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The Diagnostic Ultrasound System Aplio a550 Model CUS-AA550,Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intraoperative (abdominal), pediatric, small organs (including thyroid, breast, testicle), trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural.

This system provides high-quality ultrasound images in the following modes of operation: B (2D), M, Color Doppler (blood-flow imaging), Doppler (PWD, CWD, Power) (blood-flow spectrum), Combined (B/M; B/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD), Precision Imaging, Apli Pure, Micro Pure, BEAM, TDI, Shear wave, Elastography, SMI (ADF), 2D Wall Motion Tracking, Smart Sensor3D, 3D Color (Volume color), 4D, STIC, STIC Color, Fusion, Smart Navigation, ATI, CHI (Per FDA approved contrast agent prescribing information), Shadow Glass. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

The Aplio a550 Model CUS-AA550, Aplio a450 Model CUS-AA450 and Aplio a Model CUS-AA000 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 20 MHz.

The provided document describes the Canon Medical Systems Corporation's Aplio a550, Aplio a450, and Aplio a Diagnostic Ultrasound System, Software V5.1. While it outlines many aspects of the device and its substantial equivalence to predicate devices, it does not contain information regarding a specific clinical study with acceptance criteria and reported device performance in the format requested.

The document states: "Risk Analysis and Verification/Validation testing conducted through the bench testing which is included in this submission demonstrate that the requirements for the new and improved features have been met. Additional performance testing, using test data and volunteer studies, were conducted to assess improvements to existing features. Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended."

This statement indicates that testing was performed, but it lacks the specific details required to populate the requested table and answer questions about sample size, ground truth, expert qualifications, adjudication, or MRMC studies.

Therefore, I cannot fulfill all parts of your request with the provided input. However, I can infer some general information about the device and the nature of the testing mentioned:

Since this is a 510(k) submission for a diagnostic ultrasound system, the acceptance criteria would typically revolve around demonstrating substantial equivalence to a predicate device. This usually involves showing that the new device has the same intended use, fundamental technological characteristics, and performs as safely and effectively as the predicate device(s).

The "performance testing, using test data and volunteer studies" likely focused on proving the functionality of new and improved features, and that any modifications did not negatively impact existing functionalities.

Here's what can be inferred and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information for specific studies:

2. Sample size used for the test set and the data provenance: Not specified. The document mentions "test data and volunteer studies" but gives no numbers or details on provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not specified. The document does not mention any comparative effectiveness study with human readers with and without AI assistance. The features described (like LI-RADS Checklist, Workflow Navigator, Smart Optimization) are assistive tools, but a formal MRMC study demonstrating an "effect size" (improvement in human performance) is not described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The new features like LI-RADS Checklist and Smart Optimization imply algorithmic components, and their "requirements" were met, but specific standalone performance metrics are not provided. Given the nature of a diagnostic ultrasound system (where the human user is always in the loop), a purely standalone algorithm evaluation might not be the primary focus for the entire system at this clearance level.

7. The type of ground truth used: Not specified. For an ultrasound system, ground truth could be a combination of expert consensus readings, follow-up imaging, biopsy results (especially for features like LI-RADS or BI-RADS), or surgical findings, but these are not explicitly mentioned for the reported studies.

8. The sample size for the training set: Not applicable and not specified. This document describes a medical device, specifically an ultrasound system with software enhancements, not an AI/ML model that typically undergoes specific "training" on a dataset in the conventional sense. The "test data" mentioned refers to verification and validation data.

9. How the ground truth for the training set was established: Not applicable and not specified, as this isn't a traditional AI/ML training context.

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