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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), 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.

The proposed Philips EPIQ Diagnostic Ultrasound Systems and Philips 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. Other than the introductions of the two new transducers, the device description, accessories and components are unchanged, reference table 1.

Here's the breakdown of the acceptance criteria and supporting studies for the Philips EPIQ and Affiniti Diagnostic Ultrasound Systems based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the device's original clearance. Therefore, information regarding specific clinical performance metrics (like sensitivity, specificity, accuracy) from a de novo study is not present. Instead, the document emphasizes compliance with standards and equivalence to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device meeting safety and performance standards rather than specific clinical performance metrics like sensitivity/specificity for a novel algorithm.

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

The document does not explicitly state a "test set" in the context of clinical performance data for a novel algorithm being evaluated against a ground truth. The testing mentioned is primarily non-clinical, focusing on compliance with safety and performance standards, and demonstrating substantial equivalence to a predicate device. Therefore, a sample size for a separate test set of patient data is not provided. The data provenance is also not applicable in this context as no clinical study for a new performance claim was conducted.

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

This information is not provided as the submission is for substantial equivalence and mainly relies on non-clinical testing and comparison to predicate devices, rather than a de novo clinical study with expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided as no clinical study with a test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

An MRMC comparative effectiveness study is not mentioned in this 510(k) summary. The submission focuses on the safety and effectiveness of the ultrasound system and its transducers, not on an AI-assisted diagnostic workflow affecting human reader performance.

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

The document describes an ultrasound system and transducers, not a standalone algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable or discussed.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance data, the "ground truth" implicitly refers to the specified values and requirements within the cited technical standards (e.g., acoustic output limits, electrical safety standards). No clinical ground truth (like pathology or outcomes data) is referenced for performance evaluation.

8. The Sample Size for the Training Set

This information is not applicable as the submission describes an ultrasound system, not an AI/algorithm that would require a training set.

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

This information is not applicable, as there is no training set for an AI/algorithm mentioned in this submission.

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