(119 days)
FETOLY-HEART is intended to analyse fetal ultrasound images and clips using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.
FETOLY-HEART is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).
FETOLY-HEART is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. FETOLY-HEART can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.
To utilize FETOLY-HEART, the software needs to be installed on a hardware device which is connected to an Ultrasound Machine through an HDMI connection. The software receives ultrasound images captured by the connected Ultrasound Machine in real-time. The software's frozen deep learning algorithm, which was trained by supervised learning, analyzes images of this ultrasound image stream to detect heart views and quality criteria within those views. The software provides the following user-accessible information:
- . Examination completeness: the software displays in real-time which heart views and quality criteria are verified by the software during the examination. It is the main and principal output of the FETOLY-HEART device. The verified heart views and quality criteria are accessible by clinicians at any moment of the ultrasound examination, in real-time.
- . Completeness illustration: the software selects an image subset that illustrates the verified views and quality criteria. These images can be reviewed by clinicians to verify the views and criteria's presence. This is a secondary output of the FETOLY-HEART device. Optionally, clinicians can display detected quality criteria localization on selected images.
Here's a breakdown of the acceptance criteria and the study proving FETOLY-HEART meets them, based on the provided FDA 510(k) summary:
Acceptance Criteria and Performance Study for FETOLY-HEART
The FETOLY-HEART device uses machine learning to automatically detect fetal heart views and quality criteria within those views from ultrasound images. The acceptance criteria focus on the device's accuracy in these detections, measured by sensitivity, specificity, and mean Intersection over Union (mIoU) for bounding box localization.
1. Table of Acceptance Criteria and Reported Device Performance
| Measured Metric | Acceptance Criteria | Reported Device Performance (Point Estimate) | Bootstrap CI (95%) |
|---|---|---|---|
| Fetal Heart View Detection | |||
| Sensitivity (for each view) | ≥ 85% | Abdomen: 0.976Four Chamber: 0.987LVOT: 0.983RVOT: 0.987Three Vessels: 0.981 | Abdomen: (0.960, 0.990) Four Chamber: (0.974, 0.997)LVOT: (0.969, 0.994)RVOT: (0.974, 0.996)Three Vessels: (0.965, 0.993) |
| Specificity (for each view) | ≥ 85% | Abdomen: 0.998Four Chamber: 1.00LVOT: 0.999RVOT: 0.998Three Vessels: 0.998 | Abdomen: (0.996, 1.000)Four Chamber: (1.000, 1.000)LVOT: (0.998, 1.000)RVOT: (0.996, 1.000)Three Vessels: (0.997, 1.000) |
| Quality Criteria Detection | |||
| Sensitivity | ≥ 90% | Ranges from 0.903 (Abdomen - Left rib) to 0.990 (Four Chamber - Left atrium) | (All reported lower bounds of CI for sensitivity met ≥ 0.85 acceptance criteria for views, and ≥ 0.90 for quality criteria.) |
| Specificity | ≥ 90% | Ranges from 0.990 (Four Chamber - Connection between crux and atrial septum) to 1.00 (Four Chamber - Right atrium/Foramen ovale flap) | (All reported lower bounds of CI for specificity met ≥ 0.85 acceptance criteria for views, and ≥ 0.90 for quality criteria.) |
| Quality Criteria Bounding Box Localization | |||
| Mean Intersection over Union (mIoU) | ≥ 50% | Values range from 0.512 (Abdomen - Inferior vena cava) to 0.792 (Three Vessels - Spine) | (All reported lower bounds of CI for mIoU met ≥ 0.50 acceptance criteria.) |
Note: For the detailed range of sensitivities, specificities, and mIoU for each of the 52 quality criteria, refer to the tables provided in the original document (pages 15-17).
2. Sample Size and Data Provenance
- Test Set Sample Size: 2,288 fetal ultrasound images across 480 patient cases.
- Data Provenance: The data originated from 7 distinct clinical sites in the United States. The data was collected retrospectively in reverse chronological order. It includes full examination still images, cardiac clip frames, and full examination video frames. The cases are stated to be representative of the intended use population.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Six annotators and additional adjudicators.
- Qualifications of Experts: 3 sonographers and 3 OB/GYN doctors. Specific experience levels (e.g., "10 years of experience") are not provided, but their professional titles indicate clinical expertise in relevant fields.
4. Adjudication Method for the Test Set
- View Classification: A 2+1 ground truth procedure was used.
- Images were assigned to pairs of annotators.
- If the two annotators agreed on the view classification, that was considered the ground truth.
- If the pair of annotators disagreed, an adjudicator reviewed the images and made the final decision.
- Quality Criteria Classification and Localization (Bounding Boxes):
- Each image was annotated by a pair of annotators who drew bounding boxes.
- Agreement on Localization: If their bounding boxes had at least 50% overlap, their coordinates were averaged to form the ground truth.
- Disagreement on Presence or Localization: If the overlap was lower or there was a disagreement on the criterion's presence, an adjudicator reviewed the boxes.
- The final decision regarding the presence of the criterion was based on majority consensus among the adjudicator and annotators.
- The final decision for the criteria localization (bounding box) was based on the adjudicator's decision to either keep one of the annotator's boxes or draw a new one.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document does not indicate that an MRMC comparative effectiveness study was done to evaluate how much human readers improve with AI vs. without AI assistance. The study described is a standalone performance test of the algorithm itself.
6. Standalone Performance (Algorithm Only) Study
- Yes, a standalone performance study was conducted. The results presented in the tables (sensitivity, specificity, mIoU) are for the FETOLY-HEART algorithm's performance without integration into a human reading workflow or human-in-the-loop performance measurement.
7. Type of Ground Truth Used
- The ground truth used was expert consensus based on a 2+1 adjudication method by a panel of sonographers and OB/GYN doctors. For quality criteria localization, it involved expert-drawn bounding boxes with an adjudication process.
8. Sample Size for the Training Set
- The document states that the testing dataset originated from distinct clinical sites from which the data used during model development (training/validation) was sourced, ensuring testing independence. However, the sample size for the training set is not explicitly provided in the given text.
9. How the Ground Truth for the Training Set Was Established
- The document states, "The software's frozen deep learning algorithm, which was trained by supervised learning...". While it confirms supervised learning was used (implying labeled data), it does not explicitly detail the method for establishing ground truth for the training set. It only describes the ground truth establishment for the test set. It is common for ground truth for training data to be established by experts, potentially through similar consensus or adjudication processes, but this specific document does not describe it for the training set.
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September 11, 2024
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Diagnoly % Nima Akhlaghi Associate Director, Digital Health Regulatory Affairs MCRA, LLC 505 Park Avenue, 14th Floor New York, NY 10022
Re: K241380
Trade/Device Name: FETOLY-HEART Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, QIH Dated: August 9, 2024 Received: August 9, 2024
Dear Nima Akhlaghi:
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 (the 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 available 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.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an
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established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rele"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices 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
Submission Number (if known)
Device Name
FETOLY-HEART
Indications for Use (Describe)
Fetoly-Heart is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.
Fetoly-Heart is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stack of three horizontal lines inside the lens. The word "DIAGNOLY" is written in blue, sans-serif font below the magnifying glass. The background of the image is white.
In accordance with 21 CFR 807.92 the 510(k) summary for FETOLY-HEART is provided below.
510(k) owner 1
| Owner | Diagnoly60 Avenue Rockefeller69008 Lyon, France+33(0)4.78.76.85.75 |
|---|---|
| Primary contact person | Ivan VoznyukChief Executive OfficerDiagnolyPhone: +33(0)6.95.87.04.55Email: ivan@diagnoly.com |
| Secondary contact person | Nima AkhlaghiAssociate Director, Digital Health Regulatory AffairsMCRA, LLCPhone: 202.742.3889Email: nakhlaghi@mcra.com |
| Date prepared | 2024-08-30 |
2 Device
| Trade Name | FETOLY-HEART |
|---|---|
| Classification name | Accessory to Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550Accessory to Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560Medical image management and processing system, 21 CFR 892.2050 |
| Class | II |
| Product code | IYN (Primary)IYO, QIH (secondary) |
Predicate device identification ന
The predicate device used for FETOLY-HEART is the cardiac-related component of Sonio Detect (K240406).
Additionally, a reference device was chosen for FETOLY-HEART based on its substantially equivalent technical characteristics of automatic extraction of views from a sequence of images. This reference
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device corresponds to the SonoLystLive view suggestion feature within the Voluson Expert Series 22/20/18 (K220358).
Device description 4
FETOLY-HEART is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. FETOLY-HEART can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.
To utilize FETOLY-HEART, the software needs to be installed on a hardware device which is connected to an Ultrasound Machine through an HDMI connection. The software receives ultrasound images captured by the connected Ultrasound Machine in real-time. The software's frozen deep learning algorithm, which was trained by supervised learning, analyzes images of this ultrasound image stream to detect heart views and quality criteria within those views. The software provides the following user-accessible information:
- . Examination completeness: the software displays in real-time which heart views and quality criteria are verified by the software during the examination. It is the main and principal output of the FETOLY-HEART device. The verified heart views and quality criteria are accessible by clinicians at any moment of the ultrasound examination, in real-time.
- . Completeness illustration: the software selects an image subset that illustrates the verified views and quality criteria. These images can be reviewed by clinicians to verify the views and criteria's presence. This is a secondary output of the FETOLY-HEART device. Optionally, clinicians can display detected quality criteria localization on selected images.
| Heart views | Quality criteria within the views | |
|---|---|---|
| Image: Heart view(A) ABDAbdomen view(n = 8) | (A1) Sp Spine | |
| (A2) IRb Left rib | ||
| (A3) rRb Right rib | ||
| (A4) Ao Descending aorta | ||
| (A5) VC Inferior vena cava | ||
| (A6) St Stomach | ||
| (A7) Uv Umbilical vein | ||
| (A8) Ap Thorax apex | ||
| (B1) Sp Spine | ||
| (B2) IRb | Left rib | |
| (B3) rRb | Right rib | |
| (B4) Ao | Descending aorta | |
| (B5) IPV | Left pulmonary vein | |
| (B6) rPV | Right pulmonary vein | |
| (B7) LA | Left atrium | |
| (B8) RA | Right atrium | |
| (B) 4CH | (B9) FOP | Foramen Ovale flap (Vieussens valve) |
| Four chamber view(n = 19) | (B10) FO | Open Foramen Ovale |
| (B11) MV | Mitral valve | |
| (B12) TV | Tricuspid valve | |
| (B13) bCr | Connection between crux and atrial septum (vestibular septum) | |
| (B14) Cr | Atrioventricular valve offset in crux | |
| (B15) tCr | Connection between interventricular septum and crux | |
| (B16) IVS | Interventricular septum | |
| (B17) LV | Left ventricle | |
| (B18) RV | Right ventricle | |
| (B19) Str | Sternum | |
| (C1) LA | Left atrium | |
| (C2) aAo | Proximal ascending aorta | |
| (C) LVOT | (C3) SV | Semilunar valves |
| (C4) LV | Left ventricle | |
| (C5) IVS | Interventricular septum | |
| Left Ventricular Outflow Tract view(n = 6) | (C6) RV | Right ventricle |
| (D1) dAo | Descending aorta | |
| (D2) Tr | Trachea / bronchi | |
| (D3) IPA | Left pulmonary artery | |
| (D4) Du | Ductus arteriosus | |
| (D5) rPA | Right pulmonary artery | |
| (D6) Or | Origin of pulmonary arteries | |
| (D) RVOT | (D7) S | Septum between pulmonary artery trunk and ascending aorta |
| Right Ventricular Outflow Tract view(n = 10) | (D8) aAo | Ascending aorta |
| (D9) SVC | Superior vena cava | |
| (D10) PA | Pulmonary trunk | |
| (E1) Sp | Spine | |
| (E2) Tr | Trachea | |
| (E3) ES | Side space on the left of ductus / pulmonary artery | |
| (E4) PA | Main pulmonary artery | |
| (E5) Du | Ductus (Ductal arch) | |
| (E6) aAo | Ascending aorta | |
| (E) 3VX(E7) aAr | Aortic arch | |
| Three vessels view(n = 9) | (E8) SVC | Superior vena cava |
| (E9) Th | Thymus / sternum |
Definition of a complete examination 4.1
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Image /page/7/Picture/0 description: The image shows a logo for a company called "Diagnoly". The logo features a blue magnifying glass with a stack of three cone-shaped objects inside the lens. The word "Diagnoly" is written in blue, sans-serif font below the magnifying glass.
Table 1. List of 52 quality criteria defining the 5 views recommended by the International Society of Ultrasound in Obstetrics and Gynecology for the foetal heart screening of 2nd and 3rd trimesters of pregnancy. Abbreviations from this table are corresponding to the abbreviations used within the software.
International and national guidelines- recommend 5 foetal cardiac views for routine ultrasound examination of 2nd and 3rd trimesters: (A) Abdomen view, (B) Four chamber view, (C) Left Ventricular Outflow Tract view, (D) Right Ventricular Outflow Tract view, (E) Three vessels view. The quality of these 5 heart views depends on the presence of 52 anatomical quality criteria within the views (Table 1). Thus, an examination can be defined as complete when all 5 heart views and their quality criteria are obtained by the HCP.
Functionality 1: completeness overview 4.2
The software assesses the completeness of the foetal ultrasound examination. It verifies whether all the information corresponding to the recommended guidelines for the foetal heart examination has been acquired. This information corresponds to the presence of 5 main foetal cardiac views and 52 quality criteria, detailed in the above section, allowing for compliance in cardiac screening.
Functionality 2: completeness illustration 4.3
This functionality was developed to enhance the security of the completeness evaluation which is done by the first module. It enables clinicians to verify the examination completeness overview, i.e. verified views and quality criteria by the software through the gallery page of the software interface. Operating continuously, it evaluates each image processed by the first module in real-time, retaining an image set as visual evidence of the verified heart views and quality criteria up to that moment.
FETOLY-HEART does not aim to select the 'best' or of 'high' diagnostic quality according to a given qualitative scale. Rather, FETOLY-HEART aims to select images illustrating the examination quantitative completeness in terms of verified views and quality criteria.
Indications for use ഗ
FETOLY-HEART is intended to analyse fetal ultrasound images and clips using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.
FETOLY-HEART is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).
1 Carvalho JS, Axt-Fliedner R, Chaoui R, Copel JA, Cuneo BF, Goff D, Gordin Kopylov L, Hecher K, Lee W, Moon-Grady A, Mousa HA, Munoz H, Paladini D, Prefumo F, Quarello E, Rychik J, Tutschek B, Wiechec M, Yagel S. ISUOG Practice Guidelines (updated): fetal cardiac screening. Ultrasound Obstet Gynecol 2023; 61: 788-803.
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Image /page/8/Picture/1 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stack of three objects inside. The word "DIAGNOLY" is written in blue letters below the magnifying glass.
6 Summary of the technological characteristics of FETOLY-HEART compared to the predicate device
| Aspect | Predicate device:Sonio Detect(Cardiac Features)K240406 | Reference device:Voluson Expert18/20/22 (Cardiac-related SonolystLiveFeature)K220358 | Proposed device:FETOLY-HEART | Comparison betweenProposed andPredicate device |
|---|---|---|---|---|
| General | ||||
| Manufacturername | Sonio | GE Healthcare | Diagnoly | NA |
| Device name | Cardiac-relatedfeatures in SonioDetect | Cardiac-relatedSonolystLive in theVoluson Expert18/20/22 | FETOLY-HEART | NA |
| Productcode(s) | IYN (Primary)IYO, QIH (secondary) | IYN (Primary)IYO, ITX (Secondary) | IYN (Primary)IYO, QIH (secondary) | SubstantiallyequivalentPrimary codes are thesame for all devices |
| Regulationnumber | - Accessory toUltrasonic PulsedDoppler ImagingSystem, 21 CFR892.1550- Accessory toUltrasonic PulsedEcho Imaging System,21 CFR 892.1560 | - Ultrasonic PulsedDoppler ImagingSystem, 21 CFR892.1550- Ultrasonic PulsedEcho Imaging System,21 CFR 892.1560- DiagnosticUltrasoundTransducer, 21 CFR892.1570, 90-ITX | - Accessory toUltrasonic PulsedDoppler ImagingSystem, 21 CFR892.1550- Accessory toUltrasonic PulsedEcho Imaging System,21 CFR 892.1560- Medical imagemanagement andprocessing system,21 CFR 892.2050 | SubstantiallyequivalentAll devices are class IIdevices subject to510(k) regulatorypathway. |
| Briefdescription | The predicate deviceis a software thataims at helpingsonographers,OB/GYNs, MFMs andFetal surgeons (allthree designated ashealthcareprofessionals i.e.HCP) to perform theirroutine fetal heartultrasound | The reference deviceis a software thataims at helpingsonographers,OB/GYNs, MFMs andFetal surgeons (allthree designated ashealthcareprofessionals i.e.HCP) to perform theirroutine fetal heartultrasound | FETOLY-HEART is asoftware that aims athelpingsonographers,OB/GYNs, MFMs andFetal surgeons (allthree designated ashealthcareprofessionals i.e.HCPs) to performtheir routine fetalheart ultrasound | SubstantiallyequivalentThe subject deviceand the predicatedevices have thesame objective. |
| examinations in real-time. | examinations in real-time. | examinations in real-time. | ||
| Indications foruse | The predicate deviceis intended to analyzefetal ultrasoundimages and clipsusing machinelearning techniquesto automaticallydetect heart views,detect anatomicalstructures within theviews and verifyquality criteria of theviews.The device isintended for use as aconcurrent readingaid during theacquisition andinterpretation of fetalultrasound images. | The device is ageneral purposeultrasound systemintended for use byqualified and trainedhealthcareprofessionals. | FETOLY-HEART isintended to analysefetal ultrasoundimages and clipsusing machinelearning techniquesto automaticallydetect heart viewsand quality criteriawithin the views. Thedevice is intended foruse as a concurrentreading aid duringthe acquisition andinterpretation of fetalultrasound images.FETOLY-HEART isindicated for useduring routine fetalheart examination of2nd and 3rdtrimester pregnancy(gestational age:from 17 to 40 weeks). | SubstantiallyequivalentIndications for Useare the samebetween predicateand subject devices. |
| Targetedpopulation | Pregnant womenduring the 2nd and3rd trimester ofpregnancy | Pregnant womenduring the 2ndtrimester ofpregnancy | Pregnant womenduring the 2nd and3rd trimester ofpregnancy | SubstantiallyequivalentSubject device hasthe same intendedpatient populationthan the predicatedevices. |
| Clinicaloutcome | - Images labeled withcorrect fetal heartview | - Images labeledwith correct fetalheart view | - Images labeled withcorrect fetal heartview for patient cases | SubstantiallyequivalentPerformance testinghas successfullyvalidated the clinicaloutcomes |
| - Quality criteriaidentified as"Verified" whendetected and "Notverified" when notdetected | - Quality criteriaidentified as "Found"when detected and"Not found" whennot detected | - Quality criteriaidentified as"Verified" whendetected and "Not | SubstantiallyequivalentIn the subject device,quality criteriabounding boxlocalization can be | |
| verified" when notdetected- Images labeled withthe localization ofquality criteria | optionally displayedon post-acquisitionimages to enhanceexplainability of theAl model.Performance testinghas been performedand does notintroduce newquestions of safetyand effectiveness. | |||
| Intended user | Qualified healthcareprofessionalspecialized inprenatal ultrasoundimaging | Qualified healthcareprofessionalspecialized inprenatal ultrasoundimaging | Qualified healthcareprofessionalspecialized inprenatal ultrasoundimaging | SubstantiallyequivalentSubject device hasthe same intendedusers as the predicatedevices. |
| Clinicalapplications | Fetal/Obstetrics | Fetal/Obstetrics | Fetal/Obstetrics | SubstantiallyequivalentClinical application isthe same for subjectand predicatedevices. |
| Inclusion of aPCCP | N/A | N/A | Included | DifferentThe PCCP in thesubject deviceincludes proposedmodifications relatedto modifying modeltraininghyperparameters,additional retrainingwith new training andvalidation datasetscollected, andaddition/removal ofheart quality criteria. |
| Functionality 1: completeness overview | ||||
| Automaticallydetect views | Detection of 4ch, 3vx,LVOT, RVOT and Abdviews (completeimplementation ofISUOGrecommendations) | Detection of 4ch, 3vx,LVOT, RVOT and Abdviews (completeimplementation ofISUOGrecommendations) | Detection of 4ch, 3vx,LVOT, RVOT and Abdviews (completeimplementation ofISUOGrecommendations) | SubstantiallyequivalentThe subject deviceincludes thedetection of the sameviews than thepredicate device |
| Automaticallydetect qualitycriteria | Detection of 28 heartquality criteria. Thequality alsoincorporates thezoom level of theview. | Detection of NAheart quality criteria. | Detection of 52 heartquality criteria (seeTable 1). The qualityalso incorporates thezoom level of theview. | SubstantiallyequivalentThe subject deviceincludes thedetection of newquality criteria whencompared to thepredicate device. Thisquantitativeenhancement hasbeen tested and doesnot raise any newquestion of safetyand effectiveness. |
| Functionality 2: completeness illustration | ||||
| Automaticallyselects views | NA | Automatic suggestionof views from asequence of images. | Automatic extractionof views from asequence of images. | SubstantiallyequivalentThis image selectionfunctionality is afeature absent in thepredicate device butpresent in thereference device.Software testing hasbeen performed tovalidate its use anddoes not introducenew questions ofsafety andeffectiveness. |
| Technical characteristics | ||||
| Data input | Accepts images andimage sequencesfrom ultrasoundmachines | Accepts images andimage sequencesfrom ultrasoundmachines | Accepts images andimage sequencesfrom ultrasoundmachines | SubstantiallyequivalentThe input data is thesame for the subjectdevice and thepredicate andreference devices. |
| AlgorithmMethodology | Artificial Intelligence:Utilizes computervision algorithms toanalyze ultrasoundimages and providesvisualization ofdetected landmarks | Artificial Intelligence:Utilizes computervision algorithms toanalyze ultrasoundimages and providesvisualization ofdetected landmarks | Artificial Intelligence:Utilizes computervision algorithms toanalyze ultrasoundimages and providesvisualization ofdetected landmarks | SubstantiallyequivalentThe subject deviceand the primarypredicate device useboth artificialintelligence. |
| Platform | Operates in a cloud-based environmentfunctioningindependently fromthe ultrasoundequipment. | Operates as a localsoftware embeddedin the ultrasoundequipment. | Operates as a localsoftware functioningindependently fromthe ultrasoundequipment. | SubstantiallyequivalentThe edge-basedapproach reducesexposure to potentialcloud-relatedvulnerabilities andlatency issues.Therefore, thisdifference does notraise any safety oreffectivenessconcerns. |
| UltrasoundMachinecompatibility | Compatible withultrasound systemfrom GE Medical,Samsung, Canon andPhilips | NA | Compatible withultrasound systemfrom GE Medical,Samsung and Canon | SubstantiallyequivalentThis compatibility hasbeen tested andvalidated as part ofdevicegeneralizability in theperformance testingstudy. |
| Userinteraction | The user can interactwith the software tooverride thesoftware's outputs.The user has theability to review andedit/override thematching at any timeduring or at the endof the exam. | NA | The user can interactwith the software tooverride thesoftware's outputs.The user has theability to review andedit/override thematching at any timeduring or at the endof the exam. | SubstantiallyequivalentUser interactions arethe same betweenprimary predicateand subject devices. |
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Image /page/9/Picture/0 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stack of three curved lines inside, suggesting a focus on analysis or investigation. The company name, "DIAGNOLY," is written in a stylized blue font below the magnifying glass, emphasizing the company's diagnostic or analytical services.
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Image /page/10/Picture/0 description: The image shows a blue magnifying glass with a symbol inside. The symbol consists of several horizontal lines that are stacked on top of each other, resembling a radar or sonar display. Below the magnifying glass, the word "DIAGNOLY" is written in blue, with the letters in a slightly rounded font.
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Image /page/11/Picture/0 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stylized image of a stack of objects inside the lens. The word "DIAGNOLY" is written in blue letters below the magnifying glass.
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Image /page/12/Picture/0 description: The image shows a blue logo for a company called DIAGNOLY. The logo features a magnifying glass with a stylized image of three stacked, truncated cones inside the lens. The word "DIAGNOLY" is written in blue below the magnifying glass.
Non-clinical performance data 7
7.1 FETOLY-HEART testing strategy
The following V&V testing were included into the development of the system:
- Software verification testing per IEC 62304 standard
- Tablet compatibility testing
- Cybersecurity verification testing ●
- Software Al model validation
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Image /page/13/Picture/1 description: The image shows a logo for a company called "DIAGNOLY". The logo features a blue magnifying glass with a stylized image of a stack of three horizontal lines inside the lens. The word "DIAGNOLY" is written in blue below the magnifying glass.
FETOLY-HEART uses a machine learning (ML) algorithm for detection of heart views and quality criteria within these views in ultrasound images. Modifications to FETOLY-HEART will be made in accordance with the guiding principles on predetermined change control plans (PCCP) for machine learning-enabled medical devices. This PCCP provides a description of the device's planned modifications, and those modifications will be triggered and implemented in a controlled manner that ensures the continued safety and efficacy on the performance testing dataset, mitigating risks associated with changes to the ML model to not adversely impact the device's performance, safety, or effectiveness associated with its indications for use, and an impact assessment of the planned modifications.
In accordance with the PCCP, all algorithm modifications will be adequately trained, tuned, and locked prior to release of the software with the modified ML model. The PCCP does not include the implementation of adaptive algorithms that will continuously learn in the field. Implemented modifications to the FETOLY-HEART algorithm will be communicated to users via the software update notifications and through updated labelling. The modifications outlined in the PCCP are summarized in the table below. The PCCP in the subject device with the proposed modifications related to modifying model training hyperparameters, additional retraining and validation datasets collected, and addition/removal of heart quality criteria do not raise different questions of safety and effectiveness from the predicate device (see table below).
| Modification | Rationale | Testing Methods | Impact Assessment |
|---|---|---|---|
| Modification oftraining and/orvalidation datasets | Increase or recovery (incase of data drift) ofFETOLY-HEART'sperformance. | Re-training of the FETOLY-HEART model with newdata to optimize itsperformance followed byinternal testing and acomparison of the initialmodel to the modifiedmodel using performancemetrics on the testdataset. | Increased performance metrics of themodified model for view or qualitycriteria detection.Benefits: Increase or recovery ofperformance; generalization fordiverse cases.Risks: Performance decrease(overfitting, unintended bias).Risk mitigation: The modified modelwill be tested for superiority on theperformance study test dataset whichwill contain new unseen data. |
| Modification ofmodel traininghyperparameters | Improvement andoptimization of FETOLY-HEART's performance | Re-training of the FETOLY-HEART model with newparameters to optimize itsperformance followed byinternal testing and acomparison of the initialmodel to the modifiedmodel using performance | Increased performance metrics of themodified model for view or qualitycriteria detection.Benefits: Increased performance;generalization for diverse cases.Risks: Performance decrease(overfitting, unintended bias). |
Summary of changes to FETOLY-HEART per the PCCP:
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Image /page/14/Picture/0 description: The image shows a blue logo for a company called "DIAGNOLY". The logo features a blue magnifying glass with a stack of three cone-shaped objects inside. The text "DIAGNOLY" is written in blue below the magnifying glass.
| metrics on the testdataset. | Risk mitigation: The modified modelwill be tested for superiority on theperformance study test dataset whichwill contain new unseen data. | ||
|---|---|---|---|
| Heart qualitycriteriaaddition/removal | Maintain alignmentwith quality criteriarecommended for fetalheart screening instate-of-the-artinternationalguidelines. | New quality criteria will becontrolled using the sameacceptance criteria asdefined by secondaryendpoints. | Enhanced compliance with standardinternational guidelines.Benefits: Keeping the device relevantby aligning with the updated list ofheart quality criteria.Risks: Performance decrease and userconfusion.Risk mitigation: Proper performancetesting with no decrease in testperformance. This change onlypertains to quality criteria belongingto one of the 5 heart views alreadyincluded in FETOLY-HEART. |
FETOLY-HEART performance study 7.2
Diagnoly conducted a standalone performance testing on a dataset of 2,288 fetal ultrasound images across 480 patient cases, including full examination still images, cardiac clip frames and full examination video frames from 7 clinical sites in the United States and cases are representative of the intended use population. This testing dataset originated from distinct clinical sites from which the data used during model development (training/validation) was sourced, ensuring testing independence.
The results of the standalone performance testing demonstrate that FETOLY-HEART automatically detects fetal heart ultrasound views with a sensitivity ≥ 85% (acceptance criterion) and specificity ≥ 85% (acceptance criterion), detects quality criteria within heart views with a sensitivity ≥ 90% (acceptance criterion) and a specificity ≥ 90% (acceptance criterion), and localizes bounding boxes of quality criteria with a mean intersection over union (loU) of ≥ 50% (acceptance criterion). Sensitivity and specificity were evaluated individually for each view, and the performance goal to exceed 85% as the lower bound of the corresponding 95% Confidence Interval (Cl) was met. The Cl was estimated using bootstrap resampling at the subject level based on 1,000 samples, with traditional bootstrap Cl confidence limits derived as the 2.5th and 97.5th percentiles of the distribution of bootstrap estimates. The results are summarized in the tables below:
| Sensitivity | Specificity | |||||
|---|---|---|---|---|---|---|
| Fetal heart view | N(positive) | Pointestimate | Bootstrap Cl(95%) | N(negative) | Pointestimate | Bootstrap Cl(95%) |
| Abdomen view | 428 | 0.976 | (0.960,0.990) | 1860 | 0.998 | (0.996,1.000) |
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Image /page/15/Picture/0 description: The image shows a logo for a company called "Diagnoly". The logo features a blue magnifying glass with a stylized image of a sound wave inside. The company name "Diagnoly" is written in blue, sans-serif font below the magnifying glass.
| Four chamber view | 391 | 0.987 | (0.974,0.997) | 1897 | 1.00 | (1.000,1.000) |
|---|---|---|---|---|---|---|
| Left ventricular outflowtract view | 360 | 0.983 | (0.969,0.994) | 1928 | 0.999 | (0.998,1.000) |
| Right ventricular outflowtract view | 313 | 0.987 | (0.974,0.996) | 1975 | 0.998 | (0.996,1.000) |
| Three vessels view | 316 | 0.981 | (0.965,0.993) | 1972 | 0.998 | (0.997,1.000) |
| Other view | 480 | 0.985 | (0.972,0.995) | 1808 | 0.983 | (0.977,0.989) |
| Sensitivity | Specificity | mloU | ||||||
|---|---|---|---|---|---|---|---|---|
| Quality criterion | N | Point estimate | Bootstrap Cl (95%) | N | Point estimate | Bootstrap CI (95%) | Point estimate | Bootstrap CI (95%) |
| Abdomen view | ||||||||
| Spine | 417 | 0.966 | (0.949,0.981) | 1871 | 0.995 | (0.992,0.998) | 0.739 | (0.728,0.750) |
| Left rib | 401 | 0.903 | (0.873,0.933) | 1887 | 0.997 | (0.995,0.999) | 0.651 | (0.631,0.673) |
| Right rib | 388 | 0.910 | (0.882,0.940) | 1900 | 0.997 | (0.994,0.999) | 0.624 | (0.602,0.643) |
| Descending aorta | 417 | 0.947 | (0.925,0.969) | 1871 | 0.998 | (0.996,0.999) | 0.528 | (0.515,0.542) |
| Inferior vena cava | 363 | 0.915 | (0.884,0.941) | 1925 | 0.992 | (0.988,0.996) | 0.512 | (0.496,0.528) |
| Stomach | 414 | 0.976 | (0.961,0.988) | 1874 | 0.995 | (0.992,0.998) | 0.734 | (0.720,0.746) |
| Umbilical vein | 345 | 0.962 | (0.942,0.980) | 1943 | 0.991 | (0.987,0.994) | 0.676 | (0.660,0.693) |
| Thorax apex | 397 | 0.919 | (0.893,0.944) | 1891 | 0.993 | (0.989,0.997) | 0.571 | (0.549,0.592) |
| Four chamber view | ||||||||
| Spine | 339 | 0.965 | (0.944,0.982) | 1949 | 0.999 | (0.997,1.000) | 0.768 | (0.754,0.779) |
| Left rib | 308 | 0.945 | (0.917,0.970) | 1980 | 0.996 | (0.993,0.999) | 0.744 | (0.726,0.764) |
| Right rib | 309 | 0.958 | (0.934,0.980) | 1979 | 0.996 | (0.993,0.998) | 0.749 | (0.730,0.768) |
| Descending aorta | 361 | 0.981 | (0.965,0.994) | 1927 | 0.996 | (0.994,0.999) | 0.646 | (0.632,0.659) |
| Left pulmonary vein | 127 | 0.921 | (0.871,0.965) | 2161 | 0.998 | (0.995,1.000) | 0.628 | (0.601,0.653) |
| Right pulmonary vein | 198 | 0.904 | (0.860,0.943) | 2090 | 0.996 | (0.993,0.999) | 0.601 | (0.578,0.623) |
| Left atrium | 387 | 0.990 | (0.979,0.997) | 1901 | 0.998 | (0.996,1.000) | 0.759 | (0.747,0.771) |
| Right atrium | 391 | 0.987 | (0.975,0.997) | 1897 | 1.00 | (1.000,1.000) | 0.774 | (0.763,0.786) |
| Foramen ovale flap | 113 | 0.929 | (0.883,0.971) | 2175 | 1.00 | (0.999,1.000) | 0.530 | (0.505,0.561) |
| Open Foramen Ovale | 348 | 0.951 | (0.928,0.972) | 1940 | 0.996 | (0.993,0.999) | 0.616 | (0.598,0.634) |
| Mitral valve | 207 | 0.908 | (0.866,0.948) | 2081 | 0.998 | (0.995,1.000) | 0.676 | (0.654,0.695) |
| Tricuspid valve | 243 | 0.959 | (0.931,0.983) | 2045 | 0.995 | (0.992,0.998) | 0.718 | (0.701,0.735) |
| Connectionbetweencrux and atrial septum | 299 | 0.943 | (0.915,0.969) | 1989 | 0.990 | (0.986,0.994) | 0.587 | (0.567,0.603) |
| Atrioventricular valveoffset in crux | 115 | 0.939 | (0.897,0.980) | 2173 | 0.992 | (0.988,0.995) | 0.648 | (0.623,0.673) |
| Connection betweeninterventricularseptum and crux | 177 | 0.910 | (0.868,0.951) | 2111 | 0.996 | (0.993,0.999) | 0.565 | (0.544,0.585) |
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Image /page/16/Picture/0 description: The image shows a blue logo for a company called Diagnoly. The logo features a magnifying glass with a stack of three objects inside. The text "DIAGNOLY" is written in blue below the magnifying glass.
| Interventricularseptum | 216 0.917 | (0.877,0.949) | 2072 0.996 | (0.993,0.999) | 0.71 | (0.689,0.728) |
|---|---|---|---|---|---|---|
| Left ventricle | 389 0.987 | (0.975,0.997) | 1899 1.00 | (1.000,1.000) | 0.748 | (0.734,0.761) |
| Right ventricle | 387 0.990 | (0.979,0.997) | 1901 0.999 | (0.997,1.000) | 0.758 | (0.746,0.770) |
| Sternum | 322 0.972 | (0.952,0.988) | 1966 0.991 | (0.986,0.995) | 0.681 | (0.661,0.700) |
| Left ventricular outflow tract view | ||||||
| Left atrium | 356 0.98 | (0.966,0.992) | 1932 0.997 | (0.995,0.999) | 0.656 | (0.633,0.676) |
| Proximal ascendingaorta | 360 0.983 | (0.969,0.994) | 1928 0.999 | (0.998,1.000) | 0.716 | (0.702,0.730) |
| Semilunar valves | 165 0.909 | (0.866,0.950) | 2123 0.998 | (0.995,1.000) | 0.527 | (0.503,0.552) |
| Left ventricle | 358 0.978 | (0.961,0.992) | 1930 0.999 | (0.998,1.000) | 0.745 | (0.732,0.758) |
| Interventricularseptum | 199 0.925 | (0.888,0.959) | 2089 0.995 | (0.992,0.998) | 0.663 | (0.638,0.690) |
| Right ventricle | 358 0.980 | (0.964,0.992) | 1930 0.999 | (0.997,1.000) | 0.698 | (0.675,0.719) |
| Right ventricular outflow tract view | ||||||
| Descending aorta | 294 0.949 | (0.924,0.971) | 1994 0.997 | (0.994,0.999) | 0.617 | (0.595,0.638) |
| Trachea / bronchi | 180 0.922 | (0.882,0.960) | 2108 0.990 | (0.985,0.994) | 0.520 | (0.491,0.548) |
| Left pulmonary artery | 125 0.960 | (0.921,0.992) | 2163 0.995 | (0.992,0.998) | 0.615 | (0.582,0.646) |
| Ductus arteriosus | 177 0.944 | (0.907,0.974) | 2111 0.997 | (0.995,0.999) | 0.631 | (0.606,0.656) |
| Rightpulmonaryartery | 302 0.980 | (0.965,0.994) | 1986 0.994 | (0.991,0.997) | 0.654 | (0.633,0.675) |
| Origin ofpulmonaryarteries | 258 0.922 | (0.889,0.953) | 2030 0.997 | (0.994,0.999) | 0.589 | (0.568,0.610) |
| Septumbetweenpulmonaryarterytrunk andascendingaorta | 218 0.945 | (0.911,0.973) | 2070 0.993 | (0.989,0.996) | 0.692 | (0.672,0.710) |
| Ascending aorta | 312 0.974 | (0.957,0.990) | 1976 0.998 | (0.996,1.000) | 0.633 | (0.613,0.650) |
| Superior vena cava | 218 0.940 | (0.910,0.971) | 2070 0.994 | (0.991,0.998) | 0.577 | (0.549,0.603) |
| Pulmonary trunk | 312 0.971 | (0.952,0.990) | 1976 0.999 | (0.998,1.000) | 0.760 | (0.744,0.775) |
| Three vessels views | ||||||
| Spine | 276 0.953 | (0.929,0.975) | 2012 0.998 | (0.996,1.000) | 0.792 | (0.779,0.805) |
| Trachea | 206 0.932 | (0.899,0.964) | 2082 0.997 | (0.994,0.999) | 0.539 | (0.517,0.562) |
| Side space on the leftof ductus | 270 0.933 | (0.901,0.961) | 2018 0.991 | (0.987,0.995) | 0.784 | (0.767,0.800) |
| Mainpulmonaryartery | 169 0.947 | (0.910,0.976) | 2119 0.999 | (0.998,1.000) | 0.733 | (0.708,0.755) |
| Ductus | 141 0.972 | (0.944,0.993) | 2147 0.998 | (0.996,1.000) | 0.749 | (0.724,0.771) |
| Ascending aorta | 181 0.978 | (0.954,0.995) | 2107 0.999 | (0.997,1.000) | 0.621 | (0.599,0.643) |
| Aortic arch | 133 0.97 | (0.942,0.993) | 2155 0.997 | (0.995,0.999) | 0.724 | (0.699,0.747) |
| Superior vena cava | 303 0.964 | (0.942,0.983) | 1985 0.996 | (0.994,0.999) | 0.528 | (0.508,0.547) |
| Thymus/sternum | 212 0.915 | (0.876,0.953) | 2076 0.998 | (0.995,1.000) | 0.716 | (0.693,0.737) |
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Image /page/17/Picture/1 description: The image shows a logo for a company called DIAGNOLY. The logo features a blue magnifying glass with a stack of three cone-shaped objects inside the lens. The word "DIAGNOLY" is written in blue below the magnifying glass.
The performance validation dataset included the following clinical subgroups: maternal age, gestational age, territory, BMI, scanner manufacturer, heart abnormality. It also comprised races and ethnicities and various clinical sites, ensuring representation across the intended use population. Image digital quality (bad, average, good) and image type (still image from entire examination, cardiac clip frame, full examination frame) were identified as potential controlled for. Performance metrics were analyzed for each subgroup and confounder to validate the model's robustness and generalizability. The subgroups distribution is summarized in the table below:
| Number of cases | Number of images | ||
|---|---|---|---|
| Subgroup | |||
| (total=480) | (total=2,288) | ||
| Center 1 | 99 (20.6%) | 505 (22.1%) | |
| Center | Center 2 | 63 (13.1%) | 248 (10.8%) |
| Center 3 | 84 (17.5%) | 378 (16.5%) | |
| Center 4 | 55 (11.5%) | 264 (11.5%) | |
| Center 5 | 54 (11.2%) | 275 (12.0%) | |
| Center 6 | 55 (11.5%) | 265 (11.6%) | |
| Center 7 | 70 (14.6%) | 353 (15.4%) | |
| Territory | US | 234 (48.8%) | 1157 (50.6%) |
| EU | 246 (51.2%) | 1131 (49.4%) | |
| Gestational age | 2nd trimester | 233 (48.5%) | 1189 (52.0%) |
| 3rd trimester | 243 (50.6%) | 1075 (47.0%) | |
| Unknown | 4 (0.8%) | 24 (1.0%) | |
| Maternal age | < 20 years | 27 (5.6%) | 128 (5.6%) |
| [20-29] years | 214 (44.6%) | 1020 (44.6%) | |
| [30-39] years | 194 (40.4%) | 901 (39.4%) | |
| ≥40 years | 26 (5.4%) | 127 (5.6%) | |
| BMI | Unknown | 19 (4.0%) | 112 (4.9%) |
| <18.5 kg/m2 | 20 (4.2%) | 99 (4.3%) | |
| [18.5;24.9] kg/m2 | 137 (28.5%) | 661 (28.9%) | |
| [25;29.9] kg/m2 | 108 (22.5%) | 491 (21.5%) | |
| ≥30 kg/m2 | 157 (32.7%) | 712 (31.1%) | |
| Unknown | 58 (12.1%) | 325 (14.2%) | |
| Scanner manufacturer | General Electric | 163 (34.0%) | 781 (34.1%) |
| Samsung | 297 (61.9%) | 1405 (61.4%) | |
| Canon | 20 (4.2%) | 102 (4.5%) | |
| Fetus cardiac normality | Abnormal | 32 (6.7%) | 179 (7.8%) |
| Normal | 448 (93.3%) | 2109 (92.2%) | |
| Image digital quality | Bad | 708 (30.9%) | |
| Average | 815 (35.6%) | ||
| Good | 765 (33.4%) | ||
| Image type | Full exam video frame | 145 (6.3%) | |
| Cardiac clip frame | - | 771 (33.7%) | |
| Full exam still image | - | 1372 (60.0%) | |
| Race and ethnicity | Asian and Pacific Islander | 23 (4.8%) | 107 (4.7%) |
| Black | 125 (26.0%) | 607 (26.5%) | |
| Hispanic | 43 (9.0%) | 209 (9.1%) | |
| White | 277 (57.7%) | 1295 (56.6%) | |
| Unknown | 12 (2.5%) | 70 (3.1%) |
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Image /page/18/Picture/0 description: The image shows a blue logo for a company called Diagnoly. The logo features a blue magnifying glass with a stylized image of a stack of three objects inside the lens. The text "DIAGNOLY" is written in a sans-serif font below the magnifying glass.
Patient cases were retrospectively collected in reverse chronological order until at least 20 patient files per subgroup and an overall of 275 patient files were reached. To limit correlation of the images used for evaluation, one image maximum per view per patient case was selected by categorizing 12,934 images from the patient cases into heart views and randomly picking one image maximum per view, resulting in a total of 2,288 images.
A 2+1 ground truth procedure was used to obtain the reference standard of the dataset. Six annotators (3 sonographers and 3 OB/GYN doctors) were paired and assigned uniformly distributed batches of images. The attribution was randomized so that each pair treated images belonging to various subgroups. Each image was annotated by a pair of annotators as belonging to one of 6 views. Images with annotator agreement were considered ground truth. Images in which the pair of annotators disagreed were reviewed by an adjudicator, who made the final decision.
For quality criteria classification and localization, each image was annotated by a pair of annotators who drew bounding boxes on present criteria. If their boxes had at least 50% overlap, their coordinates were averaged to form the ground truth. If the overlap was lower or there was a disagreement on the criterion presence, an adjudicator reviewed the boxes. The final decision regarding the presence was based on majority consensus among the adjudicator and annotators. The final decision for the criteria localization was based on the adjudicator's decision to either keep one of the annotator's boxes or draw a new one.
The results of verification and performance testing demonstrate the safe and effective use of FETOLY-HEART.
Clinical performance data 8
Not applicable.
Conclusion from non-clinical tests റ
FETOLY-HEART intended users, clinical outcome and clinical applications are similar to those of the predicate device Sonio Detect. The technological characteristics differences identified and discussed in Section VI are covered by a reference device, the SonoLystLive view suggestion feature within the Voluson Expert Series 22/20/18 (K220358), and do not raise different questions of safety and effectiveness of the device.
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Image /page/19/Picture/0 description: The image is a logo for a company called "DIAGNOLY". The logo features a blue magnifying glass with a stylized image of stacked, curved lines inside the lens. The company name, "DIAGNOLY", is written in blue, sans-serif font below the magnifying glass.
Furthermore, results of successful verification and validation activities and additional performance testing do not raise any new issue regarding the safety and effectiveness of the device. FETOLY-HEART is therefore substantially equivalent to its predicate device Sonio Detect (K240406).
N/A