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USCOM 1A records and monitors beat-to-beat cardiac heamodynamics in paediatric and adult patients. Its recording and storage of patient information provides trending information of cardiovascular performance for quantitative evaluation. The USCOM 1A is for use by clinicians in the hospital environment.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Pediatric (CWD), Cardiac (CWD).

The USCOM 1A is a non-invasive tool that measures and records changes in the heamodynamic status of a patient. It is a portable Continuous Wave Doppler device using an Ultrasonic Transducer to measure blood flow. it is a portable of an easy to use touch screen display with monitoring, trending and storage The GOOM TH consisted on an odo, to a see navigates intuitive and simple screens to enter patient details and perform examinations. Targeting the patient's pulmonary or aortic valves transcutaneously, the blood flow profile can be Targeting the palifically of assisted blood flow profile, the clinician can determine a number of parameters including Stroke Volume and Cardiac Output. The USCOM 1A saves the measures in a patient file. Multiple saved measures over time are displayed The USOW TA Saves the model of the patient's change in heamodynamic status. Reports can be generated on patient measures which can be printed and exported for analysis. The device is portable, weighing less than 7 kilograms and incorporates an internal battery.

The USCOM 1A device is a non-invasive continuous wave Doppler device designed to measure and record changes in a patient's hemodynamic status. It monitors beat-to-beat cardiac hemodynamics in pediatric and adult patients, providing trending information of cardiovascular performance for quantitative evaluation. The device targets the pulmonary or aortic valves transcutaneously to determine parameters like Stroke Volume and Cardiac Output.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that no clinical tests were required for the USCOM 1A. Instead, the manufacturer demonstrated substantial equivalence to predicate devices through non-clinical testing and compliance with consensus performance standards. Therefore, there are no specific quantitative acceptance criteria or reported device performance metrics from a clinical study provided in this summary.

The conclusion states: "Testing to consensus performances standards and well proven test methods is sufficient to demonstrate that the Continuous Wave Doppler technology used in the USCOM 1A, can perform clinical requirements as intended by USCOM Ltd."

The non-clinical tests covered:

• Acoustic output
• Electrical safety including thermal properties
• EMC
• Biocompatibility
• Mechanical and environmental characteristics

And the device was found to comply with applicable medical device safety and performance standards.

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

Since no clinical tests or studies were performed, there is no test set, sample size, or data provenance information from clinical data provided in this submission for the USCOM 1A device's performance claims. The data provenance details provided in the submission refer to the regulatory information and documents, such as the date prepared (9th Nov 2004) and the company's location (Sydney, Australia for USCOM Ltd.).

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

Not applicable, as no clinical test set requiring expert ground truth establishment was conducted for this submission.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was conducted for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. The USCOM 1A is a standalone device for measuring cardiac hemodynamics and does not involve AI assistance for human readers or interpretation of medical images.

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

The document describes the USCOM 1A as a device that "records and monitors beat-to-beat cardiac heamodynamics," and "targeting the patient's pulmonary or aortic valves transcutaneously, the blood flow profile can be determined," and from this, "the clinician can determine a number of parameters including Stroke Volume and Cardiac Output." While the device performs calculations autonomously based on the Doppler signal, there is no mention of a standalone performance study in the context of comparing its algorithmic output to a clinical gold standard directly, as clinical testing was deemed "not required." The performance is implicitly demonstrated by its substantial equivalence to predicate devices and compliance with non-clinical engineering standards.

7. The Type of Ground Truth Used:

For the purpose of regulatory clearance, the "ground truth" for the USCOM 1A appears to be established through:

• Compliance with consensus performance standards: This implies that the device's measurements and functionality meet established engineering and safety benchmarks considered acceptable for medical devices.
• Substantial equivalence to predicate devices: The GE Vivid 3 Expert/Pro Diagnostic Ultrasound System (K020789) for CW Doppler performance and the BioZ.com HemoDynamic Monitor (K011439) for data management were used as benchmarks. This means the device was compared to existing, legally marketed devices, implying that their established performance serves as a form of "ground truth" for what is considered safe and effective.

No clinical "ground truth" (e.g., pathology, outcomes data, or expert consensus on patient diagnoses) was explicitly used in this submission.

8. The Sample Size for the Training Set:

Not applicable, as this device's submission does not mention machine learning or AI components requiring a "training set" in the traditional sense. The device operates based on established physical principles of Doppler ultrasound.

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

Not applicable, as there is no mention of a training set for machine learning or AI components.

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