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The HD01-series monitors are intended for use by trained medical personnel on patients receiving hemodialysis treatment, for the routine monitoring of the following patient and blood handling diagnostic parameters:

Access recirculation: a check on proper dialysis needle placement and dialysis pump setting in relation to flow in the access device. Access recirculation would prevent the patient of receiving its full hemodialysis prescription. Access recirculation that cannot be mitigated by altering needle placement should be referred to the attending physician, for a change in the patient hemodialysis prescription and as a possible indication of deteriorating flow in the access device.

Access flow: allows the routine monitoring of patency of the access device. A substantial decrease in flow passing through the shunt or fistula from the initial level may indicate deterioration of the access, and should be referred to the attending physician for further diagnostic assessment and treatment.

Delivered bloodflow: a check on the hemodialysis pump setting, to confirm that the patient receives the hemodialysis treatment prescribed by the attending physician.

The HD01 uses transit-time ultrasound principles to make the flow measurements and register sound velocity indicator dilution curves. Standard Stewart-Hamilton equations are employed for the various calculations. Portions of these technologies are covered under Transonic Systems' USA and worldwide patents and patents pending.

All Transonic HD01-series hemodialysis monitor devices consists of the following components:

• "HD01 flow/dilution meter" or "HD01 meter": A bench-top, line power operated electronic measurement unit with serial RS232 data output link;
• "Dual flow/dilution sensor", individually referred to as "arterial sensor" and "venous sensor": Two plastic-encased ultrasonic sensors, connecting to the HD01 unit, to be clipped onto the patient arterial and venous hemodialysis blood lines;
• "Monitor software" also referred to as "software": Computer software to be installed on an IBM-PC compatible computer, which performs the various device function calculations (R%, QA etc.) from the signals produced by the HD01 meter.

Here's an analysis of the acceptance criteria and supporting studies for the Transonic HD01-SERIES HEMODIALYSIS MONITOR, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state a specific "test set" sample size or its provenance (country of origin, retrospective/prospective). Instead, it references numerous publications (14 distinct publications cited) for each device function (Access Recirculation, Access Flow, Delivered Bloodflow) as evidence for effectiveness. These publications would contain the specific study designs, sample sizes, and data provenance. For example, for "Access Recirculation," studies like Depner et al., 1995, and Krivitski, 1995, are cited.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the summary. The studies referenced would likely detail how ground truth was established, but the summary document itself does not specify the number or qualifications of experts for defining ground truth in a general test set.

4. Adjudication method for the test set

The document does not describe a specific adjudication method for a test set. This type of information would typically be found within the detailed methodologies of the individual studies cited.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This document describes a medical device for measuring physiological parameters (blood flow, recirculation) and does not involve "human readers" interpreting images or data in a way that would typically necessitate an MRMC comparative effectiveness study with AI assistance. Therefore, no such study is described, and no effect size for AI assistance is provided. The device itself is the measurement tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Transonic HD01 is a standalone device in the sense that it performs its measurements (flow, dilution curves, calculations) automatically based on the input from the sensors. The "monitor software" performs the calculations from the signals. While a trained medical operator selects the measurements and performs procedures like saline injection, the core measurement and calculation process for R%, QA, etc., is done by the algorithm without human intervention in the interpretation of raw sensor data into the reported values. The effectiveness studies cited are implicitly standalone algorithm performance studies, validated against established clinical methods.

7. The type of ground truth used

The ground truth used for validation varies depending on the function:

• Access Recirculation:
  • Comparison with BUN recirculation measurements using a Boehringer Mannheim Hitachi 911 Analyzer.
  • Comparison with Urea Dilution methods.
• Access Flow:
  • Comparison with Magnetic Resonance Angiography (MRA).
  • Comparison with Duplex Ultrasonography.
  • Validation in animal models (sheep).
• Delivered Bloodflow:
  • Comparison with hemodialysis pump readouts (Fresenius 2008 Dialysis System).
  • Comparison with volumetric (beaker-stopwatch) calibration.
  • Comparison with another Transonic flowmeter (T101D/T201D).

8. The sample size for the training set

The document does not explicitly mention a "training set" or its sample size. This summary focuses on the device's validation against predicate devices and published studies. If machine learning or AI models were used in the device development, the training set information would be detailed internally or in specific technical documents, not typically in a 510(k) summary focused on substantial equivalence. The "HD01 flow/dilution meter" and "Monitor software" are described, but the method of their development (e.g., if they involved a "training set" in a modern AI sense) is not elaborated.

9. How the ground truth for the training set was established

As no specific "training set" is mentioned in the context of machine learning, there is no information provided on how its ground truth was established. The device utilizes "transit-time ultrasound principles" and "Standard Stewart-Hamilton equations" for its calculations, which are established physical and mathematical principles, rather than being learned from a labeled training set in the way a modern AI would be.

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