(126 days)
Arm Type Automatic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.
The proposed device, Arm Type Automatic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
The proposed device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.
The proposed blood pressure monitor includes 9 models, which are BP310A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, and BP-JC312. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
The provided document describes the acceptance criteria and a clinical study conducted for the Arm Type Automatic Blood Pressure Monitor to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The clinical accuracy of the device was evaluated according to the standard ISO 81060-2:2013, "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type." While the document states the device complies with the standard requirements, it does not explicitly list the detailed acceptance criteria and reported device performance from the ISO 81060-2:2013 standard within the provided text.
However, based on the general information provided for blood pressure monitors, the key performance metrics and their accuracies are stated:
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Blood Pressure Accuracy | ± 3 mmHg |
| Pulse Rate Accuracy | ± 5% |
2. Sample Size Used for the Test Set and Data Provenance
The document states that a clinical investigation was conducted according to ISO 81060-2:2013. The ISO 81060-2 standard specifies a minimum of 85 subjects for clinical validation. Although the exact number used in this specific study is not explicitly mentioned, it can be inferred that at least 85 subjects were used to comply with the standard.
- Sample Size for Test Set: Not explicitly stated, but ISO 81060-2:2013 requires a minimum of 85 subjects.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "clinical investigation... has been conducted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ISO 81060-2 standard requires that the simultaneous auscultation method, performed by human observers, serves as the reference standard (ground truth). This typically involves multiple trained observers.
- Number of Experts: Not explicitly stated in the document, but ISO 81060-2:2013 generally requires at least two experts (trained observers) for simultaneous auscultation.
- Qualifications of Experts: Not explicitly stated. For ISO 81060-2, the observers must be trained and validated against a mercury sphygmomanometer.
4. Adjudication Method for the Test Set
The ISO 81060-2 standard (which this study followed) uses a simultaneous auscultation method where mercury sphygmomanometers are used in conjunction with the test device. This involves multiple observers (typically two) taking measurements simultaneously and independently. If there's a significant discrepancy between their readings, a third observer might be involved or the measurement discarded.
- Adjudication Method: Implicitly, the method follows the procedures outlined in ISO 81060-2 for simultaneous auscultation, which includes specific rules for reconciling or handling differences between observers' readings to establish the reference blood pressure. This could be considered akin to a 2-observer consensus (or 2+1 if required) process for establishing ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This document describes the validation of a non-invasive blood pressure monitor, which is a standalone measurement device, not an AI-assisted interpretation tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was done. The clinical investigation directly assessed the accuracy of the automated blood pressure monitor against the reference standard (human auscultation) without human interpretation of the device's output influencing the measurement. The device's "algorithm only" performance (the oscillometric technique's ability to measure blood pressure) is what was validated.
7. The Type of Ground Truth Used
The ground truth used for the clinical validation was expert consensus (or reference) measurements obtained via simultaneous auscultation using mercury sphygmomanometers, as mandated by the ISO 81060-2 standard.
8. The Sample Size for the Training Set
The document does not provide information about a specific training set or its sample size. This type of blood pressure monitor relies on a pre-defined oscillometric algorithm. While the algorithm itself would have been developed and potentially refined using a dataset, information on this "training set" is not part of this medical device submission document, which focuses on the validation of the final product.
9. How the Ground Truth for the Training Set Was Established
As no information is provided about a training set, the method for establishing its ground truth is also not available in this 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).