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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 device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatic; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers. which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.

This is a 510(k) premarket notification for the GE Healthcare Voluson E6, Voluson E8, and Voluson E10 ultrasound systems. The document states that clinical studies were not required to support substantial equivalence. Therefore, there is no information about specific acceptance criteria related to a study proving device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC comparative effectiveness studies.

The document focuses on demonstrating substantial equivalence to predicate devices (K162269 Voluson E6_E8_E10 Diagnostic Ultrasound System and K150087 Vivid E80/E90/E95 Diagnostic Ultrasound System) through technological characteristics, intended use, imaging capabilities, safety, and compliance with recognized standards.

Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies were performed, there are no specific performance metrics reported for the device against acceptance criteria in the traditional sense of a clinical trial. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards.

Specific Information Regarding Studies:

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

   • No clinical test set was used, as clinical studies were not required for this 510(k) submission. Non-clinical tests were performed to ensure compliance with standards.

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 no clinical test set requiring expert ground truth was utilized.

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

   • Not applicable due to the absence of a clinical test set.

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:

   • No MRMC comparative effectiveness study was conducted or reported. The submission focuses on substantial equivalence of the ultrasound system itself, not on specific AI assistance features that would require such a study for performance evaluation. While new software features like "IOTA Simple Rules," "Fetal Heart Analysis," and "SonoMetrium" are mentioned, their specific performance metrics requiring MRMC studies are not detailed or were not deemed necessary for this 510(k) due to claimed substantial equivalence.

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

   • Not applicable, as the device is a diagnostic ultrasound system, not a standalone algorithm. The mentioned software features are integrated into the system.

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

   • Not applicable, as no clinical studies with ground truth were conducted. Compliance with safety and performance standards was demonstrated through non-clinical testing.

7. The sample size for the training set:

   • Not applicable, as no clinical studies were conducted, and therefore no training set was explicitly mentioned. The development of software features would involve internal datasets, but details are not provided in this regulatory document.

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

   • Not applicable, for the reasons stated above.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).

The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 520 mm wide (keyboard), 865 mm deep and 1760 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.1-inch LCD touch screen and color widescreen monitor.

The provided text describes a 510(k) premarket notification for the GE LOGIQ S8 ultrasound system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel claims or establishing new acceptance criteria through extensive clinical studies.

Therefore, the document does not provide specific acceptance criteria in terms of analytical or clinical performance metrics (e.g., sensitivity, specificity, accuracy for a particular disease or measurement), nor does it detail a study performed to prove such metrics against acceptance criteria. Instead, it demonstrates substantial equivalence based on technological characteristics, intended use, and compliance with recognized safety and performance standards.

Here's an breakdown of the information that can be extracted based on your request, as well as indications of what is not present in this type of regulatory filing:

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

This information is not provided in the document as it is a 510(k) summary for showing substantial equivalence, not a clinical trial report establishing new performance criteria. The "performance" described relates primarily to equivalence with predicate devices and compliance with general safety and performance standards.

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

This information is not provided. The document explicitly states: "The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence." The testing mentioned is for acoustic output, biocompatibility, cleaning/disinfection, and safety standards.

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)

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission.

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

This information is not provided. The device is an ultrasound imaging system, and there's no mention of AI assistance or MRMC studies in this document.

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

This information is not provided. The device is a diagnostic ultrasound imaging system, not an AI algorithm for standalone interpretation.

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

This information is not provided as no clinical studies are reported to have been conducted for this submission. The "ground truth" for the device's claims are the safety and performance characteristics of its predicate devices and compliance with recognized standards.

8. The sample size for the training set

This information is not provided as no machine learning or AI training is mentioned as being part of this submission's substantial equivalence argument.

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

This information is not provided as no machine learning or AI training is mentioned.

Summary of what the document does provide regarding device performance and compliance:

The document focuses on demonstrating that the GE LOGIQ S8 is substantially equivalent to legally marketed predicate devices. This is achieved by:

• Intended Use Equivalence: Stating that the LOGIQ S8 has the same clinical intended use as the predicate LOGIQ S8 (K152195).
• Technological Equivalence: Declaring that it employs the same fundamental scientific technology as its predicate device(s).
• Imaging Modes: Noting that it has the same imaging modes as the predicate LOGIQ S8, with additions of Fibroscan elastography and CAP (Controlled Attenuation Parameter), which are equivalent to features found on the reference predicate FibroScan (K160524).
• Safety and Standards Compliance:
  • Manufactured with materials evaluated and found safe.
  • Acoustic power levels are below applicable FDA limits.
  • Designed in compliance with approved electrical and physical safety standards.
  • Compliance with voluntary standards:
    • AAMI/ANSI ES60601-1 (Medical Electrical Equipment - General Requirements for Safety)
    • IEC60601-1-2 (Electromagnetic Compatibility)
    • IEC60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring Equipment Safety)
    • ISO10993-1 (Biological Evaluation of Medical Devices)
    • ISO14971 (Application of risk management to medical devices)
    • NEMA UD 2 (Acoustic Output Measurement Standard)
    • NEMA UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
    • NEMA, Digital Imaging and Communications in Medicine (DICOM) Set.
  • Quality assurance measures applied to development (Risk analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final Acceptance Testing, Performance testing, Safety testing).
  • Transducer and patient contact materials are biocompatible.

The document lists various transducers cleared with the system and for which clinical applications and modes of operation they are "previously cleared" (P), "new" (N), or "added under Appendix E" (E), primarily based on equivalence to other GE Ultrasound systems (e.g., LOGIQ E9, VIVID E90/E95).

In conclusion, for this specific 510(k) submission, the "acceptance criteria" are compliance with established medical device safety and performance standards and demonstration of substantial equivalence to predicate devices, rather than predefined performance thresholds from new clinical trials.

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