Search Results

The TensorTip - Non-invasive Hemodynamic blood pressure monitor trending device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.

The TensorTip - Non-invasive Hemodynamic Blood Pressure Monitor measurement chamber is designed to measure spot-check of heartbeat and blood pressure trending levels by simply inserting the finger into the device "chamber". It contains a dedicated finger compartment having soft gel on the upper compartment lead door suiting the finger to be placed inside. The device incorporates LEDs (Light Emitting Diode); a sensor array enables to sense the spectrum from near UV to near IR and a rechargeable battery for power supply. The device has large display for displaying temporal Pulse Per Minute (PPM) and Systolic and Diastolic Blood Pressure trending. In addition it shows the capillary blood waveform and the blood pressure variation during the measurement period. It is utilizing software that collects and presents the measured data.

Here's a breakdown of the acceptance criteria and study information for the Cnoga Medical TensorTip, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. Specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation compared to a reference method) are not explicitly stated in the provided text. However, the summary indicates that clinical validation met the requirements of ISO 81060-2, which is the standard for non-invasive sphygmomanometers. This standard typically defines accuracy requirements.

Since the exact numerical acceptance criteria are not specified, the table will reflect the general statement of conformity to the standard.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "human testing" for clinical validation.
• Data Provenance: Not explicitly stated. The document indicates "human" testing was performed, but does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given 510(k) summary. For blood pressure monitors, ground truth is typically established by trained medical professionals using a reference device (e.g., a mercury sphygmomanometer or an oscillometric device validated against an invasive arterial line).

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary.

5. 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

This information is not applicable or not provided. The device described is a non-invasive hemodynamic blood pressure monitor, not an AI-assisted diagnostic imaging system that would typically involve human "readers" or an MRMC study in this context. The 510(k) describes a standalone device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The 510(k) describes the TensorTip as a device that directly measures and displays blood pressure and pulse rate. The "Performance Data" section states that "Cnoga Medical's TensorTip spot-check pulse rate and non-invasive blood pressure trending device has been successfully tested with bench, human and safety testing to support the determination of substantial equivalence with predicate devices." This implies testing the device's inherent accuracy in measuring these physiological parameters.

7. The Type of Ground Truth Used

The ground truth used for clinical validation of blood pressure devices typically involves measurements from a validated reference device (e.g., a mercury sphygmomanometer or an oscillometric device that has itself been validated against more invasive methods like intra-arterial pressure). While not explicitly detailed, the statement "Clinical validation has met the requirement of ISO 81060-2 standard" strongly implies that such a reference standard was used to establish ground truth for the test set.

8. The Sample Size for the Training Set

This information is not provided in the given 510(k) summary. The document describes a medical device, not a machine learning model that typically involves a distinct "training set" in the conventional sense of AI development. While the device certainly uses algorithms, the summary doesn't parse out data into training/test sets in that manner.

9. How the Ground Truth for the Training Set Was Established

This information is not provided as a separate "training set" and its ground truth establishment are not directly discussed in the context of the device's development as presented in this 510(k) summary. The focus is on the device's overall performance validation against standards.

Ask a specific question about this device

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.

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.

Ask a specific question about this device