(39 days)
The CNAP Monitor 500 is intended for the monitoring of non-invasive continuous blood pressure and pulse rate in hospitals, clinical institutions, medical practices and outpatient settings. The device displays the blood pressure waveform and generates trends, beat numerics and alarms for the parameters blood pressure and pulse rate. The CNAP Monitor 500 is to be used for adults and pediatric patients from the age of 4 year and is to be operated by physicians and other medical professional staff.
The CNAP™ Monitor 500 is a device for continuous non-invasive blood pressure monitoring. The device measures continuous and oscillometric blood pressure as well as pulse rate. CNAP is a joint solution, where absolute blood pressure values are coming from an integrated OEM oscillometric blood pressure device and beat-to-beat changes as well as waveform are measured with the CNAP finger sensor. Finger-BP is automatically calibrated to absolute NIBP-values. Immediately after a NIBP, the CNAP computer puts systolic and diastolic finger BP on the same level as NIBP values. NIBP calibrations can be obtained ipsilateral as well as contralateral to the CNAP-cuff.
The CNAP Monitor 500 device is a non-invasive continuous blood pressure monitoring system. The provided text indicates that the device underwent functional and clinical performance testing to demonstrate equivalence to its predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that "Bench Testing (for continuous blood pressure measurement functionality)" and "Clinical Performance Testing (for oscillometric NIBP measurement functionality)" were conducted. However, it does not provide specific numerical acceptance criteria or detailed results for either of these tests. It only states that the device "has successfully undergone safety testing as well as functional testing to demonstrate equivalence to its predicate device." and "The results of this testing demonstrates that the device is safe and effective and substantially equivalent to its predicate device."
Without specific numerical criteria or performance metrics, a table cannot be accurately generated.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Clinical Performance Testing (for oscillometric NIBP measurement functionality)" but does not specify the sample size used for this test set or the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide information regarding the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed or described in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance Study:
The document discusses "Bench Testing (for continuous blood pressure measurement functionality)" and "Clinical Performance Testing (for oscillometric NIBP measurement functionality)," which suggest standalone performance evaluations. However, specific details about these studies and their outcomes (beyond general success and equivalence) are not provided. The device itself is an algorithm-driven monitor, implyiung its standalone performance is what was evaluated against the predicate.
7. Type of Ground Truth Used:
While the document states that clinical performance testing was done for oscillometric NIBP measurement, it does not explicitly define the "ground truth" used for these tests. For NIBP, the ground truth would typically be a more invasive or highly accurate reference measurement (e.g., intra-arterial blood pressure), but this is not specified. The phrasing "equivalence to its predicate device" implies the predicate device's measurements served as a reference point for comparison.
8. Sample Size for the Training Set:
The concept of a "training set" is usually associated with machine learning or AI model development. While the CNAP Monitor 500 uses algorithms (e.g., for beat-to-beat changes and waveform measurement, and automatic calibration), the document does not provide any information about a training set size or the development of such algorithms. It's possible the algorithms were developed and validated internally without a formally described "training set" in the context of this 510(k) summary.
9. How Ground Truth for the Training Set Was Established:
As no training set is described, the method for establishing its ground truth is also not mentioned.
§ 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).