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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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