Search Results

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 the human body. Specific clinical applications and exam types include:

Abdominal Adult Cephalic Neonatal Cephalic Cardiac Adult Cardiac Pediatric 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 (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M, B+PWD, B+C, (B+C)+PWD, (B+C)+CWD.

This device is indicated for Prescription Use Only.

The Sonosite LX 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 system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.

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 text is a 510(k) summary for the FUJIFILM SonoSite LX Ultrasound System. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that no clinical studies were required to support the determination of substantial equivalence for this device. Therefore, the device's acceptance criteria and studies proving it meets those criteria based on clinical performance metrics (like sensitivity, specificity, or reader improvement) are not detailed in this document.

The "acceptance criteria" discussed in the document are primarily related to technical and safety standards compliance rather than clinical performance based on a study.

Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical study was conducted for performance claims, there is no direct table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance from such a study.

The provided document focuses on compliance with recognized medical device safety and performance standards. The "acceptance criteria" in this context are adherence to these standards, and the "reported device performance" is a statement of compliance.

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

This information is not available as no clinical studies were performed. The non-clinical tests involved evaluations against engineering standards and internal verification processes, not a dataset of patient cases.

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

This information is not available as no clinical studies were performed requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not available as no clinical studies were performed requiring an adjudication method for a 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

No MRMC comparative effectiveness study was done. The document explicitly states: "The Sonosite LX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This device is a general-purpose ultrasound system, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context.

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

No standalone algorithm performance study was done. This device is an ultrasound system, not a standalone algorithm, and no clinical studies were conducted for substantial equivalence.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not available as no clinical studies were performed requiring a type of ground truth. For the non-clinical tests, the "ground truth" was adherence to established engineering and safety standards.

8. The Sample Size for the Training Set

This information is not available as no clinical studies were performed. The device is an ultrasound system with software, but the document does not indicate it uses machine learning/AI models that would require a dedicated "training set" in the diagnostic performance sense. The software development follows IEC 62304 standards, which involve verification and validation but not necessarily clinical "training sets."

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

This information is not available as no training set (in the context of clinical performance for an algorithm) was discussed or used in the provided documentation for establishing substantial equivalence.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal. Musculoskeletal, Pediatric, Small Organ, and Peripheral Vessel. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging.

The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.

The Uscan is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode on an off-the-shelf display. Automated bladder volume measurements are supported.

Here's an analysis of the provided text to extract information about the acceptance criteria and the supporting study for the Uscan device.

Note: The provided FDA 510(k) summary focuses primarily on establishing substantial equivalence based on technological characteristics and adherence to recognized standards. It does not present a detailed clinical study demonstrating the device "meets acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard in a human population) against specific acceptance thresholds. Instead, it emphasizes bench testing for imaging performance and measurement accuracy, and conformance to regulatory standards.

Therefore, "acceptance criteria" here largely refer to the requirements for safe and effective operation based on engineering and regulatory standards, rather than clinical performance metrics. The "study" refers to the non-clinical testing performed.

Acceptance Criteria and Reported Device Performance

Study Details (Based on the provided text)

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

   • Test Set Sample Size: Not specified in terms of clinical cases or patient data. The document refers to "bench testing" of imaging and measurement accuracy. This implies a test set of physical phantoms, simulated data, or lab-based scenarios, not a human patient cohort.
   • Data Provenance: Not applicable for a clinical test set from human subjects since the testing described is non-clinical/bench testing.

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

   • Not applicable as the testing described is non-clinical bench testing, not a clinical study involving human expert interpretation. Ground truth for bench testing would be established by the physical properties of the phantoms or known parameters of the simulated data.

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

   • Not applicable, as this refers to a clinical study interpretation process, which is not detailed here.

4. 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:

   • No MRMC comparative effectiveness study is described in this document. The focus is on the device itself and its equivalence to predicate devices, not on human-AI augmented performance.

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

   • The "bench testing for imaging performance and measurement accuracy" represents a form of standalone testing, as it evaluates the device's technical capabilities (image quality, automated measurements like bladder volume) without human interpretation in a clinical setting mentioned. However, specific metrics (e.g., accuracy, precision) are not provided beyond stating substantial equivalence to predicate devices.

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

   • For the bench testing, the ground truth would likely be physical measurements from phantoms or known parameters of simulated datasets used to evaluate imaging performance and measurement accuracy. No clinical ground truth (like pathology or expert consensus on patient data) is mentioned for the testing described.

7. The sample size for the training set:

   • Not applicable. This document does not describe the development or training of any AI/ML components in the Uscan, but rather its regulatory clearance as a diagnostic ultrasound system. While automated bladder volume determination might imply some underlying algorithm, the training data and its size are not disclosed here.

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

   • Not applicable, as the training set details are not provided.

Summary of what the document implies about "meeting acceptance criteria":

The provided 510(k) summary primarily demonstrates that the Uscan device meets regulatory acceptance criteria by:

• Conforming to a comprehensive list of FDA-recognized international and national standards for medical electrical equipment, software, usability, risk management, biological evaluation, and acoustic output.
• Undergoing bench testing that showed its imaging performance and measurement accuracy to be "substantially equivalent" to predicate devices.
• Having verified risk mitigation and functioning as intended per verification and validation reports.

It does not provide details about specific clinical performance acceptance criteria (e.g., diagnostic accuracy thresholds like sensitivity/specificity for detecting certain conditions) or a clinical study demonstrating the device's ability to meet such criteria in a human population. The approval is based on substantial equivalence and compliance with engineering and safety standards.

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 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.

Ask a specific question about this device