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U-Lite PRO is a Handheld Ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals.

It can therefore be used in different configurations, especially:

• In medical offices (general practitioner's office)
• In clinics & hospitals (incl. in emergency and critical care units)
• In a field hospital

It is used in imaging or examinations rooms.

It can be used at the bedside. It is not intended for direct use in a sterile environment.

The U-Lite PRO is not compatible with the use of the HF surgery device or in an MRI system.

U-Lite PRO is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications:

• ophthalmic
• fetal/obstetric,
• gynecological,
• abdominal,
• pediatric,
• neonatal cephalic
• adult cephalic
• small organ,
• trans-vaginal,
• trans-rectal,
• cardiac adult & pediatric
• peripheral vascular,
• urology (including prostate)
• musculoskeletal (both conventional and superficial)

Note : The application fields are dependent on the selected probes and the modes of operations.

Modes of operations include:

• B-Mode (B)
• M-Mode (M)
• Color Doppler (CD)
• Power Doppler (PD)
• Spectral Pulsed-Wave Doppler (PWD)
• Continous Wave Doppler (CWD)
• Combined :(B+M; B+CD; B+ PD; B+PWD)

U-Lite PRO is a compact, ultralight battery powered general purpose diagnostic ultrasound scanner. The U-Lite PRO is a notebook-size, battery-operated, generalpurpose track 3 diagnostic ultrasound system. The U-Lite PRO can be handheld measuring 180mm x 115mm x 20mm and weighing 0.7 kg (approximately 1.54 lbs.). The unit is a handheld ultrasound (HHU) imaging system with interchangeable probes with optional stand.

The U-Lite PRO is used to acquire and display high-resolution LED screen images, realtime ultrasound data and display the data as B Mode, M Mode, PWD Mode, CWD Mode, Color Doppler Mode, Power Doppler, Tissue Harmonic Imaging Mode, and Combined (B +M; B+CD; B+PD; B+PWD).

The provided text is a 510(k) summary for the U-Lite PRO ultrasonic pulsed Doppler imaging system. It focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with various standards, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for an AI/CADe (Computer-Aided Detection/Diagnosis) component.

Therefore, the document does not contain the information required to populate a table of acceptance criteria for AI performance, nor does it describe a study proving an AI/CADe device meets such criteria. Specifically:

• No acceptance criteria for AI were provided. The document describes acoustic output limits and measurement accuracy for the ultrasound system itself, but not for any AI/CADe features.
• No specific study proving AI performance was described. The document states, "No clinical studies were conducted," and the "Non-clinical Performance Testing" sections focus on electrical safety, EMC, usability, biocompatibility, and software verification/validation, along with acoustic output and measurement range/accuracy of the ultrasound hardware. There is no mention of a study to assess the performance of an AI algorithm in detection, diagnosis, or reader assistance.

Given the information provided in the document, it is not possible to complete the requested table or describe a study proving the device meets AI/CADe acceptance criteria, as the submission does not detail any AI component or its performance evaluation. The device described appears to be an ultrasound imaging device, not explicitly an AI/CADe system for image analysis.

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U-Lite is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications: fetal/obstetric, gynecological, abdominal, pediatric, small organ, trans-vaginal, trans-rectal, cardiac, peripheral vascular, urology, and musculoskeletal (both conventional and superficial).

The Sonoscanner U-Lite ultrasound diagnostic device is intended for use by trained health care professionals (physician, sonographer, etc.) for diagnostic ultrasound imaging and fluid flow analysis of the human body. Utilizing curved, linear, phased array, and endocavitary probes, the U-Lite allows for a wide range of clinical applications: Fetal/obstetric, gynecological, abdominal, pediatric, small organ, transvaginal, trans-rectal, cardiac, peripheral vascular, and musculoskeletal.

U-Lite is a notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. It is used to acquire and display high-resolution, real-time ultrasound data and to display the data as B Mode, M Mode, Color Mode, Power Doppler imaging, and Pulse Wave Doppler spectrum. The U-Lite device utilizes a standard range of probes, including curved array (convex), linear array, phased array (sector), and endocavitary transducers.

The handheld U-Lite tablet's display is a high-resolution 7 inch color LED screen, and the controls are intuitive and easy to use. Controls are touch-activated - there are no knobs or switches. The U-Lite is equipped with a lithium-ion battery. When fully charged, the battery can give the system a total autonomy of up to 1h30 in the scanning mode.

The provided document mentions performance data relating to safety standards for the U-Lite device, but does not describe an acceptance criteria and study proving a device's clinical performance.

Specifically, the "Performance Data" section on page 9 states:
"The device has been evaluated for acoustic output, biocompatibility, as well as for thermal, electrical, electromagnetic and mechanical safety, and has been found to conform to applicable medical device safety standards. The U-Lite complies with voluntary standards:

• IEC/EN 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety
• IEC/EN 60601-1-1 Safety Requirements for Medical Electrical Systems
• IEC/EN 60601-1-2 Amendment A1:2006, General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
• IEC/EN 60601-1-6 General Requirements for Safety Collateral Standard: Usability
• IEC/EN 60601-2-37 Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment"

This indicates that the device meets safety and electrical standards, but provides no information about performance criteria related to diagnostic accuracy, image quality, or other clinical measures. The document primarily focuses on establishing "substantial equivalence" to a predicate device (GE Venue 50) based on intended use and technological characteristics, not a separate clinical performance study with defined acceptance criteria.

Therefore, I cannot provide the requested information.

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