(94 days)
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial).
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500. APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 are mobile system. These systems are Track 3 devices that employ a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz.
The provided text is a 510(k) summary for the Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400, and APLIO 300 MODEL TUS-A300 Version 2.1. It primarily focuses on demonstrating substantial equivalence to a predicate device (Toshiba DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500 / APLIO 400 MODEL TUS-A400 / APLIO 300 MODEL TUS-A300 V2.0; 510(k) control number K110870) and outlining the intended uses for various transducers.
Based on the provided document, the information requested in your prompt about acceptance criteria and a study proving performance (specifically in the context of AI/ML or new clinical parameters) is not present. This document predates the widespread regulatory submissions for AI/ML devices in medical imaging, and its focus is on general ultrasound system functionality and traditional clinical applications.
Therefore, I cannot provide a table of acceptance criteria and reported device performance for AI features, nor can I provide details about sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance studies related to AI.
The document does include detailed tables for each transducer showing the "Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:", listing various clinical applications and modes of operation. For each application, it indicates whether it's a "P" (previously cleared by FDA) or "E" (added under this appendix) indication, or "N" (new indication) for a very few. This is essentially a declaration of the intended uses, but it does not specify performance acceptance criteria or provide study results to demonstrate performance for these applications.
The document mentions compliance with several standards, such as IEC 60601-1 and its parts, IEC 62304, and AIUM-NEMA UD2/UD3 standards. These are general safety and performance standards for medical electrical equipment and ultrasound output measurement/display. They are compliance standards, not specific acceptance criteria for AI or diagnostic performance in patient studies.
In summary, the provided content is a regulatory submission for device clearance based on substantial equivalence to a predicate device, focusing on intended uses and compliance with general safety and performance standards. It does not contain the kind of detailed information about acceptance criteria and performance studies you're asking for, particularly concerning AI or specific diagnostic efficacy metrics.
§ 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.