(58 days)
The Task Force® Monitor 3040 (TFM) is intended to noninvasively measure and display a patient's hemodynamic parameters using Impedance Cardiography (ICG), Electrocardiography (ECG), and photoplethysmography (continuous), oscillometric Blood Pressure (oscBP) and continuous blood pressure. The TFM continuously monitors the subject's hemodynamic parameters without reporting any diagnosis. Every measurement must be supervised by a medical trained professional. The Task Force® Monitor 3040 is a diagnoses aiding device and therefore not designed for vital sign monitoring or self-monitoring of patients.
The device architecture of the TFM is equivalent to the BioZ.pc. The TFM system consists of a Patient Biosignal Electronic System (PBES) and a PC for calculating and displaying the hemodynamic parameters. ICG signals from a patient are assessed using the same method as the predicate device (8 electrodes, injecting a minimal current). The user inputs the patient's data into the TFM software on the PC including gender, age, height, weight, hematocrit and the distance between the inner ICG electrodes. The PC runs Windows 2000 operating system. The parameters are displayed on a full color screen and measurement data can be stored on the PC's hard disk. The TFM calculates and displays the same hemodynamic parameters as the predicate device.
Here's a breakdown of the acceptance criteria and study information for the CNSystems Task Force® Monitor 3040, based on the provided text:
Acceptance Criteria and Reported Device Performance
The documents primarily focus on demonstrating substantial equivalence to predicate devices rather than directly stating specific acceptance criteria with quantified performance targets for the Task Force® Monitor 3040 itself. Instead, the performance specifications of the TFM are compared against its predicate devices.
However, based on the "Performance specification" section, we can infer the following:
| Acceptance Criteria (Inferred from Performance Specification) | Reported Device Performance (Task Force® Monitor 3040) | Predicate Device (BioZ.PC) Performance | Predicate Device (Ohmeda 2350 Finapres) Performance |
|---|---|---|---|
| ICG Measurement | |||
| - Measuring Current | 400µA eff., 40 kHz | 2.5mA rms, 70kHz (no further information on temporal derivative of impedance) | Not applicable (Finapres does not perform ICG) |
| - Temporal derivative of impedance (dZ/dt) | ±10 Ohm/s | Not explicitly stated | Not applicable |
| ECG Measurement | |||
| - Measuring Range | ±5mV | Not explicitly stated | Not applicable |
| - Indication Range (Heart Rate) | 30 - 150 beats/min | Not explicitly stated | Heart rate measuring range: 12 to 175bpm, accuracy: ± 5bpm or ± 5% of reading (whichever is higher) |
| - Sampling Frequency | 1000Hz (Europe), 1200Hz (USA) | 1000Hz (in Europe) | Not explicitly stated for Finapres ECG, but it measures pulse rate. |
| Oscillometric Blood Pressure (oscBP) | |||
| - Measuring Accuracy | ±5mmHg | Not explicitly stated (BioZ.PC uses manual user input or optional oscillometric BP, no accuracy specified for its oscillometric function) | BP measuring range: 20 to 260mmHg, accuracy: pressure transducer Linearity: + 2mmHg to -4.5mmHg (+ 0.25kPa to - 0.55kPa) |
| - Measuring Range | 50 to 250mmHg | Not explicitly stated | 20 to 260mmHg |
| Continuous Blood Pressure (continuous BP, based on Penaz method and corrected by oscBP) | |||
| - Measuring Accuracy | ±5mmHg (due to oscBP) | Not explicitly stated | BP measuring range: 20 to 260mmHg, accuracy: pressure transducer Linearity: + 2mmHg to -4.5mmHg (+ 0.25kPa to - 0.55kPa) for systolic and diastolic blood pressure, and also calculates mean arterial blood pressure. (Finapres itself does not state a correction against an oscillometric device like TFM). |
| - Measuring Range | 50 to 250mmHg | Not explicitly stated | 20 to 260mmHg |
| Patient Accommodation Limits | Weight: 66.14 - 440.9 lbs (30 - 200 kg) Height: 1.64 - 8.20 feet (50 - 250 cm) | Weight: 60 lb. (27.3 kg) to 340 lb. (164 kg) Mean arterial pressure greater than 130mmHg (not accommodated) Late sepsis (e.g., stage 3 and 4) (not accommodated) Aortic insufficiency (not accommodated) | Not explicitly stated |
Study Information
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Sample Size used for the test set and the data provenance:
- The document mentions "A clinical study shows, that both devices follow the arterial blood pressure very well with the difference, that the TFM has no interruptions in the signal." However, no specific sample size for this clinical study is provided.
- Data provenance is not explicitly stated. Given the manufacturer is CNSystems Medizintechnik GmbH in Austria, it is likely the study was conducted in Europe, possibly Austria, but this is an inference. It's also not stated if the study was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not provide details on the establishment of ground truth or the involvement of experts for the clinical study mentioned.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. There is no mention of an adjudication process for the clinical study.
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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:
- No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned. The document describes a comparison between the new device (Task Force® Monitor 3040) and two predicate devices, not a study comparing human performance with and without AI assistance. The TFM is a measurement device, not an AI-assisted diagnostic tool in the typical sense implied by an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The primary study mentioned is a "clinical study" comparing the TFM and the Finapres device's blood pressure measurement. This suggests a standalone performance evaluation of the device's measurement capabilities. The device is intended "to noninvasively measure and display a patient's hemodynamic parameters" and states "Every measurement must be supervised by a medical trained professional." This implies it's a device that provides data to a professional, rather than an "algorithm only" in the sense of a fully automated diagnostic AI. The "standalone" performance here refers to the accuracy of its measurements against a reference.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study, the ground truth for comparing continuous blood pressure is implied to be through direct comparison with the Finapres device and its established methods, and the TFM uses an oscillometric device for "absolute BP values." Therefore, the ground truth is likely based on established physiological measurement techniques, with the oscillometric device serving as a reference for absolute BP values.
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The sample size for the training set:
- Not applicable / Not specified. The document does not describe the Task Force® Monitor 3040 as an AI-driven device requiring a training set in the modern sense. It uses "methods and algorithms for calculating the patient's hemodynamic parameters as both predicate devices." The development would have been based on physiological principles and existing algorithms rather than machine learning training on a large dataset.
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How the ground truth for the training set was established:
- Not applicable / Not specified. As the device is not described as based on machine learning, there is no mention of a training set or ground truth establishment for it. Its validation is based on demonstrating substantial equivalence to predicate devices using established measurement principles.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.