(105 days)
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:
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in medical offices,
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in clinics,
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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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.