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The LOGIQ e is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.

LOGIQ e is intended to be used in a hospital or medical clinic.

LOGIQ e clinical application include: Ophthalmic, fetal/ob; abdominal (gyn & urology); pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiac (adult & pediatric); peripheral vascular; musculoskeletal conventional & superficial; transrectal; transvaginal; transesophageal; intraoperative (abdominal, thoracic and peripheral); thoracic/pleural for motion and fluid detection and imaging guidance of interventional procedures (e.g. Nerve block; vascular access). Mode of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.

The proposed LOGIQ e system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.

It is an ultrasound imaging & analysis system, consisting of a compact console with LCD, and control panel with new keyboard.

The system has digital acquisition, processing and display capability and operates from an integrated battery or AC/DC power adapter. It has one battery pack as standard configuration and also with an optional battery pack to be provided for additional power for longer scanning time.

The system also has an optional height-adjustable cart for comfortable standing and sitting positions. The cart is approx. 510mm length, 510mm width and adjustable height from 830 to 1130mm with optional battery box consisting of a charger box and 4pcs battery Packs to supply the system power from the cart.

LOGIQ e utilizes a variety of electronic array transducers operating in linear, curved, sector/phased array, TEE.

The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

The system supports electronic delivery of software. The system allows the user, in addition to service personnel, to update the SW by logging into a GEHC website to download SW available to them and install it on the system. Download from the GEHC website requires an account.

The provided text does NOT contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is a 510(k) premarket notification for a GE Medical Systems Ultrasound device, the LOGIQ e. It primarily focuses on demonstrating substantial equivalence to a predicate device and other reference devices, not on the performance of a new AI-powered feature with specific acceptance criteria.

The document discusses:

• Device Name: LOGIQ e
• Regulation Number/Name: 21 CFR 892.1550, Ultrasonic Pulsed Doppler Imaging System
• Regulatory Class: Class II
• Product Codes: IYN, IYO, ITX
• Indications for Use: General purpose diagnostic ultrasound for various clinical applications.
• Predicate Device: LOGIQ e (K151028)
• Reference Devices: Vivid iq (K221148), Versana Premier (K210438), Venue Go (K202233)
• Changes/Additions: New transducers, software features (AutoEF, Scan assistant, Strain Elastography, Probe check, Imaging Insights, Tricefy Uplink), hardware (new industrial design, secondary battery option, thermal solution), and accessories.
• Non-Clinical Tests: Acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety, compliance with various IEC, ISO, AAMI, and NEMA standards. Quality assurance measures like risk analysis, design reviews, and testing are mentioned.
• Clinical Tests: The document explicitly states: "The subject of this premarket submission, LOGIQ e, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the test and training sets, as these details are not present in the provided context. The submission is for a general diagnostic ultrasound system and not for a specific AI algorithm with performance metrics.

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