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GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

The provided document, K131514, is a 510(k) Premarket Notification for the GE Vivid E9 Diagnostic Ultrasound System. This document does not describe a study proving a device meets specific performance acceptance criteria for a new AI or advanced algorithm feature. Instead, it is a submission for a modified ultrasound system, primarily focusing on the addition of new transducers and two optional plug-in features (TomTec 4D MV Assessment and StereoVision) that were previously cleared.

The core of the submission revolves around demonstrating substantial equivalence to predicate devices. This means that GE Healthcare is asserting the modified Vivid E9 is as safe and effective as existing legally marketed devices, and does not raise new questions of safety and effectiveness. This is fundamentally different from a study proving a novel device or AI algorithm meets specific performance acceptance criteria.

The document explicitly states: "The subject of this premarket submission, Vivid E9, did not require clinical studies to support substantial equivalence." This indicates that no specific clinical performance study was conducted to establish acceptance criteria for a new feature demonstrating its performance.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document because it outlines a regulatory submission for device modifications based on substantial equivalence, rather than a clinical performance study for a new or significantly modified feature.

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GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal: Abdominal (including renal and GYN); Pediatric: Small Organ (breast, testes, thyroid); Neonatal Cephalic: Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

The GE Healthcare Vivid E9 Diagnostic Ultrasound System is a general-purpose ultrasound system specialized for cardiac imaging. The submission describes the device as substantially equivalent to previously cleared predicate devices (Vivid E9 K101149, Vivid i / Vivid q K102388, and 6Tc Transducer K081921).

Acceptance Criteria and Device Performance (Summary)

The documentation provided does not include specific quantitative analytical or clinical performance acceptance criteria for the device's diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to medical device safety standards. The "device performance" is implicitly considered to be equivalent to the predicate devices and compliant with the listed voluntary standards.

The table below summarizes the types of tests mentioned as being conducted to ensure device safety and effectiveness.

Study Information

1. Sample Size used for the test set and the data provenance:
   The submission explicitly states that "The subject of this premarket submission, Vivid E9, did not require clinical studies to support substantial equivalence." Therefore, there is no mention of a defined test set of patient data or its provenance for diagnostic performance evaluation, as clinical studies were not conducted for this submission. The product's compliance was primarily based on non-clinical tests and comparison to predicate devices.

2. 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 clinical studies involving test sets and ground truth from experts were not conducted for this premarket submission.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as clinical studies involving test sets were not conducted for this premarket submission.

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:
   Not applicable. This submission is for an ultrasound system, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This submission is for an ultrasound system and its software features, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as clinical studies requiring ground truth were not conducted. The "ground truth" for the non-clinical tests mentioned would be established by validated test methods and reference standards for the specific safety and performance metrics (e.g., accuracy of measurements against known physical standards, successful completion of software tests).

7. The sample size for the training set:
   Not applicable. The document does not describe a machine learning model requiring a training set. The device is an ultrasound system with enhanced software features, and its development followed a standard quality assurance process.

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

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

The GE Vivid E9 Diagnostic Ultrasound is a full-featured echocardiography imaging and analysis system with additional capability in vascular and general ultrasound imaging. It consists of a mobile console with multiple electronic array transducers that provide digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high-resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users.

The provided document is a 510(k) Premarket Notification for the GE Vivid E9 BT10 Ultrasound System. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not detail specific acceptance criteria or performance studies in the way a clinical trial report for an AI device might. Instead, it relies on established safety and effectiveness for diagnostic ultrasound systems and the equivalence to predicate devices.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance studies, ground truth establishment for training and test sets, and effect sizes of AI assistance are generally not applicable or not provided in this type of regulatory document for an ultrasound system.

However, I can extract the relevant information regarding safety and equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of explicit performance-based acceptance criteria for a new AI feature or image analysis algorithm, nor does it present detailed quantitative performance metrics for the device. The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device and adherence to general safety standards.

The reported device performance is primarily framed as improved performance and productivity compared to the predicate device, especially regarding new transducers and software features comparable to other cleared GE ultrasound systems.

Key statements on performance:

• "This modification offers improved performance and productivity for users." (Section a): Device Description)
• "The GE Vivid E9 BT10 is of a comparable type and substantially equivalent to the current GE Vivid E9 with enhanced performance and added transducers..." (Section a): Comparison with Predicate Device)

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

• Not applicable / Not provided. This 510(k) submission does not describe a clinical test set or data provenance for evaluating a new algorithm's performance. The review focuses on the device as a whole and its equivalence to predicate devices.

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

• Not applicable / Not provided. Ground truth establishment for a specific AI algorithm's performance is not part of this type of submission for a general diagnostic ultrasound system.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not applicable / Not provided. This document does not describe an MRMC study or AI assistance. The device is a diagnostic ultrasound system, not an AI-powered image analysis tool in the sense of comparing human readers with and without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable / Not provided. This relates to an AI algorithm's performance, which is not the focus of this submission.

7. The Type of Ground Truth Used:

• Not applicable / Not provided.

8. The Sample Size for the Training Set:

• Not applicable / Not provided.

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

• Not applicable / Not provided.

Summary of the Study that Proves the Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" demonstrating the device meets its "acceptance criteria" (which, in this context, means showing substantial equivalence for regulatory clearance) is summarized in Section b: Non-clinical Tests and Clinical Tests.

• Non-clinical Tests:

  • The device was evaluated for:
    • Acoustic output
    • Biocompatibility
    • Cleaning and disinfection effectiveness
    • Electromagnetic compatibility
    • Thermal, electrical, and mechanical safety
  • It was found to conform with applicable and harmonized medical device safety standards.

• Clinical Tests:

  • "None required." This indicates that for this type of device modification and the established predicate, new clinical trials to demonstrate safety and effectiveness were not deemed necessary by the manufacturer or the FDA (as per the clearance letter). The long history of safe and effective performance of diagnostic ultrasound, combined with the substantial equivalence argument, negated the need for new clinical data.

• Conclusion:

  • The manufacturer stated that intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination.
  • The design and development process conforms with 21 CFR 820, ISO 9001:2008, and ISO13485:2003 quality systems.
  • Compliance with applicable medical device safety standards is verified through 3rd party product certifications and regular production monitoring.
  • GE Healthcare's opinion is that the device is substantially equivalent in safety and effectiveness to devices already cleared for market.

The FDA's decision letter (starting on page 3 of the document) confirms that they reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, subject to general controls. This means the FDA agreed with GE Healthcare's assessment that the non-clinical tests and the comparison to predicate devices were sufficient to support clearance without a new clinical study.

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