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The SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of thid flow analysis of the human body. Specific clinical applications and exam types include:

Ophthalmic Fetal – OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel

The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purpostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. X-Porte is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. The system interface can be customized for the user and controlled using a backlit touchscreen much like what is used in consumer tablet products. X-Porte can be operated in two different configurations, standbased with AC power or battery, and desktop-based with AC power only. In desktop configuration the ultrasound engine can be removed from the stand and used by itself with a single transducer and external monitor.

The provided documentation is a 510(k) Premarket Notification for the FUJIFILM SonoSite, Inc. SonoSite X-Porte Ultrasound System. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing performance criteria through novel clinical studies. Therefore, much of the requested information regarding algorithm performance, sample sizes for test/training sets, expert qualifications, and MRMC studies is not present.

However, based on the provided text, we can extract details regarding the general acceptance criteria (primarily safety and compliance with standards) and the "study" (non-clinical tests and comparisons to predicates) used to demonstrate adherence to these criteria.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily conformance to various medical device safety and performance standards. The "reported device performance" is implicitly that the device meets these standards, enabling a substantial equivalence determination.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable in the context of this 510(k) submission. The submission relies on non-clinical testing and comparison to predicates, not a clinical test set for AI performance.
• Data Provenance: Not applicable for performance evaluation in the usual sense. The "data" here refers to measurements and tests conducted to ensure compliance with standards, and these are typically internal engineering tests. The document states "Clinical Validation" was part of product development, but no details are provided about this "validation" with respect to a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the clinical performance sense (e.g., expert consensus on diagnoses) is not described or required for this type of 510(k) submission focused on substantial equivalence of an ultrasound system, not an algorithmic diagnostic device. The "truth" is established by adherence to engineering and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no mention of an adjudication method as no clinical test set for diagnostic accuracy is described.

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

Not applicable. This is a submission for an ultrasound imaging system, not an AI-assisted diagnostic algorithm. There is no MRMC study mentioned or required for this type of device.

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

Not applicable. This is not an algorithmic diagnostic device, but rather a general-purpose ultrasound system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" or basis for the acceptance of this device primarily stems from:

• Engineering and safety standards compliance (e.g., IEC 60601-1, NEMA UD2-2004 for acoustic output).
• Biocompatibility testing for patient contact materials.
• Risk assessment outcomes.
• Comparison of technological characteristics and intended uses to previously cleared predicate devices (K152209, K133454, K162045).

8. The sample size for the training set

Not applicable. This document describes an ultrasound hardware system, not an AI/algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set for an algorithm is described.

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