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The Model HD-800 Tubing Blood Flow Meter is indicated for the measurement of volume blood flow through extracorporeal tubing during the performance of hemodialysis and cardiopulmonary bypass procedures.

The subject device is a compact, continuous-wave Doppler ultrasound blood velocity detector equipped with four interchangeable clamp-on transducers for attachment to extracorporeal tubing. All transducers operate at a nominal frequency of 2.5 MHz and vary according to the internal diameter of the tubing in use and the volume flow range to be measured. Operation: The system provides an LCD display of mean volume blood flow through the insonated tubing in liters per minute or millliliters per minute averaged over the last three seconds and updated every 0.6 second. Volume flow is calculated by deriving flow velocity from the Doppler shift frequency using the standard formula and then multiplying the velocity by the diameter of the tubing in use. Audible and LED alarms are provided for disconnection of the transducer, excessive bubbles. flow exceeding measurement limits, cessation of flow exceeding 1 second or insufficient flow to permit measurement, and low battery power. 15 volts DC. By AC adaptor or ten 1.5V AA batteries, as preferred.

The provided text describes the Koven Technology Inc. Model HD-800 Tubing Blood Flow Meter. Here's an analysis of its acceptance criteria and the study performed:

Acceptance Criteria and Reported Device Performance

The device's performance data is primarily focused on its measurement accuracy.

Study Details

The information provided describes a performance study conducted to evaluate the device.

1. Sample Size used for the test set and Data Provenance:

   • Sample Size: Not explicitly stated. The study mentions "simultaneous comparison of values obtained with the subject device and an electromagnetic flowmeter using a flow phantom in which pig blood is pumped through vinyl chloride tubing at known flow rates." This implies a series of measurements, but the number of measurements or data points is not quantified.
   • Data Provenance: The study was conducted using a "flow phantom" with "pig blood" and "vinyl chloride tubing." This indicates a laboratory, in vitro (or ex vivo if the pig blood was fresh) setting rather than human data. It is a prospective study design as the testing was specifically performed for this evaluation.

2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The ground truth for flow measurement was established by using an "electromagnetic flowmeter" as the reference standard and "known flow rates" in the flow phantom. This is a technical, rather than expert-driven, ground truth.

3. Adjudication method for the test set: Not applicable. The ground truth was based on a reference instrument and known flow rates, not on human interpretation or adjudication.

4. 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. This device is a measurement instrument, not an AI-assisted diagnostic tool requiring human reader studies.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the performance data presented is for the standalone device, as it focuses on the device's accuracy in measuring flow in a phantom. There is no human-in-the-loop aspect described for this particular performance evaluation.

6. The type of ground truth used:

   • Measurement Accuracy: An "electromagnetic flowmeter" served as the reference standard, and "known flow rates" were established in the flow phantom. This is a technical reference standard/physical measurement ground truth.
   • Doppler Sensitivity & Bubble Detection: These capabilities were also evaluated using a "flow phantom," implying specific technical criteria were used as ground truth (e.g., whether bubbles were detected, what the signal-to-noise ratio was).

7. The sample size for the training set: Not applicable. This device is a physical instrument, not a machine learning model that requires a training set.

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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