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The FUJIFILM 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 or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal – OB/GYN Abdominal Intra-operative (Abdominal organs and vascular) 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 readliy 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 text is a 510(k) Premarket Notification for the FUJIFILM SonoSite X-Porte Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study for a novel AI/algorithm.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, and standalone performance for an AI/algorithm is not applicable to this document. This document describes a traditional medical device (ultrasound system and transducers) and its substantial equivalence to previously cleared devices.

Here's a breakdown of the available and non-applicable information based on your request:

1. A table of acceptance criteria and the reported device performance

This document does not present specific acceptance criteria (e.g., sensitivity, specificity, or quantifiable performance metrics) and reported device performance in the context of an AI/algorithm for diagnostic accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices for its intended uses and technological characteristics.

The "performance" is implicitly the ability of the device to perform diagnostic ultrasound imaging and fluid flow analysis for the stated clinical applications, which is assumed to be equivalent to the predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a traditional medical device submission, not an AI/algorithm submission requiring test set data for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment by experts for a test set is typically for AI/algorithm performance validation, which is not described here. The "ground truth" for this device would be its validated capabilities for imaging and fluid flow analysis, established through technical testing and comparison to predicate devices, rather than being determined by experts for diagnostic accuracy in a study.

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

Not applicable. This document does not describe an adjudication method for a test set as it is not an AI/algorithm submission.

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 document is for an ultrasound system, not an AI diagnostic algorithm, and therefore does not include MRMC studies assessing human reader improvement with AI assistance.

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

Not applicable. The device is an ultrasound system, not a standalone algorithm.

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

Not applicable. For a traditional ultrasound system, the "ground truth" is its ability to produce images and perform measurements consistent with established medical and engineering standards, validated through a series of technical and safety tests referenced in the "Summary of Non-Clinical Tests" (e.g., electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, acoustic output).

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/algorithm submission.

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

Not applicable. There is no training set and therefore no ground truth establishment for a training set described.

Summary of Information from the Document:

The document describes the FUJIFILM SonoSite X-Porte Ultrasound System as a general-purpose ultrasound system for diagnostic imaging and fluid flow analysis. It primarily demonstrates substantial equivalence to predicate devices (SonoSite X-Porte Ultrasound System K142017 and SonoSite Edge Ultrasound System K133454).

The "acceptance criteria" and "performance" described are related to the device's adherence to safety standards and its functional equivalence to predicate devices for specific clinical applications and imaging modes.

Non-Clinical Tests Summary:
The device was evaluated for:

• Electrical safety
• Thermal safety
• Mechanical safety
• EMC safety
• Cleaning/disinfection
• Biocompatibility
• Acoustic output

The device conforms to applicable mandatory medical device safety standards, including:

• AAMI / ANSI / ISO 10993-1 (Biological evaluation of medical devices)
• AAMI / ANSI ES60601-1 (Medical electrical equipment - General requirements)
• AAMI / ANSI / IEC 60601-1-2 (Electromagnetic compatibility)
• IEC 60601-2-37 (Particular requirements for ultrasonic medical diagnostic equipment)
• IEC 62359 (Ultrasonics - Field Characterization - Thermal and Mechanical Indices)
• ISO 14971 (Risk management to medical devices)
• NEMA UD 2-2004 (Acoustic Output Measurement Standard)
• NEMA PS 3.15 (DICOM - Security and System Management Profiles)

Clinical Tests Summary:
The document explicitly states: "The SonoSite X-Porte Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

Transducer New Indications:
The submission does include "new indications" (marked with 'N') for certain transducers, where the device previously cleared ('P') for other indications. For example, the TEExp/8-3 MHz Transducer has "N" for all Cardiac Adult, Cardiac Pediatric, and Trans-esophageal (card.) modes, indicating these are new for this specific transducer. However, the document relies on comparisons to predicate devices that already have these capabilities, effectively claiming equivalence by association rather than presenting new performance data for these new indications.

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