(165 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial).
Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can guide biopsy- and puncture needles. An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive purpose.
The provided text pertains to a 510(k) summary for an Ultrasound Scanner Pro Focus 2202. This document details the device's technical specifications, compared to predicate devices, and an FDA clearance letter. It is a regulatory submission for a diagnostic ultrasound system, not a study evaluating an AI device's performance.
Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.
The text focuses on demonstrating substantial equivalence to previously cleared devices based on:
- Technical characteristics: Modes of operation, intended use, indications for use, and features (ECG, VFI, RF wireless).
- Safety standards compliance: Acoustic output, thermal, electrical, electromagnetic, and mechanical safety, and biocompatibility of patient contact materials.
The only "testing" mentioned that marginally relates to performance is:
"Additional testing of the RF wireless function was performed at five (5) different sites representing actual user requirements. Several test scenarios was performed and no interference was measured."
This statement is very high-level and does not provide quantified acceptance criteria or performance metrics as typically expected for proving a device meets specific criteria for accuracy, sensitivity, or specificity. It merely states that "no interference was measured," which implies a pass/fail outcome for the RF wireless function's basic operational integrity, but not diagnostic performance.
In summary, as per the provided document, I cannot fulfill your request for detailed acceptance criteria and a study proving device performance because the document does not contain this information for diagnostic performance. It is a regulatory submission for a traditional medical device, not an AI/ML-driven device with performance metrics based on clinical outcomes or expert labels.
§ 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.