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EPIQ Series Diagnostic Ultrasound System: 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), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
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.
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 Series Diagnostic Ultrasound Systems: 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.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
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 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.

The purpose of this 510(k) Pre-market Notification is to introduce the SVS v2 Contrast software application with the EPIQ and Affiniti Series Diagnostic Ultrasound Systems as part of the VM13.0 program.
SVS v2 Contrast is an automated software feature that assists in the selection of images for analysis with the new Philips license options 2D Auto EF Advanced (Adv) developed by DiA Imaging Analysis (K243235), now part of Philips Ultrasound LLC, and existing Philips license options AutoStrain LV; or 2D Auto LV (both K240850) license application in Adult Echo Transthoracic (TTE) examinations.
As described in 510(k) K240850, this feature automatically classifies each acquired image by view and selects an appropriate set of images for Left ventricle (LV) analysis. The classification is based on a Deep Learning AI inference engine; the selection is a non-AI algorithm that considers the view classification and image depth to select the optimal set of images. The difference in SVS v2 Contrast from the predicate SVS v1 (K240850) is that the algorithm is revised to include the selection of optimal images for analysis when contrast is used in routine TTE exams.
Users can launch existing 2D Auto EF; 2D Auto EF Adv; AutoStrain LV; or 2D Auto LV with the set of images that have been automatically selected without the need to review the acquired images and manually select the views. Users may select 2D Auto EF Adv, to process the selected views by SVS v2 Contrast. SVS v2 Contrast prioritizes the contrast image pair; however, if an appropriate pair of contrast images is not found, then Auto EF Adv may select non-contrast images. The manual approach to select views is still available and the user can override automatically selected images from SVS v2 Contrast.
No hardware changes to the EPIQ or Affiniti Series Diagnostic Ultrasound Systems are required when using SVS v2 Contrast, and existing, cleared Philips TTE transducers.
The SVS v2 Contrast feature is supported by all EPIQ models running software version 13.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SVS v2 Contrast feature is supported by the Affiniti models running software version VM13.0 or higher, including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS v2 Contrast feature is associated with the cardiac adult indication.

Acceptance Criteria and Study Details for SVS v2 Contrast Software

This document outlines the acceptance criteria and details of the study conducted to demonstrate that the Philips Ultrasound systems (EPIQ and Affiniti Series Diagnostic Ultrasound System) with the SVS v2 Contrast software application meet the established performance benchmarks.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Initial Cohort: 60 subjects
• Evaluable Study Sample (Test Set): 46 subjects (after 10 samples were non-reportable)
• Data Provenance: Retrospective data study, utilizing previously acquired exams (including contrast and non-contrast clips) with TTE transducers.
  • Country of Origin: The sample included data from two sites: one outside the USA and one in the USA.
    • 7 patient exams collected from the first site (outside USA).
    • Remaning 39 patient exams from the second site (USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Ground Truth (Primary): The ground truth for the primary endpoint (Biplane EF - Manually Selected (Ground Truth)) was generated by one sonographer (reviewer) who manually selected contrast clips from subject exams. These clips were then automatically processed within the Contrast EF application, with the automated EF results serving as this ground truth. This ground truth was created as part of the K243235 submission.
• Ground Truth (Supporting): For the comparison against "Manual Tracing (Ground Truth)," three sonographers manually measured the previously selected clips (by the single sonographer) following a physician's review. This clinical ground truth was also created as part of the K243235 submission.
• Qualifications of Experts: The document specifies "sonographer" for those involved in manual clip selection and measurements, and "physicians review" for the support ground truth. Specific details on years of experience or board certification are not provided within this document.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1).

• For the primary ground truth, it appears one sonographer made the manual selection, which then fed into an automated process.
• For the supporting ground truth ("Manual Tracing"), three sonographers performed measurements following a physician's review. It is not clear if these three sonographer measurements were averaged, or if disagreements were arbitrated by the physician or another expert.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was explicitly mentioned in the provided text, nor was an effect size of human readers improving with AI vs. without AI assistance. The study focused on the agreement between the device's automated selection and manually established ground truth, rather than human reader performance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance of the algorithm (SVS v2 Contrast) was performed. The study evaluates the algorithm's ability to automatically select appropriate clips and its subsequent impact on Biplane EF calculation. The comparison is made between the "Biplane EF - SVS Selected (Automated)" and the "Biplane EF - Manually Selected (Ground Truth)," where the latter represents a ground truth derived with manual input for clip selection but still using an automated EF calculation. Additionally, a comparison was made against "Biplane EF – by Manual Tracing (Ground Truth)," which reflects a more direct human-traced ground truth reference.

7. Type of Ground Truth Used

The ground truth used was primarily a hybrid approach:

• Expert consensus/manual selection combined with automated processing: For the primary ground truth, a single sonographer manually selected clips, which were then processed by the Contrast EF application to yield the ground truth EF.
• Expert manual tracing (with physician review): For the supporting analysis, three sonographers performed manual tracings/measurements following a physician's review.

This suggests a "clinical ground truth" established by human experts, sometimes in conjunction with other software tools. It is not pathology or direct outcomes data.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions "To ensure data separation between development and testing data, the data set to which each exam belongs was identified," indicating that there were distinct training and test sets, but the training set size is not provided.

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

The document does not provide details on how the ground truth for the training set was established. It only refers to the test set's ground truth and mentions that the algorithm is based on a Deep Learning AI inference engine, implying the use of a training set.

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EPIQ: The intended use of Philips EPIQ 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), Intra-luminal, Intra-cardiac Echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

Affiniti: The intended use of the 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 purpose of this Special 510(k) Pre-Market Notification is to modify the Segmental Wall Motion and introduce Auto EF with contrast software application onto the Philips EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems. SWM algorithm was previously cleared (K243862) and Auto EF contrast algorithm(K243235) was also previously cleared. The current software release version VM 13, replaces the previous version of the segmental wall motion algorithm included in version 11 of the software release with the current cleared version (K243862) without any modifications, and integrates Auto EF contrast algorithm(K243235) without any modifications into one software release.

The SWM v2 software automatically evaluates the segmental (regional) function of the left ventricle (LV) from adult TTE echo examinations. For input, the SWM algorithm uses 3 apical views (A4C, A2C and A3C) and performs border detection and tracking to identify each of the LV segments based on the three views. The SWM v2 software is a semi-automated quantitative imaging algorithm, as users are generally expected to review and concur with the initial and generated results. The users can also manually edit algorithm-generated segmental wall motion scores for individual segments based on their clinical expertise.

Auto EF with contrast is an AI based automated software feature that assists clinicians with assessing Left Ventricular Ejection Fraction (LVEF) from images acquired with contrast agent as part of an adult transthoracic echo (TTE) examination. The feature is located within the Philips Auto EF Adv application. Auto EF with contrast uses 2 apical views (Apical four chamber view (A4C), Apical two chamber (A2C)) and provides EF for each view and a biplane Simpsons EF.

No hardware changes to the EPIQ or Affiniti systems were made due to the SWM v2 and Auto EF with contrast, and existing, cleared Philips TTE transducers are used with these software applications.

This FDA 510(k) clearance (K251110) modifies the Segmental Wall Motion (SWM) algorithm and integrates an existing Auto EF with contrast software into Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The study details for each software component are primarily based on retrospective data analyses.

Here's a breakdown of the acceptance criteria and study information for each feature:

SWM v2 (Segmental Wall Motion v2)

Auto EF with Contrast

Overall Context:

It's important to note that this 510(k) is a Special 510(k). This type of submission is usually for modifications to a currently cleared device where the changed device does not raise new questions of safety and effectiveness. Both SWM v2 and Auto EF with contrast were previously cleared as standalone applications (K243862 and K243235, respectively). This clearance focuses on integrating these previously cleared algorithms into the Philips EPIQ and Affiniti ultrasound systems and replacing an older SWM algorithm. Therefore, the performance studies described here are primarily to demonstrate that the algorithms maintain their previously established performance when integrated into the new platform, or to provide updated performance data for the newer version of the SWM algorithm.

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