(207 days)
The Citizen CH-601A and CH-601B digital wrist sphygmomanometers are intended to be used for the oscillometric measurement of systolic blood pressure and pulse. They are intended to be sold over-the-counter.
The Citizen Ch-601A and CH-601B digital wrist sphygmomanometers are small handheld noninvasive blood pressure measurement systems that measure systolic and diastolic blood pressure and pulse from the user's left wrist. The units are contained in a hard plastic housing that contains a user interface panel and an adjustable wrist cuff. The user interface panel has a power switch, a start switch, and a liquid crystal display ("LCD") for displaying the systolic and diastolic blood pressure and pulse. The device measures blood pressure through the use of an automatically-inflating wrist cuff. The cuff automatically deflates during blood pressure measurement. The only difference between the CH-601A and the CH-601B is that the CH-601B has a memory function which displays the last blood pressure readout (but not the last pulse) when the system is turned on.
Here's an analysis of the provided text to extract the acceptance criteria and details of the study proving the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Citizen CH-601A/B) |
|---|---|---|
| Blood Pressure Range | 0 to 280 mm Hg | 0 to 280 mm Hg |
| Blood Pressure Accuracy | Greater of ± 3 mm Hg or ± 2% of reading | Greater of ± 3 mm Hg or ± 2% of the reading |
| Pulse Measurement Range | 40 to 200 pulses/minute | 40 to 200 pulses/minute |
| Pulse Measurement Accuracy | ± 5% of the measured pulse frequency | ± 5% of the measured pulse frequency |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Citizen submitted laboratory testing data to establish the accuracy of its Sphygmomanometers for comparison to the Omron predicate device." However, it does not specify the sample size used for this test set nor the provenance (e.g., country of origin, retrospective/prospective nature) of the data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. Blood pressure measurements are typically compared against a standard reference method (e.g., auscultatory method with a trained observer), but this detail is absent.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not mentioned. The document focuses on the device's standalone accuracy compared to a predicate device.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The document states, "Citizen submitted laboratory testing data to establish the accuracy of its Sphygmomanometers for comparison to the Omron predicate device." This indicates that the device's performance (accuracy for blood pressure and pulse) was directly measured and compared against the stated accuracy of the predicate device (Omron HEM-605).
7. Type of Ground Truth Used:
The document implies the ground truth for blood pressure and pulse accuracy was established through laboratory testing, likely by comparing the device's readings against a validated reference method (though the specific method is not detailed). It's not explicitly stated as expert consensus, pathology, or outcomes data. Given the nature of blood pressure measurement devices, the ground truth would typically be derived from a validated method of direct physiological measurement.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. This type of device (oscillometric sphygmomanometer) typically relies on established algorithms for signal processing and does not usually involve a "training set" in the machine learning sense for its core function.
9. How Ground Truth for the Training Set Was Established:
As no training set is mentioned for this device, information on how its ground truth was established is not applicable and therefore not provided in the document.
§ 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).