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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

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 FDA 510(k) K161119 document for the FUJIFILM SonoSite iViz Ultrasound System does not contain acceptance criteria or a study demonstrating the device meets such criteria in terms of diagnostic performance or clinical effectiveness.

Instead, this document focuses on establishing substantial equivalence to previously cleared predicate devices (K152983 and K133454) based on technological characteristics and adherence to recognized safety and performance standards for diagnostic ultrasound equipment.

Here's an analysis of the provided information concerning your questions:

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

• No diagnostic acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the Sonosite iViz Ultrasound System in this document. The tables (1.3-1, 1.3-2, 1.3-3) describe the Indications for Use for the system and its associated transducers, indicating which clinical applications (e.g., Fetal, Abdominal, Pediatric) are supported with different imaging modes (B-mode, M-mode, Color Doppler, etc.). The "P" in these tables signifies that these indications were Previously cleared by the FDA for the predicate devices, indicating that the new device supports the same established uses.

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

• No test set sample size or data provenance is mentioned. 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 means no new clinical data was generated or analyzed for this submission regarding diagnostic performance.

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. Since no clinical studies were performed for this submission, there were no experts establishing ground truth for a test set.

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

• Not applicable. No clinical test set.

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. No MRMC study was done, and this device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm.

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

• Not applicable. This is a hardware and software system for diagnostic ultrasound, not a standalone algorithm.

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

• Not applicable. No new ground truth was established for the purpose of this submission's substantial equivalence determination. The "ground truth" for accepting the device's indications for use implicitly relies on the established safety and efficacy of the predicate devices.

8. The sample size for the training set

• Not applicable. The document describes a medical device, an ultrasound system, not a machine learning model that would have a training set. The development process relies on engineering and medical device standards (e.g., IEC 60601 series, ISO 14971) rather than a "training set" of data in the AI sense.

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

• Not applicable. As above, no training set in the machine learning context is described.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "study" that proves this device meets "acceptance criteria" is essentially a documentation review demonstrating substantial equivalence to predicate devices and compliance with recognized safety and performance standards.

• Acceptance Criteria (implied): The device is substantially equivalent to existing cleared devices (K152983 and K133454) in terms of:
  • Intended Use and Indications for Use: The new device covers the same or a subset of indications as the predicates (Section 7 and Tables 1.3-1, 1.3-2, 1.3-3). The "P" in the tables indicates "previously cleared by FDA." New indications ("N") are also listed, showing some expansion.
  • Technological Characteristics: Similar fundamental scientific technology, imaging modes, transducer types, and operating frequencies. Differences are noted but deemed not to raise new questions of safety or efficacy (Section 6, Table comparing features).
  • Safety and Performance Standards: Compliance with a list of FDA-recognized safety standards for medical electrical equipment, biological evaluation, electromagnetic compatibility, usability, and acoustic output (Section 7, "Summary of Non-Clinical Tests" and table of standards).
• Study (Proof): The specific "study" mentioned is the "Summary of Non-Clinical Tests" which involved:
  • Evaluation for electrical, thermal, mechanical, and EMC safety.
  • Cleaning/disinfection, biocompatibility, and acoustic output evaluation.
  • Adherence to quality system elements like Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.
  • 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." This means it was not a clinical effectiveness study.

In conclusion, this FDA submission is for a traditional medical device (ultrasound system) seeking market clearance based on substantial equivalence, not an AI/ML device requiring performance evaluation against diagnostic ground truth. Therefore, many of your specific questions related to AI/ML validation are not applicable to this document.

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The FUJIFILM 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 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-vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
Peripheral Vessel

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.

This document is a 510(k) premarket notification for the FUJIFILM SonoSite Edge II Ultrasound System. It is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission is not a clinical study designed to test acceptance criteria for an AI/ML device in the way you've outlined.

Therefore, many of the specific questions about acceptance criteria for AI/ML performance, sample size for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to this document. This document focuses on demonstrating physical, technological, and intended use equivalence to existing ultrasound systems.

However, I can extract information relevant to similar underlying principles where applicable:

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, AUC) that one would typically see for an AI/ML device's diagnostic performance. Instead, the acceptance criteria are based on substantial equivalence to predicate devices in terms of:

• Intended Use: The device performs diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications.
• Technological Characteristics: The device utilizes similar transducer types, frequency ranges, modes of operation (B-mode, M-mode, Doppler, etc.), and patient contact materials as the predicate devices.
• Safety and Effectiveness: Demonstrated by compliance with recognized FDA standards for electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, and acoustic output. This is a qualitative acceptance criterion based on meeting established regulatory standards, not a quantitative performance metric.

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

This document is for a traditional diagnostic ultrasound system, not an AI/ML device. Therefore, there is no "test set" of patient data in the sense of an AI/ML algorithm's performance evaluation. The "testing" referred to is against engineering and safety standards.

The document explicitly states under "Summary of Clinical Tests": "The SonoSite Edge II Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." (Page 21). This means no patient data was used for a clinical performance evaluation in the context of this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. As no clinical studies were required, there was no ground truth for a test set to be established by experts.

4. Adjudication Method for the Test Set:

Not applicable, as no test set of clinical images requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The document states that clinical studies were not required. The comparison is between the technological characteristics and indications for use of the new device and its predicates, not an improvement in human reader performance.

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

Not applicable. This is a hardware and software system for diagnostic imaging, not an AI/ML algorithm that operates independently.

7. The Type of Ground Truth Used:

Not applicable in the context of diagnostic accuracy. The "ground truth" for this submission revolves around:

• Confirmation that the device functions as designed and meets technical specifications.
• Compliance with recognized industry and regulatory safety standards.
• Verification that the device's capabilities align with its stated intended uses and are substantially equivalent to its predicates.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML product developed with training data.

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

Not applicable.

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The FUJIFILM 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 Cardiac Adult Cardiac Pediatric

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.

This document is a 510(k) premarket notification for the FUJIFILM SonoSite iViz Ultrasound System, dated November 12, 2015. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against defined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, proven device performance through a study, expert involvement, and ground truth establishment is not present in this document.

Here's an analysis based on the provided text:

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

The document does not provide a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) or report quantitative device performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing intended use, technological characteristics, and conformance to recognized safety standards.

The closest to "acceptance criteria" are the standards it aims to comply with, listed in the "Summary of Non-Clinical Tests" section:

The "reported device performance" is implicitly stated as "the device has been found to conform to applicable mandatory medical device safety standards" and "Assurance of quality was established by employing the following elements of product development but were not limited to: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation."

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

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 means there was no test set of patient data used for clinical performance evaluation. The evaluation was based on non-clinical tests (electrical, thermal, mechanical, EMC safety, cleaning/disinfection, biocompatibility, acoustic output) and comparison to predicate devices.

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

Since no clinical study was conducted using a test set of patient data, there were no experts involved in establishing ground truth for a test set in this context.

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

Not applicable, as no clinical test set 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 ultrasound system, not an AI-powered image analysis tool that would typically be evaluated with MRMC studies for human reader improvement. The submission is for the base ultrasound system.

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

Not applicable. This device is a diagnostic ultrasound system intended for use by a "qualified physician and healthcare professionals," implying human operation and interpretation. It is not a standalone algorithm.

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

Not applicable. No clinical ground truth was established from patient data. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the referenced standards.

8. The sample size for the training set:

Not applicable. This document describes a medical device clearance process based on substantial equivalence, not the training of an AI algorithm. There is no mention of a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:
Not applicable, as no training set for an algorithm was mentioned or used for this submission.

In summary, the provided document is a 510(k) submission for an ultrasound system, demonstrating its safety and effectiveness through substantial equivalence to existing predicate devices and compliance with recognized industrial standards, rather than through clinical performance studies against specific acceptance criteria for diagnostic accuracy or through AI algorithm validation.

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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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The SonoSite Edge 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 and exam types include:

Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (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 Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel

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

The provided 510(k) summary for the SonoSite Edge Ultrasound System (K133454) states that clinical studies were not required to support the determination of substantial equivalence. The submission relies on non-clinical tests and a comparison of technological characteristics to predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not explicitly mentioned in the provided text as they would typically stem from a clinical study.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed for this 510(k) submission, there are no specific performance criteria or reported performance results in the context of a clinical evaluation. The document focuses on compliance with established safety standards and equivalence to predicate devices.

The "acceptance criteria" here are implicitly the existing standards and the characteristics of the predicate devices. The "reported device performance" is that it conforms to these standards and shares similar features, functionality, and performance parameters with its predicates.

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

Not applicable, as no clinical study was performed. The evaluation relied on non-clinical testing and comparison to predicate devices, which implies leveraging existing data and regulatory clearances from those predicate devices.

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

Not applicable, as no clinical study and associated ground truth establishment for a test set were conducted.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study was performed.

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 no clinical study, particularly an MRMC study, comparing AI assistance to human readers was performed. The device described is a general-purpose ultrasound system, not an AI-powered diagnostic tool.

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

Not applicable, as the device is a diagnostic ultrasound system, which inherently involves a human operator (qualified physician) for its intended use. It is not an AI algorithm operating autonomously.

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

Not applicable, as no clinical study was performed requiring the establishment of ground truth for diagnostic accuracy. For non-clinical aspects like safety and performance, the "ground truth" is adherence to recognized standards and engineering specifications.

8. The sample size for the training set:

Not applicable, as no clinical study was performed, and the device is not described as utilizing a machine learning algorithm that would require a training set of patient data.

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

Not applicable, as no clinical study was performed and no machine learning training set is mentioned for the device.

Ask a specific question about this device

The FUJIFILM SonoSite X-Porte 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 and exam types include:

Ophthalmic
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Pediatric
Small Organ (breast, thyroid, testicles, prostate)
Trans-vaginal
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Cardiac Adult
Cardiac Pediatric
Peripheral vessel

The SonoSite X-Porte Ultrasound System is a highly mobile, full featured, general purposic 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 readly 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 appears to be a 510(k) summary for a medical device (ultrasound system) and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document mainly focuses on establishing substantial equivalence to a predicate device based on technological characteristics and general safety standards.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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." This means no clinical performance studies were conducted or reported for this submission to demonstrate device performance against specific acceptance criteria. The approval was based on demonstrating equivalence to an existing marketed device through non-clinical tests (electrical safety, thermal, mechanical, EMC, biocompatibility, acoustic output, etc.) and shared technological characteristics.

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The SonoSite Maxx™ Series 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, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.

The SonoSite Maxx Series 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 a number of exam types and clinical applications. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging adaptations and system feature selections. Maxx Series can operate on either battery or AC power.

The provided document is a 510(k) summary for the FUJIFILM SonoSite Maxx™ Series Ultrasound System and its associated transducers. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing novel clinical studies to establish new acceptance criteria. Therefore, the document primarily lists the features and performance of the device and compares them to the predicate devices, rather than defining specific acceptance criteria for performance metrics and studies to prove they are met.

Based on the document, here's the information that can be extracted or inferred:

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

The document does not define specific quantitative "acceptance criteria" for the device's imaging performance (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence by demonstrating that the device's technological characteristics, intended use, and indications for use are comparable to legally marketed predicate devices and that it complies with relevant safety and performance standards.

The "reported device performance" is implicitly that it performs equivalently to the predicate devices for the listed applications and modes. The tables provided (Table 1.3-1 to 1.3-17) list the clinical applications and modes of operation for the main system and each transducer. "P" indicates that these indications and modes were "previously cleared" for the predicate devices, which implies the current device meets existing performance expectations for these.

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

The document explicitly states: "The SonoSite Maxx Series Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." This means there was no specific "test set" of patient data used for clinical performance validation as would be the case for a new or significantly modified device. The data provenance is therefore not applicable in the context of clinical performance testing.

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)

Since no clinical studies were performed, there was no "test set" or explicit "ground truth" establishment by experts for performance metrics.

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

Not applicable, as no clinical studies with test sets were performed.

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, and no MRMC studies are mentioned.

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

Not applicable. This is a medical imaging device, not an algorithm.

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

Not applicable, as no clinical studies with specific performance endpoints requiring ground truth were performed. The "ground truth" for this 510(k) submission relies on demonstrating substantial equivalence to predicate devices that have an established history of safety and effectiveness, meaning their performance was already accepted by regulatory bodies.

8. The sample size for the training set

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

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

Not applicable, as this is not an AI/ML device that requires a training set and ground truth for it.

In summary:

The submission for the SonoSite Maxx™ Series Ultrasound System is a 510(k) premarket notification. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. For such submissions, extensive new clinical performance studies are often not required if the device is sufficiently similar to existing ones.

In this case, the manufacturer has established substantial equivalence by:

• Comparing the Intended Use and Indications for Use of the new device and its transducers to those of predicate devices (K082098, K101757, K113156, K112953). The tables indicate that almost all applications and modes ("P" for previously cleared) are identical or highly similar to those cleared for the predicate devices.
• Detailing the Technological Characteristics (e.g., transducer types, frequency, modes of operation, system specifications) and showing they are equivalent to or improve upon predicate devices without introducing new safety or effectiveness concerns.
• Demonstrating compliance with a comprehensive list of national and international safety and performance standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, NEMA UD series for acoustic output). These standards define a baseline of acceptable performance and safety for such devices.
• Explicitly stating that clinical studies were not required, as the equivalence was demonstrated through non-clinical testing and comparison to predicates.

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