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The Sonosite PX Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Abdominal Adult cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral Vessel Small Organ (breast, thyroid, testicles, prostate) Transvaginal Needle Guidance This device is indicated for Prescription Use Only. The Sonosite PX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.

The SonoSite SII 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 Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel

The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include: Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic

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 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 Edge II Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

The SonoSite Maxx Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatic, Trans-esophageal (cardiac), Peripheral Vessel.

The Sonosite Diagnostic Ultrasound Systems are full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. They are intended to be used for general purpose ultrasound examination, cardiac imaging, fetal imaging and OB/GYN applications, vascular imaging and trans-rectal applications and fluid flow analysis among others. Some Sonosite Ultrasound Systems (Sonosite PX) also have needle guidance capabilities. They are intended to be used by qualified physicians and trained professionals in various patient care settings including hospitals, clinics, and point-of-care settings. Software modes/applications, scanning protocols, and pre-installed settings or functionality to create dedicated settings for imaging of specific anatomy are available with the subject Sonosite Ultrasound Systems and may vary among the different model configurations. The Sonosite Ultrasound Systems work on either battery or AC power. Some Sonosite Diagnostic Ultrasound Systems support Bluetooth and wireless connectivity for image transfer and over-the-air (OTA) software updates. The diagnostic ultrasound systems are manufactured with hardware components which consist of: 1) a primary console (e.g., workstation, tablet with touchscreen) with built-in software components, features, and various clinical applications, and 2) a range of compatible ultrasound transducers. A suite of compatible transducers are offered with the Sonosic Ultrasound Systems. These include linear array, curved array, phased array, intra-cavitary, static probes and trans-esophageal transducers. Linear array transducers (prefixed with the letter L) produce a rectangular field of view with uniform beam density throughout and are useful for imaging shallow structures and small parts. Curved array transducers (prefixed with the letter C) allow for a wider field of vith decreased line density at depth and reduced lateral resolution. They are the ideal probe for lung ultrasound imaging. Phased array transducers (prefixed with the letter P) are small faced transducers allowing for imaging in small spaces. They are able to change the focus of the ultrasound beam. It is the optimal transducer recommended for cardiac imaging. Trans-esophageal transducers (prefixed with the letters TE) are commonly used for evaluation of cardiac and aortic structures. Intra-cavitary transducers (prefixed with the letters IC) are used for trans-rectal ultrasounds. Some models may have additional previously-cleared accessories, or components which are manufactured by other manufacturers.

The provided document is a 510(k) Summary for multiple FUJIFILM Sonosite Diagnostic Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. The document explicitly states: "Relevant performance data does not apply to this submission. Design control measures described within the submission support a decision of substantial equivalence."

Therefore, the document does not include a study or acceptance criteria related to a new device or algorithm performance evaluation. Instead, it relies on the predicate devices' established safety and effectiveness. The modifications mentioned are primarily "Additional user labeling ... for patients with coronavirus disease 2019 (COVID-19)" based on existing methods or society guidelines, not a new AI-powered diagnostic feature.

Given this, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, experts, or MRMC studies, as these types of studies were explicitly stated as not applicable to this submission.

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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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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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