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The Diaqnostic 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 diaqnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small orqans, trans-vaqinal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophaqeal, musculo-skeletal (both conventional and superficial) and laparoscopic.

The Aplio 500 Model TUS-A500, Aplio 400 Model TUS-A400 and Aplio 300 Model TUS-A300 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

This document describes the 510(k) premarket notification for the Toshiba Medical Systems Corporation's Aplio 500/400/300 V5.0 Diagnostic Ultrasound System. The submission is a modification of a previously cleared device (K133761) and includes improvements to image quality, existing features (Needle Enhancement), and new features (Shear wave and Smart Navigation) along with four new transducers.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with reported device performance values. Instead, it describes "three studies" conducted to demonstrate that the new features perform as intended. The "reported device performance" is qualitative, indicating successful demonstration.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "three studies were conducted," and the testing involved "bench testing" and "an elasticity phantom." It also mentions "targets at various depths." However, it does not specify numerical sample sizes for the test sets used in any of these studies.

The data provenance is from bench testing, implying controlled laboratory conditions rather than clinical human data. The country of origin of the data is not explicitly stated, but the submission is from "Toshiba Medical Systems Corporation, Shimoishigami Otawara-shi, Tochigi-ken, Japan 324-8550". It's likely the testing occurred in Japan or the US (as part of Toshiba America Medical Systems, Inc.). The studies are prospective in nature, as they were conducted to validate the new features of the device before market clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications for establishing ground truth for the bench testing.

For the shear wave study, "known targets within an elasticity phantom" were used. This indicates a physical phantom with pre-defined or known elastic properties, which serves as the ground truth. Therefore, expert input for ground truth establishment might have been less relevant or was built into the design of the phantom itself.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set results. The testing described appears to be objective performance evaluation based on physical measurements (e.g., accurately measuring shear wave speed) or functional confirmation (improving needle visualization, successful navigation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in this document. The studies described are focused on the technical performance of new features rather than comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The performance of the "Needle Enhancement" and "Shear wave" features likely involves standalone measurements by the algorithm/system, as they are inherent imaging modes or measurement capabilities. For example, "accurately measured the shear wave speed and elasticity of known targets within an elasticity phantom" implies an algorithm-only measurement. The "Smart Navigation" feature "successfully navigates needles to targets" where the system displays a "projected path," which could be interpreted as the algorithm providing guidance that a human then follows. While not explicitly stated as "standalone evaluation," the nature of these tests suggests measuring the direct output of the device's enhanced functionalities.

7. The Type of Ground Truth Used

The types of ground truth used for the specific performance tests are:

• Needle Enhancement: Implicitly, the visibility of a physical needle in an ultrasound image. The ground truth for "improved visualization" would be a qualitative assessment, possibly against a baseline or a known ideal.
• Shear Wave: "Known targets within an elasticity phantom." This indicates a physical phantom with established mechanical properties (e.g., known elasticity values).
• Smart Navigation: "Targets at various depths" with a "projected path displayed on the system." The ground truth here would be the physical location of the targets and the actual path the needle takes compared to the projected path.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is not uncommon for 510(k) submissions, especially for ultrasound systems where "AI" might refer to advanced image processing algorithms rather than deep learning models requiring large training datasets. The focus here is on the functional performance validation of hardware and software features.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

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