(29 days)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic): Pediatric: Small Organ (breast, testes, thyroid, salivary gland. lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial: Transrectal (TR); Transvaginal (TV).
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The study discussed is a 510(k) Premarket Notification Submission for the GE Healthcare Voluson S6, Voluson S8 Ultrasound System. This submission asserts substantial equivalence to predicate devices, rather than presenting a de novo clinical study with specific acceptance criteria and performance metrics.
Therefore, this specific document does not contain the information requested in points 1-7, and 9 because no new clinical studies were conducted for this submission. The device's safety and effectiveness are established through comparison to legally marketed predicate devices.
However, based on the provided text, the following information can be extracted:
8. The Sample Size for the Training Set: Not applicable. This submission is for an ultrasound system, not an AI/ML device that requires a training set in the conventional sense. The "training" for such a device is implicitly in its design and manufacturing process to meet established standards.
No other information regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, or standalone performance is present because the submission explicitly states:
"The subject of this premarket submission, Voluson S6, Voluson S8, did not require clinical studies to support substantial equivalence." (Page 3)
The "study" used to demonstrate substantial equivalence relies on non-clinical tests and comparison to predicate devices, which already have established safety and effectiveness. The non-clinical tests involved:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety
The device was found to conform to applicable medical device safety standards and voluntary standards such as: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, and NEMA DICOM 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.