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The iMago c21 medical ultrasound system is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets. The detailed application is listed in the User Guide-and-all these applications must be operated by qualified and trained Physician or "Sonographer".

The iMago c21 Diagnostic Ultrasound System is highly mobile, software-controlled, totally digital processing and PC-based ultrasound imaging system capable of the following operating modes: B, M, Pulsed Doppler, Color Flow(including amplitude Doppler). The system can generate real-time compound images and harmonic images, as well as 3D images and Wide-Field-of-View images. The system is designed for use in convex and linear scanning modes, and supports convex and linear array probes.

This 510(k) summary (K090059) describes the iMago c21 Diagnostic Ultrasound System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. As such, information regarding acceptance criteria and performance metrics (sensitivity, specificity, AUC) from a typical clinical study is not present. The document focuses on technical specifications, intended use, and compliance with general safety standards.

Here's a breakdown of the available information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) or a table comparing them to reported device performance metrics are provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices by comparing intended use, principles of operation, and technological characteristics.

Instead, the device's "performance" is implicitly evaluated through its compliance with recognized safety and performance standards for ultrasound equipment.

2. Sample size used for the test set and the data provenance:

Not applicable. This 510(k) submission does not describe a clinical study with a test set of patient data to evaluate algorithmic performance. The submission relies on technical specifications and comparison to predicate devices, not on a new clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth establishment using experts is mentioned, as there was no clinical performance study presented in this document.

4. Adjudication method for the test set:

Not applicable, as no clinical performance study with a test set is outlined.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

Not applicable. No clinical ground truth was established for a performance study. The "ground truth" for the device's functionality is its adherence to industry standards and its demonstrated substantial equivalence to existing, legally marketed ultrasound systems.

8. The sample size for the training set:

Not applicable. This document describes a medical device (ultrasound system), not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:

Not applicable, as no training set for an AI/ML algorithm is relevant to this submission.

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