(45 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal/GYN (including infertility monitoring of follicle development); Pediatric; Small Orqan (breast, testes, thyroid etc.); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
The Voluson 730 Pro or Expert is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 68 cm wide, 100 cm deep and 145 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color LCD/TFT display (Expert version) and a color video CRT. This modification will provide users with additional probe options, improved user interface and image enhancement.
The GE Voluson 730 Pro/Expert Diagnostic Ultrasound System is a general purpose diagnostic ultrasound system. It is substantially equivalent to the predicate devices GE Voluson 730 Pro/Expert and GE LOGIQ 9.
1. Acceptance Criteria and Reported Device Performance:
The provided documentation does not include specific quantitative acceptance criteria or a reported performance table for the device's diagnostic accuracy (e.g., sensitivity, specificity). The submission is a 510(k) premarket notification for substantial equivalence, which primarily focuses on demonstrating that the new device has the same technological characteristics and intended uses as a legally marketed predicate device.
The "device performance" in this context refers to its ability to perform the intended diagnostic ultrasound imaging and fluid flow analysis in various clinical applications and with various transducers. The approval implies that it performs comparably to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
No clinical test set or sample size for performance evaluation is mentioned. The document explicitly states: "Clinical Tests: None required." This indicates that no specific clinical study data from a test set was used to demonstrate effectiveness for this 510(k) submission, as substantial equivalence was claimed based on technological characteristics and intended uses being comparable to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as no clinical test set was used for performance evaluation that required establishing ground truth via expert consensus.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used for performance evaluation that required adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. The submission does not include any comparison of human reader performance with or without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Not applicable. The GE Voluson 730 Pro/Expert is a diagnostic ultrasound system operated by a qualified physician, not an AI-driven algorithm intended for standalone performance.
7. Type of Ground Truth Used:
Not applicable, as no clinical test set was used for performance evaluation that required establishing ground truth. The basis for clearance is substantial equivalence to a legally marketed predicate device, rather than de novo performance evaluation against a defined ground truth.
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/ML device that requires a training set.
§ 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.