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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

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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), Transrectal, Transvaginal, Lung.
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 R-Trigger algorithm software feature on Philips EPIQ and Affiniti Ultrasound System is intended to support detection of R-wave peak (R-trigger) as an input to certain TTE clinical applications, initially including AutoStrain LV, AutoEF, 2D Auto LV (collectively referred to as "AutoStrain"), and AutoMeasure applications. The R-trigger algorithm is planned to be implemented as workflow enhancement for transthoracic clinical applications on EPIQ and Affiniti Ultrasound Systems in the VM13 software release. The Auto-Measure and AutoStrain features support users during B-mode (2D), CW-, PW- and TDI-Doppler measurements by automating some of the measurements needed to complete a routine transthoracic echo (TTE) exam for adult patients. The R-trigger feature (non-ECG-based) has been developed to enable clinical users to use AutoMeasure and AutoStrain application without the R-trigger (ECG based) input, which is currently required. There are no hardware changes to the EPIQ and Affiniti systems due to change to the introduction of the R-Trigger software application. The software application is supported by all EPIQ and Affiniti models running software version 13.0 or higher.

The provided FDA 510(k) clearance letter describes the R-Trigger software application on Philips EPIQ and Affiniti Ultrasound Systems, which aims to provide an alternative method for detecting R-wave peaks (R-triggers) for cardiac clinical applications like AutoStrain and AutoMeasure, especially when the ECG signal is unavailable or unusable.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the R-Trigger algorithm are related to the agreement of its R-wave time stamp detection with the ground truth (ECG-based R-trigger) and the subsequent impact on the clinical outputs of AutoMeasure and AutoStrain. These are evaluated using Bland-Altman analysis (for agreement, specifically the Upper and Lower Limits of Agreement, LoA) and Pearson's correlation (for correlation, specifically the Lower Confidence Bound, LCB).

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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), Transrectal, Transvaginal, Lung. 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.

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 purpose of this Traditional 510(k) Pre-Market Notification is to introduce Remote Software Management (RSM) software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems with new RSM software feature, which is a workflow-enhancement software feature, is equivalent to predicate device, K242020. The Philips RSM feature provides the capabilities to remotely upgrade EPIQ/Affiniti Systems, with the existing RSM capabilities, only patch upgrade was possible, and full upgrade (including OS components) was not supported. The full RSM feature provides the capabilities to perform a remote upgrade to EPIQ/Affiniti Systems. The RSM feature is capable of deploying following packages onto the system: OS Packages, Device Drivers, Printer Drivers, BIOS/UEFI version, Application Packages, Service Application Packages, Automatic backup/restore of existing system settings. Along with the above functionalities, it also supports Automatic and Scheduled software downloads/Installation. No hardware changes to the EPIQ or Affiniti Systems are required when using RSM software feature, and existing, commercialized Philips transducers are used for the RSM software feature. The feature is supported by EPIQ and Affiniti models running software version 12.0.

The provided FDA 510(k) clearance letter (K250177) describes the Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems with a new feature: Remote Software Management (RSM). The submission focuses on demonstrating substantial equivalence to a predicate device (K242020), specifically highlighting the enhancements to the RSM feature.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

Acceptance Criteria and Device Performance

The document describes the acceptance criteria in terms of the RSM feature's capabilities and its performance in comparison to the predicate device's existing RSM. The key acceptance criteria revolve around the ability to perform comprehensive remote software upgrades without compromising safety or effectiveness.

Table 1: Acceptance Criteria and Reported Device Performance for Remote Software Management (RSM)

Study Details for Demonstrating Equivalence and Meeting Criteria

The provided document does not describe a clinical study or a comparative diagnostic performance study in the traditional sense, as the submission focuses on a software workflow enhancement feature (Remote Software Management). Instead, the "study" for this feature is a series of non-clinical performance tests and a demonstration of substantial equivalence.

1. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a numerical sample size of patient data or images. The "test set" in this context refers to the simulated testing environments or actual ultrasound systems used to validate the RSM feature.
• Data Provenance: Not applicable in the context of diagnostic image data. The validation would have involved testing the software functionality on the EPIQ and Affiniti platforms. The document mentions "Philips Internal Procedures" for testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this submission is for a software management feature, not a diagnostic algorithm that requires ground truth established by medical experts. The validation would have been performed by software/system engineers and subject matter experts in software deployment and system functionality.

3. Adjudication method for the test set:

• Not applicable for this type of submission. The "adjudication" would be internal verification and validation against functional and performance requirements by the development and quality assurance teams.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was done. This submission is for a Remote Software Management feature, which is a workflow enhancement for system maintenance, not a diagnostic AI tool that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• The "standalone" performance here refers to the RSM feature functioning correctly on its own in deploying software updates. The document states:
  • "All software verification tests met the acceptance criteria."
  • "Results of these tests show that the proposed Remote Software Management software feature meets the intended use."
  • This implies that the algorithm/feature was tested to ensure it performs its intended function (remote upgrades, backups, scheduled downloads) accurately and reliably.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable in the medical/diagnostic sense. The "ground truth" for the RSM feature would be the successful execution of its defined functional and performance requirements (e.g., a software package is correctly installed, system settings are retained, the system remains operational after an upgrade).

7. The sample size for the training set:

• Not applicable. This is not a machine learning or AI algorithm in the context of diagnostic interpretation that requires a "training set" of patient data.

8. How the ground truth for the training set was established:

• Not applicable as there is no training set for a diagnostic algorithm.

Summary of the Study and Equivalence Argument:

The "study" described in K250177 for the Remote Software Management (RSM) feature primarily consisted of non-clinical performance testing and software verification/validation.

• Approach: Philips evaluated the RSM feature against internal procedures, adhering to software lifecycle processes (IEC 62304) and risk management (ISO 14971).
• Comparison Basis: The proposed RSM feature was compared to the predicate device's existing, more limited RSM capabilities (which only supported bug fixes and patch upgrades). The new feature expands this to include major software releases, OS components, drivers, BIOS/UEFI versions, application packages, service application packages, and automatic backup/restore.
• Conclusion of Testing: "All software verification tests met the acceptance criteria." and "Results of these tests show that the proposed Remote Software Management software feature meets the intended use."
• Substantial Equivalence Argument: The document argues that this enhancement is substantially equivalent to the predicate device because it does not introduce new questions of safety or effectiveness. The core function of the ultrasound system (diagnostic imaging) remains unchanged, and the RSM feature is purely a workflow enhancement for system maintenance. No hardware changes are required, and existing transducers are used. The comparison table directly addresses the differences and highlights how the improved RSM capabilities are an extension of the predicate's feature, not a fundamentally new diagnostic function.

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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), 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 quidance. 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. 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 Traditional 510(k) Pre-Market Notification is to introduce the change in AutoMeasure V3 software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems. Philips AutoMeasure feature provides the end user semi-automated 2D, Doppler and M-mode measurements with an adult cardiology transthoracic transducer and acquisitions that includes an electrocardiogram (ECG). The Auto Measure feature is designed to provide semi-automated and editable measures during an echocardiography. When Auto Measure is enabled, the healthcare professional performs an echocardiography with a workflow that provides the user with a semiautomated measurement that can be edited, accepted, or rejected. AutoMeasure is available in the Adult Echo analysis applications with ECG. Availability is also controlled by transducer and preset via the EPM. The software applications are supported by all EPIQ and Affiniti models running software version 13.0 or higher.

Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) summary for Philips AutoMeasure V3 software.

Overview of the Device and Study:
The Philips AutoMeasure V3 software is an optional feature for EPIQ and Affiniti Series Diagnostic Ultrasound Systems. It provides semi-automated 2D, Doppler, and M-mode measurements during adult transthoracic echocardiography (TTE) using an AI-algorithm trained via machine learning. The study aimed to evaluate the performance of AutoMeasure V3 compared to standard of care (SOC) measurements.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list a table of acceptance criteria in numerical ranges for specific performance metrics (e.g., "accuracy > X%"). Instead, it describes a general acceptance methodology:

Acceptance Criteria for AutoMeasure V3 Software:
"meeting the pre-defined acceptance criteria for the study. Taken together, the results of the study demonstrated clinically reasonable, relevant and meaningful performance of the AutoMeasure V3 software supporting automation of measurements during cardiac TTE exams. Specifically, success on the hypotheses testing for AutoMeasure V3 agreement with ground truth measurements indicate that the safety and effectiveness of the proposed software is acceptable and aligns with previously reported agreement for cardiac assessment. Since the acceptance criteria were based on inter-observer data for echocardiographic measurements, the AutoMeasure V3 performance supports the conclusion that the algorithm behaves like any average human observer. Therefore, the clinical acceptability of AutoMeasure V3 is met."

This implies that the acceptance criteria for each of the 32 tested hypotheses were based on achieving agreement within the confidence intervals typically observed between human observers for echocardiographic measurements. The specific numerical thresholds for these confidence intervals are not provided in the summary.

Reported Device Performance:
The study concluded: "The results of the 32 hypotheses tested, demonstrated high agreement of AutoMeasure V3 software with Standard of Care Measurements (ground truth) obtained during initial subject exam, by producing confidence intervals for the limits of agreement, for each parameter (hypothesis) tested, meeting the pre-defined acceptance criteria for the study."

This indicates that for all 32 tested parameters, the AutoMeasure V3's performance was within the pre-defined limits of agreement, deemed comparable to human inter-observer variability.

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

• Test Set Sample Size: 7127 transthoracic echocardiography (TTE) cardiac clips from 3964 subjects.
• Data Provenance: Retrospective, multi-institutional.
  • Country of Origin: USA, Asia, and Europe.
  • Retrospective/Prospective: "Subjects were enrolled at institutions between 2015 and June 2024, and the timeframes varied for different hospitals." This indicates retrospective data collection from existing patient records/imaging archives.
  • Nature of Data: "Patients referred for clinical TTE as well as healthy volunteers were invited to participate."

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

• Number of Experts: Not explicitly stated as a specific number of unique experts who reviewed the test set for adjudication. The document states "Standard of Care (SOC) measurements obtained during initial subject visit, performed by qualified healthcare professional(s)." This implies that the ground truth was established by the original healthcare professional(s) performing the TTE exam in clinical practice.
• Qualifications of Experts: "qualified healthcare professional(s)". Specific qualifications (e.g., radiologist, cardiologist, sonographer, years of experience) are not detailed beyond "qualified". Given the context of echocardiography, these would likely be sonographers or cardiologists.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. The ground truth was based on "Standard of Care (SOC) measurements obtained during initial subject visit." This suggests a single reader paradigm where the initial clinical measurement serves as the ground truth, rather than a multi-reader consensus process specifically for the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, a traditional MRMC comparative effectiveness study where multiple human readers systematically re-read cases with and without AI assistance was not explicitly described. The study focused on the agreement between the AI's measurements and existing Standard of Care human measurements.
• Effect Size of Human Improvement with AI Assistance: Not applicable, as this type of MRMC study was not performed. The study aimed to show that the AI's measurements were comparable to typical human variability.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Performance: Yes, implicitly. The "Performance Validation Study" evaluated "the performance of the AutoMeasure V3 software... compared to ground truth." While the user can edit the semi-automated measurements, the study's focus on "agreement of AutoMeasure V3 software with Standard of Care Measurements" suggests an evaluation of the algorithm's initial output before human intervention, establishing its standalone capability. The document states, "AutoMeasure V3 is created semi-automatically using machine learning algorithm without user interaction."

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (implicitly, as SOC measurements by "qualified healthcare professional(s)"). More specifically, it is "Standard of Care (SOC) measurements obtained during initial subject visit". This suggests reliance on clinical practice measurements rather than a separate, dedicated "gold standard" panel review or pathological confirmation.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated in this 510(k) summary. The document mentions "training via machine-learning techniques" but does not give the size of the dataset used for this training.

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

• Training Set Ground Truth Establishment: Not explicitly stated in this 510(k) summary. However, it's highly probable that the training data's ground truth was also established by human expert annotation or existing clinical measurements, similar to how the test set ground truth was derived.

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

Modes of operation include: B 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 healtheare 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 (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculosketal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

Modes of operation include: B 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 healtheare 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 Traditional 510(k) Pre-Market Notification is to introduce the Auto ElastQ software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems with new Auto ElastQ software feature, which is a workflow-enhancement software feature, is equivalent to predicate device, K240850.

The Auto ElastQ software feature is intended to assist users in making stiffness measurements using 2D-SWE in the liver by recommending specific frames and ROI positions to the user.

No hardware changes to the EPIQ or Affiniti Systems are reguired when using the Auto ElastQ software feature, and existing, commercialized Philips transducers are used for the Auto ElastQ software feature. The feature is supported by EPIQ and Affiniti models running software version 12.0.

Here's a summary of the acceptance criteria and the study conducted for the Philips Auto ElastQ software feature, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "a retrospective data analysis study was conducted to evaluate the performance of the Auto ElastQ software compared to manual measurements."
• Data Provenance: Retrospective data analysis. Country of origin not specified.

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

• Number of Experts: Not explicitly stated. The ground truth was established by "manual measurements performed by expert readers."
• Qualifications of Experts: Not explicitly stated beyond "expert readers."

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The ground truth was established by "manual measurements performed by expert readers," implying an expert consensus or single expert reading for the manual measurements. No information suggestive of a 2+1 or 3+1 method is provided.

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

• MRMC Study: No. This document describes a study comparing the algorithm's performance to expert manual measurements, not a comparative effectiveness study of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes. The "retrospective data analysis study" directly evaluated the performance of the Auto ElastQ software (algorithm) "compared to manual measurements performed by expert readers." This indicates a standalone performance assessment of the algorithm.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus/manual measurements. The summary states, "with the manual measurements used as ground truth for the study."

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated. The document focuses on the performance study and does not detail the training set size for the AI algorithm.

9. How Ground Truth for the Training Set Was Established

• Training Set Ground Truth Establishment: Not explicitly stated. The document describes the "Auto ElastQ software feature is intended to assist users in making stiffness measurements using 2D-SWE in the liver by recommending specific frames and ROI positions to the user." While the testing involves expert manual measurements as ground truth, the method for establishing ground truth for the training data used to develop the algorithm is not detailed in this summary.

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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.

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 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.

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

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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. Intra-cardiac Echo. Intra-luminal, Intraoperative (Vascular). Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Transesophageal (Cardiac), Transrectal, Transvaginal, Lung,

The clinical environments where Philips EPIQ 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.

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), 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, 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 healtheare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems are durable, reusable capital equipment medical devices intended for high-resolution general imaging; interventional radiology, cardiology, vascular, obstetrics, and gynecology applications; and fluid flow analysis. They are intended to be used by trained professionals at various settings of patient care such as clinical admission, periodic evaluations, prior to hospitalization discharge, and/or academic research, via maneuverable caster wheels or mobile handheld components.

The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure software-only feature for use on the Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The Philips Auto Measure feature provides the end user with semiautomated functionality for a subset of 2D and Doppler measurements currently available on the Philips EPIQ and Affiniti systems when performing or reviewing an adult transthoracic echocardiography (TTE) with simultaneously acquired electrocardiogram (ECG). The AI/MLenabled algorithm is designed to produce semi-automated and editable measures.

The provided text is a 510(k) summary for the Philips EPIQ and Affiniti Ultrasound Systems with the new "Auto Measure" feature. It focuses on demonstrating substantial equivalence to predicate devices. However, the document does not contain the detailed performance data, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically found in a clinical study report or a more comprehensive validation study.

The "Performance Data" section in the K211597 summary only broadly states that non-clinical testing included a "Performance Validation Study" and that "Software Verification and Validation testing were used to support substantial equivalence." It also mentions "adherence to the aforementioned Philips internal processes."

Therefore, I cannot extract the specific information requested in your prompt based on the provided text. The document clearly omits the granular details of the validation study.

Here's what the document does tell us about the study, albeit at a high level:

• Study Type: A "Performance Validation Study" was conducted for the Auto Measure software, alongside Software Verification and Validation testing.
• Purpose: To demonstrate that the Auto Measure feature meets defined requirements and performance claims, and to support substantial equivalence to the currently marketed manual measuring options.
• What was tested: The "Auto Measure" software-only feature, which provides semi-automated functionality for a subset of 2D and Doppler measurements during adult transthoracic echocardiography (TTE) with simultaneously acquired ECG. The end user can edit, accept, or reject the measurements.

Without the actual performance validation study report or more detailed information, I cannot fill in the table or answer most of your specific questions.

If this information were available, here's how I would attempt to reconstruct it:

Hypothetical Acceptance Criteria and Device Performance (Based on common FDA expectations for such devices, NOT from the provided text)

Missing Information from the Provided Document:

1. A table of acceptance criteria and the reported device performance: NOT PROVIDED. The document only states that testing demonstrated the feature "meets the defined requirements and performance claims" but does not enumerate these.
2. Sample sizes used for the test set and the data provenance: NOT PROVIDED.
   • Test Set Sample Size: Unknown
   • Data Provenance: Unknown (country of origin, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NOT PROVIDED. The document refers to "manual measuring options" as a comparison, implying human expert measurements, but doesn't detail the ground truth process.
   • Number of Experts: Unknown
   • Qualifications: Unknown
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: NOT PROVIDED.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: NOT PROVIDED. The document discusses "semi-automated and editable measures" which implies human-in-the-loop, but doesn't describe an MRMC study or effect size. It only states the AI offers "semi-automated functionality" compared to "manual" on predicate devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "Auto Measure" feature is described as providing "semi-automated and editable measures," suggesting human oversight is intended. A purely standalone performance might have been part of the internal validation, but it's not explicitly detailed as a primary regulatory performance endpoint in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Based on the comparison to "manual measuring options," the ground truth likely involved expert human measurements (manual measurements by sonographers/cardiologists). Whether this was a single expert, consensus, or other method is NOT SPECIFIED.
8. The sample size for the training set: NOT PROVIDED.
9. How the ground truth for the training set was established: NOT PROVIDED.

In conclusion, while the document confirms that performance validation was conducted and software V&V was performed in accordance with FDA guidance, it lacks all the granular details about the study design and results that your prompt requested. This level of detail is typically found in the full 510(k) submission and supporting technical reports, not usually in the summary made publicly available.

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