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The Sonosite LX 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:

• Abdominal
• Adult Cephalic
• Neonatal Cephalic
• Cardiac Adult
• Cardiac Pediatric
• Dermatological
• Fetal OB/GYN
• Musculo-skeletal (Conventional)
• Musculo-skeletal (Superficial)
• Ophthalmic
• Pediatric
• Peripheral vessel
• Small Organ (breast, thyroid, testicles, prostate)
• Transesophageal (cardiac)
• Transrectal
• Transvaginal
• Needle Guidance

Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M Mode), PW Doppler (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (CWD), Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD.

This device is indicated for Prescription Use Only.

The Sonosite LX 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 LX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler (CPD), and color Doppler (Color) or in a combination of these modes. The Sonosite LX is designed as an integrated unit with its kiosk-style stand.

The system includes a variety of accessories including needle guide starter kits. The system includes USB host support for peripherals such as input devices, storage devices, and an Ethernet port. Input devices include wired and wireless devices. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.

The provided FDA 510(k) clearance letter for the Sonosite LX Ultrasound System (K251830) describes a general-purpose ultrasound system. As such, the clearance does not detail specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with AI-powered diagnostic devices. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with general safety and performance standards.

However, based on the information provided, we can infer some "acceptance criteria" related to the device's technical specifications and safety, and how the study addresses them.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a general-purpose ultrasound system and not an AI/diagnostic algorithm, the acceptance criteria are not in the form of diagnostic performance metrics. Instead, they are related to equivalence with predicate devices, safety, and general performance standards.

Regarding specific AI-related questions (2-9), this clearance letter does not pertain to an AI/ML device for diagnostic interpretation. It's for a general-purpose ultrasound system. Therefore, most of these questions are not applicable to the information provided.

However, I will address them to indicate their non-applicability or provide any remotely relevant information.

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

• Not Applicable. This submission is for a general-purpose ultrasound system, not an AI/ML algorithm requiring a specific test set for diagnostic performance. The evaluation was primarily based on engineering testing (electrical, thermal, mechanical, EMC safety, biocompatibility, acoustic output, standards compliance) and comparison to predicate devices, rather than a dataset of patient cases.

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. No ground truth (in the context of diagnostic accuracy) was established for a test set in this submission, as it's not an AI/ML diagnostic algorithm.

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

• Not Applicable. No test set requiring expert adjudication for diagnostic ground truth.

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 not an AI-assisted diagnostic device, so no MRMC study comparing human readers with and without AI assistance was performed or reported.

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

• Not Applicable. This is a hardware device (ultrasound system), not a standalone algorithm.

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

• Not Applicable. The "ground truth" here relates to engineering specifications and safety standards, such as:
  • Biocompatibility confirmed by ISO 10993-1 standards (chemical testing, etc.)
  • Acoustic output confirmed by IEC 62359 standards.
  • Electrical safety confirmed by IEC 60601-1 standards.
  • Functional "ground truth" confirmed by successful testing in a clinical environment, meaning it operates as intended for imaging and fluid flow analysis.

8. The sample size for the training set

• Not Applicable. This clearance is not for an AI/ML device that requires a training set.

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

• Not Applicable. No training set for an AI/ML device.

In summary, the FDA 510(k) clearance for the Sonosite LX Ultrasound System is focused on demonstrating substantial equivalence to pre-existing, legally marketed predicate ultrasound systems and compliance with international safety and performance standards. The "study" proving it meets acceptance criteria primarily involves comprehensive engineering validation and verification testing (electrical, thermal, mechanical, EMC, acoustic output, biocompatibility, cleaning/disinfection) and documented adherence to a robust Quality System, rather than a clinical study evaluating diagnostic accuracy with a patient dataset or the performance of an AI algorithm.

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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, Transesophageal (cardiac), Transrectal, Needle Guidance. Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler Mode (B), M-Mode (M) (Including simultaneo (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (including Velocity Color Dopler), Tissue Harmonic Imaging (THI), Tissue Dopler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD. 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 PX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode (including Simultaneous M-Mode and anatomical M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. including Triplex imaging. The system includes a variety of accessories including optional needle guide starter kits. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.

The provided text does not contain information about acceptance criteria for a medical device or a study proving its performance against these criteria. Instead, it is a 510(k) summary for the FUJIFILM Sonosite PX Ultrasound System, establishing its substantial equivalence to previously cleared predicate devices.

The document focuses on:

• Indications for Use: Listing the clinical applications and exam types for which the ultrasound system is intended.
• Technological Characteristics: Comparing the subject device (Sonosite PX Ultrasound System) with its predicate devices (Sonosite PX Ultrasound System K200964 and SonoSite Edge II Ultrasound System K162045) in terms of features like intended use, indications for use (subsets of predicates), transducer types and frequencies, acoustic output, modes of operation, DICOM support, and safety certifications.
• Non-Clinical Tests: Stating that the device underwent evaluations for electrical, thermal, mechanical, and EMC safety, as well as cleaning/disinfection, biocompatibility, and acoustic output, conforming to applicable medical device safety standards. It also mentions compliance with specific ISO and IEC standards.
• Clinical Tests: Explicitly stating that clinical studies were not required to support the determination of substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving performance against them, as it is not present in the given text.

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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 Healthicare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.

The Sonosite PX Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D, M-Mode (including Simultaneous M-Mode), Pulsed Wave (PW) Doppler (including Pulsed Wave Tissue Doppler), Continuous Wave (CW) Doppler, Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging or in a combination of these modes. The Sonosite PX Ultrasound System also includes needle guidance capability. The system is capable of working with two different types of needle guide brackets available, including 1) Fixed-angle, in-plane brackets where a pair of guidelines are generated that represent the path of the needle and 2) Transverse-angle, out-of-plane brackets (adjustable depths) where the quidelines appear down the center of the imaqe. Each Sonosite PX transducer has an appropriate needle quide bracket kit to support needle quidance with the system.

The provided text is a 510(k) Pre-Market Notification for the FUJIFILM SonoSite PX Ultrasound System. It focuses on demonstrating substantial equivalence to existing predicate devices (SonoSite Edge II Ultrasound System and SonoSite X-Porte Ultrasound System) rather than presenting a study to prove acceptance criteria for a new AI/algorithm-based diagnostic device.

Therefore, many of the requested details about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, and comparative effectiveness studies are not applicable as they are specific to studies evaluating the performance of diagnostic algorithms.

However, I can extract and summarize the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, AUC) for an AI or algorithmic function. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards.

The "reported device performance" in this context refers to the device's ability to perform various ultrasound imaging modes across different clinical applications, which is considered equivalent to the predicate devices.

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

• Not Applicable. The document explicitly states: "The Sonosite PX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." Non-clinical tests were conducted for safety and technological characteristics, not for clinical performance evaluation comparable to an AI algorithm's test set.

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

• Not Applicable. No clinical test set requiring expert ground truth was conducted for this submission. The device is a general-purpose ultrasound system, and its functionality relies on the interpretation of images by qualified healthcare professionals.

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

• Not Applicable. No clinical test set requiring adjudication was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• Not Applicable. This is a submission for a general-purpose ultrasound imaging system, not an AI-assisted diagnostic algorithm. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted or mentioned.

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

• Not Applicable. This device is an imaging system, not a standalone algorithm. Its intended use is for qualified physicians and healthcare professionals to perform evaluations using the ultrasound images.

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

• Not Applicable. As no clinical studies were performed to establish performance metrics for a diagnostic algorithm, no specific ground truth type was established for that purpose. The "ground truth" for demonstrating substantial equivalence was conformity to recognized safety standards and verification of technological functionality against predicate devices.

8. The sample size for the training set:

• Not Applicable. This device is an ultrasound system. While it includes "software controlled" elements and features like "Speckle reduction algorithm" and "SonoMB/MBe Image Compounding," these are traditional image processing techniques inherent to ultrasound technology, not machine learning algorithms that would require a distinct "training set" in the modern AI sense.

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

• Not Applicable. See point 8.

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The Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.

Specific clinical applications and exam types include:

Abdominal
Dermatological
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Neonatal Cephalic
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicles, prostate)

The Vevo MD Imaging System is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire ad display high-resolution, real-time ultrasound data in 2D, Color Doppler, Power Doppler, PW Doppler and M-Mode. The Vevo MD Imaging System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

This document, K190476, details the 510(k) premarket notification for the FUJIFILM SonoSite Vevo MD Imaging System.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and performance metrics from device testing. The document states that the device was evaluated for safety and effectiveness against its predicate. The "acceptance criteria" for a 510(k) typically involve demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The study presented does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity thresholds) or report numerical device performance against such metrics. Instead, it relies on demonstrating equivalence through:

• Intended Use Alignment: Both the new device and the primary predicate (FUJIFILM SonoSite Vevo MD Imaging System K160674) share the same intended use.
• Technological Characteristics Comparison: The document provides a table comparing features, modes of operation, acoustic output, DICOM capabilities, and channels with the predicate devices. The new device and primary predicate are highly similar, particularly for "Track 3" devices.
• Compliance with Voluntary Standards: The device is designed to comply with several recognized standards related to biological evaluation, electrical safety, electromagnetic disturbances, ultrasonic medical diagnostic equipment, field characterization, software life cycle, and risk management. This compliance forms a key part of demonstrating safety.

Summary of "Acceptance Criteria" (Implicit) and Reported Performance:

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

The document explicitly states: "The Vevo MD Imaging System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means there was no clinical "test set" in the traditional sense of patient data used to evaluate performance metrics like sensitivity or specificity. The evaluation was primarily non-clinical, comparing technical specifications and adherence to standards against a predicate device. Therefore, no information on sample size or data provenance for a clinical test set is provided.

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

As no clinical study was conducted for performance evaluation in this 510(k) submission, there was no "ground truth" to be established by experts for a test set of patient data.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set for performance evaluation was used.

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 device is an imaging system, not an AI-based diagnostic aid that would involve human readers improving with AI assistance. Clinical studies were not performed for this submission.

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

Not applicable. This device is an imaging system, not a standalone algorithm. Clinical studies were not performed for this submission.

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

Not applicable, as no clinical study for performance evaluation was conducted where ground truth would be established. The "ground truth" for this submission revolves around the technical specifications and safety profile of the device aligning with regulated standards and the predicate device.

8. The sample size for the training set

Not applicable. As this 510(k) is for an ultrasound imaging system and not for an AI/ML-driven device or an algorithm requiring a training set, no information about a training set size is provided.

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

Not applicable, as there was no training set.

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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 SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.

This is an FDA 510(k) premarket notification for the FUJIFILM SonoSite, Inc. SonoSite SII Ultrasound System. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, expert qualifications, and comparison with human readers is not directly available in this type of regulatory submission for a standard ultrasound system. This document is a clearance for a medical device that does not appear to involve AI/ML components for diagnostic interpretation that would necessitate such detailed performance studies.

However, I can extract information relevant to the device's characteristics and how its substantial equivalence was determined based on what is provided:

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

The document doesn't present a table of specific acceptance criteria in numerical performance metrics typically seen with AI devices (e.g., sensitivity, specificity, AUC). Instead, substantial equivalence is claimed based on similar technological characteristics, intended uses, and compliance with recognized safety and performance standards to the predicate devices.

Here's a summary of the characteristics of the SonoSite SII Ultrasound System as reported in the submission, compared to its predicates (K162045 SonoSite SII Ultrasound System and K162045 SonoSite Edge II Ultrasound System):

Acceptance Criteria for Substantial Equivalence (General, inferred from 510(k) process):

• Identical Intended Use: The device must have the same intended use as a legally marketed predicate device.
• Similar Technological Characteristics: The device must have similar technological characteristics to the predicate, or if there are differences, these differences must not raise new questions of safety or effectiveness.
• Equivalent Safety and Effectiveness: The device must be as safe and effective as the predicate device. This is often demonstrated through adherence to recognized standards for electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output.
• Compliance with Standards: Conformance to relevant national and international medical device safety and performance standards (e.g., ISO, IEC, NEMA UD).

Reported Performance (Relevant to ultrasound system functionality, not AI-specific):

The performance of the device is assessed against the established standards and its predicate's performance. The submission states: "The SonoSite SII Ultrasound System and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards."
New "N" indications for specific transducers (found in Tables 1.3-1 to 1.3-14) for Pulsed Wave Doppler (PWD), and in some cases, Color Doppler modes show the scope of the device's capabilities are being expanded or specifically detailed for certain transducers.

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

The document explicitly states: "The SonoSite SII Ultrasound System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."
Therefore, there is no test set sample size or data provenance related to clinical performance metrics for this device as it is not an AI/ML device requiring such validation for regulatory clearance. The assessment is based on technical, safety, and performance characteristic comparison.

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

Not applicable, as no clinical study or test set with ground truth established by experts was conducted or required for this 510(k) submission.

4. Adjudication method for the test set:

Not applicable, as no clinical study or test set requiring adjudication was conducted or required for this 510(k) 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, as this device is a general-purpose ultrasound system and does not appear to incorporate AI assistance for diagnostic interpretation. Hence, no MRMC study or AI assistance effect size is mentioned.

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

Not applicable, as this is a medical imaging device as opposed to an AI algorithm.

7. The type of ground truth used:

Not applicable, as no clinical study requiring ground truth for clinical decision or diagnostic performance was conducted. The "ground truth" in this context refers to compliance with performance and safety standards, and equivalence to predicate devices, rather than diagnostic accuracy.

8. The sample size for the training set:

Not applicable, as this is a traditional ultrasound system and not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable, for the same reason as above.

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The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring 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 iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.

The provided document is a 510(k) premarket notification for the FUJIFILM SonoSite iViz Ultrasound System. The purpose of this document is to demonstrate that the iViz Ultrasound System is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, image quality scores) for the device's diagnostic capabilities. Instead, the "acceptance criteria" are implied through the comparisons to predicate devices and adherence to recognized standards.

The primary method to demonstrate acceptance is through substantial equivalence to existing, legally marketed predicate devices by showing comparable:

• Intended Use
• Indications for Use
• Technological Characteristics
• Safety and Effectiveness (via non-clinical testing)

Below is a table summarizing the general "acceptance criteria" (implicitly by comparison to predicates and standards) and the device's reported performance (by asserting compliance and equivalence).

Study Proving Acceptance Criteria:

The document states: "The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence."

Instead, the determination of substantial equivalence is based on non-clinical tests and a comparison of technological characteristics and intended uses with identified predicate devices.

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

No clinical test set was used, as no clinical studies were deemed necessary. The acceptance was based on non-clinical testing and comparison to predicates.

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

Not applicable, as no clinical test set requiring expert ground truth was utilized.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was utilized.

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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool for interpretation by human readers. The document makes no mention of AI assistance.

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

Not applicable. The device is a diagnostic ultrasound system, operated by a qualified physician or healthcare professional. It is not a standalone algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests (e.g., electrical, thermal, EMC, acoustic output), the "ground truth" would be the specifications and requirements defined by the referenced industry standards (e.g., IEC 60601 series, ISO 10993, NEMA UD 2-2004). The device's performance against these standards served as the "ground truth" for non-clinical acceptance.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe the development of an AI model or algorithm that would require a "training set."

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

Not applicable, as there was no mention of a training set for an AI model.

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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.

Ask a specific question about this device

The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care 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:

Fetal - OB
Abdominal
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral vessel

The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.

The provided document is a 510(k) premarket notification for the FUJIFILM SonoSite iViz Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through clinical trials with defined acceptance criteria and study designs.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the performance of an AI or algorithm. This notification is for an ultrasound imaging system, which produces images for human interpretation, not an AI-powered diagnostic device that would have specific performance metrics like sensitivity, specificity, or reader improvement.

Here's why the requested information cannot be extracted from this document:

• No AI/Algorithm: The document describes a general-purpose ultrasound system. There is no mention of any integrated AI, machine learning algorithm, or software that performs automated diagnoses or assists in interpretation beyond standard imaging functionalities (e.g., SonoHD3 Imaging for speckle reduction, which is a signal processing technique, not an AI for diagnosis).
• Substantial Equivalence: The core of a 510(k) submission is to show that the new device is "substantially equivalent" to a legally marketed device (predicate) in terms of intended use, technological characteristics, and safety/effectiveness. This typically involves non-clinical tests (electrical safety, EMC, biocompatibility, acoustic output, and adherence to standards) rather than clinical performance studies for diagnostic accuracy against predefined acceptance criteria for an AI.
• No Clinical Performance Data on "AI": The document explicitly states: "The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This further confirms that no clinical performance data (like sensitivity, specificity, or MRMC studies) related to an AI or algorithm's diagnostic performance was generated or presented in this submission.
• "Acceptance Criteria" for a PURE Imaging Device: For an ultrasound imaging system, acceptance criteria would revolve around image quality (resolution, contrast, penetration, etc.), safety (acoustic output, electrical safety), usability, and reliability, rather than diagnostic accuracy metrics of an AI. These are typically assessed through engineering tests and comparison to the predicate's performance specifications, not through studies with expert ground truth establishment for a test set of diagnoses.

In summary, as this document pertains to a general diagnostic ultrasound system and not an AI/ML-powered diagnostic device, the requested information (AI acceptance criteria, test set, experts, MRMC studies, etc.) is not applicable and therefore not present.

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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 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

SONOSITE EDGE II ULTRASOUND SYSTEM: The SonoSite Edge II Ultrasound System is a portable laptop style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge II is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge II can operate on either battery or AC power.

SONOSITE SII ULTRASOUND SYSTEM The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.

The provided text is a 510(k) Premarket Notification summary for the FUJIFILM SonoSite Edge II and SonoSite SII Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a novel AI/ML algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML algorithm. The document discusses:

• Indications for Use: The clinical applications for which the ultrasound systems are intended.
• Technological Characteristics: A comparison of the subject devices (SonoSite Edge II and SII) with their predicate devices (various SonoSite Edge and FC1 models), highlighting similarities in intended use, transducer types, frequency ranges, maximum acoustic outputs, modes of operation (e.g., B-mode, M-mode, Color Doppler), ECG features, DICOM compatibility, and various safety and electromagnetic compatibility standards.
• Non-Clinical Tests Summary: Mention of electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output evaluations, and conformity to applicable mandatory medical device safety standards.
• Clinical Tests Summary: Explicitly states that clinical studies were not required to support the determination of substantial equivalence.

Since this document describes an ultrasound system (a hardware device) and its transducers, and not an AI/ML algorithm, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, AUC) are not addressed. The "acceptance criteria" here are implicitly about demonstrating equivalence to existing, cleared ultrasound systems based on technological characteristics and non-clinical safety/performance data.

Specifically, the requested information cannot be extracted from the provided text because:

1. A table of acceptance criteria and the reported device performance: Not provided in the context of AI/ML performance. The tables list device features and intended uses, comparing them to predicates.
2. Sample size used for the test set and the data provenance: No test set or data provenance for AI/ML performance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no AI/ML performance ground truth is established.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or mentioned for AI/ML assistance.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a hardware ultrasound system.
7. The type of ground truth used: Not applicable for AI/ML. The provided information relates to the regulatory approval of a medical device (ultrasound system) based on substantial equivalence to predicates.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.

Specific clinical applications and exam types include:

Abdominal
Pediatric
Small Organ (breast, thyroid, testicles, prostrate)
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Peripheral vessel
Dermatological

The Vevo MD system is a high frequency general purpose, software controlled, diagnostic Imaging System used to acquire and display high-resolution, real-time ultrasound data in 2D, Color Doppler, and M-Mode. The Vevo MD System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

The provided text describes the FUJIFILM SonoSite Vevo MD Imaging System, an ultrasonic pulsed doppler imaging system, and the rationale for its substantial equivalence to predicate devices, rather than detailing a specific study to prove its performance against acceptance criteria for a new AI/CAD device.

The document states that "The Vevo MD Imaging System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This indicates that no specific performance study, as typically described for AI/CAD devices, was conducted or presented in this submission to demonstrate the device meets new acceptance criteria. Instead, the submission relies on the device's technological similarity and compliance with safety standards to established predicate devices.

Therefore, many of the requested categories regarding acceptance criteria and performance study specifics cannot be extracted directly from this document.

However, I can provide information based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no specific performance study against new acceptance criteria is presented, a direct table cannot be created. The document focuses on showing the device's intended use and technical specifications are similar to legally marketed predicate devices, implying that their established performance is the "acceptance criterion" for substantial equivalence.

The following points cannot be answered as the document explicitly states no clinical studies were required for this 510(k) submission to support the determination of substantial equivalence. The submission does not describe a performance study as typically seen for AI/CAD devices with new acceptance criteria.

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

• Not applicable as no performance study was conducted.

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

• Not applicable as no performance study was conducted.

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

• Not applicable as no performance study was conducted.

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 as this is not an AI/CAD product and no comparative effectiveness study was done.

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

• Not applicable as this is not an AI/CAD product and no standalone performance study was done.

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

• Not applicable as no performance study was conducted. The ground truth for proving substantial equivalence relies on the established safety and efficacy of the predicate devices and the new device's compliance with engineering and safety standards.

8. The sample size for the training set:

• Not applicable as no AI/CAD model is discussed, and thus no training set.

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

• Not applicable as no AI/CAD model is discussed, and thus no training set.

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