(105 days)
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.
| Acceptance Criteria (Implied by Predicate Comparison & Standards) | Reported Device Performance (U-Lite EXP) |
|---|---|
| Intended Use: Diagnostic ultrasound analysis and fluid flow analysis for specified clinical applications. | Identical to predicate. |
| Technological Characteristics: Similar operating principle, scanning modes (B, Color, Power Doppler, M, Pulse Wave Doppler). | Similar operating principle, Identical scanning modes to predicate. Offers advantage of exchangeable probes vs. fixed probes of predicate. |
| Physical Dimensions & Weight: (7.5 x 5.3 x 0.8 inches, 1.8 lbs) | Identical to predicate. |
| Battery Life: (1 hour 30 minutes) | Identical to predicate. |
| Display Size: (7 inches) | Identical to predicate. |
| Core Clinical Applications: Fetal, Abdominal, Pediatric, Small Organ, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional & Superficial), Cardiac Adult, Cardiac Pediatric, Gynecological, Peripheral Vessel, Urology (including prostate). | Identical to predicate for these applications. |
| Added Clinical Applications (compared to predicate): Neonatal Cephalic. | Added Neonatal Cephalic indication. |
| Enhanced Features (compared to predicate): Mobile Cart, DICOM. | Added Mobile Cart and DICOM functionality. |
| Safety and Performance Standards Compliance: Acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety per listed EN/ISO/IEC standards. | Conforms to applicable medical device safety standards (EN ISO 13485, EN 60601 series, EN ISO 14971, EN 62304, EN 62366, EN ISO 10993 series). |
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.
§ 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.