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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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EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic,3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV): Intraoperative ( vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.

EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.

The provided FDA 510(k) summary for GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC's EchoPAC Software Only/EchoPAC Plug-in includes an "AI Summary of Testing" section for the Easy Auto EF and Easy AFI LV algorithms. This section provides information relevant to acceptance criteria and study details.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance figures, as they state the accuracy achieved.

Note: The document only provides Dice score for "accuracy." Other common performance metrics like sensitivity, specificity, or F1-score are not explicitly stated.

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

• Sample Size for Test Set:
  • 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: Europe, Asia, US (retrospective, as indicated by anonymization and collection for testing).

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

• Number of Experts: Two certified cardiologists initially, with a panel of experienced experts for adjudication.
• Qualifications of Experts:
  • Two certified cardiologists (for initial manual delineation and review).
  • A panel of experienced experts (for reviewing annotations that the two cardiologists could not agree on). Specific years of experience are not mentioned beyond "experienced."

4. Adjudication Method

The adjudication method used was a 2+1 process (consensus followed by expert panel review):

1. Consensus Reading: Two certified cardiologists performed manual delineation and then reviewed each other's annotations. They discussed disagreements to reach a consensus.
2. Expert Panel Review: If the two cardiologists could not agree on an annotation, a panel of experienced experts further reviewed those annotations to establish the final ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It focuses on the standalone performance of the AI algorithm. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. Standalone Performance Study

Yes, a standalone (i.e., algorithm-only without human-in-the-loop performance) study was done. The reported Dice scores directly evaluate the algorithm's accuracy in segmenting regions of interest, independent of human interaction during the measurement process.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus. It was derived from manual delineations by certified cardiologists, with a further review and consensus by an expert panel for disagreements.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only mentions that "datasets from different clinical sites for testing as compared to the clinical sites for training" were used.

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

The document does not explicitly state how the ground truth for the training set was established. It only describes the process for the test set's ground truth. However, it is generally assumed that similar expert-driven annotation processes would have been used for training data.

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Vivid S60N/Vivid S70N 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, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD or CWD, B/ Color/PWD or CWD, B/Power/PWD.

Vivid S60N / Vivid S70N 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 capability.

The Vivid S60N / Vivid S70N consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor 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. System can also be used with compatible ICE transducers.

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 USBadapter) connection.

The provided text focuses on the 510(k) premarket notification for the GE Vivid S60N/S70N ultrasound system. It details device descriptions, intended use, technological characteristics, and non-clinical tests. Crucially, it includes information on the "AI Summary of Testing: Easy Auto EF and Easy AFI LV," which addresses the performance of the AI algorithms incorporated into the device.

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

Acceptance Criteria and Study that Proves Device Meets Acceptance Criteria

The document states that the acceptance criterion for the AI algorithms (Easy Auto EF and Easy AFI LV) is an average dice score of 91% or higher across various testing conditions.

Study Proving Device Meets Acceptance Criteria:

The study involved testing the AI algorithms on datasets from different countries, scanning views, and left ventricle volumes.

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The text states "92% or higher" and "91% or higher" for the reported performance, implying the acceptance criterion was at least 91%.

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

• Sample Size: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization). 135 images extracted from the 45 exams.
• Data Provenance:
  • Country of Origin: Europe, Asia, US (mixed data from different countries).
  • Retrospective/Prospective: Not explicitly stated, but the description of "data collection protocol was standardized across all data collection sites" and "During testing of the AI algorithm, we have included images from different countries..." suggests a pre-existing collected dataset, making it likely retrospective.

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

• Number of Experts:
  • Initial Delineation and Review: 2 certified cardiologists.
  • Consensus Review: A panel of experienced experts.
• Qualifications of Experts:
  • "Certified cardiologists" (for initial delineation and review).
  • "Experienced experts" (for the consensus review panel). Specific number of years of experience is not provided, but "certified" and "experienced" imply relevant qualifications.

4. Adjudication Method for the Test Set:

• Method: A multi-stage adjudication process was used:
  1. Two certified cardiologists performed manual delineation.
  2. They then reviewed each other's annotations.
  3. A "consensus reading" was performed where the two cardiologists discussed agreement/disagreement.
  4. A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on.
• The final ground truth relied on annotations that the two cardiologists agreed upon, and the consensus annotations achieved by the expert panel.

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

• No MRMC comparative effectiveness study was done. The information provided focuses on the standalone performance of the AI algorithm (Easy Auto EF and Easy AFI LV) in terms of Dice score accuracy for image segmentation, not on reader performance with or without AI assistance.

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 was done. The reported "average dice score" is a metric for the algorithm's performance in automatically segmenting cardiac structures (Left Ventricle volume). The study describes the AI's accuracy in delineating these structures.

7. The Type of Ground Truth Used:

• Expert Consensus. The ground truth was established through manual delineation by certified cardiologists, followed by their mutual review, and a final consensus adjudicated by a panel of experienced experts.

8. The Sample Size for the Training Set:

• Not explicitly stated in the provided text. The document only mentions that "To ensure that the testing dataset is not mixed with the training data, we used datasets from different clinical sites for testing as compared to the clinical sites for training." This implies a training set existed and was distinct, but its size is not given.

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

• Not explicitly stated in the provided text. While the method for establishing ground truth for the test set is detailed, the process for the training set is not described. It is implied that ground truth was established, as AI models require labeled data for training, but the specific methodology is omitted.

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The Versana Premier is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Premier clinical applications include : Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, VascularPeripheral Vascular, Musculoskeletal Conventional, Musculosketal Superficial, Thoracic/Pleural, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular access). Modes of operation include : B. M. PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. Versana Premier is intended to be used in a hospital or medical clinic.

The Versana Premier is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers. The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector, dual and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial. Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating during scanning. The system has a HDMI port, VGA connection port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer box of the console and an option for external Printer USB Isolator for other printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the external Bluetooth USB adapter is connected to the system.

The provided text is a 510(k) Premarket Notification Submission for the GE Versana Premier ultrasound system. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that a new AI-powered diagnostic device meets specific performance acceptance criteria through a dedicated clinical study.

Therefore, the information required to populate the fields related to acceptance criteria, ground truth, sample size, expert adjudication, and comparative effectiveness studies is not present in this document. The document explicitly states: "The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence."

The only mention of an "Artificial Intelligence (AI) feature" is "Whizz Label," and no performance data or study details are provided for this feature. The document indicates that the Versana Premier employs "the same fundamental scientific technology as its predicate device and reference devices," and that it is "substantially equivalent ... with regard to intended use, imaging capabilities, technological characteristics, imaging modes, hardware, and safety effectiveness."

Here's what can be extracted from the document regarding the AI feature, acknowledging the absence of the requested study details:

• AI Feature Mentioned: Whizz Label is an Artificial Intelligence (AI) feature that is being added.

All other requested information cannot be found in the provided document:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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: Explicitly stated that clinical studies were not required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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