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The intended use of the EPIQ series, Affiniti 50 and Affiniti 70 system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:
Fetal/Obstetric, Abdominal, Intraoperative (Vascular), Intraoperative (Cardiac), Pediatric, Small Organ (Breast, Thyroid, Testicle), Cephalic (Neonatal), Cephalic (Adult), Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial) Gynecological, Other: Urology, Cardiac Adult, Cardiac Pediatric, Transesophageal (Cardiac), Cardiac other (Fetal), Peripheral Vessel, Cerebral Vascular.
When Philips EPIQ system is 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 proposed EPIO and Affiniti Diagnostic Ultrasound Systems are general purpose. software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers).
The removable transducers are connected to the system using a standard technology, multipin connectors.

The acceptance criteria for the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 30, 50, and 70 Diagnostic Ultrasound Systems, are detailed via compliance with several international and FDA-recognized consensus standards for medical electrical equipment and diagnostic ultrasound. The reported performance is that the devices meet these standards and are substantially equivalent to their predicate devices.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a test set in the context of diagnostic performance (e.g., image interpretation accuracy). The testing described is primarily focused on non-clinical verification and validation testing against technical and safety standards. This includes:

• Compliance with various IEC safety standards (electrical, EMC, usability, ultrasound-specific safety).
• Acoustic output measurements.
• Biocompatibility (stated as no changes from predicate, implying prior testing or material equivalence).

The data provenance is not explicitly mentioned as retrospective or prospective in relation to diagnostic performance studies. Instead, the document discusses non-clinical performance data obtained through testing to ensure safety and effectiveness of the proposed devices against established standards and predicate devices (K163120 and K121781). The nature of these tests suggests they were performed in a controlled, prospective manner in a lab or engineering environment to demonstrate compliance. There is no mention of patient data being used for the purpose of proving the device meets its acceptance criteria.

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

This information is not provided in the document, as the clearance is based on non-clinical performance testing (technical and safety standards) and substantial equivalence to predicate devices. There is no mention of a diagnostic performance study that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation primarily involved non-clinical testing against technical specifications and safety standards, rather than diagnostic interpretation requiring adjudication of results.

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

No, an MRMC comparative effectiveness study was not done or at least not mentioned in this summary. The submission focuses on demonstrating substantial equivalence to predicate devices through technical performance and safety compliance, rather than comparative diagnostic effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not specified or applicable to the type of device. The devices are diagnostic ultrasound systems, which inherently involve a human operator (sonographer/clinician) to acquire and interpret images. The EchoNavigator integration is described as assisting the interventionalist, implying human-in-the-loop, not standalone AI performance. There is no mention of an algorithm operating independently for diagnostic purposes.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" would be the specified parameters and thresholds in the international and FDA-recognized consensus standards (e.g., maximum acoustic output levels, electrical safety limits, EMC compatibility levels). For biocompatibility, the ground truth would be the ISO 10993 standards. These are objective, quantifiable criteria established by regulatory and standards bodies.

8. The Sample Size for the Training Set

This information is not applicable as this device is a diagnostic ultrasound system and not an AI/ML algorithm that requires a training set of data for its primary function. While the system may incorporate advanced processing, the document does not describe it as an AI/ML algorithm requiring a distinct "training set."

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

This information is not applicable for the same reasons as point 8.

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