(165 days)
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions.
To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as:
- Segmentation of cardiovascular structures
- Visualization and image reconstruction techniques: 2D review, MPR
- Measurement and annotation tools
- Reporting tools
FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g., FEops HEARTguide™ Simulation Application cleared as K214066).
The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement.
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions.
The software is used in a service-based business model: the customer (clinician) provides the necessary input data, FEops prepares the anatomical analysis, and delivers the results to the customer.
The results of the anatomical analysis are provided to the clinician via FEops HEART guide™ ALPACA's web application. They are available in a PDF report and as interactive 3D and DICOM MPR visualizations. The web application is intended to be used by clinicians to review the results as well as to create additional landmarks and related measurements, if needed.
The FEops HEARTguide™ ALPACA device underwent non-clinical performance testing to demonstrate its substantial equivalence to a predicate device (3mensio Workstation/3mensio Structural Heart/3mensio Vascular, K153736) for preprocedural planning and sizing of structural heart interventions. The study details are provided below.
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated for two primary applications: Left Atrial Appendage Occlusion (LAAO) and Transcatheter Aortic Valve Implantation (TAVI) procedures, focusing on quantitative measurements and segmentation accuracy.
Table: Acceptance Criteria and Reported Device Performance
| Metric | Performance Goal (Acceptance Criteria) | Reported Device Performance (Semi-Automatic Output) | Reported Device Performance (Fully Automatic Output) |
|---|---|---|---|
| LAAO Procedures | |||
| LAA Landing Zone Mean Diameter Difference (Bland-Altman) | Lower CI on inferior LoA within ±18% | Lower CI on inferior LoA: -10.5% | Lower CI on inferior LoA: -14.4% |
| Upper CI on superior LoA within ±18% | Upper CI on superior LoA: 13.2% | Upper CI on superior LoA: 22.6% (Failed for Fully Automatic) | |
| LAA Region Segmentation (Dice Score) | (Implicitly high accuracy for clinical utility) | Mean: 0.98 ± 0.01 Minimum: 0.95 | Mean: 0.93 ± 0.04 Minimum: 0.83 |
| TAVI Procedures | |||
| Aortic Annulus Perimeter-Based Diameter Difference (Bland-Altman) | Lower CI on inferior LoA within ±10% | Lower CI on inferior LoA: -4.3% | Not applicable (Manual measurement required) |
| Upper CI on superior LoA within ±10% | Upper CI on superior LoA: 5.3% | Not applicable (Manual measurement required) | |
| Aortic Root Segmentation (Dice Score) | (Implicitly high accuracy for clinical utility) | Mean: 0.97 ± 0.01 Minimum: 0.92 | Mean: 0.96 ± 0.01 Minimum: 0.92 |
Note on LAAO Fully Automatic Output: While the semi-automatic output met the ±18% performance goal for LAAO landing zone mean diameter, the fully automatic output's upper CI on superior LoA (22.6%) exceeded the 18% threshold, indicating it did not meet the performance goal. However, the overall submission focuses on the semi-automatic workflow which incorporates human supervision.
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- LAAO: 35 representative retrospective cases.
- TAVI: 35 representative retrospective cases.
- Data Provenance: The data consisted of "Recent datasets representative for the intended population," covering different CT manufacturers, imaging parameters (e.g., slice thickness), and regions. The text does not specify the country of origin but implies clinical relevance for the intended user base. All data used for testing were retrospective and specifically excluded any datasets used for training the AI models.
3. Number of Experts and Qualifications for Ground Truth
The document states that the ground truth was "manually annotated data." It does not explicitly specify the number of experts or their qualifications (e.g., radiologist with 10 years of experience). However, the context of regulatory submission for medical devices strongly implies that such manual annotations would be performed by qualified medical professionals.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (such as 2+1 or 3+1) for establishing the ground truth. It states that the ground truth was "manually annotated data." Given that the process for "semi-automatic output" involves "human supervision and a quality check by a FEops Case analyst," it suggests an internal review process, but not a formal multi-reader adjudication for the initial ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance was reported in the provided text. The evaluation focused on the accuracy of the device's measurements and segmentations against manually established ground truth, rather than directly assessing human reader improvement. The "semi-automatic" workflow inherently describes a human-in-the-loop process where human supervision and quality checks are applied after AI segmentation.
6. Standalone (Algorithm Only) Performance
Standalone (algorithm only) performance was evaluated for:
- LAAO: "Fully automatic output" for mean diameter of the landing zone and dice score for segmentation.
- TAVI: "Fully automatic output" for dice score on aortic root segmentation.
- For TAVI perimeter-based diameter, the document explicitly states, "there is no automatically calculated perimeter-based diameter of the aortic annulus, as the algorithm only identifies the annular plane, and the measurement itself requires a manual action." This implies that a fully standalone measurement for this metric is not applicable.
7. Type of Ground Truth Used
The ground truth used for both LAAO and TAVI studies was expert manual annotation of imaging data, referred to as "manually annotated data."
8. Sample Size for the Training Set
The document explicitly states that the test datasets were "No datasets were included that were used for training the AI models." It does not provide the specific sample size for the training set used for the AI models.
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. It only mentions that the test set cases were not used for training.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
FEops nv % Mieke Janssen RA Consultant OrthoGrow nv Davincilaan 1 Zaventem, Flemish-Brabant 1930 BELGIUM
June 6, 2023
Re: K223855
Trade/Device Name: FEops HEARTguide™. FEops HEARTguide™ ALPACA Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: May 17, 2023 Received: May 17, 2023
Dear Mieke Janssen:
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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K223855
Device Name FEops HEARTguide™ FEops HEARTguide™ALPACA
Indications for Use (Describe)
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions.
To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as:
- · Segmentation of cardiovascular structures
- · Visualization and image reconstruction techniques: 2D review, MPR
- · Measurement and annotation tools
- · Reporting tools
FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g., FEops HEARTguide™ Simulation Application cleared as K214066).
The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement.
| 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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Submitter: FEops NV Device: FEops HEARTguideTM ALPACA
EOPS
its for excellence
510(K) SUMMARY (21CFR807.92)
SUBMITTER
Company Name: Establishment registration number: Address:
Phone number: Principal contact person: Principal contact e-mail address Additional contact person: Additional contact e-mail address Summary date: June 6, 2023
DEVICE
Name & trade name:
Common name: Classification name:
Regulatory class: Regulation number: Product code:
FEops nv 3020703662 Technologiepark 122, 9052 Gent - Zwijnaarde, Belgium +32496564131 Mieke Janssen mieke@ortho-grow.com Peter Mortier peter.mortier@feops.com
FEops HEARTguide™, FEops HEARTguide™ ALPACA FEops HEARTguide™ Picture Archiving and Communications System II 21 CFR 892.2050 OIH
PREDICATE DEVICE
The predicate device to which substantial equivalence is claimed:
| Trade or proprietary or model name | 3mensio Workstation/3mensio Structural Heart/3mensio Vascular |
|---|---|
| 510(k) number: | K153736 |
| Decision date | May 27, 2016 |
| Classification product code | LLZ |
| Regulation Number | 21 CFR 892.2050 |
| Manufacturer | Pie Medial Imaging BV |
Image /page/3/Picture/17 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in large, bold, black letters, with the words "insights for excellence" in smaller, gray letters underneath. To the right of the word "FEOPS" is a vertical gray line, followed by a black speech bubble containing a white icon that resembles an open book or brackets.
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DESCRIPTION AND FUNCTIONING OF THE DEVICE
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions.
The software is used in a service-based business model: the customer (clinician) provides the necessary input data, FEops prepares the anatomical analysis, and delivers the results to the customer.
The results of the anatomical analysis are provided to the clinician via FEops HEART guide™ ALPACA's web application. They are available in a PDF report and as interactive 3D and DICOM MPR visualizations. The web application is intended to be used by clinicians to review the results as well as to create additional landmarks and related measurements, if needed.
INTENDED USE
FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions.
To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as:
- . Segmentation of cardiovascular structures
- Visualization and image reconstruction techniques: 2D review, MPR .
- . Measurement and annotation tools
- . Reporting tools
FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g. FEops HEARTguide™ Simulation Application cleared as K214066).
The results are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional iudgment.
FEops HEARTguide™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement.
Image /page/4/Picture/16 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in large, bold, black letters, with the words "insights for excellence" in smaller, gray letters underneath. To the right of the word "FEOPS" is a vertical gray line, followed by a black speech bubble with a white icon inside. The icon appears to be a stylized book or document.
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TECHNOLOGICAL CHARACTERISTICS
Both the subject device and the predicate device are intended for visualization of medical images of the heart and allow analysis of structures of the heart and vessels. Both devices are to be used for preprocedural planning and sizing of transcatheter cardiovascular interventions. Both devices enable automatic image segmentation for which the output is reviewed and adapted if needed. The predicate device includes additional functionality for post-operative evaluation of structural heart interventions as well as tools to support clinical diagnosis by quantifying calcifications and dimensions in coronary arteries.
| Subject device | Predicate device | Comparison | |
|---|---|---|---|
| Device Name | FEops HEARTguide™ALPACATM | 3mensioWorkstation/3mensioStructuralHeart/3mensio Vascular | / |
| 510(k) Number | / | K153736 | / |
| Manufacturer | FEops NV | Pie Medical ImagingBV | / |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | same |
| DeviceClassificationName | Picture archiving andcommunications system | Picture archivingandcommunications system | same |
| Common Name | 3mensio Workstation | / | |
| Product Code | QIH | LLZ | Similar,the subjectdeviceimplementsartificialintelligenceincludingnonadaptivemachinelearningalgorithms |
| Intended use | FEops HEARTguide™ALPACAenablesvisualizationandmeasurementofstructures of the heartandvesselsforpreprocedural planningand sizing of structuralheart interventions. | 3mensio Workstation isa software solution thatis intended to provideCardiologists,RadiologistsandClinical Specialistsadditional informationto aid them in readingandinterpretingDICOMcompliantmedicalimagesof | Same,both the subject andpredicate device sharethe same intended use,in that they enablevisualization of medicalimages of the heart, andanalysis of structures ofthe heart and vessels. |
Image /page/5/Picture/5 description: The image contains the logo for FEOPS, which is a company that provides insights for excellence. The logo consists of the word "FEOPS" in large, bold, black letters, with the tagline "insights for excellence" in smaller, gray letters underneath. To the right of the text is a black speech bubble containing a stylized image of an open book.
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| To facilitate the above,FEops HEARTguide™ALPACA providesgeneral functionalitysuch as: Segmentation of cardiovascular structures Visualization and image reconstruction techniques: 2D review, MPR Measurement and annotation tools Reporting toolsFEops HEARTguide™ALPACA also allowsvisualization of outputgenerated by othermedical device software(e.g. FEopsHEARTguide™Simulation Applicationcleared as K214066).The results are intendedto be used by qualifiedclinicians in conjunctionwith the patient'sclinical history,symptoms, and otherpreproceduralevaluations, as well as theclinician'sprofessional judgment. | structures of the heartand vessels.3mensio StructuralHeart enables the userto: Visualize and measure (diameters, lengths, areas, volumes, angles) structures of the heart and vessels, Quantify calcium (volume, density)3mensio Vascularenables the user to: Visualize and assess stenosis, aneurisms and vascular structures Measure the dimensions of vessels (diameters, lengths, areas, volumes, angles) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Image /page/6/Picture/3 description: The image shows the logo for FEOPS. The logo has the word "FEOPS" in bold, black letters. Below the word is the phrase "insights for excellence" in a smaller, gray font. To the right of the word is a black circle with a white book icon inside of it.
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| FEops HEARTguide™ALPACA is notintended to replace theimplant deviceinstructions for use forfinal LAAO and TAVIdevice selection andplacement. | |||
|---|---|---|---|
| Indications for Use | FEops HEARTguide™ALPACA enablesvisualization andmeasurement ofstructures of the heartand vessels forpreprocedural planningand sizing of structuralheart interventions.To facilitate the above, FEops HEARTguide™ALPACA providesgeneral functionalitysuch as:Segmentation ofcardiovascularstructures Visualization andimage reconstructiontechniques: 2D review,MPR Measurement andannotation tools Reporting tools FEops HEARTguide™ALPACA also allowsvisualization of outputgenerated by othermedical device software | 3mensio Workstationenables visualizationand measurement ofstructure of the heartand vessels for:Preoperationalplanning andsizing forcardiovascularinterventionsand surgery Postoperativeevaluation Support ofclinical diagnosis byquantifyingdimensions incoronary arteries Support ofclinical diagnosis byquantifyingcalcifications(calcium scoring) in thecoronary arteries To facilitate the above,the 3mensioWorkstation providesgeneral functionalitysuch as: | Similar,Both devices areindicated to be used forpreprocedural planningand sizing of structuralheart interventions.Whereas the subjectdevice solely focuses onpreprocedural planning,the predicate deviceadditionally includesfunctionality forpostoperativeevaluation of structuralheart interventions. Thisdoes not impact theindication for use forpreprocedural planning.The predicate devicealso supports clinicaldiagnosis byquantifyingcalcifications andquantifying dimensionsin coronary arteries.This functionality is notpresent in the subjectdevice. |
| FEops(e.g.HEARTguide™Simulation Applicationcleared as K214066). | - Segmentationofcardiovascularstructures- Automatic andmanualcenterlinedetection- Visualizationandimagereconstructiontechniques: 2Dreview,Volumerendering,MPR, CurvedMPR,StretchedCMPR,Slabbing, MIP,AIP, MinIP- Measurementand annotationtools- Reportingtools | ||
| The results are intendedto be used by qualifiedclinicians in conjunctionwith the patient'sclinical history,symptoms, and otherpreproceduralevaluations, as well asthe clinician'sprofessional judgment. | |||
| FEops HEARTguide™ALPACA is notintended to replace theimplant deviceinstructions for use forfinal LAAO and TAVIdevice selection andplacement. | |||
| Prescription Use | Yes | Yes | same |
| DICOM visualization(including MPR) | Yes, CT data in DICOM format | Yes, CT data in DICOM format | same |
| Image segmentation | Segmentationfunctionality based onartificial intelligenceincluding nonadaptivemachine learning,followed by humansupervision and aquality check by aFEops Case analyst. | 3mensio enablesautomatic segmentation | Similar, both devicesinclude human-supervised automatedsegmentationfunctionality. Bothdevices include theoption for the physicianto review thesegmentation. |
| 3D Visualization | FEops HEARTguideALPACA includes 3Dvisualization of medical | 3mensio includes 3Dvisualization of medical | Similar |
| images (using 3Dsurfaces). | images (volumerendering). | ||
| Landmark identificationand measurements | Both manual and AIsupported functions forlandmark identification. | Both manual and AIsupported functions forlandmark identification. | Same |
| Scope - Structural heartinterventions | Transcatheter heartinterventions | Transcatheter heartinterventions | Same, both devices arelimited to transcatheterinterventions. |
| Functionality for post-intervention evaluation | No | Yes | The predicate deviceincludes functionalityfor post-interventionevaluation.Thisfunctionality is absent inthe subject device. |
| VerificationandValidation | Software verificationand validation wasperformed.Documentation isprovided asrecommended byFDA's Guidance forIndustry and FDA Staff"Guidance for theContent of PremarketSubmissions forSoftware Contained inMedical Devices".Design verificationconfirmed that thesystem requirementswere implementedcorrectly.Design validationestablished that theFEops HEARTguideALPACA conforms tothe intended use anddefined user needs,demonstrating the safety | Verification showedthat the systemrequirements – derivedfrom the intended useand indications for use –were implementedcorrectly, demonstratingthe effectiveness of thedevice.A validation plan for thefinal validation of therelease build wasexecuted on the finalbuild.A test report comparingthe numerical results ofthe device comparedwith the predicatedevices was generated. | Same |
| and effectiveness of thesubject device. | |||
| Cloud-based | Yes | No, 3mensio is atraditional softwarepackage, to be installedon a specific computer | Different, while thesubject device is cloud-based, the predicatedevice is a traditionalsoftware package to beinstalled on a specificcomputer. FEopsHEARTguideTMALPACA is subject tocybersecurity measures(see Section 16). |
| Reporting tools | FEops HEARTguidegenerates pdf reports | 3mensio generates pdfreports | Same |
Image /page/7/Picture/3 description: The image shows the logo for FEOPS, which is written in bold, black letters. Below the logo, the words "insights for excellence" are written in a smaller, lighter font. The logo is simple and modern, and the words below it suggest that the company is focused on providing insights that help its clients achieve excellence.
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Submitter: FEops NV Device: FEops HEARTguide™ ALPACA
Image /page/8/Picture/3 description: The image shows the logo for FEOPS, which is written in bold, black letters. Below the logo, the words "insights for excellence" are written in a smaller, lighter font. To the right of the logo, there is a black icon that resembles a speech bubble with curly brackets inside.
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Image /page/9/Picture/3 description: The image shows the logo for FEOPS, which is a company that provides insights for excellence. The logo is composed of the word "FEOPS" in large, bold, black letters, with the tagline "insights for excellence" in smaller, gray letters below. To the right of the text is a black speech bubble icon with a white "C" inside.
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The provided detailed comparison demonstrates the subject device is substantially equivalent in intended use, design, operating principles and performance characteristics to the predicate device.
Image /page/10/Picture/4 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in large, bold, black letters, with the tagline "insights for excellence" in smaller, gray letters below. To the right of the wordmark is a black speech bubble containing a white icon that resembles an open book or brackets.
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PERFORMANCE DATA
Non-clinical performance data was included in the 510(k)-submission demonstrating FEops HEARTguide™ ALPACA has been validated for its intended use and is substantial equivalent to the predicate device. Software verification and validation was performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user needs. In addition, documentation following "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions" was provided to demonstrate the performance of the quantitative imaging function included within FEops HEARTguide™ ALPACA. The results of the accuracy or performance validation are summarized below.
For LAAO, a study was performed on a cohort of 35 representative retrospective cases, during which quantitative outputs of FEops HEARTguide™ ALPACA were compared with manually annotated data (i.e. ground truth). The age of the studied cohort is 76.2±8.7y (50-92y), 51% were male subjects, and the LAA morphology was chicken wing (43%), reversed chicken wing (11%) or non-angulated (46%). Recent datasets representative for the intended population were used in this test cohort, covering different CT manufacturers, imaging parameters (e.g. slice thickness) and regions. No datasets were included that were used for training the AI models.
A performance goal was set for the mean diameter of the semi-automatically identified landing zone, as this is considered the most important landmark for the pre-operative planning of LAAO procedures. The maximum allowed difference in percentage must be less than the predetermined performance goal of ±18%.
The Bland-Altman analysis conducted on the mean diameter of the landing zone provided the following results for the semi-automatic and fully automatic outputs respectively:
| Semi-automatic output | Fully automatic output | |
|---|---|---|
| Mean of differences (%) | 1.4 ± 4.6 | 4.1 ± 7.2 |
| Confidence interval (CI) on the mean (%) | (-0.2, 2.9) | (1.6, 6.6) |
| Inferior Limit of Agreement (LoA) (%) | -7.7 | -10.1 |
| Superior LoA (%) | 10.4 | 18.3 |
Image /page/11/Picture/8 description: The image shows the logo for FEOPS. The logo consists of the word "FEOPS" in large, bold, black letters, followed by the tagline "insights for excellence" in a smaller, lighter font. To the right of the text is a black speech bubble containing a white icon that resembles an open book or document.
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| CI on inferior LoA (%) | (-10.5, -5.0) | (-14.4, -5.8) |
|---|---|---|
| CI on superior LoA (%) | (7.7, 13.2) | (14.0, 22.6) |
For the semi-automatically identified landing zone, the lower limit of the CI calculated on the inferior LoA (-10.5%) and the upper limit of the CI calculated on the superior LoA (13.2%) are within the maximum allowed difference of ±18%, so the performance goal has been met. For all quantitative output, consistent performance has been observed for all relevant subgroups including CT manufacturers, imaging parameter, patient sex and age as well as LAA morphology.
The segmentation output was compared with manually annotated data (i.e. ground truth) by calculating the dice score on the region of interest: the region of the left atrium containing the ostium and the main part of the left atrial appendage.
| Semi-automatic output | Fully automatic output | |
|---|---|---|
| Mean dice score | $0.98 \pm 0.01$ | $0.93 \pm 0.04$ |
| Minimum Dice score | 0.95 | 0.83 |
| Maximum Dice score | 0.99 | 0.97 |
| Median Dice score | 0.98 | 0.94 |
For TAVI, a study was performed on a cohort of 35 representative retrospective cases, during which quantitative outputs of FEops HEARTguide™ ALPACA were compared with manually annotated data (i.e. ground truth). The age of the studied cohort is 76.3±9.5y (48-91y), 46% were male subjects, and the aortic valve morphology was tricuspid in 74% of cases. Recent datasets representative for the intended population were used in this test cohort, covering different CT manufacturers, imaging parameters (e.g. slice thickness) and regions. No datasets were included that were used for training the AI models.
A performance goal was set for the perimeter-based diameter of the semi-automatically identified aortic annulus, as this is considered the most important landmark for the pre-operative planning of TAVI procedures. The maximum allowed difference in percentage must be less than the predetermined performance goal of ±10%. Please note that there is no automatically calculated perimeter-based diameter of the aortic annulus, as the algorithm only identifies the annular plane, and the measurement itself requires a manual action.
Image /page/12/Picture/8 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in bold, black letters, with the words "insights for excellence" in a smaller, gray font underneath. To the right of the wordmark is a vertical line, followed by a black speech bubble containing a white icon that resembles an open book or brackets. The overall design is clean and modern.
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The Bland-Altman analysis conducted on the perimeter-based diameter of the aortic annulus provided the following results:
| Semi-automatic output | |
|---|---|
| Mean of differences (%) | 0.5 ± 1.9 |
| Confidence interval (CI) on the mean (%) | (-0.1, 1.2) |
| Inferior Limit of Agreement (LoA) (%) | -3.2 |
| Superior LoA (%) | 4.2 |
| CI on inferior LoA (%) | (-4.3, -2.1) |
| CI on superior LoA (%) | (3.1, 5.3) |
The lower limit of the CI calculated on the inferior LoA (-4.3%) and the upper limit of the CI calculated on the superior LoA (5.3%) are within the maximum allowed difference of ±10%, so the performance goal has been met. For all quantitative output, consistent performance has been observed for all relevant subgroups including CT manufacturers, imaging parameter, patient sex and age as well as aortic valve morphology.
The segmentation output was compared with manually annotated data (i.e. ground truth) by calculating the dice score on the region of interest: the region of the aortic root, including the ascending aorta and the left ventricle.
| Semi-automatic output | Fully automatic output | |
|---|---|---|
| Mean dice score | 0.97 ± 0.01 | 0.96 ± 0.01 |
| Minimum Dice score | 0.92 | 0.92 |
| Maximum Dice score | 0.99 | 0.98 |
| Median Dice score | 0.97 | 0.96 |
SUMMARY
The characteristics that determine the functionality and performance of FEops HEART guide™ ALPACA, the subject device, are substantially equivalent to the predicate device cleared under
Image /page/13/Picture/8 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in large, bold, black letters, followed by the phrase "insights for excellence" in smaller, gray letters. To the right of the text is a black speech bubble with a white book icon inside. The book icon is stylized with brackets on the top and bottom.
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K153736. The testing indicates that the subject device is as safe, as effective, and performs as well as the predicate.
Image /page/14/Picture/3 description: The image is a logo for FEOPS, which stands for "insights for excellence". The logo is composed of the word "FEOPS" in large, bold, black letters, with the words "insights for excellence" in a smaller, lighter font underneath. To the right of the text is a black speech bubble containing a white icon that resembles an open book or document with stylized brackets.
§ 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).