(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.
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R -3 1997
510(k) SUMMARY 1.
This summary statement complies with 21 CFR, section 807.92 as amended March 14, l 995 :
This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-1700 diagnostic ultrasound system and associated transducers. The address is:
10 Fairfield Boulevard Wallingford, CT. 06492
The contact person is Paul D. Smolenski, Manager, Quality and Regulatory Affairs.
The proprietary name is the Aloka SSD-1700 diagnostic ultrasound system. The common name for this type of device is a diagnostic ultrasound system.
The items in this submission are covered under the following classifications:
90 IYN - System, Imaging, Pulsed Doppler, Ultrasonic 90 IYO - System, Imaging, Pulsed Echo, Ultrasonic 90 ITX - Transducer, Ultrasonic, Diagnostic
The above as stated in 21 CFR, part 892.1550, 892.1560 and 892.1570, have been classified as regulatory Class II.
The Aloka SSD-1700 is substantially equivalent to the Aloka Omniview diagnostic ultrasound system and transducers. The Aloka Omniview was originally cleared for market via the 510(k) process in 1996.
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 Aloka SSD-1700, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
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The Aloka SSD-1700 diagnostic ultrasound system with gray-scale and Doppler imaging modalities is similar in technological characteristics to ultrasound systems marketed by Aloka and others:
- The SSD-1700 is indicated for the same diagnostic ultrasound applications as other • products currently marketed by ALOKA and others.
- The SSD-1700 has the same gray-scale and Doppler abilities as other products . currently offered by ALOKA and others.
- The SSD-1700 uses essentially the same technologies for imaging, Doppler functions . and signal processing as other products currently marketed by ALOKA and others.
- The SSD-1700 has the same method of use as other products currently marketed by . ALOKA and others.
- The SSD-1700 acoustic power output levels are below the maximum levels allowed . by the FDA.
- The SSD-1700 is subjected to the same Quality Assurance systems in development . and production as other products currently marketed by ALOKA.
- The patient contact materials used in the probes for the SSD-1700 are the same as . those currently used in probes for other ultrasound systems currently marketed by ALOKA. These materials have been evaluated and found to be safe for this application.
- The SSD-1700 complies with the same electrical and physical safety standards as . other products currently marketed by ALOKA.
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§ 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.