(205 days)
The Aloka SSD-1700, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
The Aloka SSD-1700 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is processed into an image. The Aloka SSD-1700 can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The provided text is a 510(k) summary for the Aloka SSD-1700 diagnostic ultrasound system. It primarily discusses the device's substantial equivalence to existing devices and its technological characteristics. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in reports for AI/CADe devices.
This document describes a diagnostic ultrasound system, which is a medical imaging device operated by a human. It's not an AI or CADe (Computer-Aided Detection/Diagnosis) device itself, and therefore, the typical AI/CADe study components you've listed (such as sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable in this context.
The document states:
- Substantial Equivalence: The Aloka SSD-1700 is substantially equivalent to the Aloka Omniview diagnostic ultrasound system, which was cleared via 510(k) in 1996. This is the primary "proof" of its safety and effectiveness for a 510(k) submission for this type of device.
- Performance Claims: The device performs "in the same manner as other diagnostic ultrasound devices." It's indicated for "imaging body structures to aid in the diagnosis of disease or abnormality."
- Technological Characteristics: It also lists similarities in technology, applications, gray-scale and Doppler abilities, method of use, acoustic power output (below FDA maximums), quality assurance, patient contact materials, and compliance with electrical and physical safety standards to other Aloka products.
In summary, the provided text does not contain the specific information requested for an AI/CADe device performance study. The "acceptance criteria" for a device like the Aloka SSD-1700 in a 510(k) submission are largely met by demonstrating substantial equivalence to a predicate device and adherence to relevant safety standards, rather than through quantitative performance metrics against a defined ground truth in a clinical study as would be expected for an AI system.
§ 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.