Search Results

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 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.

Ask a specific question about this device

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

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

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

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

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

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

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. The Type of Ground Truth Used:

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

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

8. The Sample Size for the Training Set:

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

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

Not applicable.

Ask a specific question about this device