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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 SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

Ophthalmic
Fetal - OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Peripheral Vessel

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4. Adjudication method for the test set:

Not applicable, as no clinical study or test set requiring adjudication was conducted or required for this 510(k) submission.

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

Not applicable, as this device is a general-purpose ultrasound system and does not appear to incorporate AI assistance for diagnostic interpretation. Hence, no MRMC study or AI assistance effect size is mentioned.

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

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

7. The type of ground truth used:

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

8. The sample size for the training set:

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

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

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

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

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

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

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

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

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

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

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

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

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The 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 thuid 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 Peripheral Vessel

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

This document is a 510(k) premarket notification for the SonoSite SII Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared predicate devices, not to present a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity for a particular medical condition.

Therefore, many of the requested elements for describing acceptance criteria and a study proving their fulfillment are not applicable or cannot be extracted from this type of regulatory submission. The document focuses on demonstrating safety and technological equivalence, not clinical performance for a diagnostic task.

Here's a breakdown based on the provided document:

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

• Not Applicable in the traditional sense. This document does not present clinical performance acceptance criteria (e.g., specific sensitivity or specificity thresholds) because it is a 510(k) submission for an ultrasound system, not a device interpreting ultrasound images to make a diagnosis. The "performance" discussed relates to technical specifications and compliance with safety standards rather than diagnostic accuracy.
• The closest "acceptance criteria" are compliance with various safety and performance standards (e.g., ISO, IEC, NEMA) and demonstrating similar technological characteristics and intended uses to predicate devices. The "reported device performance" is the conclusion that the device conforms to these standards and is technologically equivalent.

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

• Not Applicable. The document explicitly states: "The SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." Therefore, there is no clinical test set, sample size, or data provenance from such a study.

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. As no clinical studies were performed, there was no test set requiring expert-established ground truth.

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. This device is an ultrasound system itself, not an AI or CAD (Computer-Aided Detection/Diagnosis) software designed to assist human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

• Not Applicable. This is an ultrasound imaging device, not an algorithm for standalone diagnostic performance.

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

• Not Applicable. No clinical ground truth was established as no clinical studies were conducted to assess diagnostic accuracy. The "ground truth" for this submission concerns compliance with engineering standards and performance specifications, demonstrated through non-clinical testing.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that would require a training set for an algorithm.

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

• Not Applicable. No training set for an algorithm.

Summary from the document regarding acceptance criteria and study:

The acceptance criteria for the SonoSite SII Ultrasound System, as described in this 510(k) submission, are primarily focused on safety, technological equivalence to predicate devices, and compliance with recognized industry standards.

The "study" or justification for meeting these criteria involved:

• Non-Clinical Tests: Evaluation of electrical, thermal, mechanical, and EMC safety. Cleaning/disinfection, biocompatibility, and acoustic output were also evaluated.
• Compliance with Standards: The device was designed to comply with a list of FDA-recognized standards, including:
  • ISO 10993-1 (Biological evaluation of medical devices)
  • IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
  • IEC 60601-1-2 (Electromagnetic compatibility)
  • IEC 60601-1-6 (Usability)
  • IEC 60601-2-37 (Particular requirements for ultrasonic medical diagnostic and monitoring equipment)
  • IEC 62304 (Medical device software - Software life cycle processes)
  • IEC 62359 (Ultrasonics - Field characterization - Test methods)
  • ISO 14971 (Application of risk management to medical devices)
  • NEMA UD 2-2004 (Acoustic Output Measurement Standard)
• Quality Assurance Processes: Assurance of quality was established through Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.
• Substantial Equivalence Argument: The document argues that the SII system shares the same intended uses and fundamental scientific technology as the predicate devices (SonoSite Edge II and SonoSite S Series Ultrasound Systems), with a detailed comparison table showing technological characteristics.

The report explicitly states, "The SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means that the regulatory pathway for this device did not necessitate clinical performance data demonstrating diagnostic accuracy against a ground truth.

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