(79 days)
The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications.
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
The SIUI Apogee 1000 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
The provided text is a 510(k) summary for the Apogee 1000 Digital Color Doppler Ultrasound Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
The document focuses on regulatory compliance, safety considerations (acoustic output, electrical safety), and the classification of the device and its transducers for various clinical applications and operating modes. The "Conclusion" section states that "The conclusions drawn from testing of the Apogee 1000 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device," but it does not detail what specific performance tests were conducted or what the results were.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
The 510(k) summary provided is primarily a declaration of substantial equivalence based on technical characteristics and safety standards rather than detailed diagnostic performance metrics.
§ 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.