(167 days)
The NUSONO Handheld Ultrasound Scanner is a portable and software-based ultrasound imaging system, indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
NUSONO-C35
Fetal, Abdominal, Pediatric, Urology, Gynecology, Lung
NUSONO-L75
Pediatric, Small Organ (Thyroid, Prostate, Scrotum, Breast), Musculoskeletal (Superficial and Conventional), Peripheral Vessel, Others (Carotid), Lung
NUSONO-P25
Fetal, Abdominal, Pediatric, Urology, Gynecology, Cardiac (adult and pediatric), Lung
The system provides diagnostic ultrasound imaging in B mode, M mode, Color Doppler mode, Power Doppler mode and combine mode (B+M. B+CD. B+PD), intended for use in environments where healthcare is provided by trained healthcare professionals. The environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.
The NUSONO Handheld Ultrasound Scanner is a portable, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-self (OTS) iOS 14, 15 and Android 12 or higher versions based mobile device. The system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with the NUSONO App on traditional smartphone/tablet devices via direct Wi-Fi. The NUSONO App provides the interface for mode/setting control and image display, acquisition, and storage functions. The 128-channel beamformer and image signal processing technology maximize the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system.
The provided document describes the regulatory submission for the NUSONO Handheld Ultrasound Scanner, not a study evaluating its acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.
Specifically:
- Acceptance Criteria and Reported Device Performance: The document does not list specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular diagnostic task) or the device's measured performance against such criteria. It notes non-clinical performance tests for compliance with general medical device standards.
- Sample size and data provenance for the test set: Not applicable as a clinical study proving acceptance criteria is not detailed.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not explicitly discussed in terms of a clinical study.
- Type of ground truth: Not applicable as no clinical study is presented.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, technological characteristics, and compliance with non-clinical performance standards (electrical safety, EMC, software, biocompatibility, etc.). It explicitly states: "The NUSONO Handheld Ultrasound Scanner did not require clinical testing to establish substantial equivalence."
§ 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.