(197 days)
Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Automatic Upper Arm Blood Pressure Monitor:
This document is a 510(k) Summary for a medical device called "Automatic Upper Arm Blood Pressure Monitor" (Model: BA-815, BA-816) by DONGGUAN E-TEST TECHNOLOGY CO., LTD. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document states: "All hardware and software of the subject device are based on that of the predicate device (K172895), since no new testing is presented in the submission." This means that the acceptance criteria and performance data presented implicitly refer to the predicate device, as the subject device is deemed identical.
Acceptance Criteria and Reported Device Performance
The device is a non-invasive blood pressure monitor. The performance criteria are defined by the standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type.
| Acceptance Criterion (from standards body) | Reported Device Performance (from comparison table) | Additional Details / Notes |
|---|---|---|
| Measuring Accuracy | Pressure: ± 3mmHg | This is a core accuracy requirement for blood pressure monitors, specifically for the measurement of pressure (systolic and diastolic). The device claims to meet this standard. |
| Pulse: ±5% | This is the accuracy requirement for pulse rate measurement. The device claims to meet this standard. | |
| Pressure Resolution | 1 mmHg or 0.1kPa | This indicates the smallest increment the device can display for pressure readings. This is a technical specification rather than a direct performance metric against a clinical standard, but it contributes to the overall measurement capability. |
| Measuring Range | Pressure: 0~280 mmHg | This specifies the operational range for pressure measurement. |
| Pulse: 40~199 beats/minute | This specifies the operational range for pulse rate measurement. | |
| Cuff Circumference | For BA-815: 22-34 cm; For BA-816: 28-42 cm; | While not a direct performance metric, proper cuff sizing is critical for accurate blood pressure measurement. These ranges align with standard adult and large adult arm circumferences. The predicate device also had similar cuff sizes for these models, and additional sizes for other predicate models (which are not subject devices). |
Study Details (Based on the predicate device's compliance with AAMI / ANSI / ISO 81060-2)
Since "no new testing is presented in the submission" and the subject device is identical to the predicate, the compliance is based on the predicate device's clinical validation to AAMI / ANSI / ISO 81060-2 Second Edition. This standard outlines the requirements for clinical validation studies for automated non-invasive sphygmomanometers. The details below are inferred requirements from that standard, as the specific clinical study report is not provided in this 510(k) summary.
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Sample Size used for the test set and the data provenance:
- Sample Size: The AAMI / ANSI / ISO 81060-2 standard generally recommends a minimum of 85 participants for clinical validation studies, with a balanced distribution across age groups, genders, and blood pressure ranges (normotensive, hypertensive, hypotensive) to ensure robustness. The document does not explicitly state the sample size used in the predicate's study.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Clinical validation studies according to AAMI are typically prospective in nature, conducted in a controlled clinical environment.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The AAMI / ANSI / ISO 81060-2 standard requires at least two trained observers (experts) to perform simultaneous auscultatory measurements using a mercury sphygmomanometer as the reference standard (ground truth). These observers should be blinded to each other's readings and to the device under test.
- The standard typically requires observers to be medically trained professionals (e.g., physicians, nurses) with demonstrated proficiency in indirect blood pressure measurement. Specific years of experience are not explicitly stated in the general overview of the standard but implied through training and certification. The document does not explicitly state the number or qualifications of experts for the predicate's study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The AAMI / ANSI / ISO 81060-2 standard outlines specific protocols for comparing the automated device readings against the auscultatory measurements. If the two observers' readings differ by more than a predefined threshold, a third observer ("2+1") or a repeat measurement might be required to establish the ground truth or resolve discrepancies.
- The document does not explicitly state the adjudication method used for the predicate's study, but a standard compliant study would have such a method.
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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 comparative effectiveness study was not done. This type of study is relevant for imaging analysis or diagnostic aids where human interpretation is assisted by AI. This device is an automated blood pressure monitor; it does not involve human "readers" or AI assistance for interpretation in the same way an imaging system would. It provides direct numerical outputs for blood pressure and pulse rate.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was done. The clinical validation per AAMI / ANSI / ISO 81060-2 is fundamentally a standalone clinical performance study. The automatic blood pressure monitor operates on its own, providing measurements, and its performance is compared directly against the reference standard (auscultatory method). There is no "human-in-the-loop" for the device's measurement process itself, although human interaction is required to apply the cuff and initiate the measurement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth used for validating the accuracy of non-invasive blood pressure monitors under AAMI / ANSI / ISO 81060-2 is simultaneous auscultatory measurement performed by trained human observers using a mercury sphygmomanometer. This is considered the clinical reference standard for indirect blood pressure measurement.
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The sample size for the training set:
- Since no new testing was performed for the subject device and it is stated that "All hardware and software of the subject device are based on that of the predicate device," there is no specific mention of a training set for the subject device or for the predicate device's original validation. Automated blood pressure monitors are often developed and calibrated using internal data, but the AAMI validation focuses on clinical performance rather than a 'training/test' split akin to machine learning models. If the device uses a machine learning algorithm, the training set details would typically be proprietary and not disclosed in a 510(k) summary (unless it directly impacts the safety and effectiveness and needs specific validation).
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How the ground truth for the training set was established:
- As there's no explicitly mentioned "training set" in the context of this 510(k) summary, the method for establishing its ground truth is not provided. For the initial development and calibration of such a device, ground truth would likely be established through a combination of simulated physiological signals and clinical data obtained using reference methods like direct intra-arterial measurements or auscultatory measurements.
§ 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).