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

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

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

The SonoSite X-Porte Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal – OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Peripheral Vessel

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

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

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

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

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

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

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The SonoSite 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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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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