Intended Use / Indications for Use

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, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), 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 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.

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.

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 judgment and best clinical procedure.

The purpose of this Special 510(k) Pre-Market Notification is to expand the Smart View Select (SVS) software application onto the Affiniti Series Diagnostic Ultrasound Systems and to modify the Smart View Select software application onto both the EPIQ Series Diagnostic Ultrasound Systems.

Smart View Select is an automated software feature that assists the user in selection of images for analysis with the existing Philips AutoStrain LV or 2D Auto LV application in Adult Echo Transthoracic (TTE) examination. 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 interface engine; the selection is a non-AI algorithm that considers the view classification and image depth to select the optimal set of images.

No hardware changes to the EPIQ or Affiniti systems are required when using SVS, and existing, cleared Philips TTE transducers are used with these software applications.

The SVS v2 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 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 and SWM software features are associated with the cardiac adult indication.

The provided document details the 510(k) clearance for Philips Ultrasound's EPIQ and Affiniti Series Diagnostic Ultrasound Systems with the Smart View Select (SVS) v2 software. The SVS feature is an automated software that assists users in selecting images for Left Ventricle (LV) analysis using existing Philips AutoStrain LV or 2D Auto LV applications in Adult Echo Transthoracic (TTE) examinations. It classifies acquired images by view using a Deep Learning AI interface and then uses a non-AI algorithm to select an optimal set of images.

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

1. Table of Acceptance Criteria and Reported Device Performance

The study aimed to demonstrate agreement between LV analysis outputs (Ejection Fraction - EF, and Global Longitudinal Strain - GLS) derived from manually selected clips (ground truth) and automatically selected clips by the SVS software.

2. Sample Size and Data Provenance

• Test Set Sample Size: The exact number of patients or cases in the test set is not explicitly stated as a single number. However, the demographic characteristics section indicates n=71 for various demographic variables like Sex, Age, Height, Weight, BMI, Race, LV systolic function, RWMA, Known CAD, Previous reported MI Location, and LV Hypertrophy, suggesting the test dataset comprised data from at least 71 unique patients.
• Data Provenance: The data was collected from a US-based medical center. The study was a retrospective data analysis.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three (3) reviewers (clinical experts) participated in establishing the ground truth.
• Qualifications of Experts: They are referred to as "clinical experts." No further specific qualifications (e.g., years of experience, specific board certifications like radiologist/cardiologist) are provided in the document.

4. Adjudication Method for the Test Set

The adjudication method used to establish ground truth was consensus/averaging. For each output (GLS and EF), the average across the three reviewers was used as the ground truth.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was described. The study focused on comparing the AI-selected clips' performance (GLS and EF) against the ground truth established by human experts using manually selected clips. There is no information provided regarding how much human readers improve with AI vs. without AI assistance. The study evaluates the AI's ability to select optimal clips, a step that precedes human analysis with AutoStrain LV.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The performance of the SVS software was evaluated solely based on its ability to automatically select appropriate clips, and then the subsequent, un-edited evaluation of GLS and EF through AutoStrain LV using these SVS-selected clips was compared against the human-selected clips. This represents the algorithm's performance in its specific task (clip selection) without direct human intervention in the selection process.

7. Type of Ground Truth Used

The ground truth used was expert consensus. Specifically, it was the average of GLS and EF measurements obtained from clips manually selected and subsequently semi-automatically processed by three clinical experts using the AutoStrain LV software.

8. Sample Size for the Training Set

The document does not provide the sample size used for the training set of the deep learning AI model for image classification. It only states that "the neural network of the subject device was revised as described in attachment 002," implying updates to an existing model rather than a completely new one, but no training data details are given.

9. How Ground Truth for Training Set was Established

The document does not explicitly state how the ground truth for the training set was established. It mentions that the "classification is based on a Deep Learning AI interface engine," but details regarding the training data annotation and ground truth establishment are not provided within the excerpt.

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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)

1. Comparison of the average WMSI from ground truthers to the SWM v2 software's WMSI.
2. Majority agreement: A minimum of 2 out of 3 ground truthers were required to agree on WMSI = 1 (normal) or WMSI > 1 (abnormal) for the exam, which was then compared to the software's WMSI. |
   | 5. Multi-Reader Multi-Case (MRMC) Study | No, an MRMC comparative effectiveness study was not explicitly described. The study compared the algorithm's performance to expert visual estimation as the ground truth. |
   | 6. Standalone Performance | Yes, this was a standalone (algorithm only) performance evaluation against an expert-established ground truth. Although it is a "semi-automated quantitative imaging algorithm" where "users are generally expected to review and concur," the performance assessment described here focuses on the algorithm's output prior to user editing. |
   | 7. Type of Ground Truth Used | Expert consensus/visual estimation by 3 expert cardiologists. |
   | 8. Training Set Sample Size | Not provided in this document. This clearance refers to a previous clearance (K243862) for the SWM v2 algorithm. |
   | 9. Training Set Ground Truth Establishment | Not provided in this document. This clearance refers to a previous clearance (K243862). |

Auto EF with Contrast

1. Manual selection of clips by an experienced sonographer.
2. Manual EF assessment using Simpson's method of disks by 3 qualified sonographers.
3. "Shoulder to shoulder" consensus meetings among the 3 sonographers to review manual measurements, jointly select best traced images ("Best Trace"), and adjust traces if needed.
4. A cardiologist specializing in echo subsequently reviewed the selected A4C and A2C clips with "Best Trace" and the resulting LV EF measurements, performing manual adjustments if needed. These final measurements were used as ground truth. |
   | 5. Multi-Reader Multi-Case (MRMC) Study | No, an MRMC comparative effectiveness study was not explicitly described. This was a direct comparison of the algorithm's standalone performance against a consensus-derived ground truth. |
   | 6. Standalone Performance | Yes, the study describes the "Contrast EF application to an EF output" in an automated fashion, and "The ground truth EF measurements were compared to the Contrast EF automated results for EF (biplane)." This indicates a standalone performance evaluation. |
   | 7. Type of Ground Truth Used | Expert consensus (between 3 sonographers and 1 cardiologist) using manual EF assessment via Simpson's method of disks. |
   | 8. Training Set Sample Size | Not provided. This clearance refers to a previous clearance (K243235) for the Contrast EF algorithm. |
   | 9. Training Set Ground Truth Establishment | Not provided. This clearance refers to a previous clearance (K243235). |

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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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 Special 510(k) Pre-Market Notification is to introduce the Smart View Select (SVS) software application onto the EPIQ Series Diagnostic Ultrasound Systems and to introduce the Segmental Wall Motion software application onto both the EPIQ and Affiniti Series Diagnostic Ultrasound Systems.

Smart View Select is an automated software feature that assists the user in selection of images for analysis with the existing Philips AutoStrain LV or 2D Auto LV application in Adult Echo Transthoracic (TTE) examination. 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 Al interface engine; the selection is a non-Al algorithm that considers the view classification and image depth to select the optimal set of images.

The Segmental Wall Motion 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 application then provides segmental wall motion scores for each of the 17 segments of the LV by using machine learning algorithms and an overall wall motion score index (WMSI) is calculated as the average of the segmental scores.

No hardware changes to the EPIQ or Affiniti systems are required when using SVS or SWM, and existing, cleared Philips TTE transducers are used with these software applications.

The SVS feature is supported by all EPIQ models running software version 11.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SWM feature is supported by the same EPIQ models running software version VM11.0 or higher, as well as all Affiniti models including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS and SWM software are associated with the cardiac adult indication.

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and a study conducted to prove that the Philips EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems, with the new Smart View Select (SVS) and Segmental Wall Motion (SWM) software applications, meet these criteria for substantial equivalence.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Device Under Evaluation: Philips EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems with Smart View Select (SVS) and Segmental Wall Motion (SWM) software applications.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the exact numerical sample size (number of subjects/exams) for the test sets in either study. It mentions the studies were retrospective.

• Data Provenance: Retrospective (from existing subject exams). The country of origin of the data is not specified in the provided text.

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

• Number of Experts: Three (3) reviewers participated in establishing ground truth for both studies.
• Qualifications of Experts: Described as "clinical experts." No further specific qualifications (e.g., years of experience, subspecialty) are provided in the document.

4. Adjudication method for the test set

• Adjudication Method: For both the SVS and SWM studies, the ground truth was established as the "average across reviewers" for each output (GLS and EF for SVS; WMSI for SWM). This implies a consensus or averaging approach rather than a specific hierarchical adjudication process (like 2+1 or 3+1).

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

• MRMC Study: The studies described are not MRMC comparative effectiveness studies designed to evaluate the improvement of human readers with AI assistance. Instead, they are analytical validity studies evaluating the agreement of the AI-powered workflows (SVS and SWM) with an established ground truth or reference (manual clip selection and LVivo SWM, respectively).
• Effect Size of Human Improvement: Therefore, no effect size related to how much human readers improve with AI vs. without AI assistance is reported. The focus is on the performance of the AI-assisted workflow compared to a manual or reference workflow.

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

• Standalone Performance: For the SVS study, the "automatically obtained GLS and EF results with SVS selected clips" were compared against the ground truth. This suggests a form of standalone evaluation of the SVS algorithm's selection capability and its impact on the subsequent automated analysis. The SWM algorithm, while described as "semi-automated" where users are expected to review and concur, was also tested in an "un-edited" fashion for comparison in the SVS workflow path, which leans towards evaluating its automated output. However, the overall claims and clinical use imply human review (semi-automated).

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

• Smart View Select (SVS) Study Ground Truth: "Manual selection of clips from subject exam and subsequent semi-automated processing of the clips with AutoStrain LV software to evaluate GLS and EF, which served as ground truth (average across reviewers for each output)." This is based on expert consensus (average across reviewers) following a manual workflow using a previously cleared software (AutoStrain LV).
• Segmental Wall Motion (SWM) Study Ground Truth: "Processing of the clips with LVivo application for WMSI output, which served as ground truth in the study (average across reviewers)." This is also based on expert consensus using a previously cleared or referenced software (LVivo SWM, which is the reference device K161382).

8. The sample size for the training set

• The document does not provide any information about the sample size used for training the Deep Learning AI interface engine for SVS or the machine learning algorithms for SWM. It only mentions the retrospective data analysis studies for performance evaluation (test set).

9. How the ground truth for the training set was established

• As the document does not provide information on the training set, details about how its ground truth was established are also not available in the provided text.

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

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, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Philips EPIQ Diagnostic Ultrasound Systems are durable capital equipment / medical devices which are software-controlled and intended for high-resolution general imaging, interventional radiology, cardiology, vascular and OB/GYN 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.

Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Philips EPIQ Diagnostic Ultrasound Systems and may vary among model configurations.

The systems are manufactured with hardware components which consist of:

• a primary console (e.g., workstation, tablet) with built-in software components, features, and various 1) clinical applications, and
• 2. a range of compatible ultrasound transducers and ultrasound intravascular catheters.

A suite of reusable compatible transducer types are offered such as transesophageal echocardiography (TEE) transducers, non-imaging (pencil) probes, curved array and sector/phased array. Philips ultrasound transducers may be bagged into compatible transducer/probe cover sheaths, designed by other manufacturers, for each procedure to prevent cross-contamination and reduce the risk of healthcareassociated infections. Philips EPIQ Diagnostic Ultrasound Systems are also compatible with single-use diagnostic intravascular ultrasound catheters (i.e., Philips VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro Intracardiac Echocardiography (ICE) Catheter) that are intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart for image guidance during cardiac interventional procedures.

Some configurations may have additional previously-cleared accessories, components and software features which are manufactured by Philips Ultrasound, Inc. or other manufacturers.

The provided FDA 510(k) summary for the Philips EPIQ Series Diagnostic Ultrasound Systems with VeriSight ICE / Pro ICE Catheters does not contain the specific acceptance criteria or the study details that prove the device meets these criteria in the format requested.

The document states that "all pre-determined acceptance criteria were met" and that "Results of these tests show that the proposed subject Philips EPIQ Series Diagnostic Ultrasound Systems with VeriSight ICE / PRO ICE Catheters meet their intended use." However, it does not explicitly list these criteria or provide detailed results from studies designed to demonstrate compliance.

Instead, the document focuses on:

• Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is primarily done through comparison of technological characteristics and safety standards.
• Compliance with Standards: It lists several IEC and ANSI standards that the device complies with, which are general safety and performance standards for medical electrical equipment and diagnostic ultrasound.
• Non-Clinical Verification Testing: It mentions that "Relevant non-clinical verification testing and compatibility information has been performed... to address system level requirements according to system and design specifications, and risk control measures." This implies internal testing was done, but details are not provided.
• Lack of Clinical Data: It explicitly states that "The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence." This means a human-in-the-loop (MRMC) study or standalone clinical performance study was not conducted or required for this 510(k) clearance.

Therefore, for the information requested in your bullet points, I can only extract general statements about compliance and the types of testing performed, not specific performance metrics against defined acceptance criteria.

Here's a breakdown of what can and cannot be derived from the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided from the text. The document states "all pre-determined acceptance criteria were met" and that the device meets its intended use, but it does not specify what those criteria are or report concrete performance metrics against them. The focus is on compliance with general safety and performance standards.

2. Sample size used for the test set and the data provenance

Cannot be provided from the text. The document does not describe a clinical test set or its provenance because it explicitly states that "The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence." The testing mentioned is "non-clinical verification testing and compatibility information." Details like sample size or data provenance for these internal non-clinical tests are not given.

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

Not applicable/Cannot be provided from the text. Since no clinical test set was required or described, there were no experts used to establish ground truth in the context of clinical performance.

4. Adjudication method for the test set

Not applicable/Cannot be provided from the text. As no clinical test set or ground truth establishment by experts is described, no adjudication method would have been used.

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

No. The document explicitly states: "The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence." This implies no MRMC comparative effectiveness study was conducted or needed. Furthermore, the device described is a general diagnostic ultrasound system, not explicitly an "AI" device with human-in-the-loop assistance in the context of improving reader performance.

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

No. The document states that "The proposed Philips EPIQ Diagnostic Ultrasound Systems did not require clinical data for determination of substantial equivalence." While "non-clinical verification testing" was performed, this refers to engineering and quality assurance testing against technical specifications and safety standards, not a standalone clinical performance study of an algorithm. The device is described as software-controlled, but not as an "algorithm only" device subject to standalone performance evaluation in a clinical sense.

7. The type of ground truth used

Not applicable/Cannot be provided from the text for clinical performance. For the non-clinical verification testing mentioned, the "ground truth" would likely be engineering specifications, established physical properties, and compliance with the listed safety standards (e.g., electrical safety, electromagnetic compatibility, acoustic output limits).

8. The sample size for the training set

Not applicable/Cannot be provided from the text. The document pertains to a diagnostic ultrasound system, not an AI model that undergoes a "training set" in the machine learning sense. The "software-controlled" aspect refers to the operational control of the ultrasound system itself, not necessarily an AI algorithm.

9. How the ground truth for the training set was established

Not applicable/Cannot be provided from the text. As above, this is not applicable for this type of device and submission.

In summary, the provided text from the FDA 510(k) summary demonstrates compliance by:

• Stating that "all pre-determined acceptance criteria were met" for internal non-clinical verification testing.
• Listing adherence to recognized safety and performance standards (ANSI/AAMI 60601-1, IEC 60601-1-2, IEC 60601-2-37).
• Asserting that no clinical data was required for substantial equivalence, implying that its performance is presumed to be equivalent to the predicate device based on technical and safety specifications.

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