These are general statements rather than specific, measurable performance metrics.
Similarly, there are no reported quantitative device performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) for the AI/ML algorithm's measurements mentioned in this summary. The summary focuses on the functional equivalence and safety of the AI-powered feature compared to existing manual measurements and predicate devices.
However, the document does imply a core "acceptance criterion":
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence/Accuracy: The semi-automated measurements (BMODE and DOPPLER) should provide measurement suggestions that are comparable in principle/technology to those included in the reference device and can be edited, accepted, or rejected by the user. | "Support of additional semi-automated measurements compared to reference device. Additional measurements rely on same principle/technology (e.g. line detection, single-point) as those included in reference device.""The measurement suggestion can be edited. Manual measurements as with TTA2.40.00 are still possible." |
| Safety and Effectiveness: The introduction of semi-automated measurements should not adversely affect the safety and effectiveness of the device. | "No impact to the safety or effectiveness of the device." "Verification activities performed confirmed that the differences in the design did not adversely affect the safety and effectiveness of the subject device." |
| Usability: The device is safe and effective for intended users, uses, and environments. | "TOMTEC-ARENA has been found to be safe and effective for the intended users, uses, and use environments." |
| Compliance: Adherence to relevant standards (IEC 62304, IEC 62366-1) and internal processes. | "Software verification was performed according to the standard IEC 62304...""A Summative Usability Evaluation was performed... according to the standard IEC 62366-1...""The proposed modifications were tested in accordance with TOMTEC's internal processes." |
Without specific quantitative metrics for the AI's measurement accuracy, it's challenging to provide a detailed performance table. The provided information focuses on the design validation process rather than specific benchmark results for the AI's performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Approximately 500 studies.
- Data Provenance: The document does not specify the country of origin of the data. It states, "The echocardiographic studies were randomly assigned to be either used for training (approx. 2,800 studies) or testing (approx. 500 studies)." It does not explicitly state if the data was retrospective or prospective. Given that these are "studies" used for training and testing an algorithm, it is highly probable that they are retrospective data sets, collected prior to the algorithm's deployment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified. The document states "a large number of echocardiographic data manually generated by qualified healthcare professionals." This implies multiple professionals but does not quantify them.
- Qualifications of Experts: "qualified healthcare professionals." Specific qualifications (e.g., radiologist with X years of experience, sonographer, cardiologist) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The ground truth was "manually generated by qualified healthcare professionals," but the process for resolving discrepancies among multiple professionals (if multiple were involved per case) is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The summary explicitly states: "No clinical testing conducted in support of substantial equivalence when compared to the predicate devices." The nature of the AI algorithm as providing semi-automated, editable measurements, rather than a diagnostic output, likely informed this decision. The user is always in the loop and can accept, edit, or reject the AI's suggestions.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Not explicitly detailed in terms of quantitative performance metrics. While the algorithm "predicts the position of start and end caliper in the pixel coordinate system" and this prediction is mentioned as being evaluated against the test pool, the results are not presented as a standalone performance metric. The nature of the device, where the user can "edit, accept, or reject the measurement(s)", strongly implies that standalone performance is not the primary focus for regulatory purposes, as it is always intended to be used with human oversight. The comparison is generally with the predicate device's manual measurement workflow and a reference device's semi-automated features.
7. Type of Ground Truth Used
- Type of Ground Truth: "manually generated by qualified healthcare professionals." This suggests expert consensus or expert-derived measurements serving as the reference standard for the algorithm's training and testing.
8. Sample Size for the Training Set
- Sample Size for Training Set: Approximately 2,800 studies.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: "The Al/ML algorithm learned to predict measurements by being presented with a large number of echocardiographic data manually generated by qualified healthcare professionals." This indicates that human experts manually performed the measurements on the training data, and these manual measurements served as the ground truth for the supervised learning model.
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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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
TOMTEC Imaging Systems GmbH % Mr. Marc Bergenthal Manager Regulatory Affairs Freisinger Strasse 9 Unterschleissheim, Bavaria 85716 GERMANY
January 6, 2022
Re: K213544
Trade/Device Name: TOMTEC-ARENA Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: October 27, 2021 Received: November 8, 2021
Dear Mr. Bergenthal:
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) K213544
Device Name TOMTEC-ARENA
Indications for Use (Describe)
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
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/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "TT" symbol on the left, followed by the word "TOMTEC" in a simple, sans-serif font. The entire logo is in black and white.
510(K) SUMMARY
This 510(k) summary is provided as part of the Premarket Notification in compliance with 21CFR, Part 807, Subpart E, Section 807.92.
1) SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON
| Primary Contact: | Marc BergenthalEmail: regulatory@tomtec.deTel: (+49) 89 32175 555Fax: (+49) 89 32175 750 |
|---|---|
| Sponsor: | TOMTEC Imaging Systems GmbHFreisinger Strasse 985716 UnterschleissheimGermany |
Date prepared: October 27, 2021
2) NAME OF THE DEVICE, INCLUDING THE TRADE OR PROPRIETARY NAME IF APPLICABLE, THE COMMON OR USUAL NAME, AND THE CLASSIFICATION NAME, IF KNOWN
| Common Name: | Picture archiving and communications system |
|---|---|
| Proprietary Name: | TOMTEC-ARENA |
| Classification Name: | 21 CFR 892.2050,System, Image Processing, Radiological |
| Class: | 2 |
| Classification Product Code: | QIH |
| Subsequent Product Code: | LLZ |
3) INDICATIONS FOR USE
Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
4) DEVICE DESCRIPTION
TOMTEC-ARENA is a clinical software package for reviewing, quantifying and reporting digital medical data. The software can be integrated into third party platforms.
Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes.
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Image /page/4/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of two stylized black "T" letters next to the word "TOMTEC" in a bold, sans-serif font. The two "T" letters are connected at the top, forming a unique design element.
TTA2 consists of the following optional modules:
- IMAGE-COM
- I REPORTING
- AutoStrain LV / SAX / RV / LA I
- 2D CPA
- FETAL 2D CPA ■
- 4D LV-ANALYSIS
- . 4D RV-FUNCTION
- I 4D CARDIO-VIEW
- I 4D MV-ASSESSMENT
- I 4D SONO-SCAN
- TOMTEC DATACENTER (incl. STUDY LIST, DATA MAINTENANCE, WEB ■ REVIEW)
The purpose of this traditional 510(k) pre-market notification is to introduce semi-automated cardiac measurements based on an artificial intelligence and machine learning (AI/ML) algorithm. The Al/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach.
This Al/ML algorithm enables TOMTEC-ARENA to produce semi-automated and editable echocardiographic measurements on BMODE and DOPPLER datasets. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and deployment of the algorithm:
The training process begins with the model observing, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project.
During the training process, the Al/ML algorithm learned to predict measurements by being presented with a large number of echocardiographic data manually generated by qualified healthcare professionals.
The echocardiographic studies were randomly assigned to be either used for training (approx. 2,800 studies) or testing (approx. 500 studies).
A semi-automated measurement consists of a cascade of detection steps. It starts with a rough geometric estimate, which is subsequently refined more and more:
The user selects a frame on which the semi-automated measurements shall be performed in TOMTEC-ARENA. Image- & metadata, e.g. pixel spacing, are transferred to the semi-automated measurement detector. The semi-automated measurement detector predicts the position of start and end caliper in the pixel coordinate system. These co-coordinates are transferred back to the CalcEngine, which converts the received data back into real world coordinates (e.g. mm) and creates the graphical overlay. This superimposed line can be edited by the user.
The end user can edit, accept, or reject the measurement(s).
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This feature does not introduce any new measurements, but allows the end user to perform semi-automated measurements. The end user can also still perform manual measurements and it is not mandatory to use the semi-automated measurements. The semi-automated measurements are licensed separately.
5) SUBSTANTIALLY EQUIVALENT DEVICES
TOMTEC-ARENA Predicate Device: K201632 (August 14, 2020) Reference Device: EPIQ and Affiniti Series Diagnostic Ultrasound System K211597 (September 08, 2021)
TOMTEC Imaging Systems GmbH believes that the TOMTEC-ARENA (TTA2.50) modifications that are the subject of this 510(k) are substantially equivalent to TOMTEC-ARENA (TTA2.40) (K201632).
6) TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES
The TOMTEC-ARENA software with the modified modules has the same intended use and technological characteristics as the legally marketed predicate devices. A comparison of the proposed TOMTEC-ARENA application to the currently marketed predicate device (TOMTEC-ARENA) and reference device (Philips EPIQ and Affiniti Ultrasound Systems with Auto Measure) are provided in the tables below:
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Image /page/6/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" and "F" joined together, followed by the word "TOMTEC" in all capital letters. The logo and text are in black and are set against a white background.
| GENERAL COMPARISON | ||||
|---|---|---|---|---|
| Feature | Predicate DeviceTOMTEC-ARENA | Reference DevicePhilips EPIQ and Affiniti UltrasoundSystems with Auto Measure | Subject DeviceTOMTEC-ARENA | Discussion /Comment |
| K-number | K201632 | K211597 | Not available | Subject of thissubmission isTOMTEC-ARENA. |
| Regulation Numberand Regulation Name | 21 CFR 892.2050;System, Image processing,Radiological -Picture Archiving andCommunications System(PACS) | 21 CRF 892.1550Ultrasonic pulsed doppler imaging system. | 21 CFR 892.2050;System, Image processing,Radiological -Picture Archiving andCommunications System(PACS) | Identical to predicatedevice. |
| Classification ProductCode | LLZ | IYN | QIH | Identical to predicatedevice (primary andsecondary productcode switched). |
| Subsequent ProductCodes | QIH | ITX, IYO, OBJ, QIH | LLZ | Identical to predicatedevice (primary andsecondary productcode switched). |
| Class | 2 | 2 | 2 | Identical to predicateand reference device. |
| Classification Panel | Radiology | Radiology | Radiology | Identical to predicateand reference device. |
| Device Name | TOMTEC-ARENA | EPIQ Series Diagnostic Ultrasound System,Affiniti Series Diagnostic Ultrasound System | TOMTEC-ARENA | Identical to predicatedevice. |
| Version | TTA2.40 | VM 9.0(Ultrasound System Softwareversion/platform) | TTA2.50 | Version of subjectdevice changed due tonew features. |
| Intended Use | TOMTEC-ARENA software isa clinical software packagedesigned for review,quantification and reporting ofstructures and function basedon multi-dimensional digitalmedical data acquired withdifferent modalities. TOMTEC-ARENA is not intended to beused for reading ofmammography images. | The intended use of Philips EPIQ seriesdiagnostic ultrasound systems is diagnosticultrasound imaging and fluid flow analysis of thehuman body, with the following indications foruse:Abdominal, Cardiac Adult, Cardiac other(Fetal), Cardiac Pediatric, Cerebral Vascular,Cephalic (Adult), Cephalic (Neonatal),Fetal/Obstetric, Gynecological, Intra-cardiacEcho, Intra-luminal, Intraoperative (Vascular),Intraoperative (Cardiac),Musculoskeletal(Conventional), Musculoskeletal(Superficial), Other: Urology, Pediatric, PeripheralVessel, Small Organ (Breast, Thyroid, Testicle),Transesophageal (Cardiac), Transrectal,Transvaginal, Lung. | TOMTEC-ARENA software isa clinical software packagedesigned for review,quantification and reporting ofstructures and function basedon multi-dimensional digitalmedical data acquired withdifferent modalities. TOMTEC-ARENA is not intended to beused for reading ofmammography images. | Intended Use/Indications for use ofpredicate and subjectdevice are identical(unchanged).IntendedUse/ Indications foruse of referencedevice and subjectdevice are similar andconsidered equivalent(specifically ifcompared for theclinical use case/workflow of the subject |
| Indications for Use | Indications for use of TomTec-Arena TTA2 software arequantification and reporting ofcardiovascular, fetal,abdominal structures andfunction of patients withsuspected disease to supportthe physician in the diagnosis | The clinical environments where Philips EPIQdiagnostic ultrasound systems can be usedinclude clinics, hospitals, and clinical point-of carefor diagnosis of patients.When integrated with Philips EchoNavigator, thesystems can assist the interventionalist andsurgeon with image guidance during treatment ofcardiovascular disease in which the procedureuses both live X-ray and live echo guidance.Thesystems are intended to be installed, used, andoperated only in accordance with the safetyprocedures and operating instructions given inthe product user information. Systems are to beoperated only by appropriately trained healthcareprofessionals for the purposes for which theywere designed.However, nothing stated in the user informationreduces your responsibility for sound clinicaljudgement and best clinical procedure. | Indications for use ofTOMTEC-ARENA TTA2software are quantification andreporting of cardiovascular,fetal, abdominal structuresand function of patients withsuspected disease to supportthe physician in the diagnosis | feature). |
| where used(hospital, home,ambulance, etc.) | Hospitals, clinics, andphysician's offices. | Clinics, hospitals, and clinical point-of carefor diagnosis of patients. | Inside and outside ofHospitals, Clinics, andPhysician's offices. | Subject of submission;The intended useenvironment wasrevised and extended.Environmentalconditions have beenconsidered. |
| Design | Software as a medical device | Hardware and Software | Software as a medical device | Identical to predicateand reference device. |
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ТГтомтес
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Image /page/8/Picture/1 description: The image contains a logo with the text "TOMTEC" in a bold, sans-serif font. To the left of the text is a stylized graphic consisting of two intersecting lines that form a shape resembling the letters "T" and "Г". The logo is simple and modern in appearance, with a focus on clean lines and geometric shapes.
| IMAGE-COM | ||||
|---|---|---|---|---|
| Feature | Predicate DeviceTOMTEC-ARENA | Reference DevicePhilips EPIQ and Affiniti UltrasoundSystemswith Auto Measure | Subject DeviceTOMTEC-ARENA | Discussion /Comment |
| Applicationdescription | IMAGE-COM is a basicmodule for reviewing andmeasuring digital medicaldata. It supports routineworkflows for loading,analyzing and saving medicalstudies, e.g. for the purpose ofcreating reports. IMAGE-COMis where basic measurementscan be performed and theentry point for advancedanalysis modules. Studyrelated routine measurementscan be imported, displayed,edited and exported toaccompanying reportingsystems. | Auto Measure is an optional software featureon the EPIQ/Affinity Series DiagnosticUltrasound System that provides the enduser with semi automated adultechocardiography 2D and Dopplermeasurements through an Al-algorithm,training via machine-learning techniques. Itis intended to be used with an AdultCardiology Transthoracic transducer andacquisitions that include an ECG. Thesemeasurements are routinely collected duringa transthoracic ECG, per The AmericanSociety of Echo cardiography (ASE)recommendations | unchanged | Identical to predicatedevice.Similar and consideredequivalent to thereference device(specifically ifcompared for theclinical usecase/workflow of thesubject feature). |
| SW Version | 5.5.5 | 9.0 | 5.5.7 | Version of moduleIMAGE-COM changeddue to new features. |
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Image /page/9/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of two parts: a stylized "T" symbol on the left and the word "TOMTEC" on the right. The "T" symbol is made up of thick, black lines, and the word "TOMTEC" is written in a simple, sans-serif font, also in black.
| Semi-automatedmeasurements(BMODE) | Ao Asc diamAo Ann diamAo STJ diamAo SV diamIVSdLA diam systoleLVIDdLVIDsLVOT diamLVPWdRVDd base (RVD1)RVDd mid (RVD2)RVLdRVOT diam laxRVOT diam proxTV Ann diam ant-postIVSd-LVIDd-LVPWd (same line) | Asc Ao DiamAo STJ DiamAo Sinus DiamIVSdLVIDdLVIDsLVOT DiamLVPWdRV BaseRV MidRV LengthTV Annulus | unchanged | For thesemeasurements, ameasurementsuggestion can now beinitialized on a self-selected image withina clip. Themeasurementsuggestion can beedited. Manualmeasurements as withTTA2.40.00 are stillpossible.Support ofadditional semi-automatedmeasurementscompared to referencedevice. Additionalmeasurements rely onsame principle/technology (e.g. linedetection, single-point)as those included inreference device. |
|---|---|---|---|---|
| ------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------- | ----------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Image /page/10/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" followed by the word "TOMTEC" in a sans-serif font. The logo is in black and white.
| Semi-automatedmeasurements(DOPPLER) | MV A Vel | MV Peak A Vel | unchanged | For thesemeasurements, ameasurementsuggestion can now beinitialized on a self-selected image withina clip. Themeasurementsuggestion can beedited. Manualmeasurements as withTTA2.40.00 are stillpossible. |
|---|---|---|---|---|
| MV E Vel | MV Peak E Vel | |||
| MV E/A Slope | MV Inflow | |||
| (MV A Vel, MV E Vel, MV Time) | (MV Dec Time, MV Peak E Vel, MV Peak A Vel) | |||
| MV Dec. Slope | ||||
| (MV Dec Time, MV E Vel) | ||||
| LVOT VTI | LVOT VTI | |||
| LVOT Vmax | ||||
| AV VTI | AV VTI | |||
| AV Vmax | ||||
| PV VTI | PV VTI | |||
| PV Vmax | ||||
| TR Vmax | TR Vmax | |||
| LV E'(I) | Lat E' Vel | |||
| LV A'(I) | Lat A' Vel | |||
| Lat Vel | Support of additionalsemi-automatedmeasurementscompared to referencedevice. Additionalmeasurements rely onsame principle/technology (e.g. linedetection, single-point)as those included inreference device. | |||
| (Lat E' Vel, Lat A' Vel) | ||||
| LV E'(s) | Med E' Vel | |||
| LV A'(s) | Med A' Vel | |||
| Med Vel | ||||
| RV A'(I) | (Med E' Vel, Med A' Vel) | |||
| (MV Dec. Slope iscalculated from MV EVel and MV DecTime) | ||||
| RV E'(I) | RV S Vel | |||
| RV S'(I) |
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ТГтомтес
| Semi-AutomationTechnology | As cleared | Semi-automated adult echocardiography 2Dand Doppler measurements are generatedusing an artificial intelligence (AI) detectionalgorithm without user interaction. Aftermeasurement is generated, the user can edit(manually adjust the caliper positions),accept, or reject the measurements. Theautomation of measurements is constrainedto the specific imaging mode (2D, Doppler)as recommended by ASE guidelines. | Semi-automated adultechocardiography 2D andDoppler measurements aregenerated using an artificialintelligence (AI) detectionalgorithm without userinteraction. Aftermeasurement is generated,the user can edit (manuallyadjust the caliper positions),accept, or reject themeasurements. Theautomation of measurementsis constrained to the specificimaging mode (2D, Doppler)as recommended by ASEguidelines. | Subject of submission;Proposed featureincludes optional semi-automation of existingmeasurementsavailable to the enduser during routineultrasound examsimilar to referencedevice. Semi-automatedmeasurementsquantify image datathrough an Al-basedalgorithm that wastrained with amachine-learningmodel.Workflowimprovements for userconvenience.Noimpact to the safety oreffectiveness of thedevice. |
|---|---|---|---|---|
| User InterfacePresentation | As cleared | User selects an adult echocardiography 2Dor Doppler measurement to perform then thecaliper positions are initialized based on theoutput of the AI detection algorithm.The user can edit, accept, or reject themeasurements. | User selects an adultechocardiography 2D orDoppler measurement toperform then the caliperpositions are initialized basedon the output of the Aldetection algorithm.The user can edit, accept, orreject the measurements. | Similar to predicateand reference device.The set of availablemeasurements areunchanged to thepredicate device.Workflowimprovements for userconvenience.No impact to the safetyor effectiveness of thedevice. |
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Image /page/12/Picture/1 description: The image shows the logo for TOMTEC. The logo consists of a stylized "T" symbol on the left, followed by the word "TOMTEC" in a bold, sans-serif font. The entire logo is in black and the background is white.
7) NON-CLINICAL PERFORMANCE DATA
The proposed modifications were tested in accordance with TOMTEC's internal processes. Design Control activities to assure the safe and effective performance of the modified TOMTEC-ARENA include but are not limited to the following:
- I Product Specifications
- Design Review
- Risk Analysis
- Software Verification 트
TOMTEC-ARENA is considered a Moderate Level of Concern. Software verification was performed according to the standard IEC 62304 "Medical device software - Software lifecycle processes".
A Summative Usability Evaluation was performed considering FDA's Guidance for Industry and FDA Staff "Applying Human Factors and Usability Engineering to Medical Devices" and according to the standard IEC 62366-1 "Medical devices - Part 1: Application of usability engineering to medical devices". TOMTEC-ARENA has been found to be safe and effective for the intended users, uses, and use environments.
Completion of all verification activities demonstrated that the subject device meets all design and performance requirements. Venfication activities performed confirmed that the differences in the design did not adversely affect the safety and effectiveness of the subject device.
8) SUMMARY OF CLINICAL TESTS:
No clinical testing conducted in support of substantial equivalence when compared to the predicate devices.
9) CONCLUSION
Verification and validation activities required to establish the performance, functionality. and reliability characteristics of the modified TOMTEC-ARENA software with respect to the predicate device(s) were performed successfully. Testing performed demonstrated that the proposed TOMTEC-ARENA (TTA2.50) meets defined requirements and performance claims.
Based on the conformance to standards, development under TOMTEC's Quality Management System, and the successful verification and validation testing. TOMTEC believes that the proposed TOMTEC-ARENA (TTA2.50) is substantially equivalent to the legally marketed predicate device(s).
§ 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).