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The Vivid iq is high-performance compact diagnostic ultrasound system designed for cardiovascular and shared services. It is intended for use by Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.

The proposed Vivid ig system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, color LCD Touch Panel that includes an on-screen alfa-numeric keyboard. The system also has an optional height-adjustable cart for comfortable standing and sitting positions. An extended battery is integrated within the Vivid ig cart and provides additional power for longer scanning time.

There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes 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 can also be used with compatible ICE transducers.

The system includes electronics for transmit and receive of 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.

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes the performance of the AI algorithms, "Easy Auto EF" and "Easy AFI LV," which are components of the Vivid iq system. The primary acceptance criterion appears to be the accuracy of the AI algorithm in terms of its Dice score.

Note: The document only provides performance metrics for the AI algorithms specifically, not for the entire Vivid iq system's overall clinical performance beyond safety and equivalence to predicates for its general ultrasound functions.

Study Details for AI Algorithms (Easy Auto EF and Easy AFI LV)

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

• Number of images: 135 images.
• Number of exams: 45 exams.
• Assumed number of patients: 45 patients (exact number unknown due to anonymization).
• Provenance: Retrospective data collected from different countries, including Europe, Asia, and the US. The document states that the testing dataset came from different clinical sites than the training data to ensure independence.

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

• Initial Experts: Two certified cardiologists.
• Adjudication Panel: An unspecified "panel of experienced experts" for cases where the initial two cardiologists did not agree. Specific qualifications for the panel are not provided beyond "experienced experts."

4. Adjudication method for the test set:

• Primary Method: Consensus reading between two certified cardiologists. They performed manual delineation and then reviewed each other's annotations. They discussed and agreed upon annotations.
• Secondary Method: For annotations where the two cardiologists could not agree, a "panel of experienced experts" further reviewed and established a consensus ground truth. This suggests a 2+1 (or 2+N) approach for disagreements.

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 involving human readers with and without AI assistance is described in the provided text. The evaluation focuses solely on the standalone performance of the AI algorithm against expert-established ground truth.

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 conducted. The reported Dice scores (91-92% or higher) reflect the algorithm's accuracy in autonomously delineating structures.

7. The type of ground truth used:

• Expert consensus was used as the ground truth. This was derived from manual delineations by two certified cardiologists, with a panel of experienced experts resolving disagreements.

8. The sample size for the training set:

• The sample size for the training set is not specified in the provided document. It only mentions that datasets from different clinical sites were used for training compared to the test set.

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

• The document does not explicitly describe how the ground truth for the training set was established. However, given the description for the test set, it is highly probable that a similar expert-driven delineation and consensus process was used.

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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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