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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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