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Vivid Pioneer 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 or sonographer for ultrasound imaging, measurement, display and analysis of the human body and fluid.

Vivid Pioneer 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, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Intra-cardiac, Intra-luminal and Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural 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.

The proposed Vivid Pioneer is a general purpose, Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It provides digital acquisition, processing, display and analysis capabilities. It consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and a display monitor.

Vivid Pioneer 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 proposed Vivid Pioneer can be used with the stated compatible OEM ICE transducers. The system includes capability to output data to other devices like printing devices.

The user-interface includes an operator control panel, a 23.8" High-Definition Ultrasound LCD type of display monitor (mounted on an arm for rotation and / or adjustment of height), a layout of pre-defined user controls (hard-keys) and a 15.6-inch multi-touch LCD panel with mode-and operation dependent soft-keys.

The operator panel also includes two loudspeakers for audio, shelves for convenient placement of papers or accessories, and 6 holders with cable management for the connected transducers.

The lower console is mounted on 4 rotational wheels with brakes, for ergonomic transport and safe parking. The lower console also includes all 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 USB-adapter) connection.

This document describes the acceptance criteria and study proving the device meets the criteria for two AI features of the Vivid Pioneer Ultrasound System: AI Cardiac Auto Doppler and AI FlexiViews LAA.

1. Table of Acceptance Criteria and Reported Device Performance

AI Cardiac Auto Doppler

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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, testes, 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), and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, 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 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 USB-adapter) connection.

The provided document is a 510(k) Premarket Notification Submission for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid S60N / Vivid S70N diagnostic ultrasound systems. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study that would define acceptance criteria and prove its fulfillment.

Therefore, the requested information elements related to detailed study design, acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document.

The document explicitly states: "The subject of this premarket submission, Vivid S60N and Vivid S70N, did not require clinical studies to support substantial equivalence."

This indicates that clinical studies, which would typically involve the kind of detailed performance metrics, acceptance criteria, and study methodology you're asking about, were not conducted or submitted for this particular premarket notification. The submission relies instead on demonstrating equivalence to legally marketed predicate devices based on technological characteristics and non-clinical testing.

Therefore, I cannot provide a table of acceptance criteria or a study that proves the device meets those criteria based on the provided text.

Here's what information I can extract regarding the device and the nature of the submission:

• Device Name: Vivid S60N / Vivid S70N Diagnostic Ultrasound System
• Regulation Number: 21 CFR 892.1550 (Ultrasonic pulsed doppler imaging system)
• Regulation Name: Ultrasonic pulsed doppler imaging system
• Regulatory Class: Class II

Elements that cannot be provided from this document:

1. Table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical study was conducted.
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 was conducted.
4. Adjudication method for the test set: Not applicable as no 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 present. This device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no standalone algorithm performance study was mentioned.
7. The type of ground truth used: Not applicable as no clinical study was conducted.
8. The sample size for the training set: Not applicable as no clinical study data for training was mentioned.
9. How the ground truth for the training set was established: Not applicable as no clinical study data for training was mentioned.

This 510(k) submission primarily addresses the substantial equivalence of the Vivid S60N / Vivid S70N to its predicate and reference devices by outlining:

• Its intended use and indications for use.
• Its technological characteristics.
• Non-clinical testing for safety and performance (acoustic output, biocompatibility, cleaning, electrical, electromagnetic, mechanical safety, and compliance with various standards like IEC 60601 series, ISO 10993-1, ISO 14971, NEMA PS 3.1-3.20 DICOM).
• Quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing).

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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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The Vivid T9 / Vivid T8 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculosketal Superficial/Conventional, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.

The Vivid T9 / Vivid T8 is a high performance digital ultrasound imaging system with total data management. The system provides image generation in 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectral, Tissue Velocity imaging, advanced Strain and Contrast applications. The fully digital architecture of the Vivid T9 / Vivid T8 unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.

The document is a 510(k) Premarket Notification Submission for the GE Vivid T8 and Vivid T9 ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through new clinical studies.

Based on the provided text, there are no specific acceptance criteria or a study detailed that directly proves the device meets such criteria in terms of diagnostic accuracy or effectiveness. Instead, the submission focuses on comparing the new device to predicate devices to establish substantial equivalence.

Here's a breakdown of the information that can be extracted, particularly in relation to the questions asked, even if direct answers for "acceptance criteria" and "study proving it" are not present:

1. Table of Acceptance Criteria and Reported Device Performance:
   Not applicable in the direct sense of a new study with explicit performance metrics against acceptance criteria. The document claims "performance is substantially equivalent to the predicate device(s)" based on similar technology, intended use, imaging capabilities, and safety/effectiveness. The performance comparison is implicitly tied to the cleared performance of the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document states: "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." Therefore, no test set sample size, data provenance, or study type (retrospective/prospective) is provided for 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):
   Since no new clinical studies were conducted to establish performance against ground truth, this information is not available in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no new clinical performance 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. This is a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no new clinical performance study was required. The "ground truth" for substantial equivalence is based on the previously established safety and effectiveness of the predicate devices.

8. The sample size for the training set:
   Not applicable for a clinical training set, as no new clinical studies were conducted. The device's "training" refers to its design and evaluation based on engineering principles and comparison to existing, cleared technologies.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of what the document focuses on instead:

The submission relies on demonstrating Substantial Equivalence to legally marketed predicate devices, primarily the Vivid T8 (K160078), Vivid E95 (K170823), Vivid iq (K161706), and Vscan Extend (K180995), along with other LOGIQ systems for specific transducer applications.

The key points for establishing substantial equivalence are:

• Intended Use: The Vivid T9 / Vivid T8 shares the same intended use as predicate devices: ultrasound imaging, measurement, and analysis of the human body for multiple clinical applications (Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult/Neonatal Cephalic, Musculoskeletal Superficial/Conventional, Transcranial, Transrectal, Transvaginal, Transesophageal, Intraoperative, and Tissue Biopsy).
• Technological Characteristics: The device employs the same fundamental scientific technology as its predicate devices.
• Imaging Modes: Identical imaging modes to the predicate Vivid T8 (K160078).
• Transducers: Similar transducers, with new additions (C1-5-RS and E8Cs-RS for Vivid T9) and expanded applications for existing transducers (e.g., Intraoperative for L8-18i-RS, and various clinical applications for 4C-RS, 8C-RS, 3Sc-RS, 6S-RS, 12S-RS, 9T-RS, L8-18i-RS, C1-5-RS, E8Cs-RS) that were cleared on other predicate systems.
• New Features: New features like Virtual convex, QuickApps, Cardiac AutoDoppler, Virtual Apex, Strain and Strain Rate, and Pediatric Z-score (expanded data) were cleared in predicate Vivid E95 (K170823). Tricefy Uplink was cleared with predicate Vscan Extend (K180995). Improvements were made to AFI and Auto EF, which were cleared on predicate Vivid T8 (K160078).
• Safety and Performance: The systems are manufactured with safe materials, have acoustic power levels below FDA limits, and comply with approved electrical and physical safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM). Quality assurance measures (Risk Analysis, Requirements/Design Reviews, various levels of testing) are applied.

Conclusion: The document explicitly states that the device "did not require clinical studies to support substantial equivalence." This means that the acceptance criteria are largely met by demonstrating that the device is as safe and effective as existing, legally marketed ultrasound systems, based on an engineering and feature-by-feature comparison rather than a new clinical trial with specific performance metrics.

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