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The upper arm blood pressure monitor is used for non-invasive measurement and monitoring of adults' arterial blood pressure. You can use it to measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the upper arm. Quickly and easily, storing the results and displaying the progression of readings together with the average.

Device Description

Digital Automatic Blood Pressure Monitor BPM28 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Grandway Technology (Shenzhen) Limited Digital Automatic Blood Pressure Monitor BPM28 Series:

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (BPM28 Series)	Comment
Indication for Use	Non-invasive measurement and monitoring of arterial blood pressure in adults.	Non-invasive measurement and monitoring of adults' arterial blood pressure. Measure systolic, diastolic, and pulse rate. Store results, display progression, and average.	Equivalent. The BPM28 Series provides additional functionality of storing results and displaying progression/average, which is a feature enhancement and not a deviation from the core indication.
Measurement Method	Non-invasive, Oscillometric	Non-invasive, Oscillometric	Identical
IHB Detection	Yes	Yes	Identical
Patient Population	Age 16 or above	Age 16 or above	Identical
BP Measurement Range - Cuff Pressure	0 - 300 mmHg	0 - 300 mmHg	Identical
BP Measurement Range - Systolic	50 - 250 mmHg	50 - 250 mmHg	Identical
BP Measurement Range - Diastolic	30 - 200 mmHg	30 - 200 mmHg	Identical
Number of Users	2 independent users	2 independent users	Identical
Memory Space	2 users × 120 memory space	2 users × 60 memory space	Equivalent. The memory space is smaller for the BPM28 Series, but this would likely be considered equivalent if the reduced memory doesn't negatively impact the intended use or safety. The document does not specify why this is acceptable, but for an over-the-counter device, 60 memory slots per user might be considered sufficient.
Resolution of Measurement - BP	1 mmHg or 0.1 kPa	1 mmHg	Identical. The "or 0.1 kPa" might be a unit conversion, so 1 mmHg is the primary specification.
Resolution of Measurement - Pulse	1 beat/min	1 beat/min	Identical
Blood Pressure Measurement Accuracy	± 3 mmHg or 2% of reading	± 3 mmHg	Equivalent. The predicate standard includes "or 2% of reading" which is often a more stringent requirement for higher blood pressure values. By only stating "± 3 mmHg", the BPM28 Series is meeting the absolute criteria, but it's important to note the slight difference in wording from the predicate. However, in the context of many blood pressure monitor standards (like AAMI/ISO), ±3 mmHg is a common primary accuracy criterion.
Pulse Rate Measurement Range	30 - 180 beats/min	40 - 180 beats/min	Equivalent. The lower limit for the pulse rate measurement is higher in the BPM28 Series (40 vs 30 beats/min). This could be considered a minor difference, potentially affecting patients with very low pulse rates, but for a general "adults" indication, it may be deemed clinically equivalent.
Pulse Rate Measurement Accuracy	± 5 % of the reading	± 5 % of the reading	Identical
Display Type	LCD	LCD	Identical
Power Source	4 × 1.5 V AAA-batteries; and/or AC adaptor (6V/600mA)	4 × 1.5 V AAA-batteries; and/or AC adaptor (6V/600mA)	Identical
Pressurization Mode	Automatic Inflation	Automatic Inflation	Identical
Deflation Mode	Automatic Exhaust/ Deflation	Automatic Exhaust/ Deflation	Identical
Operating Condition - Temperature	10 - 40 °C	+5 to +40 °C	Equivalent. The lower temperature limit is extended, but the upper limit remains the same.
Operating Condition - Humidity	30 - 85 % R.H. max	15 to 93 % R.H. max	Equivalent. The range of acceptable humidity is expanded for BPM28 Series.
Operating Condition - Pressure	700 - 1060 kPa	700 - 1060 kPa	Identical
Storage/Transport Condition - Temperature	-20 - 60 °C	-25 to +70 °C	Equivalent. The storage temperature range is notably wider for the BPM28 Series, indicating greater robustness to environmental conditions during storage and transport.
Storage/Transport Condition - Humidity	10 - 95 % R.H. max	up to 93% R.H. max	Equivalent. The upper limit for humidity is slightly reduced but within a similar range.
Storage/Transport Condition - Pressure	700 - 1060 kPa	700 - 1060 hPa	Identical (assuming kPa and hPa are equivalent units in this context; 1 kPa = 10 hPa, so there might be a unit error in the document, or it intends to say hPa for both which would be equivalent.) Given the context, it's likely a typo and intended to be equivalent.
Material	Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging	Resistances, capacitance, transistors, amplifiers, pressure sensor, CPU, PCB, cuff ABS button, ABS cabinet, batteries and packaging	Identical
Compatibility with Environment and Other Devices	No influence with environment and other device	No influence with environment and other device	Identical
Applicable Standards	EN 1060-1, EN 1060-3, IEC 60601-1, EN 60601-1-2, FCC Part 15 Subpart B, ISO 10993-5, ISO 10993-10, IEC 62304, IEC 81060-2:2009	EN 1060-1, EN 1060-3, IEC 60601-1, EN 60601-1-2, FCC Part 15 Subpart B, ISO 10993-5, ISO 10993-10, IEC 62304, IEC 81060-2:2013	Equivalent. The updated standard for IEC 81060-2 (2013 vs 2009) is a positive change, indicating compliance with a more recent version of the standard for non-invasive sphygmomanometers.

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 100 patients (46 males, 54 females)
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "Clinical Test report" and does not specify if it was retrospective or prospective, but the description of "patients were invited for the study" and "measurements were repeated alternatively" suggests a prospective design.
Number of Experts and Qualifications for Ground Truth:
- The document implies the "standard auscultation method" was used as the reference blood pressure measurement. This method involves a trained professional (e.g., doctor, nurse) using a stethoscope and sphygmomanometer. However, it does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). It relies on the inherent understanding of "standard auscultation method" implying qualified medical personnel.
Adjudication Method for the Test Set:
- Not applicable in the typical sense for a diagnostic device reviewing images or complex data. The "ground truth" (reference blood pressure) was established through the standard auscultation method, and the device measurements were compared against these. There is no mention of multiple experts adjudicating discrepancies between readings.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance to measure a change in diagnostic accuracy or efficiency. For a blood pressure monitor, the performance is compared against a gold standard measurement, not against human interpretation of the device's output.
Standalone (Algorithm Only) Performance:
- Yes, the clinical test described is essentially a standalone (algorithm only) performance assessment. The device's measurements are directly compared to the reference standard (auscultation) without human intervention in the device's measurement process or interpretation of its output.
Type of Ground Truth Used:
- Expert consensus/Reference Standard: The "standard auscultation method" performed by presumably trained medical professionals served as the ground truth. This is the established clinical method for accurate blood pressure measurement against which automated devices are validated.
Sample Size for the Training Set:
- The document does not specify a separate training set for the algorithm. For a device like a blood pressure monitor using oscillometric methodology, the core algorithm is typically developed and refined using extensive engineering and testing against physiological models and clinical data during R&D phases (which would constitute a large internal "training" process), but a distinct "training set" in the machine learning sense is not explicitly detailed in the regulatory submission summary provided. The clinical test described is a validation test (test set) for the final product.
How Ground Truth for the Training Set Was Established:
- As a distinct training set is not explicitly mentioned or quantified, how its ground truth was established is also not detailed. However, the oscillometric method itself is based on well-established physiological principles and previous generations of blood pressure monitors. The development would involve internal calibration and validation using reference sphygmomanometers and potentially human subjects, similar to the method used for the clinical validation.

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