(111 days)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
The 2006-2B, 2006, 2006, 2005 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement. The measurement results including diastolic, systolic pressures and heart pulse rate are displayed on the LCD. The proposed device equipped with Bluetooth transmission function, which enable user to transmit the measurement results from the device to a mobile phone through Bluetooth. Users can manage the measurement results by the mobile application.
The provided 510(k) summary describes the acceptance criteria and the study that proves the Bioland Technology Ltd. Blood Pressure Monitor (models 2005, 2006, 2006-2, 2006-2B) meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The core clinical performance acceptance criteria for the Blood Pressure Monitor are derived from the ISO 81060-2 standard ("Non-Invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type"). While the document states "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards," it doesn't explicitly list the numerical acceptance criteria from ISO 81060-2 within the summary. However, based on common interpretations of ISO 81060-2 for blood pressure monitors, the key performance metrics involve accuracy and standard deviation for both systolic and diastolic blood pressure.
A general understanding of typical ISO 81060-2 requirements suggests the following for blood pressure:
- Mean difference: within ±5 mmHg
- Standard deviation: ≤ 8 mmHg
The document only states "The subject device complies with the applicable requirements set forth in the referenced performance standard" for performance and clinical testing, implying these ISO-defined criteria were met. For pulse rate, the non-clinical comparison table mentions "Pulse Rate: Within ±5%," which is a direct performance claim.
| Criterion Type | Acceptance Criteria (typically from ISO 81060-2 and product specification) | Reported Device Performance (Summary statement) |
|---|---|---|
| Blood Pressure | Clinical Accuracy (ISO 81060-2): |
- Mean difference: ≤ ±5 mmHg
- Standard deviation: ≤ 8 mmHg | Assessed to meet the requirements of clinical accuracy per the referenced standards (ISO 81060-2). Explicit numerical values for mean difference and standard deviation are not provided in this summary, but compliance with the standard implies these criteria were met. |
| Pulse Rate Accuracy | Within ±5% (as per non-clinical comparison table) | "Pulse Rate: Within ±5%" (This is listed under "Measuring accuracy" in the non-clinical comparison table, implying both predicate and subject meet this. The clinical study also assesses repeatability.) The clinical study summary states "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards," which would include pulse rate. |
| Repeatability | (Criteria defined by ISO 81060-2 for repeatability) | Clinical accuracy and repeatability testing assessed to meet the requirements of clinical accuracy per the referenced standards. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: 86 subjects.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Clinical studies for device approval are almost universally prospective, but this is not explicitly confirmed here. The manufacturer is based in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish the ground truth. Clinical validation of automated sphygmomanometers per ISO 81060-2 typically involves simultaneous auscultatory measurements by trained observers (at least two) as the reference method. However, this detail is missing from the summary.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method. For ISO 81060-2, it would typically involve comparing measurements from two (or more) trained observers to ensure high inter-observer agreement, or using standardized automated devices as a reference.
5. 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
This section is not applicable to this device. This is a standalone diagnostic device for blood pressure measurement, not an AI-powered image analysis or diagnostic aid requiring human reader comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The clinical testing described as "Clinical accuracy and repeatability testing" against the ISO 81060-2 standard is a standalone assessment of the device's algorithmic performance. The device provides automatic measurements without requiring human interpretation of raw data.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for blood pressure measurement in ISO 81060-2 studies is typically established by simultaneous measurements using a reference method, usually auscultatory measurements performed by trained human observers using a mercury or an appropriate non-invasive sphygmomanometer. The document states it meets ISO 81060-2, implying this method was used, but does not explicitly detail it.
8. The Sample Size for the Training Set
The document does not provide any information about a training set. This device is likely based on established oscillometric principles and does not typically involve machine learning requiring large training datasets in the same way an AI diagnostic algorithm would. The "clinical testing" described here is for validation, not training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or directly implied for this type of device, this information is not applicable.
§ 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).