(243 days)
The blood pressure monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm-32 cm. It is intended to be used in hospital environment or at home.
The Arm-type Electronic Blood Pressure Monitor is a battery powered automatic non-invasive blood pressure monitor, of which BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, and BSX523 is powered by 3.7V 400mAh Li-ion Battery. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The difference between the six models include the battery type and the backlight indicator. BSX516, BSX525, BSX583, BSX593 and BSX595 are powered by 4x1.5V AAA Alkaline Battery, while BSX523 is powered by 3.7V 400mAh Li-ion Battery. Moreover, the subject device is equipped with backlight indicator except models BSX516 and BSX525. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed Arm-type Electronic Blood Pressure Monitor share the similar software, measurement principle and NIBP algorithm. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use.
The provided text describes the 510(k) premarket notification for an Arm-type Electronic Blood Pressure Monitor (K183058) from Shenzhen BSX Technology Electronics Co., Ltd. Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document references compliance with several international standards which inherently contain acceptance criteria for the respective tests. However, it does not explicitly present a table detailing specific numerical acceptance criteria and the device's reported performance against each. Instead, it states that "all testing passed pre-specified criteria."
The most directly comparable performance criteria mentioned are related to accuracy, in comparison to the predicate device:
| Performance Metric | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Accuracy (Static Pressure) | ±3 mmHg | ±3 mmHg (stated as "Same" as predicate) |
| Accuracy (Pulse) | ±5% | ±5% (stated as "Same" as predicate) |
| Blood Pressure Measurement Range | 30 ~ 280 mmHg (Predicate) | 0 ~ 299 mmHg (Proposed Device) |
| Pulse Rate Measurement Range | 40 - 199 bpm (Predicate) | 40 - 180 bpm (Proposed Device) |
Note: While the proposed device's measurement ranges differ, the document concludes that these are "minor differences, which do not raise different questions of safety or effectiveness," implying they still meet acceptable performance for the intended use. The critical accuracy metrics (static pressure and pulse) are identical to the predicate device.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document states that "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard specifies requirements for the number of subjects (typically a minimum of 85 subjects with specific demographic distribution) for clinical validation of automated non-invasive sphygmomanometers. While the exact number of subjects tested for this specific submission is not explicitly stated, the reference to the standard implies adherence to its sample size requirements.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that this is a 510(k) submission for a medical device by a Chinese company (Shenzhen BSX Technology Electronics Co., Ltd.), it is highly probable that the data originated from studies conducted in China. Clinical validation studies according to ISO 81060-2 are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical test set. For a blood pressure monitor, ground truth is typically established by simultaneous auscultatory measurements performed by trained and certified observers according to specific protocols (e.g., those outlined in ISO 81060-2).
4. Adjudication method for the test set
The document does not explicitly mention the adjudication method. However, for a clinical validation study of an automated sphygmomanometer according to ISO 81060-2, the ground truth is established by simultaneous auscultatory measurements, typically by two independent observers blinded to each other's readings and ideally to the automated device's readings. If there's a discrepancy, a third observer might be involved, or a pre-defined adjudication process would be followed, but these specifics are not detailed in the provided text.
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 the described device. The device is an "Arm-type Electronic Blood Pressure Monitor," which is an automated measurement system, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is applicable and describes the primary performance evaluation. The device is a standalone automated blood pressure monitor. Its performance, as evaluated against the ISO 81060-2 standard, inherently assesses the algorithm's (and the device's overall system's) ability to accurately measure blood pressure without human intervention other than proper placement and initiation of the measurement. The clinical data section confirms this: "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
7. The type of ground truth used
For the clinical validation, the ground truth for blood pressure measurements is established through simultaneous auscultatory measurements performed by trained observers, as specified by the ISO 81060-2 standard. This is the universally accepted reference method for validating automated blood pressure monitors.
8. The sample size for the training set
This information is not provided. The document focuses on regulatory submission requirements for safety and effectiveness, not on the developmental aspects of the device's algorithm, which would involve a training set. For an oscillometric blood pressure monitor, the "training set" would refer to the data used to develop and refine the proprietary oscillometric algorithm. This data is part of the manufacturer's internal development process and is typically not disclosed in a 510(k) summary, which focuses on validation.
9. How the ground truth for the training set was established
This information is not provided. Similar to the training set sample size, the specifics of algorithm development and the establishment of ground truth for that process are proprietary and not typically included in a public 510(k) summary. It would involve a similar process of comparing oscillometric waveforms to simultaneously obtained auscultatory or invasive blood pressure readings in a large and diverse patient population to train and validate the algorithm.
§ 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).