(21 days)
The Aplio ARTIDA is intended to be used to display cardiac images.
The Aplio ARTIDA Ultrasound System is a mobile system. This system is a Track 3 device that employs sector array with a frequency range of approximately 2.5 MHz to 3.0 MHz.
The provided text is a 510(k) Summary for a Toshiba America Medical Systems, Inc. diagnostic ultrasound system (Aplio ARTIDA Version 1.00). This document is primarily concerned with establishing substantial equivalence to previously cleared devices rather than presenting a study that proves the device meets specific acceptance criteria in terms of performance (e.g., accuracy, sensitivity, specificity) for a particular clinical application.
Therefore, the specific information requested in your prompt regarding acceptance criteria, device performance metrics, study design, ground truth establishment, and expert involvement is not available within the provided text.
The document focuses on regulatory compliance, outlining the device's intended use (displaying cardiac images), classifying it according to FDA regulations, and identifying predicate devices. It also lists the transducers associated with the system and their respective modes of operation for cardiac applications (adult and pediatric). The "Safety Considerations" section mentions adherence to various IEC standards and AIUM-NEMA output standards, which relate to the safety and technical specifications of the device rather than its clinical diagnostic performance in terms of accuracy or efficacy benchmarks.
In summary, this document does not contain information about:
- Acceptance criteria and reported device performance (in terms of clinical efficacy/accuracy): The document does not define specific performance metrics (e.g., sensitivity, specificity, AUC) or provide results from a clinical study demonstrating these.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance for a test set: These elements are characteristic of studies evaluating the clinical performance of a device or algorithm, which are absent here.
- Type of ground truth, training set sample size, or how ground truth was established for a training set: This information would be relevant for an AI-powered device undergoing a performance study, which is not described.
The purpose of this 510(k) submission is to demonstrate that the new device is "substantially equivalent" to already legally marketed devices, implying that its safety and effectiveness are comparable, without necessarily requiring new clinical performance studies against defined metrics.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.