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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 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.

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

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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