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Vivid E80/Vivid E90/Vivid E95 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 and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal Guidance (including Biopsy, Vascular Access), ThoracicPleural and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Vivid™ E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capabilities.

The Vivid E80 / Vivid E90 / Vivid E95 consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and display monitor. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducers. System can also be used with compatible ICE transducer.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection. The system includes capability to output data to other devices like printing devices.

The device in question is the Vivid E80/Vivid E90/Vivid E95 ultrasound system, which includes Artificial Intelligence (AI) features named Easy Auto EF and Easy AFI LV.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Number of individual patients' images: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization).
• Number of samples (images): 135 images extracted from the 45 exams.
• Data Provenance: Retrospective, collected from different countries across Europe, Asia, and the US. The dataset included adult patients; specific age and gender were unknown due to anonymization.
• Clinical Subgroups and Confounders: The test dataset included images from different countries, different scanning views, and a range of different Left Ventricle (LV) volumes.
• Equipment and Protocols: Mixed data from 5 different probes and 4 different Console variants. Data collection protocol was standardized across all sites.

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

• Initial Ground Truthing: Two certified cardiologists.
• Adjudication/Consensus: A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on.
• Qualifications: "Certified cardiologists" for initial delineation and "experienced experts" for the panel. Specific experience levels (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set:

• Method: A 2+1 (or 2+panel) adjudication method was used.
  • First, two certified cardiologists performed manual delineation and reviewed each other's annotations.
  • A consensus reading was performed where the two cardiologists discussed disagreements.
  • If they could not agree, a panel of experienced experts reviewed the annotations to reach a final consensus.
• Ground Truth Definition: The ground truth used was the annotations that the initial two cardiologists agreed upon, and the consensus annotations achieved by the expert panel for disagreed cases.

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

• No MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned in the provided text. The evaluation focuses on the standalone performance of the AI algorithm.

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

• Yes, a standalone performance evaluation of the AI algorithm (Easy Auto EF and Easy AFI LV) was conducted. The accuracy was measured using the average Dice score based on the ground truth established by expert consensus.

7. The Type of Ground Truth Used:

• Expert Consensus: The ground truth for the test set was established through a multi-stage process involving manual delineation by two certified cardiologists, their peer review, and a final consensus by a panel of experienced experts.

8. The Sample Size for the Training Set:

• The document states that to ensure independence, "we used datasets from different clinical sites for testing as compared to the clinical sites for training." However, the specific sample size of the training set is not provided in the given text.

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

• The document implies that training data existed ("datasets from different clinical sites for training"), but it does not explicitly describe how the ground truth for the training set was established.

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Vivid E80 / Vivid E90 / Vivid E95 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 and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculoskeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Interventional Guidance (including Biopsy, Vascular Access), Intra-cardiac. Intra-luminal and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Vivid E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability. The Vivid E80 / Vivid E90 / Vivid E95 consists of a mobile console with a height-adjustable control panel, color LCD touch panel, OLED or LCD display monitor (alternatives) and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN adapter) connection.

This document describes the FDA's 510(k) clearance for the GE Medical Systems Ultrasound and Primary Care Diagnostics' Vivid E80/E90/E95 ultrasound system. It outlines the regulatory process and provides a summary of the device's characteristics and equivalence to predicate devices. However, it explicitly states that no clinical studies were required to support substantial equivalence for this premarket submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such a study was not described or conducted as part of this particular FDA submission for the Vivid E80/E90/E95 ultrasound system. The clearance was based on demonstrating substantial equivalence to already legally marketed predicate devices through non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety).

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Vivid E80 / Vivid E90 / Vivid E95 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 and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vasculo-sketal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Interventional Guidance (including Biopsy, Vascular Access), and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D Mode (4D), B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/ Power/PWD.

Vivid E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability. The Vivid E80 / Vivid E90 / Vivid E95 consists of a mobile console with a height-adjustable control panel, color LCD touch panel, OLED or LCD display monitor (alternatives) and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN adapter) connection.

This document is a 510(k) premarket notification for the GE Medical Systems Ultrasound and Primary Care Diagnostics Vivid E80/Vivid E90/Vivid E95 ultrasound systems. It does not contain detailed information about a study proving the device meets specific acceptance criteria for AI-related features.

The document states:

• "The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence."
• "Summary of Non-Clinical Tests: Vivid E80 / Vivid E90 / Vivid E95 were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards."

While new AI features are mentioned (AI Auto Measure - 2D, AI Auto Measure Spectrum Recognition, AFI 3.0, Auto EF 3.0, AFI RV, AFI LA, 4D Auto TVQ), the document primarily focuses on demonstrating substantial equivalence to predicate devices based on safety, technological characteristics, and intended use, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for these AI features.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, and adjudication methods for a study proving AI device performance is not available in the provided text.

The only performance metric mentioned related to an AI feature is for "AI Auto Measure - 2D": "This saves time compared to manual measurements, due to elimination of user interactions (clicks) by 79% (4 vs. 19)." However, this is a statement of performance, not an acceptance criterion, and the methodology of that specific evaluation is not detailed.

Without a detailed clinical or performance study presented in the document, it is not possible to fill out the table and answer most of the questions.

However, based on the limited information provided, I can infer the following about what kind of information would be relevant if such a study were present:

Hypothetical Example of Desired Information (Not Found in Document):

If a study were present for the AI Auto Measure - 2D feature, here's what the requested information might look like:

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

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

• Hypothetical: Test Set: 500 cardiac ultrasound studies (images/clips).
• Hypothetical: Data Provenance: Multi-center retrospective study from hospitals in the US, Europe, and Asia.

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

• Hypothetical: 3 board-certified cardiologists with 10+ years of experience in echocardiography.

4. Adjudication method for the test set:

• Hypothetical: 2+1 (two experts independently reviewed cases, and a third expert adjudicated disagreements).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Hypothetical: Yes, an MRMC study was performed comparing human performance with and without AI assistance for tasks involving cardiac structure measurements (e.g., LVEDD, LVESV, EF).
• Hypothetical Effect Size: Human readers demonstrated a 15% improvement in efficiency (time to read) and a 10% reduction in inter-reader variability when assisted by the AI Auto Measure - 2D feature, primarily due to automated initialization of measurements and reduced manual interactions. The diagnostic accuracy (e.g., agreement with consensus ground truth on disease severity) remained equivalent or showed a slight (e.g., 2%) non-significant improvement with AI assistance.

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

• Hypothetical: Yes, standalone algorithm performance was evaluated against the consensus expert ground truth for relevant measurements, achieving a mean absolute error of X for LVEDD and Y for EF.

7. The type of ground truth used:

• Hypothetical: Expert consensus measurements by highly experienced cardiologists on the ultrasound images/clips.

8. The sample size for the training set:

• Hypothetical: 10,000 cardiac ultrasound studies (images/clips) for AI Auto Measure - 2D.

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

• Hypothetical: Initial ground truth was established by automated scripts based on existing clinical reports and validated by a team of trained sonographers under the supervision of cardiologists. A subset of the training data (e.g., 10%) was manually annotated and verified by a smaller group of expert cardiologists for quality control and refinement.

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Vivid E80 / Vivid E90 / Vivid E95 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/Obstetrios; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultrasound systems primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / Vivid E90 / Vivid E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers. Vivid E80 will support 2D imaging, while Vivid E90 and Vivid E95 will support real time 3D imaging in addition to 2D, and incorporate several real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid 95 consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, an OLED or LCD color video display, DVI connector for optional external video display, and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

This document is a 510(k) Premarket Notification submission for the GE Vivid E80, Vivid E90, and Vivid E95 diagnostic ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and does not describe a study to establish new acceptance criteria or performance metrics for the core ultrasound imaging functionalities.

Instead, the submission highlights updates and new features compared to the predicate devices and confirms adherence to established safety and performance standards. Therefore, the device doesn't "meet acceptance criteria" in the sense of a novel clinical efficacy study, but rather demonstrates that changes and new features do not negatively impact safety or effectiveness, and that the device continues to conform to existing regulatory and voluntary standards.

Here's a breakdown of the information requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a submission for substantial equivalence based on updates to a previously cleared device (K173341) and new features, the "acceptance criteria" discussed are primarily compliance with general safety and performance standards and demonstrating that the new features do not compromise this. There are no specific numerical performance metrics for clinical efficacy presented for the overall device in this document, as the core diagnostic ultrasound functionality has been cleared previously.

The document lists compliance with several voluntary standards:

For the new features, the "acceptance criteria" are implied to be that they perform as intended and are substantially equivalent to existing functionalities or enhance workflow without impacting safety or effectiveness. The document asserts this by stating:

• CT Fusion: "substantially equivalent to the V Nav feature with Fusion on LOGIQ E9 (K082185)."
• 4D Marker: "an extension of existing image annotation capabilities on the predicate Vivid E90 / Vivid E95 (K173341)."
• 4D Auto LAO: "substantially equivalent to the 4D Auto RVQ already present on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)."
• AutoEF 2.0 & AFI 2.0: "workflow improvement of functionality already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)." and "expanded ... for pediatric use."
• Automatic View Recognition: "workflow improvement to AFI 2.0 and Auto EF 2.0 and provides an automated alternative to manual image selection already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)."
• "Whitelisting", "Texture", "Hybrid Filter", 24" LCD monitor, reduced weight: Explicitly state "no impact on the safety or effectiveness of the clinical functionality" or device.

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

The document does not detail specific sample sizes or data provenance for a test set in the context of a clinical study for performance evaluation. The submission relies on non-clinical tests and demonstrations of substantial equivalence for feature updates rather than a new clinical performance 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)

No information provided. Clinical studies with expert ground truth establishment are not described for this submission.

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

No information provided, as clinical studies with adjudication methods are not described.

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 is mentioned in this document. The "Automatic View Recognition" feature uses a deep neural network, but its performance is described as an "automated alternative to manual image selection" and a "workflow improvement" to existing functionalities, rather than a comparative effectiveness study showing human reader improvement with AI assistance.

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

The document mentions "Automatic View Recognition" which is "new functionality based on deep neural network embedded into the software." While this suggests a standalone algorithm, no standalone performance metrics (e.g., sensitivity, specificity) are provided for this feature. Its role is described as a "workflow improvement" and "automated alternative" to manual processes.

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

For the new AI/software features, the "ground truth" seems to be implicitly the functionality of the predicate device or a clinical outcome (e.g., left atrium volumes as measured by the device for "4D Auto LAO"). However, the explicit method of establishing this ground truth (e.g., expert consensus on specific cases for validation) is not detailed in this summary.

8. The sample size for the training set

The document states that "Automatic View Recognition" is "new functionality based on deep neural network." However, it does not provide any information regarding the sample size of the training set used for this deep neural network.

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

The document does not provide any information regarding how the ground truth for the training set was established for the deep neural network used in "Automatic View Recognition."

Ask a specific question about this device

Vivid E80 / Vivid E90 / Vivid E95 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/Obstetrios; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultrasound systems primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / Vivid E90 / Vivid E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers. Vivid E80 will support 2D imaging, while Vivid E90 and Vivid E95 will support real time 3D imaging in addition to 2D, and incorporate several real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid 95 consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, OLED color video display, DVI connector for optional external 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 is a 510(k) Premarket Notification Submission for the GE Vivid E80, Vivid E90, and Vivid E95 diagnostic ultrasound systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results and acceptance criteria in the manner one might find in a full clinical trial report for novel technologies.

Based on the provided text, the device itself is a diagnostic ultrasound system (Vivid E80, Vivid E90, Vivid E95) and the acceptance criteria and study information are presented in the context of demonstrating substantial equivalence to a predicate device (Vivid E80, Vivid E90, Vivid E95 (K170823)).

Here's the breakdown of the requested information based on the provided document:

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

The document does not provide a specific table of quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding reported performance values from a dedicated clinical study for the entire device. Instead, it states that the device complies with voluntary standards for safety and performance (summarized below). The "performance" reported is primarily in terms of equivalency to the predicate device and the added capabilities.

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

The document explicitly states: "The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence." This means no clinical "test set" in the traditional sense of patient data was used for this 510(k) submission. The evaluation was based on non-clinical tests (bench testing, engineering verification).

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)

Since no clinical studies were required, there were no "experts" establishing ground truth in the context of a clinical test set. The substantial equivalence argument relies on the established safety and effectiveness of the predicate device and the demonstration that the modified device (including new transducers and GPU option) does not raise new questions of safety or effectiveness.

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

Not applicable, as no clinical test set requiring ground truth adjudication 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 (hardware and software), not an AI-assisted diagnostic tool in the sense of providing interpretations that would be evaluated in an MRMC study for reader improvement.

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

Not applicable. As above, this is a diagnostic ultrasound imaging system, not a standalone algorithm.

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

Not applicable, as no clinical studies were required and the submission relies on non-clinical testing and substantial equivalence to a predicate device. The "ground truth" here is compliance with recognized safety and performance standards for ultrasound equipment.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that undergoes training on a dataset. The device is a diagnostic ultrasound system.

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

Not applicable, as this is not an AI/ML device that undergoes training on a dataset.

Ask a specific question about this device

Vivid E80 / Vivid E90 / Vivid E95 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/Obstetrios; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultrasound systems primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / Vivid E90 / Vivid E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers. Vivid E80 will support 2D imaging, while Vivid E90 and Vivid E95 will support real time 3D imaging in addition to 2D, and incorporate several real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid 95 consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, OLED color video display, DVI connector for optional external 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 text describes a 510(k) premarket notification for the GE Vivid E80, E90, and E95 ultrasound systems. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness. Therefore, the document explicitly states that "The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence."

Because no new clinical study was required or performed for this specific submission, detailed information regarding acceptance criteria, device performance from such a study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available within this document. The device's acceptance is based on its similarity to existing, cleared devices and its compliance with non-clinical performance and safety standards.

Here's a breakdown of the information that is available based on your request, understanding that a new clinical study to "prove acceptance" was not conducted:

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

Since no new clinical study was presented for this submission, there are no specific performance metrics to report from such a study that demonstrate the device meets acceptance criteria. The acceptance is based on:

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

Not applicable, as no new clinical study was conducted for this 510(k) submission. Acceptance is based on non-clinical testing 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 (e.g. radiologist with 10 years of experience)

Not applicable, as no new clinical study was conducted.

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

Not applicable, as no new clinical study was conducted.

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 no new clinical study was conducted for this 510(k) submission. The document mentions new features like "Myocardial Work" (builds on existing functionality), "4D Auto RVQ" and "4D Auto MVQ" (alternative implementations of existing functionality), "Cardiac AutoDoppler", "FlexiViews", and "QuickApps" (workflow improvements). "Blood Speckle Imaging" (BSI) is a new tool described as displaying graphical presentations of blood flow trajectories, but its performance is not assessed in a comparative effectiveness study within this document.

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

Not applicable, as no new clinical study was conducted. The document broadly covers "Diagnostic Ultrasound System" and its various transducers; it is not a submission for a standalone algorithm.

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

Not applicable, as no new clinical study was conducted.

8. The sample size for the training set

Not applicable, as no new clinical study or AI algorithm training data details are provided in this regulatory submission.

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

Not applicable, as no new clinical study or AI algorithm training data details are provided in this regulatory submission.

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