(184 days)
No change from existing SD 800 platform reviewed during 510(k) 935923.
This SW modification allows for automatic determination of the flow angles used in Doppler and CVI imaging.
This document does not contain the information required to populate the provided template regarding acceptance criteria and a study proving device performance.
The document is a 510(k) summary for a software modification to an ultrasound imaging system (SD 800 SonoDiagnost). It describes a change that automates the determination of flow angles in Doppler and CVI imaging.
Here's why the requested information is not present:
- Acceptance Criteria and Reported Device Performance: The document describes a functionality (automatic determination of flow angles) but does not provide specific performance metrics (e.g., accuracy, precision, speed improvement) or acceptance criteria for those metrics.
- Sample Size, Ground Truth, Expert Qualifications, Adjudication, MRMC, Standalone Performance, Training Set Information: This document is a high-level summary for regulatory submission, focusing on device description, intended use, and comparison to a predicate device. It does not detail specific validation studies, clinical trials, or the methodologies used to establish ground truth or train algorithms. It mentions an "algorithm that is described in detail in Appendix C of the 510(k) report," but Appendix C is not provided here.
In essence, this document is a regulatory overview of a software change, not a detailed study report.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.