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The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 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, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

The Diagnostic Ultrasound Systems 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, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G 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, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonatic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal(superficial), cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are mobile, compact diagnostic ultrasound systems which implement the latest technologies. 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 30 MHz.

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 Xario200G Model CUS-X200G and Xario100G Model CUS-X100G 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 a 510(k) premarket notification for several diagnostic ultrasound systems from Canon Medical Systems Corporation. The submission is not related to a new AI/ML device but rather a modification of labeling for existing cleared devices to include information about lung and cardiac imaging functionality for patients with COVID-19, based on societal guidelines.

Therefore, the provided text does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.

The "REASON FOR SUBMISSION" section (Item 11 in page 6) explicitly states: "Modification of labeling for a cleared device."
Additionally, the "TESTING" section (Item 15 in page 8) states: "Performance data is not required for this submission. Design control measures are discussed within the submission."
Finally, the "CONCLUSION" section (Item 16 in page 8) reinforces: "The major change to the devices is to expand the labeling to include information about lung and cardiac imaging, based upon societal guidelines, for patients who have been diagnosed with the novel coronavirus disease 2019 (COVID-19). This labeling update is being provided without changes to the software, hardware and intended use of the subject devices. This labeling change did not impact the previous design controls for the subject devices."

In summary, the provided document does not contain the information requested in your prompt because it is for a labeling modification of existing devices, not a new device or a study involving an AI/ML component with performance metrics.

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