EPIQ:
The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.

The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image quidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Affiniti:
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

Device Description

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Smart Doppler View ID software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.

The purpose of the Smart Doppler View ID feature is to enhance the user's workflow through providing automation of the navigation of the touch screen groups on the Ultrasound System associated with Dopler Measurements. Without the Smart Doppler View ID feature, users must manually navigate to the desired Doppler Calculation Package Group on the Ultrasound System's various screens to perform a measurement. The Smart Doppler View ID feature automates this navigation and selects the associated calculation package group for the user based on the provided Doppler Spectrum acquired by the user using an artificial intelligence-based algorithm.

Smart Doppler View ID maps to six Doppler Calculations Package groups on the Ultrasound System screen:

Aortic Valve
Mitral Valve
Tricuspid Valve
Pulmonic Valve
Venous Flow
TDI Vel (Tissue Doppler Imaging Velocity) & Ratio

No hardware changes to the EPIQ or Affiniti systems are required when using the Smart Doppler View ID feature, and existing, commercialized Philips transducers are used for the Smart Doppler View ID feature.

The feature is supported by all EPIQ and Affiniti models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ 7, EPIQ 5, Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The Smart Doppler View ID feature is associated with the cardiac adult indication.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Smart Doppler View ID feature, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Algorithm Accuracy	97.5% (95% CI 96.3%, 98.3%), p-value < 0.0001

2. Sample Size for Test Set and Data Provenance

Sample Size (Test Set): 1100 TTE (transthoracic echo) cardiac clips
Number of Subjects: 400 subjects
Data Provenance: Retrospective, collected from a US-based hospital.

3. Number of Experts and Qualifications for Ground Truth Establishment

Number of Experts: 16 cardiac sonographers, and board-certified cardiologists.
Qualifications of Experts:
- Cardiac Sonographers: Possessed a high level of expertise in acquiring Doppler TTE clips.
- Board-Certified Cardiologists: Successfully passed the National Board of Echocardiography Examination and vetted and interpreted the studies.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1). However, it states that the ground truth was "based on a group of measurements performed by intended users (i.e., Board certified cardiologists and cardiac sonographers) of the Ultrasound Systems as part of Standard of Care TTE exam per ASE guidelines at a large US-based hospital." This implies a consensus or expert-driven process for establishing the ground truth, but the specific mechanics of how disagreements were resolved are not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done to compare human readers with and without AI assistance. The study focuses solely on the standalone performance of the AI algorithm in automatically detecting touchscreens.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance study was done. The study evaluated the accuracy with which the Smart Doppler View ID algorithm could automatically recommend the correct Doppler Calculation Package group. The reported accuracy of 97.5% (95% CI 96.3%, 98.3%) refers to this standalone performance.

7. Type of Ground Truth Used

The ground truth used was expert consensus based on the "Standard of Care obtained group of measurements (touch screens)" and "measurements performed by intended users (i.e., Board certified cardiologists and cardiac sonographers) of the Ultrasound Systems as part of Standard of Care TTE exam per ASE guidelines." This ground truth was mapped to the appropriate touchscreen groups.

8. Sample Size for the Training Set

The document explicitly states: "The clinical performance study were completely distinct from that used during training of the algorithm, and there was no overlap between the two data sets." However, it does not provide the sample size for the training set.

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

The document does not provide information on how the ground truth for the training set was established. It only mentions that the test set was distinct from the training set.

Summary

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February 13, 2024

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Ultrasound LLC Michael Chambers Sr. Regulatory Affairs Specialist 22100 Bothell Everett Hwy BOTHELL WA 98021

Re: K233788

Trade/Device Name: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, QIH Dated: November 17, 2023 Received: November 28, 2023

Dear Michael Chambers:

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.

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).

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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 (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.

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-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

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Indications for Use

Submission Number (if known)

K233788

Device Name

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Indications for Use (Describe)

EPIQ:

The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

Affiniti:

The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be

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operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

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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PHIL

l. 510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.

510(k) Number: K233788

Date Prepared: February 13, 2024

II. Submitter

Manufacturer Name andAddress	Philips Ultrasound LLC22100 Bothell Everett HwyBothell, WA 98021-8431 USA
Contact Information	Mike ChambersSenior Regulatory Affairs Specialist22100 Bothell Everett HwyBothell, WA 98021-8431 USA+1 (315) 262-7702
Secondary Contact	Tamara DanielsSenior Regulatory Affairs Manager22100 Bothell Everett HwyBothell, WA 98021-8431 USA+1 (203) 213-6862

lll. Device

Proprietary Name	EPIQ Series Diagnostic Ultrasound SystemAffiniti Series Diagnostic Ultrasound System
Common Name	Diagnostic Ultrasound System and Transducers
Regulation Description	Classification Description	21 CFR §	Product Code
	Primary
	System, imaging, pulsed doppler,ultrasonic	892.1550	IYN
	Secondary
	System, imaging, pulsed echo,ultrasonic	892.1560	IYO
	Transducer, ultrasonic, diagnostic	892.1570	ITX
	Automated Radiological ImageProcessing Software	892.2050	QIH
	Diagnostic Intravascular Catheter	870.1200	OBJ*
	*Applicable only to Philips EPIQ Series Diagnostic Ultrasound System, per clearanceunder K202216; Not applicable for Philips Affiniti Series Diagnostic Ultrasound System
Device Class	Class II
Review Panel	Radiology
Predicate Device	K211597; Philips EPIQ Series Diagnostic Ultrasound SystemK211597; Philips Affiniti Series Diagnostic Ultrasound System
Reference Device	K231190; Philips EPIQ Series Diagnostic Ultrasound System

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IV. Device Description

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Smart Doppler View ID software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.

Smart Doppler View ID maps to six Doppler Calculations Package groups on the Ultrasound System screen:

Aortic Valve
Mitral Valve
Tricuspid Valve
. Pulmonic Valve
Venous Flow
· TDI Vel (Tissue Doppler Imaging Velocity) & Ratio

V. Intended Use and Indications for Use

EPIQ Intended Use

The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body.

EPIQ Indications for Use:

The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.

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Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in blue, block letters against a white background. The font is bold and sans-serif, giving the logo a clean and modern appearance. The letters are evenly spaced and aligned, creating a visually balanced and recognizable brand mark.

However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Note: There are no changes to the EPIQ Ultrasound System Indications for Use due to the introduction of the Smart Doppler View ID feature. The Smart Doppler View ID is associated with the Cardiac Adult indication.

Affiniti Intended Use:

The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body.

Affiniti Indications for Use:

The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

Note: There are no changes to the Affiniti Ultrasound System Indications for Use due to the introduction of the Smart Doppler View ID feature. The Smart Doppler View ID is associated with the Cardiac Adult indication.

VI. Comparison of Technological Characteristics with the Predicate

The purpose of the submission is to introduce the Smart Doppler View ID feature to the EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System. The subject devices are substantially equivalent to the predicate devices (K211597) and reference device (K231190).

Feature	EPIQ Series DiagnosticUltrasound SystemAffiniti Series DiagnosticUltrasound SystemProposed Devices	Philips EPIQ SeriesDiagnostic UltrasoundSystemAffiniti DiagnosticUltrasound System(K211597)Predicate Devices	Philips EPIQ SeriesDiagnostic UltrasoundSystem(K231190)Reference Device	Comparison
USA FDAClassification	Class II	Class II	Class II	Identical
Primary ProductCode	IYN	IYN	IYN	Identical
PrimaryRegulationNumber	21 CFR 892.1550	21 CFR 892.1550	21 CFR 892.1550	Identical
Marketing Name ofApplication	Smart Doppler View ID	Not applicable since theapplication is new	Not applicable since theapplication is new	Subject of this submission
	EPIQ Series DiagnosticUltrasound System	Philips EPIQ SeriesDiagnostic UltrasoundSystem	Philips EPIQ SeriesDiagnostic UltrasoundSystem
Feature	Affiniti Series DiagnosticUltrasound System	Affiniti DiagnosticUltrasound System		Comparison
	Proposed Devices	(K211597)Predicate Devices	(K231190)Reference Device
ApplicationDescription	The proposed SmartDoppler View ID feature isintended to be used AdultCardiology Transthoracicexaminations to automatethe navigation of theCalculations Packagegroup associated withDoppler Measurements.Without the Smart DopplerView ID feature, usersmust manually navigate tothe desired DopplerCalculations PackageGroup on the UltrasoundSystem to perform ameasurement. The SmartDoppler View ID featureautomates this navigationand selects the associatedCalculations Packagegroup for the user basedon the provided DopplerSpectrum acquired by theuser.Automated selection ofCalculation PackageGroups by Smart Doppler	Manual selection by theuser of CalculationsPackage group on theultrasound systemassociated withmeasurement groups onthe ultrasound system.Manual selection ofCalculation PackageGroups by the user:	Manual selection by theuser of CalculationsPackage group on theultrasound systemassociated withmeasurement groups onthe ultrasound system.Manual selection ofCalculation PackageGroups by the user:	Subject of this submission.The Smart Doppler View IDautomates the selection ofCalculations Package groupon the ultrasound systemduring Adult CardiologyTransthoracic examinations,where the predicate andreference devices requireusers to manually navigate totheir desired CalculationsPackage group to performsubsequent measurements.The Smart Doppler View IDfeature does not perform anymeasurements itself and isonly intended to automate theselection of the CalculationsPackage group associatedwith an acquired dopplerspectrum.There is no change to theCalculation Package Groupsavailable to the user.
	View ID:• Aortic Valve• Mitral Valve• Tricuspid Valve• Pulmonic Valve• Venous Flow• TDI Vel & Ratio	• Aortic Valve• Mitral Valve• Tricuspid Valve• Pulmonic Valve• Venous Flow• TDI Vel & Ratio	• Aortic Valve• Mitral Valve• Tricuspid Valve• Pulmonic Valve• Venous Flow• TDI Vel & Ratio
User InterfacePresentation	After a user acquires adoppler spectrum, aCalculations Packagegroup is automaticallyhighlighted on theultrasound system displayfor the user by SmartDoppler View ID. From thehighlighted CalculationsPackage group, the usermay select a desiredmeasurement to performon the image. If the userdisagrees with thehighlighted CalculationsPackage group, they canmanually navigate to theirdesired CalculationsPackage group.	After a user acquires adoppler spectrum, the usermust manually navigate tothe desired CalculationsPackage group. From themanually selectedCalculations Packagegroup, the user may selecta desired measurement toperform on the image.	After a user acquires adoppler spectrum, the usermust manually navigate tothe desired CalculationsPackage group. From themanually selectedCalculations Packagegroup, the user may selecta desired measurement toperform on the image.	The only difference with SmartDoppler View ID is that theMeasurement CalculationsPackage group isautomatically highlighted forthe user after a dopplerspectrum is acquired. WithoutSmart Doppler View ID, usersmust manually navigate totheir desired CalculationsPackage group.There is no change to theuser's functionality once theCalculations Package group isselected for them compared totheir workflow without DopplerView ID.
	EPIQ Series DiagnosticUltrasound SystemAffiniti Series DiagnosticUltrasound SystemProposed Devices	Philips EPIQ SeriesDiagnostic UltrasoundSystemAffiniti DiagnosticUltrasound System(K211597)Predicate Devices	Philips EPIQ SeriesDiagnostic UltrasoundSystem(K231190)Reference Device	Comparison
Feature
Compatibletransducers	EPIQ:X5-1, X5-1c, and S5-1 arealready commerciallyavailable and compatiblewith the EPIQ UltrasoundSystem.Affiniti:S5-1, X5-1, and S4-2 arealready commerciallyavailable and compatiblewith the Affiniti UltrasoundSystem.No new transducers.Transducer modes forSmart Doppler View ID:2D, PWD, CWD, TDI. Nonew transducer modes.	No new transducers and nonew modes	The K231190 submissionintroduced the mL26-8transducer. This transduceris not compatible with theproposed Smart DopplerView ID feature.	No new transducers or modesare being introduced in thissubmission. All transducersare already available with theEPIQ and Affiniti UltrasoundSystems.
MeasurementsPerformed	No measurements areperformed by the SmartDoppler View ID feature.Any cardiac adult TTEmeasurements resultingfrom the view selection areperformed either manuallyby the user or by thecommercially availableAutoMeasure function(K211597).	Any cardiac adult TTEmeasurements resultingfrom the view selection areperformed either manuallyby the user or by thecommercially availableAutoMeasure function(K211597).	Any cardiac adult TTEmeasurements resultingfrom the view selection areperformed either manuallyby the user or by thecommercially availableAutoMeasure function(K211597)	No new measurements arebeing introduced in thissubmission. The subject of thissubmission is to provideworkflow enhancements usingan artificial intelligence -application.
Applicationperformance	Algorithm accuracy of97.5% (95%CI 96.3%,98.3%), p-value <0.0001compared to the groundtruth	N/A - the equivalentfunctionality is performedmanually by users to selectthe appropriate calculationpackage group (touchscreen group)	N/A - the equivalentfunctionality is performedmanually by users to selectthe appropriate calculationpackage group (touchscreen group)	Subject of this submission

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PHILIPS

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VII. Safety Considerations

The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System, including Smart Doppler View ID feature, and compatible transducers are all Track 3 Devices and comply with the referenced standards as well as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023.

Nonclinical Performance Data VIII.

The proposed modification of the EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems was tested in accordance with Philips internal procedures. Philips Ultrasound tested the subject devices per the following standards to ensure the continued safe and effective performance:

. IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015
. ISO 14971 Medical devices- Application of risk management to medical devices, 2019

Non-clinical verification testing was conducted to address the change and performance test data were provided to support the introduction of the subject software algorithm for the Smart Doppler View ID

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software feature. The activities to assure the safe and effective performance of the software revision included, but are not limited to, the following:

. Requirements Review
. Risk Analysis and Management Review
. Product Specification Review
. Design Reviews

Non-Clinical Verification Testing of requirements, consisted of feature-specific functional testing, transducer compatibility, user interface and workflow testing related to Smart Doppler View ID Software Feature introduced in this submission as part of the software verification activities for the system and for X5-1, S5-1, X5-1c, and S4-2 transducers supporting the Smart Doppler View ID Software feature.

Since this is a software-only change and no new hardware was added, no acoustic output, cleaning and disinfectant, thermal, electromagnetic, and mechanical safety testing were required. Biocompatibility testing is not needed for the subject EPIQ and Affiniti Series Diagnostic Ultrasound Systems with Smart Doppler View ID. The transducer patient contact materials and manufacturing processes are not impacted by the release of the subject EPIQ and Affiniti Series Diagnostic Ultrasound Systems with Smart Doppler View ID.

IX. Clinical Data

Summary of Clinical Tests

There was no clinical investigation needed for this premarket submission of the EPIQ and Affiniti Series Diagnostic Ultrasound Systems with Smart Doppler View ID feature, which is an artificial intelligencebased feature.

Artificial Intelligence Summary

The Smart Doppler View ID algorithm is an Artificial Intelligence (Al) based tool that automates the navigation of the touch screen groups on the Ultrasound System associated with Doppler Measurements.

A study was conducted to evaluate the performance of the new algorithm, where 1100 previously collected TTE (transthoracic echo) cardiac clips acquired with doppler mode from 400 subject videos were processed through the Smart Doppler View ID algorithm and its output (touch screens) compared to Standard of Care obtained group of measurements (touch screens). The Standard of Care measurements are those measurements recommended by the American Society of Echocardiography (ASE) guidelines for routine TTE cardiac exams. The dinical performance study were completely distinct from that used during training of the algorithm, and there was no overlap between the two data sets.

The primary endpoint was accuracy between Smart Doppler View ID and ground truth. The Ground truth for the study was based on a group of measurements performed by intended users (i.e., Board certified cardiologists and cardiac sonographers) of the Ultrasound Systems as part of Standard of Care TTE exam per ASE guidelines at a large US-based hospital. The Ground truth (touch screen) was determined on a set of measurements performed on acquired Doppler waveforms and mapped to touch screens (i.e., a Power Doppler Waveform acquired to measure the mitral valve inflow is mapped to the Mitral Valve Touch Screen group). All of the Doppler TTE clips included in the ground truthing were acquired by the 16 cardiac sonographers with a high level of expertise, and all these studies have been vetted and interpreted by Board certified cardiologists that have successfully passed the National Board of Echocardiography Examination. Accuracy was evaluated by comparing the ground truth touch screens and Smart Doppler View ID auto-detected touch screen for the same TTE clips as outputted by the algorithm.

Dataset

Subjects from whom the study data were sampled had presented to a USA-based hospital und

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underwent routine TTE adult cardiac exam. Overall. 400 subjects contributed 1100 clips evaluated in this study. The touchscreen distribution in the study closely resembled the anticipated clinical distribution based on typical measurements performed as part of standard of care TTE cardiac assessment exams as recommended by the American Society of Echocardiography (ASE) guidelines. Moreover, subjects whose clips contributed to the study represented a broad range of demographics and body habitus, representative of the intended population.

Demographic	Result (N=400) (% (xx/N)
Sex
Female	56.3% (225/400)
Male	43.8% (175/400)
Age (years, mean ± SD (range))	61.9 ± 16.6 (18.4, 98.7)
Height (cm, mean ± SD (range))	169.2 ± 10.7 (125,196)
Weight (kg, mean ± SD (range))	84.2 ± 23.7 (40.8, 263.0)
BSA (m2, mean ± SD (range))	1.9 ± 0.3 (1.3, 3.4)
BMI (kg/m2, mean ± SD (range))	29.5 ± 7.8 (15.8,78.5)
Race
White	31.3% (125/400)
Asian	2.8% (11/400)
Black or African American	53.8% (215/400)
American Indian or Alaska Native	0.3% (1/400)
Native Hawaiian or Other Pacific Islander	0.8% (3/400)
Mixed/More than one race	9.5% (38/400)
Other/Unknown/Not Reported	1.8% (7/400)

The demographic distribution of the study population includes the following:

Results

The results of the primary endpoint analysis demonstrated algorithm accuracy of 97.5% (95%C) 96.3%, 98.3%), p-value <0.0001, thereby meeting the acceptance criteria for the study.

Conclusion

The results of the study demonstrated clinically reasonable, relevant and meaningful performance of the Smart Doppler View ID algorithm in supporting clinicians' workflow by automatically detecting touchscreens during adult cardiac TTE exams with doppler mode. Specifically, success on the primary endpoint of accuracy indicates that the safety and effectiveness of the proposed algorithm is acceptable. Lastly, the algorithm workflow allows users to adjust the touchscreen outputs, if necessary.

X. Sterilization

Not applicable. The ultrasound transducers are not supplied sterile.

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XI. Conclusion

For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed subject devices meets their intended use.

The changes made to the subject devices do not affect the use of the devices, nor do they introduce any new or significantly modified risks. The relevant performance and compatibility tests support a determination that the proposed subject devices do not raise new questions of safety or effectiveness.

Therefore, the subject devices are substantially equivalent to the predicate and reference devices in terms of indications for use, design, technological characteristics, modes of operations, safety, and effectiveness.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.