(127 days)
The BMEYE NEXFIN_HD is intended to, non-invasively and continuously, measure blood pressure and hemodynamic parameters in adult patients. The NEXFIN_HD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.
The BMEYE NEXFIN_HD cardiovascular monitor is a non-invasive monitor that enables the continuous assessment of a patient's cardiovascular function based on the scientific method of Peňáz - Wesseling.
The NEXFIN_HD measures continuous non-invasive blood pressure (Systolic, Diastolic and Mean) and heart rate as well as a Cardiac Output (CO), which is derived, non-invasively, from the blood pressure waveform. The monitor also calculates derived hemodynamic parameters.
The provided text is a 510(k) summary for the NEXFIN_HD Continuous Non-Invasive Hemodynamic Monitor. It focuses on establishing substantial equivalence to a predicate device (Finometer K023723) through functional and safety testing, rather than an AI-based performance study with specific acceptance criteria and ground truth for an algorithm.
Therefore, many of the requested categories for a study proving device acceptance criteria in an AI context are not applicable or cannot be extracted from this document, as the device described is a hardware medical device with embedded functional technology, not an AI/ML algorithm.
Here's an attempt to address the request based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria in numerical thresholds for performance metrics for the NEXFIN_HD versus a reference or ground truth. Instead, the "acceptance criteria" are implied by the successful completion of various tests to demonstrate safety, effectiveness, and substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | Device employs the same functional technology as its predicate device. |
| Safety Testing Passed | Successfully undergone safety testing. |
| Functional Testing Passed | Successfully undergone functional testing (for Cardiac Output functionality). |
| Clinical Testing for NBP functionality Passed | Successfully undergone clinical testing (for NBP functionality). |
| Risk Analysis Conducted | Risk Analysis applied. |
| Requirements Review Conducted | Requirements Review applied. |
| Design Reviews Conducted | Design reviews applied. |
| Code Inspections Conducted | Code Inspections applied. |
| Verification and Validation Conducted | Verification and Validation applied. |
| Biocompatibility Testing Passed | Biocompatibility Testing applied. |
| Conclusion of Safety and Effectiveness and Substantial Equivalence | Results of testing demonstrate the device is safe and effective and substantially equivalent to its predicate device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The document mentions "Clinical Testing (for NBP functionality)" but does not specify the sample size used for this clinical testing.
- Data Provenance: Not specified. It's likely prospective for clinical testing, but the location is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable as this is a functional/measurement device, not an AI-driven diagnostic or interpretative device where expert-established ground truth would be relevant in the way this question implies. Ground truth for blood pressure and hemodynamic parameters would typically come from other validated medical devices or established physiological measurements (e.g., thermodilution for cardiac output, invasive arterial line for blood pressure).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for a functional medical device as described.
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:
Not applicable. This device is a measurement tool, not an AI-assisted diagnostic tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of an AI algorithm. The device itself is a standalone monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document states: "The NEXFIN_HD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy." This strongly suggests that a gold standard for Cardiac Output (like thermodilution) was used as a reference (ground truth) during testing or for calibration. For Blood Pressure (NBP), it would typically be compared against another validated NBP device or an invasive arterial line.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that undergoes a training phase with a specific dataset.
9. How the ground truth for the training set was established:
Not applicable.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).