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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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 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.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the device itself (e.g., accuracy, sensitivity, specificity for diagnostic tasks). Instead, it focuses on demonstrating compliance with recognized safety and performance standards for ultrasound devices, and equivalence to predicate devices. The "performance" described relates more to meeting these technical and regulatory standards.

However, based on the Safety Considerations and Nonclinical Performance Data sections, we can infer the following:

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

The document does not detail specific sample sizes for clinical test sets as it states that no clinical study was required. The non-clinical performance data appears to involve bench testing.

• Test Set Sample Size: Not applicable for clinical data. For non-clinical tests like ElastQ Imaging Measurement, X8-2t Transducer Verification, and Software Verification and Validation, the sample sizes are not specified but would typically refer to the number of tests performed on the physical hardware/software.
• Data Provenance: The data provenance is non-clinical performance and engineering testing conducted by Philips Ultrasound, Inc. The country of origin for this testing is not explicitly stated, but Philips Ultrasound, Inc. is located in Bothell, WA, USA. The data is prospective in the sense of being generated during the device development and validation process.

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

This information is not provided as the submission relies on non-clinical performance data and substantial equivalence to predicate devices, rather than a clinical study requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided, as no clinical study with human readers/interpreters needing adjudication was conducted or required.

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 device, an ultrasound system, does not appear to incorporate AI for interpretation that would necessitate such a study in this submission. The new features (ElastQ Imaging and the X8-2t transducer) are extensions of existing ultrasound technology, not AI-driven diagnostic aids.

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

This is not applicable. The device is a diagnostic ultrasound system that requires a human operator and interpretation, not a standalone AI algorithm for diagnosis. The "ElastQ Imaging" is a quantitative measurement tool, not an autonomous diagnostic algorithm.

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

For the non-clinical tests, the "ground truth" would be established by:

• Acoustic Output: Reference measurements against standardized phantoms and measurement equipment.
• Safety Standards: Compliance with the specified IEC and ISO standards through documented testing procedures.
• ElastQ Imaging Measurement: Performance against known physical properties of test phantoms.
• Software V&V: Meeting predefined software requirements and specifications.
  This is a technical, engineering-based "ground truth" rather than a clinical one from expert consensus or pathology.

8. The Sample Size for the Training Set

Not applicable. This submission is for a diagnostic ultrasound system, not an AI/machine learning algorithm requiring a "training set."

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

Not applicable, as no training set for an algorithm was used.

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