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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.

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