(119 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
The 2008, A221-2 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic, diastolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement. The measurement results including diastolic, systolic pressures and heart pulse rate are displayed on the LCD.
Here's an analysis of the provided text regarding the acceptance criteria and study for the blood pressure monitor, organized according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is gauged against established international standards. The most relevant standard for clinical accuracy is ISO 81060-2:2018.
| Acceptance Criteria (from ISO 81060-2:2018) | Reported Device Performance (from Clinical Testing) |
|---|---|
| Clinical accuracy and repeatability requirements as per ISO 81060-2:2018 | The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards. (Verdict: Pass) |
| Pressure Measurement Accuracy: Within ± 3mmHg | Within ± 3mmHg (Also listed in "Substantial Equivalence table") |
| Pulse Rate Measurement Accuracy: Within ± 5% | Within ± 5% (Also listed in "Substantial Equivalence table") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 86 subjects.
- Data Provenance: The clinical data for the subject device (2008, A221-2) came from a clinical report of its predicate device (model: 2005, K number: K201467). The document does not specify the country of origin of this clinical data, nor does it explicitly state if the study was retrospective or prospective. However, given that it's a clinical validation study for a medical device according to a standard, it is highly probable that it was a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the clinical study. ISO 81060-2:2018, the referenced standard for clinical accuracy, typically outlines requirements for independent observers and reference measurement methods, often involving trained clinicians using auscultation for comparison.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used for the clinical study. Clinical validation studies for blood pressure monitors following ISO 81060-2 typically involve multiple observers taking reference measurements (e.g., auscultation) to compare against the automated device, and often mechanisms for resolving discrepancies. However, specific details are not provided here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. This type of study is more common for imaging diagnostics where multiple human readers interpret cases. The clinical study performed here focuses on the accuracy and repeatability of the device itself against established reference methods per ISO 81060-2.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The clinical accuracy and repeatability testing, based on ISO 81060-2, assesses the device's performance directly in measuring blood pressure and pulse rate without human-in-the-loop assistance for the measurement process itself. The document states "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." This refers to the device operating autonomously to take measurements.
7. The Type of Ground Truth Used
The ground truth for the clinical accuracy study would have been established by a reference method as stipulated by ISO 81060-2. This typically involves simultaneous auscultatory measurements performed by trained observers (often two) using a mercury sphygmomanometer or another validated reference device, compared against the readings from the automated blood pressure monitor.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This type of information is usually relevant for AI/ML-based devices. For a non-invasive blood pressure monitor, the "algorithm" refers to the signal processing and oscillometric method used to derive blood pressure values, which is based on established physiological principles and engineering, rather than a trainable machine learning model in the conventional sense that would require a distinct training set. The device's "algorithm" (the software algorithm for measurement) is stated to be the same as the predicate, suggesting it's a fixed algorithm, not one that undergoes iterative training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.
§ 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).