(206 days)
Belter Blood pressure meter is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
The Belter Blood pressure meter can automatically complete the inflation,deflation and measurement .which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 36cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa.
The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve and LCD. The subject device is powered by four AA alkaline batteries.
The device has a memory function that automatically stores up to 60 sets of the latest measurements. It can also display the latest measurement result.
The subject device embeds a Bluetooth that allows it to transport the measurement data to nearby receiving end.
The device also detects the appearance of irregular heartbeats during measurement. and gives a warning signal with readings.
The "Belter Blood pressure meter, Model: ePA-46B" is intended to measure systolic and diastolic blood pressure and pulse rate in adults, for use in medical facilities or at home, and to detect irregular heartbeats. The study demonstrating its performance and meeting acceptance criteria is based on conformance to regulatory and performance standards.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Belter Blood pressure meter are defined by the conformance to various international standards, including ANSI/AAMI SP10 for automated sphygmomanometers. The reported device performance metrics are directly against the stated accuracy requirements within these standards.
| Acceptance Criteria (from ANSI/AAMI SP10, and general accuracy for BP meters) | Reported Device Performance (Belter Blood pressure meter) |
|---|---|
| Pressure Accuracy: ±3 mmHg or 2% of reading (from predicate, similar to standard expectations) | Pressure Accuracy: ±3 mmHg (±0.4 kPa) |
| Pulse Rate Accuracy: ±5% | Pulse Rate Accuracy: ±5% |
| Measurement Range - Pressure: 0-299 mmHg (from predicate, similar to standard expectations) | Measurement Range - Pressure: 0-280 mmHg |
| Measurement Range - Pulse Rate: 40-180 bpm (from predicate, similar to standard expectations) | Measurement Range - Pulse Rate: 40-200 bpm |
| Cuff Size: (Predicate: 22-46cm) | Cuff Size: 22-36 cm |
| Conformance Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI SP10, ISO 10993-5, -10 | Conforms to: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI SP10, ISO 10993-5, -10, IEC60601-1-11, ISO 10993-1, ISO 10993-10, EN1060-1, EN1060-3, EN1060-4 |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the ANSI/AAMI SP10 standard (Manual, electronic, or automated sphygmomanometers, 2002/A1:2003) was followed. The EN1060-4 standard (Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated Non-invasive sphygmomanometers, 2004) was also followed.
These standards typically specify subject recruitment criteria and sample sizes for clinical validation studies (e.g., minimum of 85 subjects with specific blood pressure ranges for AAMI SP10). However, the specific sample size used for the test set for the Belter device is not explicitly stated in the provided document. Similarly, the data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the study appears to be a clinical validation against established reference methods (auditory auscultation by trained observers often used in these standards), the "ground truth" would be established by these trained observers. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in this document. Standard practice for AAMI SP10 typically involves two or three trained observers whose measurements are averaged or adjudicated.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used. However, given the reliance on standards like ANSI/AAMI SP10 and EN1060-4, these standards typically outline methods for comparing automated device readings to reference measurements (e.g., using two or three trained observers whose readings are within a specified tolerance, and if not, a third observer or an adjudication process is used). The document does not specify a "2+1, 3+1, none" adjudication method, but the adherence to the standards implies a structured approach for ground truth determination.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with imaging diagnostics or other AI-assisted detection tasks where human readers interpret data, and the AI's impact on their performance is measured. For a blood pressure monitor, the performance is assessed against a standard reference method, not by comparing human interpretation with and without AI assistance on complex cases.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The performance data presented and the conformance to standards like ANSI/AAMI SP10 and EN1060-4 refer to the device's accuracy in autonomously measuring blood pressure and pulse rate, without human intervention in the measurement process itself. The device is purely algorithmic in its core function of calculating BP from oscillometric data.
7. The Type of Ground Truth Used
The ground truth used for validating blood pressure monitors against standards like ANSI/AAMI SP10 and EN1060-4 is typically reference measurements obtained by trained observers using a calibrated auscultatory method (e.g., a mercury sphygmomanometer). This is considered the clinical 'gold standard' for non-invasive blood pressure measurement against which automated devices are compared. It's effectively an "expert consensus" or "expert reference" type of ground truth in a clinical setting.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" for the device. Automated blood pressure monitors like the Belter device are typically developed and calibrated based on established oscillometric algorithms and physical principles, rather than being "trained" on a dataset in the way a machine learning model would be. Calibration and internal testing would be part of the development process, but this is distinct from a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth would have been established. The device operates based on a pre-defined algorithm derived from established physiological principles of oscillometry and is then validated clinically.
§ 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).