(175 days)
The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.
The Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor, comprised of the host machine and the wrist cuff. It can measure systolic and diastolic blood pressure and pulse rate of the adult person at wrist via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device can store 199 groups of measurement data for two users.
This document describes the regulatory approval of an Electronic Blood Pressure Monitor (Models HWA11, HWA10) by Shenzhen Jumper Medical Equipment Co., Ltd. The approval is based on demonstrating substantial equivalence to a predicate device (Omron Model BP6100, K182127).
The provided text does not contain detailed acceptance criteria or a comprehensive study plan with the specific information requested in the prompt (e.g., specific thresholds for accuracy, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC study details, etc.).
However, based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and the supporting study:
Implied Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily implied by conformance to international standards for blood pressure monitors and demonstration of statistical equivalence to a recognized measurement method.
Table of Acceptance Criteria and Reported Device Performance (Inferred from Text):
| Acceptance Criterion (Implied) | Reported Device Performance (HWA11 & HWA10) |
|---|---|
| Blood Pressure Accuracy: Conformance to ANSI/AAMI/ISO 81060-2:2013 statistical accuracy requirements for automated measurement type. | The clinical investigation "demonstrated that HWA11 performed equivalently to the auscultation method and is in conformance with ANSI/AAMI/ISO 81060-2:2013." Blood Pressure: Within ± 3mmHg (This is likely the manufacturer's specified accuracy, which the clinical study aimed to validate adherence to the standard). |
| Pulse Rate Accuracy: Conformance to relevant standards. | Pulse Rate: Within ± 5 % of reading (This is likely the manufacturer's specified accuracy, which the clinical study aimed to validate adherence to the standard). |
| Biocompatibility: Meet ISO 10993-1 requirements. | "Biocompatibility of patient-contacting materials per ISO 10993-1 requirements." (Tested and presumably met). |
| Electrical Safety, EMC, ESD: Meet relevant standards. | "Electrical safety, electromagnetic compatibility, and electrostatic discharge testing." (Tested and presumably met). |
| Software Verification & Validation: Meet V&V requirements. | "Software verification and validation." (Tested and presumably met). |
| Performance Verification: Acceptable performance of features. | "Performance verification testing to confirm acceptable performance of device features and functions" (e.g., measurement range, inflation/deflation methods). The device specifications included: Cuff pressure range 0 to 295mmHg, Pulse Rate: 40 to 199 beats/min. |
| Cleaning Verification: Retain performance after cleaning. | "Cleaning verification testing to confirm device retains its performance when cuff is cleaned with household detergents as may be required in home use environment." (Tested and presumably met). |
| Environmental Performance: Operation/Storage within specified conditions | Operating Conditions: 5 to 40 °C (41 to 104 °F), 15 to 85 %RH (non-condensing), 700 to 1060 hPa. Storage/Transport Conditions: -20 to 55 °C (-4 to 131 °F), 10 to 93 %RH (non-condensing), 700 to 1060 hPa. The text states these comply with IEC 60601-1, IEC 60601-1-11 and IEC 80601-2-30. |
Study Information (Extracted and Inferred):
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Sample size used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text mentions a "clinical investigation" but does not specify the number of subjects. However, for validation to ANSI/AAMI/ISO 81060-2:2013, a specific number of subjects (usually 85 for the initial phase, and more for specific populations) from a defined demographic (e.g., age and blood pressure ranges) are typically required.
- Data Provenance: Not explicitly stated, but clinical studies for such devices are typically prospective. The text does not mention the country of origin where the clinical study was conducted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: "Trained medical staff" were used for the auscultation method. ANSI/AAMI/ISO 81060-2:2013 guidelines require specific training and certification for these observers.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned. The ground truth was established by "trained medical staff" using the auscultation method, implying a direct comparison rather than a multi-reader consensus process for image interpretation.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was NOT done. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device. The "study" here refers to the clinical validation of its measurement accuracy compared to a standard reference method (auscultation), not a human-in-the-loop diagnostic improvement study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, this was a standalone performance study for the device. The study validated the "accuracy of blood pressure measurements by HWA11 based on an oscillometric method as compared to an auscultation method." This is the device's inherent performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Reference Method (Auscultation): The ground truth for blood pressure measurements was established using the "auscultation method using a calibrated sphygmomanometer by trained medical staff." This is considered the gold standard for clinical blood pressure measurement in such validation studies.
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The sample size for the training set:
- This is not applicable for this type of device and study. The device is a non-AI, oscillometric blood pressure monitor. It uses a defined algorithm, not a machine learning model that requires a "training set" in the common AI sense.
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How the ground truth for the training set was established:
- Not applicable (see point 7).
§ 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).