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The SonoTT FlowLab® with the accessories is a system to measure the flow rate of liquids (e.g. blood) with the ultrasonic transit-time and velocity patterns of blood with Doppler method. It supports the planning, implementation, efficiency control and documentation of interventions carried out in the area of cardiovascular, vascular and, transplantation, or the monitoring of extracorporeal circulatory systems.

The following medical applications are supported:

• Intraoperative blood flow measurement with the SonoTT Vascular Probe to assist e surgeons at surgical interventions
• Measurement of flow direction and velocities of blood in vessels using the SonoTT Pulse . Wave Doppler Probe to assist the surgeon in the non-invasive assessment of vascular changes.
• Extracorporeal flow measurement in continuous operation on tube systems in . combination with the SonoTT Clamp-On Transducer in intensive care units and operating theatres

The following actions can be performed simultaneously when these measurements are in progress:

• Pressure measurement in combination with a standard blood pressure transducer t
• Secondary displays of additional physiological analogue signals and corresponding . derived parameters

The SonoTT Vascular Probe is intended for transient use only with continuous contact with patient of less than 60 minutes.

The SonoTT FlowLab® is used for the volumetric measurement of liquid flowing through tubing systems (in combination with the SonoTT Clamp-On Transducer), to measure blood volume flow (in combination with the SonoTT Vascular Probe) and flow velocity in arteries and veins (in combination with the SonoTT Pulse Wave Doppler Probe). The measurement principle is the ultrasound transit-time and Doppler method.

The SonoTT FlowLab® is a blood flow meter that uses ultrasound transit-time and Doppler methods to measure liquid flow rate and blood velocity. It is intended for use in cardiovascular, vascular, and transplantation interventions, as well as for monitoring extracorporeal circulatory systems.

Acceptance Criteria and Device Performance:

The provided document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific accuracy thresholds for flow measurement). Instead, the substantial equivalence argument relies on demonstrating that the SonoTT FlowLab® performs as well as the predicate devices (MediStim VeriQ and SonoTT Ultrasonic Flowcomputer) based on intended use, patient population, measurement and sensor technology, and auxiliary channels.

However, the "Test Data" section indicates that various tests were performed to "assure reliable design and performance under the specified testing parameters." While the results are not detailed in the provided text, the successful completion of these tests suggests that the device met internal performance benchmarks.

Study Information:

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

   • The provided document does not specify sample sizes for any of the performance tests (e.g., number of measurements, number of devices tested).
   • There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective nature).

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

   • The document does not mention the use of experts to establish ground truth for the device performance tests. These tests (Electrical Safety, EMC, etc.) are typically evaluated against established engineering standards and specifications rather than expert consensus on clinical data.

3. Adjudication Method for the Test Set:

   • Not applicable as the nature of the described tests does not involve a need for adjudication in the context of clinical expert review.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or performed. The device is a measurement instrument, not an AI diagnostic tool that assists human readers in interpreting medical images or data.

5. Standalone (Algorithm Only Without Human-In-The-Loop Performance) Study:

   • While the device functions as a standalone measurement instrument, the document does not describe a formal "standalone study" in the context of comparing its performance against a human operator or a gold standard algorithmically. The validation tests listed (electrical safety, EMC, etc.) focus on the device's adherence to regulatory and engineering standards.

6. Type of Ground Truth Used:

   • For the technical and performance tests listed (Electrical Safety, EMC, etc.), the "ground truth" would be established engineering standards, regulatory requirements, and internal design specifications.
   • For the core function of flow measurement, the accuracy would typically be validated against a known physical standard (e.g., a calibrated flow measurement system), though the details of such validation are not provided.

7. Sample Size for the Training Set:

   • Not applicable. The SonoTT FlowLab® is a hardware-based measurement device, not an AI or machine learning algorithm requiring a "training set" in the conventional sense. Its functionality is based on established physical principles (ultrasound transit-time and Doppler).

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

   • Not applicable, as there is no training set for this type of device.

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