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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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The T-Lite ultrasound system is intended for use by an appropriately- trained healthcare professional. We recommend that all users receive proper training by an authorized Sonoscanner representative before attempting to use the scanner. You must also follow corresponding local government rules and guidelines at all times.

T-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, musculoskeletal (both conventional and superficial), neonatal cephalic
  NOTE : The application fields are dependent on the selected probe.

NOTE : T-Lite is a general-purpose ultrasound. It can therefore be used in different configurations, especially:

• in medical offices,

• in clinics,

• in hospitals.

It is used in imaging or examination rooms.

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

NOTE : The T-Lite is not compatible with the use of the HF surgery device or in an MRI system.

Modes of operation include:

· B-Mode

• · B-Mode + M-Mode
• · B-Mode + Color Doppler
• · B-Mode + Power Doppler
• · Spectral Pulsed-Wave Doppler

T-Lite is a compact, ultralight, battery powered general purpose diagnostic ultrasound scanner. The T-Lite is a notebook-size, battery operated, general purpose track 3 diagnostic ultrasound system. The T-Lite can be handheld measuring 253mm x 19mm and weighing just 1kg (approximately 2.2lbs). The unit has a built-in kick stand or optional stand.

The T-Lite is used to acquire and display high-resolution LED screen images, real-time ultrasound data and display the data as B Mode, M Mode, PWD Mode, Color Doppler Mode, Color Power Doppler, Duplex Mode, Tissue Harmonic Imaging Mode, Tissue Doppler and Combined (B + Color Doppler Mode).

The provided document is a 510(k) premarket notification for a medical device called the "T-Lite" ultrasound system. It is a submission to the FDA demonstrating that the T-Lite is substantially equivalent to a previously cleared predicate device, the "U-Lite Exp".

This type of submission focuses on substantial equivalence rather than proving a device meets specific acceptance criteria based on studies demonstrating clinical performance or diagnostic accuracy of an AI algorithm. The core of this document is a comparison of technical specifications and performance against a predicate device, along with non-clinical (engineering and safety) testing.

Therefore, many of the requested points regarding acceptance criteria for AI performance, sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment for AI models are not applicable to this document. This submission does not involve an AI algorithm for diagnostic interpretation that would require such studies.

Here's a breakdown of the information available in the document that relates to your request:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for a general diagnostic ultrasound system and not an AI-driven interpretive device, there isn't a table of specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, AUC) for an algorithm. Instead, the "acceptance criteria" are implied by the standards of "substantial equivalence" to the predicate device and compliance with relevant medical device safety and performance standards.

The document demonstrates equivalence through a "Predicate Product Comparison Table" (on page 5-6), which shows that the T-Lite has similar:

• Regulation Numbers (21 CFR 892.1550, 21 CFR 892.1560, 21 CFR 893.1570) - Same
• Product Codes (IYN, ITX, IYO) - Same
• Intended Use (diagnostic ultrasound analysis and fluid flow analysis) - Same
• Track (Track 3) - Same
• Configuration/Design (Notebook, handheld) - Same
• Scanning Modes (B Mode, Color Mode, Power Doppler, M Mode, Pulse Wave Doppler) - Same
• Indications for Use (a comprehensive list of clinical applications like fetal, abdominal, cardiac, etc.) - Same

Differences are noted for:

• Dimensions and Weight (T-Lite is slightly larger/heavier)
• Battery Life (T-Lite has longer battery life: 3 hours vs 1hr 30mins)
• Display Size (T-Lite has larger display: 10.1in vs 7in)
• Power Supply (T-Lite is 15V DC vs 5V DC for predicate)

The manufacturer states that these differences do not raise any new safety issues and were tested to relevant safety standards (listed under Nonclinical Performance Testing).

2. Sample sizes used for the test set and the data provenance

• Sample size for test set: Not applicable. This document is not performing a diagnostic accuracy study on a test set of patient data for an AI algorithm. Its evaluation is based on engineering and performance testing against a predicate device and adherence to international safety standards.
• Data provenance: Not applicable.

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

• Not applicable. Ground truth establishment for a test set of patient data is not described as part of this 510(k) submission, as it relates to an AI diagnostic performance study, which was not performed or required for this device.

4. Adjudication method for the test set

• Not applicable.

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 applicable. This device is a general-purpose ultrasound system, not an AI-assisted diagnostic tool for image interpretation that would require an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this submission is effectively the established performance and safety profile of the predicate device (U-Lite Exp) and compliance with international consensus standards for medical electrical equipment. No clinical ground truth derived from patient studies is mentioned or required for this type of submission.

8. The sample size for the training set

• Not applicable. This document does not describe the development or training of an AI algorithm.

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

• Not applicable.

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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:

Abdominal
Small Parts
Vascular
Cardiac
Obstetrics
Gynecology
Fetal
Pediatrics

The U-Lite EXP are 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 display the data as B Mode, Color Mode, Power Doppler Imaging, and Pulse Wave Doppler spectrum.

The handheld U-Lite EXP 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 EXP 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sonoscanner U-Lite EXP, structured to answer your questions:

Acceptance Criteria and Device Performance for Sonoscanner U-Lite EXP

The provided document, a 510(k) premarket notification, indicates that the Sonoscanner U-Lite EXP is an ultrasonic pulsed Doppler imaging system. For such medical devices, "acceptance criteria" are typically met through demonstrating substantial equivalence to a legally marketed predicate device, focusing on technological characteristics, intended use, and safety/performance standards. Performance data is primarily based on non-clinical testing and comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device (U-Lite K143601) and compliance with relevant safety and performance standards. The table below summarizes the comparative performance and features, which serve as the basis for acceptance. The acceptance criterion is generally that the new device's performance is identical or equivalent to the predicate while adhering to safety standards.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of clinical images or patient data. The performance evaluation is based on non-clinical testing for compliance with harmonized standards. There is no mention of a dataset of patient images or specific patient studies used for testing the device's diagnostic performance. Therefore, also no information on country of origin or retrospective/prospective nature of such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Since no clinical "test set" of patient data was used for evaluating diagnostic performance, there were no experts used to establish ground truth for such a set. The evaluation focuses on technical performance and safety compliance.

4. Adjudication Method for the Test Set

As no clinical "test set" was described, no adjudication method for a test set was mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study was conducted." This type of study would typically be performed to assess the diagnostic accuracy or effectiveness of the device with human readers, potentially comparing performance with and without AI assistance if AI were a component of the diagnostic process.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance evaluation was not described in the document. The U-Lite EXP is a general-purpose diagnostic ultrasound system, not an AI-driven algorithm with standalone diagnostic capabilities. Its functionality is to acquire and display real-time ultrasound data for human interpretation.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on regulatory standards and technical specifications for ultrasonic diagnostic equipment. Compliance with these standards (e.g., for acoustic output, electrical safety, biocompatibility) serves as the "ground truth" for the device's safety and fundamental performance characteristics. No clinical "ground truth" (e.g., pathology, expert consensus on images, outcomes data) for diagnostic accuracy was utilized as no clinical study was performed.

8. The Sample Size for the Training Set

Not applicable. The U-Lite EXP is a hardware-based ultrasonic imaging system. There is no mention of an algorithm or AI component that would require a "training set" of data in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no described training set for an AI/algorithm component.

In summary: The submission for the Sonoscanner U-Lite EXP primarily focuses on demonstrating substantial equivalence to a predicate device and compliance with established safety and performance standards through non-clinical testing. It explicitly states that "No clinical study was conducted." Therefore, information related to clinical test sets, training sets, ground truth based on medical diagnoses, or expert evaluations of diagnostic performance is not present in this document.

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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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