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The intended use of the EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 70 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), 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.

The proposed EPIQ 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, multi-pin connectors.

The Philips EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50, and Affiniti 70 Diagnostic Ultrasound Systems are general purpose, software-controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and display it in various modes of operation. They consist of a system console and transducers.

The device's performance was evaluated through non-clinical testing to demonstrate substantial equivalence to a predicate device (Philips EPIQ Diagnostic Ultrasound System and Philips Affiniti Diagnostic Ultrasound System, K172607). No clinical studies were required.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not explicitly provided in the document. The document states that "Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures in Appendix M. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users." However, specific sample sizes for these tests are not mentioned.

The data provenance is from Philips Ultrasound, Inc.'s internal testing, as indicated by "Philips Ultrasound performed the following testing to ensure the safety and effectiveness..." It is considered retrospective as it refers to testing already completed to support the submission.

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

This information is not explicitly provided. Since the evaluation relied on non-clinical performance data and compliance with standards, and no clinical studies were performed, there isn't a "test set" in the context of expert-labeled medical data for algorithm performance. Usability testing involved "representative intended users," but their qualifications or number for establishing ground truth are not detailed.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication for ground truth is mentioned. The assessment relied on non-clinical testing and compliance with recognized standards.

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 MRMC comparative effectiveness study was mentioned or performed. The submission relies on demonstrating substantial equivalence to a predicate device through technological comparison and non-clinical data, not on comparing human reader performance with and without AI assistance. The device is a diagnostic ultrasound system, not an AI-powered diagnostic aid in the context of this submission.

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

Not directly applicable in the conventional sense of an AI algorithm's standalone performance. The document describes a diagnostic ultrasound system with expanded features (ElastQ Imaging Linear) and a new transducer (S9-2). The "algorithm" here refers to image processing and diagnostic functions integrated into the ultrasound system itself, not a separate AI-driven software that would have a standalone performance measured against human interpretation. The non-clinical verification and validation testing would cover the performance of these integrated functions.

7. The Type of Ground Truth Used

For compliance with standards like IEC 60601-1, 60601-1-2, 60601-2-37, and 62359, the "ground truth" would be the established specifications and limits defined by these international standards. For non-clinical verification and validation testing, the "ground truth" would be derived from engineering specifications and controlled test conditions designed to evaluate the system's output against known desired performance parameters. For usability testing, the "ground truth" would be user feedback and observed user interactions against predefined usability requirements.

8. The Sample Size for the Training Set

Not applicable. This submission is for a diagnostic ultrasound system, not an AI/ML algorithm that requires a "training set" in the machine learning sense. The development of the ultrasound system's functionalities, including the new ElastQ Imaging Linear mode, would involve internal engineering development and testing, but not a distinct "training set" like an AI model.

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

Not applicable, as there is no mention of a "training set" for an AI/ML algorithm in this context. The "ground truth" for the device's development and testing would be based on established engineering principles, physics, and international performance and safety standards for medical ultrasound equipment.

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