(11 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, cardiac, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).
The Aplio XG v4.0 is a mobile system. This system is a Track 3 device that employs 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 510(k) Premarket Notification for the Aplio™ XG (v4.0) SSA-790A Ultrasound System does not contain detailed acceptance criteria, a study proving the device meets those criteria, or specific performance metrics with sample sizes. This document primarily focuses on establishing substantial equivalence to a predicate device (Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V3.0 K082119) and outlining the intended uses and associated transducers.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The document lists "Modes of Operation" for various clinical applications and transducers, indicating whether they are "previously cleared by FDA" (P) or a "new indication" (N). However, it does not specify quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for these modes or report performance data against such criteria.
The "Modes of Operation" essentially indicate the capabilities of the device rather than its quantitative performance against specific criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the provided document. The 510(k) summary focuses on substantial equivalence based on technical specifications and intended use, rather than clinical trial data with test sets.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not present in the provided document.
4. Adjudication Method for the Test Set
This information is not present in the provided document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs Without AI Assistance
This information is not present in the provided document, and it's highly unlikely for an ultrasound system from 2009. The document does not mention AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not present in the provided document, and it's highly unlikely for an ultrasound system from 2009. The device is a diagnostic ultrasound system, implying human operation and interpretation.
7. The Type of Ground Truth Used
This information is not present in the provided document. As no performance studies are detailed, no ground truth methodology is described.
8. The Sample Size for the Training Set
This information is not present in the provided document. The document doesn't describe any machine learning or AI components that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not present in the provided document. (See point 8).
Summary of available information related to acceptance and study:
The provided document is a 510(k) Premarket Notification, which primarily seeks to demonstrate "substantial equivalence" of the Aplio™ XG (v4.0) SSA-790A Ultrasound System to a legally marketed predicate device (Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V3.0 K082119).
The "study that proves the device meets the acceptance criteria" in the context of a 510(k) for an ultrasound system typically refers to:
- Conformance to standards: The document explicitly states that the device is "designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC60601-2-37, IEC 62304 and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard." Meeting these recognized standards serves as evidence of safety and effectiveness, implicitly defining an "acceptance criterion" for fundamental device performance and safety.
- Comparison to predicate device: The core of a 510(k) is the comparison to a predicate. The tables detailing "Intended Use" and "Mode of Operation" for each transducer (e.g., PST-25BT, PVT-375MV) show whether a particular mode or application was "previously cleared by FDA" (P) with the predicate device (K082119) or is a "new indication" (N). This implies that the current device is accepted if its performance for existing indications is equivalent to the predicate, and new indications are justified through other means (though not detailed here).
Specifics on "new indications" (N): The document lists several "new indications" (e.g., for transducer PVT-375MV, Fetal and Abdominal applications now include B, M, PWD, Color Doppler, Combined, THI, Dynamic Flow, Power, CHI 2D, and 3D modes as "N"). For these new indications, the submission would typically include data (often bench testing, phantom studies, or limited clinical data) to demonstrate their safety and effectiveness. However, this specific data and its acceptance criteria are not included in this summary.
In essence, the "acceptance criteria" here are mainly regulatory conformance and substantial equivalence to a previously cleared device, rather than detailed, quantitative clinical performance metrics against specific benchmarks as might be seen for novel AI-powered diagnostic devices.
§ 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.