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The intended use of this system is to visualize structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis for cardiac and vascular.

The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel, Abdominal, Small Organ (Specify) (1), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

The APLIO ARTIDA SSH-880CV is a mobile Ultrasound Diagnostic System for cardiology and vascular imaging. It has a capability of providing a 3D real time image of a heart as well as 2D images. The system is consists of a main console, a color LCD display and several transducers. The compatible transducers are linear array, curved linear and phased array with a frequency range of 2.5 MHz to 7.5MHz. Accordingly it has various software options for cardiac and vascular examinations.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on the substantial equivalence of the APLIO ARTIDA MODEL SSH-880CV V3.0 (subject device) to the APLIO ARTIDA MODEL SSH-880CV V2.0 (predicate device), with the addition of a new feature: Activation Imaging (AI) - 3D Wall Motion Tracking (3D WMT). The acceptance criteria for this new feature is qualitative and tied to its ability to display activation timing.

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

• Sample Size: 10 subjects.
• Data Provenance: The text states, "A clinical evaluation of Activation Imaging (AI) was conducted at a evaluation site for the validation of AI." No specific country of origin is mentioned, but the submitter's address is in Tustin, CA, USA, and the device manufacturer is Toshiba Medical Systems Corporation, Japan. This suggests it could be a US-based study or an international study. The study was prospective in nature, as indicated by "scheduled for routine Echocardiographic Evaluation."

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only mentions that subjects were "scheduled for routine Echocardiographic Evaluation by their physician," implying that physicians (likely cardiologists or specialized sonographers) were involved in the standard diagnostic process which would inform the assessment of "dyssynchrony."

4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. The study was a clinical evaluation of the AI feature itself, not a comparison of human readers with vs. without AI assistance. The focus was on whether the AI images provided activation timing, not on how it improved human reader performance.

6. If a Standalone (Algorithm-Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone evaluation was performed. The "pass/fail criterion was used to determine if the AI images provided the activation timing." This directly assesses the algorithm's output without requiring human interpretation for its performance evaluation against a specific criterion.

7. The Type of Ground Truth Used

The ground truth was established by assessing if the AI images "provided the activation timing" for subjects with "dyssynchrony." This implies a clinical assessment of myocardial movement from the acquired 3D images, likely evaluated against established medical understanding of cardiac dyssynchrony and activation timing. While not explicitly stated as "expert consensus," the nature of the evaluation for a diagnostic ultrasound feature inherently relies on clinical judgment and established diagnostic criteria within the medical field. It's an implicit clinical ground truth based on the physician's evaluation rather than a pathology result or outcome data.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. The focus is solely on the clinical evaluation of the new feature.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

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