Who is the manufacturer of Clarius OB AI?

Clarius Mobile Health Corp. filed the 510(k) submission for Clarius OB AI (K233955).

What is the FDA product code for Clarius OB AI?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Clarius OB AI?

510(k) clearance (submission type: Traditional).

Does Clarius OB AI use AI or machine learning?

Yes. Clarius OB AI (K233955) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list and has a Predetermined Change Control Plan (PCCP).

Who can help prepare an FDA 510(k) submission like Clarius OB AI?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Clarius OB AI get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Clarius OB AI

K233955 · Clarius Mobile Health Corp. · IYN · Jun 14, 2024 · Radiology

Device Facts

Record ID	K233955
Device Name	Clarius OB AI
Applicant	Clarius Mobile Health Corp.
Product Code	IYN · Radiology
Decision Date	Jun 14, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, PCCP

Intended Use

Clarius OB Al is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius OB Al is indicated for use in adult patients only.

Device Story

Clarius OB AI is a machine learning-based software feature embedded within the Clarius Ultrasound App. It processes B-mode ultrasound images acquired by Clarius curvilinear scanners to automatically detect and segment fetal anatomy, placing calipers for biometric measurements (HC, AC, FL, BPD, CRL). Used in clinical settings (hospitals, clinics) by trained healthcare professionals, the device acts as an assistive tool. The clinician reviews the AI-generated measurements, which can be manually adjusted via the app interface. The output informs clinical decision-making regarding fetal gestational age. The device benefits patients by providing semi-automated, consistent biometric measurements, reducing manual effort while maintaining clinical oversight.

Clinical Evidence

Retrospective verification study (n=347) using multi-center, anonymized ultrasound images (gestational age 58-271 days). Primary endpoint: non-inferiority of AI measurements to expert manual measurements. Results showed strong agreement (ICC 0.99; 95% CI 0.994-0.997) and statistically significant p-values (<2.2e-16). Segmentation performance (Dice scores 0.84-0.97; Jaccard scores 0.73-0.94) confirmed accuracy. Clinical validation study confirmed usability and performance in representative user environments.

Technological Characteristics

Software-based AI/ML algorithm embedded in Clarius App. Uses deep learning image segmentation. Compatible with Clarius curvilinear scanners. Connectivity via mobile platform (iOS/Android). Standards: IEC 62304 (software lifecycle), ISO 14971 (risk management), NEMA PS 3.1-3.20 (DICOM), IEC 62366-1 (usability).

Indications for Use

Indicated for adult patients to assist trained healthcare professionals in measuring fetal biometric parameters (HC, AC, FL, BPD, CRL) using ultrasound data from Clarius curvilinear scanners.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Sonio Detect (K230365)

Related Devices

K242594 — DEEPECHO · Deepecho · May 23, 2025
K230084 — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System · Samsung Medison Co., Ltd. · Apr 21, 2023
K232257 — Clarius Bladder AI · Clarius Mobile Health Corp. · Nov 13, 2023
K243853 — Clarius Prostate AI · Clarius Mobile Health Corp. · Apr 16, 2025
K251368 — FETOLY · Diagnoly · Sep 12, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Clarius Mobile Health Corp. Agatha Szeliga Director, Regulatory Affairs 205-2980 Virtual Way Vancouver, BC V5M 4X3 Canada Re: K233955 June 14, 2024 Trade/Device Name: Clarius OB AI Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, QIH Dated: May 7, 2024 Received: May 7, 2024 Dear Agatha Szeliga: 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 established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new {1}------------------------------------------------ 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 (QS) 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 (OS) 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. 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/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 DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {3}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K233955 Device Name Clarius OB Al Indications for Use (Describe) Clarius OB Al is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius OB Al is indicated for use in adult patients only. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Clarius logo. On the left is an orange icon that looks like three curved lines that form a C shape. To the right of the icon is the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" in a smaller font, also in dark teal. # 510(k) Summary This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92. | Subject Device Trade Name: | Clarius OB AI | |-----------------------------|-----------------------------------------------------------------------------------------------| | Device Classification Name: | Ultrasonic Pulsed Doppler Imaging System; Automated Radiological Image Processing Software | #### Regulation Number, Name and Product Code: | Regulation Number | Regulation Name | Primary Product Code | |-------------------|------------------------------------------------|------------------------| | 21 CFR § 892.1550 | Ultrasonic Pulsed Doppler Imaging System | IYN | | Regulation Number | Regulation Name | Secondary Product Code | | 21 CFR § 892.2050 | Medical Image Management and Processing System | QIH | | FDA 510(k) Review Panel: | Radiology | |-------------------------------|-------------------------------------------------------------------------------------| | Classification: | Class II | | Manufacturer: | Clarius Mobile Health Corp. 205-2980 Virtual Way Vancouver, BC V5M 4X3 Canada | | Contact Name: | Agatha Szeliga Director, Regulatory Affairs agatha.szeliga@clarius.com | | Date 510(k) Summary Prepared: | June 13, 2024 | ### Predicate Device Information: | Device Trade Name: | Sonio Detect | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Reference: | K230365 | | Manufacturer Name: | Sonio | | Regulation Name: | Ultrasonic Pulsed Doppler Imaging System | | Device Classification Name: | Ultrasonic Pulsed Doppler Imaging System Ultrasonic Pulsed Echo Imaging System Medical Image Management and Processing System | | Product Code(s): | IYN; IYO; QIH | | Regulation Number: | 21 CFR § 892.1550; 21 CFR § 892.1560; 21 CFR § 892.2050 | | Regulatory Class: | Class II | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange icon on the left and the word "clarius" in dark teal on the right. To the right of the word "clarius" are the words "ultrasound anywhere" in a smaller font, also in dark teal. The icon on the left is a stylized "C" made up of three curved lines. Note: The predicate device has not been subject to a design-related recall. ### Device Description Clarius OB Al is a machine learning algorithm that is incorporated into the Clarius App software as part of the complete Clarius Ultrasound Scanner system for use in obstetric (OB) ultrasound imaging applications. Clarius OB Al is intended for use by trained healthcare practitioners for non-invasive measurements of fetal biometric parameters on ultrasound data acquired by the Clarius Ultrasound Scanner system (i.e., curvilinear scanner) using a deep learning image segmentation algorithm. During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (i.e., OB, Early OB) within the Clarius App in which Clarius OB Al will engage to segment the fetal anatomy and place calipers for measurement of fetal biometric parameters. Clarius OB Al operates by performing the following tasks: - Automatic detection and measurement of head circumference (HC) - Automatic detection and measurement of abdominal circumference (AC) - Automatic detection and measurement of femur length (FL) - Automatic detection and measurement of bi-parietal diameter (BPD) - Automatic detection and measurement of crown rump length (CRL) Clarius OB Al operates by performing automatic measurements of fetal biometric parameters. The user has the option to manually adjust the measurements made by Clarius OB Al by moving the caliper crosshairs. Clarius OB Al does not perform any functions that could not be accomplished manually by a trained and qualified user. Clarius OB AI is intended for use in B-Mode only. Clarius OB Al is an assistive tool intended to inform clinical management and is not intended to replace The clinician retains the ultimate responsibility of ascertaining the clinical decision-making. measurements based on standard practices and clinical judgment. Clarius OB Al is indicated for use in adult patients only. Clarius OB Al is incorporated into the Clarius App software, which is compatible with iOS and Android operating systems two versions prior to the latest iOS or Android stable release build and is intended for use with the following Clarius Ultrasound Scanner system transducer (previously 510(k)-cleared in K213436). Clarius OB Al is not a stand-alone software device. | Clarius Ultrasound Transducer | C3 HD3 | |-------------------------------|---------------------------------------------------------------------------------------------------| | Clarius App Software | Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android | #### Indications for Use for Clarius OB Al Clarius OB Al is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). The user shall {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is the logo for Clarius Ultrasound. The logo consists of an orange symbol that looks like a stylized letter C made of three curved lines. To the right of the symbol is the word "clarius" in dark teal, followed by the words "ultrasound anywhere" in a smaller font and the same dark teal color. The logo is simple and modern, and the colors are bright and eye-catching. be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius OB Al is indicated for use in adult patients only. ### Comparison of the Subject Device and Legally Marketed Device for Demonstration of Substantial Equivalence The following table provides a comparison of the subject device, Clarius OB Al, to the predicate device. A comparison of the subject device to the predicate device shows that the subject device has the same intended use, similar indications for use, the same principle of operation, and is based on a similar Al/ML algorithm providing segmentation and measurement of fetal biometric parameters, comparable to the legally marketed device referenced herein. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Clarius ultrasound anywhere logo. The logo consists of an orange symbol that looks like three letter C's nested inside each other. To the right of the symbol is the word "clarius" in dark teal, followed by the words "ultrasound anywhere" stacked on top of each other, also in dark teal. ### Table 1 - Comparison of the Subject Device to the Legally Marketed Predicate Device | Criteria | SUBJECT DEVICE | PREDICATE DEVICE | RATIONALE (if subject device differs from predicate device) | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Clarius OB AI | Sonio Detect | | | 510(k) Holder/ Manufacturer | Clarius Mobile Health Corp. | Sonio | Not applicable | | Submission Reference | Current Submission | K230365 | Not applicable | | Product Code(s) | IYN; QIH | IYN; IYO; QIH | The "IYN" primary product code is the same as the predicate device and the "QIH" secondary product code is the same as the predicate device. | | Device Classification Name | Ultrasonic Pulsed Doppler Imaging System; Medical Image Management and Processing System | Ultrasonic Pulsed Doppler Imaging System; Ultrasonic Pulsed Echo Imaging System; Medical Image Management and Processing System | The "Ultrasonic Pulsed Doppler Imaging System" and the "Medical Image Management and Processing System" device classification names are the same as the predicate device. | | Regulation Number | 21 CFR § 892.1550; 21 CFR § 892.2050 | 21 CFR § 892.1550; 21 CFR § 892.1560; 21 CFR § 892.2050 | The "21 CFR § 892.1550" regulation number and the "21 CFR § 892.2050" regulation number are the same as the predicate device. | | Intended Use | Intended for use as an assistive tool/aid during the acquisition and interpretation of fetal ultrasound images through non- invasive processing of ultrasound images utilizing an artificial intelligence/machine- learning algorithm. | Intended for use as an assistive tool/aid during the acquisition and interpretation of fetal ultrasound images through non- invasive processing of ultrasound images utilizing an artificial intelligence/machine- learning algorithm. | Same as predicate device. | | Indications for Use | Clarius OB AI is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur | Sonio Detect is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect views, detect | Both the predicate and subject device are indicated for analysis of fetal ultrasound images | | Criteria | SUBJECT DEVICE | PREDICATE DEVICE | RATIONALE (if subject device differs | | | Clarius OB AI | Sonio Detect | from predicate device) | | | length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius OB AI is indicated for use in adult patients only. | anatomical structures within the views and verify quality criteria of the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. | using AI/ML techniques. Both devices detect various fetal anatomies; the predicate device provides qualitative information to the user, whereas the subject device provides semi- automated quantitative information regarding fetal biometrics. Both the predicate and subject devices are intended for use as an adjunctive 'tool' or aid by the user for the interpretation of fetal ultrasound images and are not intended to replace clinical decision making. The differences in the indications for use do not impact the safety and effectiveness of the subject device relative to the predicate device. | | Radiological application/ Supported modality | Ultrasound | Ultrasound | Same as predicate device. | | Clinical application(s) | Obstetrics/Fetal | Obstetrics/Fetal | Same as predicate device. | | Principle of Operation/ Technology | Ultrasound image processing software application implementing artificial intelligence utilizing non-adaptive machine learning algorithms trained with | Ultrasound image processing software application implementing artificial intelligence utilizing non-adaptive machine learning algorithms trained with | Same as predicate device. | | | clinical and/or artificial data intended for | clinical and/or artificial data intended for | | | Criteria | SUBJECT DEVICE | PREDICATE DEVICE | RATIONALE (if subject device differs from predicate device) | | | Clarius OB AI | Sonio Detect | | | Quantitative and/or Qualitative Analysis | non-invasive analysis (i.e., quantitative and/or qualitative) of ultrasound data. Fetal biometry/measurement of fetal biometric parameters (i.e., HC, AC, BPD, CRL, FL) | non-invasive analysis (i.e., quantitative and/or qualitative) of ultrasound data. Detection, verification, and qualitative analysis of fetal anatomical structures | The subject device performs semi-automated measurements of fetal biometrics, whereas the predicate device detects, verifies, and performs qualitative analysis of fetal anatomies. | | Algorithm Methodology | Artificial Intelligence (AI) | Artificial Intelligence (AI) | Same as predicate device. | | Automation (Yes or No) | Yes | Yes | Same as predicate device. | | Environment of Use | Healthcare setting (e.g., hospital, clinic) | Healthcare setting (e.g., hospital, clinic) | Same as predicate device. | | Intended Users | Licensed healthcare professionals | Licensed healthcare professionals | Same as predicate device. | | Platform | Embedded in the Clarius ultrasound app | Cloud-based and stand-alone software | The subject device is embedded in the ultrasound app, which is part of the ultrasound system, whereas, the predicate device is cloud- based, stand-alone software | {8}------------------------------------------------ ### sound y anywhere {9}------------------------------------------------ ### sound ر where {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange icon that looks like three curved lines forming a C shape. To the right of the icon is the word "clarius" in dark teal, followed by the words "ultrasound anywhere" stacked on top of each other in a smaller font size and the same dark teal color. ### Non-Clinical Performance Testing Summary Clarius OB Al was designed and developed by Clarius Mobile Health Corp. in accordance with the applicable requirements, design controls, and standards to establish safety and effectiveness of the device. Non-clinical performance testing has demonstrated that Clarius OB Al complies with the following FDArecognized consensus standards: | Standard Recognition Number | Title of Standard | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | 13-79 | IEC 62304:2006 + A1:2015 - Medical device software — Software life cycle processes | | 5-125 | ISO 14971:2019 Medical devices — Application of risk management to medical devices | | 12-349 | NEMA PS 3.1 - 3.20 (2022d) Digital Imaging and Communications in Medicine (DICOM) Set | | 5-129 | IEC 62366-1:2015 + A1:2020 Medical devices — Part 1: Application of usability engineering to medical devices | | 5-134 | ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied | Safety and performance of Clarius OB Al have been evaluated through verification testing in accordance with applicable specifications and performance standards. The traceability analysis provides traceability between the requirement specifications, risks, and verifications, risks, and verification testing of the subject device. All requirements and risk controls have been successfully verified and traced. A comprehensive risk analysis was performed for the subject device and appropriate risk controls have been implemented to mitigate hazards. Software verification and validation activities were conducted in accordance with IEC 62304:2006 + AMD1:2015 – Medical device software – Software lifecycle processes and ISO 14971:2019 Medical devices – Application of risk management to medical devices, and in accordance with relevant FDA guidance documents, General Principles of Software Validation, Final Guidance for Industry and FDA Staff (issued January 11, 2002), Guidance for the Content of Premarket Submissions for Device Software Functions (issued June 14, 2023), and Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued September 27, 2023). Clarius conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Clarius OB Al was tested and found to be safe and effective for the intended users, intended patient population, and use environments, as demonstrated through verification testing. Validation testing was performed to ensure that the final product meets the requirements for the specified clinical application and performs as intended to meet users' needs, while demonstrating substantial equivalence to the predicate device. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the Clarius ultrasound logo. The logo consists of an orange symbol that looks like three letter C's nested inside each other, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" in a smaller font, also in dark teal. ### Clinical Performance Testing Summary Following completion of the Clarius OB Al model training and tuning, which was conducted to create a documented baseline of the AI model, verification testing, and clinical validation were performed. The clinical performance of Clarius OB Al was evaluated through a retrospective analysis of anonymized ultrasound images from 25 clinical sites in the United States, Canada, Philippines, Australia, Kenya, Belgium, and Malaysia, representing different ethnic groups and ages. The age of the subjects in the study ranged from 15 - 45 years. The verification data was entirely independent from the training, validation (tuning), and test datasets. The Clarius OB Al deep neural network (DNN) model was trained using three data sets: training, validation (tuning), and testing. The validation (tuning) data was 10% of the training data, while the test data was independent and labelled by experts. The DNN parameters and weights were updated based on the validation (tuning) data at each epoch. The model's generalizability was evaluated on the test data. The test data was exclusive and independent to ensure robust results. The objective of clinical performance testing (verification) was to verify that Clarius OB Al automeasurements are non-inferior to manual measurements performed by qualified experts with relevant (i.e., OB/fetal) ultrasound experience. ### Summary of the Verification Study Ultrasound images were randomly obtained from an anonymized multi-center database of images from the United States, Philippines, Australia, Kenya, Belgium, Malaysia, and Canada, representing various ethnicities and ages. The age of the study ranged from 15 - 45 years. Institutions included in the Clarius OB Al model training and tuning dataset were excluded from this study. Images of the fetal head, abdomen, and femur were collected in cases where the gestational age was greater than 13 weeks and images of the entire fetus were collected in cases where the gestational age was less than 13 weeks. The total sample size included in the study was 347 subjects. The primary objective of the retrospective verification study was to verify that Clarius OB Al fetal biometric measurements (i.e., CRL, BPD, HC, AC, and FL) are non-inferior to manual measurements performed by expert clinicians. The secondary objective of the study was to verify a high correlation between fetal gestational age calculated using manual expert measurements and Clarius OB Al biometric measurements. To calculate the gestational age from fetal biometric measurements Hadlock equations were used. Each reviewer also outlined the boundaries (segmentation) of the fetus, fetal head, and femur as applicable. Each image had fetal biometric measurements performed by 3 reviewers (clinical truthers). Each reviewer was blinded to the Clarius OB Al output and the other reviewers' annotations as well. All obstetric exams of the fetus/fetal anatomy were captured using a Clarius C3 (curvilinear) ultrasound scanner. An assessment of the magnitude of the difference between Clarius OB Al and human experts' fetal biometric measurements was performed to ascertain whether Clarius OB Al measurement is non-inferior to those of human experts/ qualified ultrasound users. Clarius OB Al was found to be non-inferior to human experts with statistically significant p-values (<2.2 e-16) for the various fetal biometric measurements. The fetal gestational age in the study ranged from around 58 days to 271 days. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the Clarius ultrasound anywhere logo. The logo consists of an orange symbol that looks like three concentric letter C's, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" in a smaller font, also in dark teal. Strong agreement was shown between the Clarius OB Al measurements and the mean of the expert clinicians' measurements for all fetal biometrics (HC, BPD, FL, AC, and CRL). The Clarius OB Al model also showed strong agreements with individual expert measurements. The intraclass correlation coefficients (ICC) for inter-rater reliability were calculated between reviewer pairs and between the Clarius OB Al output and the mean reviewer measurement. ICC across all fetal biometrics between Clarius OB Al and the reviewers was calculated to be 0.99 (95% Cl 0.994—0.997). To assess the segmentation performance of Clarius OB Al, the average dice and Jaccard scores between the Clarius OB Al model vs. each reviewer and between each reviewer pair were also calculated. The range of the average Jaccard scores (for all anatomical structures) between Clarius OB Al and the reviewers was 0.73 (95% Cl 0.72--0.74) to 0.94 (95% Cl 0.93--0.94), and the range of the average dice scores (for all anatomical structures) between Clarius OB Al and the reviewers was 0.84 (95% Cl 0.83--0.87) to 0.97 (95% Cl 0.96--0.97). The results of the retrospective analysis have demonstrated that Clarius OB Al measurement output adequately aligns with expert clinicians' manual measurement, confirming that Clarius OB Al measurements of fetal biometric parameters are non-inferior to those of human clinical experts. Therefore, the performance of Clarius OB Al has been verified for fetal biometric measurements for use in obstetric/fetal ultrasound applications and has been determined as reliable and accurate to clinical experts. ### Summary of the Clinical Validation Study A clinical validation study was conducted to evaluate the design and clinical utility of Clarius OB AI, as incorporated into the Clarius App software, to determine if the device performs as intended in a representative user environment, meets the product requirements, is clinically usable, and meets users' needs for use in semi-automated fetal biometric measurements. The results of the validation study showed consistent results among all users, meeting the pre-defined acceptance criteria. The users were able to activate Clarius OB AI using Clarius' C3 scanner and choose the appropriate preset (i.e., OB, Early OB), obtain images of the fetal anatomy of interest (i.e., fetal head, femur, abdomen, or fetus), perform live segmentation, perform automatic measurements of fetal biometric parameters (AC, FL, HC, BPD, CRL), manually adjust the measurements, change the segmentation mask opacity, and save the fetal biometric measurements with each exam. Therefore, based on the results of the clinical validation study it has been determined that Clarius OB Al performs as intended and meets user needs for use in semi-automated measurements of fetal biometric parameters in obstetric/fetal ultrasound applications for calculation of fetal gestational age. ### Predetermined Change Control Plan (PCCP) Clarius OB Al uses a machine learning (ML) algorithm for measurement of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound image data acquired by the Clarius Ultrasound Scanner. Modifications to Clarius OB Al will be made in accordance with its Predetermined Change Control Plan (PCCP). The PCCP provides a description of the device's planned modifications, a modification protocol to test, verify, validate, and implement the modifications in a manner that ensures the continued safety and effectiveness of the device, mitigating risks associated with changes to the OB Al model to not {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the Clarius ultrasound anywhere logo. The logo consists of an orange icon on the left, followed by the word "clarius" in dark teal, and the words "ultrasound anywhere" in a smaller font size, also in dark teal, on the right. The icon is a stylized letter C made up of three curved lines. adversely impact the device's performance, safety, or effectiveness associated with its indications for use, and an impact assessment of the planned modifications. The modifications outlined in the PCCP are summarized in the table below. In accordance with the PCCP, the modified Clarius OB AI algorithm will be adequately trained, tested, and locked before release of the modified OB Al model. Implemented modifications to the Clarius OB Al algorithm will be communicated to users via the Clarius App software update notification and through updated labelling. | Modification | Rationale | Testing Methods | Impact Assessment | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Modification of model architecture | Improvement and optimization of Clarius OB Al's performance | Re-training of the OB Al model with new data to optimize its performance followed by internal testing and a comparison of the original OB Al model to the modified OB Al model (using performance metrics) and clinical performance testing (verification and validation). | Improved performance metrics of modified OB Al model with increased accuracy and more robust gestational age estimates displayed to users. Benefit-Risk Analysis: Benefits: Improved performance; generalization for diverse cases. Risks: Overfitting; unintended bias. Risk Mitigation: Proper regularization techniques and cross-validation and dropout will be employed to mitigate overfitting. Internal testing and verification will be conducted to mitigate unintended biases. | | Modification of model training methods and parameters | Improvement and optimization of Clarius OB AI's performance | Internal testing and a comparison of the original OB Al model to the modified OB AI model (using | Improved performance metrics of modified OB Al model. | | Modification | Rationale | Testing Methods | Impact Assessment | | | | performance metrics) and clinical performance testing (verification and validation). | Benefit-Risk Analysis: Benefits: Improved performance; generalization for diverse cases. Risks: Overfitting; unintended bias. Risk Mitigation: Proper regularization techniques and cross-validation and dropout will be employed to mitigate overfitting. Internal testing and verification will be conducted to mitigate unintended biases. | | Modification of post- processing algorithms | Improvement and optimization of Clarius OB Al's performance and robustness | Internal testing and a comparison of the original OB Al model to the modified OB AI model (using performance metrics) and clinical performance testing (verification and validation). | Improved performance metrics of modified OB Al model. Benefit-Risk Analysis: Benefits: Improved performance; generalization for diverse cases. Risks: Overfitting; unintended bias. Risk Mitigation: Proper regularization techniques and cross-validation and dropout will be employed to mitigate overfitting. | | Modification | Rationale | Testing Methods | Impact Assessment | | | | | Internal testing and verification will be conducted to mitigate unintended biases. | | Modification of data input sources | To enable use of Clarius OB Al on newer models of the 510(k)-cleared Clarius Ultrasound Scanner system | Re-training of the OB AI model to expand its use with new data sources (i.e., new 510(k)- cleared models of the Clarius Ultrasound Scanner), internal testing, and clinical performance testing (verification and validation) to assesses its performance with the new data input sources. | By accommodating a wider array of image geometries and characteristics with the use of new 510(k)-cleared Clarius scanners, the updated OB Al model will be better equipped to handle different models of the Clarius Ultrasound Scanner used in varying clinical scenarios. Benefit-Risk Analysis: Benefits: Enhanced compatibility; Flexibility for diverse clinical settings. Risks: Data skewing and concept drift. Risk Mitigation: Internal testing and verification datasets within the intended patient population will ensure that data skewing and concept drift are mitigated. | ### Summary of changes to Clarius OB AI per the PCCP: {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three letter C's nested inside each other. To the right of the symbol is the word "clarius" in dark teal, followed by the words "ultrasound anywhere" stacked on top of each other in a smaller font. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three concentric letter C's, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal. ### Conclusion & Summary of Substantial Equivalence Based on the information presented in this Traditional 510(k) premarket notification and based on the fundamental scientific technology utilizing artificial intelligence/machine learning algorithms, {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the Clarius ultrasound anywhere logo. The logo consists of an orange icon that looks like a stylized letter C, followed by the word "clarius" in dark teal. To the right of "clarius" is the phrase "ultrasound anywhere", also in dark teal. The logo is simple and modern, and it conveys the idea of portable ultrasound technology. technological characteristics, principle of operation, intended use, and environment of use, Clarius OB Al has been determined to be substantially equivalent in terms of safety and effectiveness to the legally marketed predicate device. T…