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The Vivid ig is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid.

Vivid in clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy, Vascular access), 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/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 alphanumeric keyboard. The system also has standard height-adjustable new ergonomic mobile cart for comfortable standing and sitting positions. The Charge Box in the Mobile Cart provides Vivid iq up to 4 hours scanning time without power supply.

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 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 text is a 510(k) Summary for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid iq. It details the device's characteristics and its comparison to predicate devices, but it explicitly states that no clinical studies were required to support substantial equivalence for this particular submission. Therefore, it is not possible to provide acceptance criteria or a study that proves the device meets those criteria, as such studies were not conducted or submitted for this 510(k).

The document is primarily focused on demonstrating substantial equivalence to a predicate device (Vivid iq K221148) through design similarities, conformance to recognized performance standards, and non-clinical performance testing.

Here's what can be extracted based on the provided text, while acknowledging the absence of clinical study data for this submission:

Summary of Non-Clinical Tests (from the document):

The document does list the non-clinical tests conducted and the standards to which the device conforms:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic and mechanical safety

Voluntary Standards Complied With:

• AAMI/ANSI ES60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005/A2:2021
• AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems
• IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.1, 2020
• IEC 60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015
• ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within Risk Management Process, Fifth edition, 2018
• ISO 14971, Application of risk management to medical devices. 2019
• NEMA PS 3.1 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2022d
• IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017

Quality Assurance Measures:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification & Validation)
• Safety testing (Verification)

In conclusion, for this specific 510(k) submission (K243620), "Vivid iq," the device met acceptance criteria by demonstrating substantial equivalence to a predicate device through non-clinical testing and adherence to recognized standards, rather than through clinical studies with specific performance metrics.

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The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals 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 in private medical offices.

The systems support the following clinical applications: 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, Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage, Vascular Access), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/ PWD, B/Color/PWD, B/Power/PWD.

Vivid T9/Vivid T8 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 T9/Vivid T8 consists of a mobile console with 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, and dual array including dedicated CW transducers.

The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alphanumeric keyboard.

The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.

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.

Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.

The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.

The provided text is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a new, innovative device.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment for performance claims cannot be found in this document.

The document primarily states that the device is "substantially equivalent" to predicate devices, and relies on non-clinical tests (safety, electrical, etc.) and design similarities to justify this claim. It explicitly states: "The subject of this premarket submission, Vivid T9/Vivid T8, did not require clinical studies to support substantial equivalence."

Below is a table summarizing the information that could be extracted from the provided text, and noted where information is explicitly not available or not applicable based on the content.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not applicable. The document explicitly states: "The subject of this premarket submission, Vivid T9/Vivid T8, did not require clinical studies to support substantial equivalence." Therefore, no "test set" in the context of clinical performance evaluation is described. The non-clinical tests (acoustic, electrical, thermal, etc.) inherently involve testing of the device itself rather than patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was performed for substantial equivalence.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set requiring adjudication was performed.
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: Not applicable. This document pertains to a general-purpose ultrasound system without specific mention of AI features that would necessitate an MRMC study for improved human reader performance. The "Clarity +" feature is described as "real-time image processing/filtering technique," not an AI-driven diagnostic aid that would directly impact human reader performance in a quantifiable way for this type of submission.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an ultrasound system, not a standalone algorithm. Its "Clarity +" feature is an image processing technique integrated into the system, not a separate diagnostic algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a clinical performance evaluation, as no clinical studies were deemed necessary. For the non-clinical tests (e.g., safety, electrical, acoustic), the "ground truth" is adherence to recognized performance standards and internal quality assurance measures.
7. The sample size for the training set: Not applicable. As this device did not require clinical studies, there is no mention of a "training set" for algorithm development related to diagnostic performance.
8. How the ground truth for the training set was established: Not applicable, as no training set for diagnostic algorithm development is mentioned or required in this submission.

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