Search Results

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:

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.

Ask a specific question about this device

Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult at household or medical center. (Not suitable for neonate, pregnancy or pre-eclampsia).

The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The series will automatically starting to take measurements after the inflation of the cuff finished, the results will show the systolic pressure and diastolic pressure and pulse rate. The monitor will store the measurements automatically, which including the time, date, blood pressure and pulse. The record could be revisited. Total 74 sets of data could be stored for YE670A, 60 sets of data for YE670D, 60 sets of data for YE650A, 80 sets of data for YE650D and 74 sets of data for YE660B.

The provided text describes the 510(k) premarket notification for a series of Upper Arm Type Electronic Blood Pressure Monitors (YE650A, YE650D, YE660B, YE670A, and YE670D). The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through novel clinical study data.

Therefore, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML or diagnostic device that would typically involve a test set, ground truth, expert consensus, or MRMC studies. This is a blood pressure monitor, and its performance acceptance criteria are typically met through validation against recognized standards like ANSI/AAMI/ISO 81060-2 and IEC 80601-2-30.

Here's an analysis based on the provided text, focusing on what is stated or implied about performance validation for this type of device:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for blood pressure monitors are established by international standards. The document states that the Performance of the devices (YE650A, YE650D, YE670A, YE670D, and YE660B) meets:

• ANSI/AAMI/ISO 81060-2
• IEC 80601-2-30

These standards specify the accuracy requirements for non-invasive sphygmomanometers. While the document doesn't explicitly present a table of acceptance criteria and reported performance values from a clinical study for these specific devices, it does provide the following specifications and states they comply with the standards:

The core "proof" of meeting acceptance criteria for this device type, as documented here, is the declaration of compliance with these recognized international standards. These standards encompass the clinical validation of blood pressure measuring devices.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size or data provenance (e.g., country of origin, retrospective/prospective) for the clinical validation studies that would have been conducted to demonstrate compliance with ANSI/AAMI/ISO 81060-2. These details are typically found in the full test reports, which are not part of this summary document. For ISO 81060-2, a specific number of subjects (e.g., typically at least 85 subjects with a certain distribution of blood pressures) are required for the clinical validation test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable in the context of a blood pressure monitor's clinical validation. The "ground truth" for blood pressure measurements in validation studies (per ISO 81060-2) involves simultaneous auscultatory measurements performed by trained observers (often two observers for redundancy and comparison), against which the device's readings are compared. It's not about expert interpretation of an image or signal.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable in the sense of image interpretation adjudication. For blood pressure validation per ISO 81060-2, the method involves comparing the device's readings to those obtained by two trained auscultatory observers, often with a third observer or specific rules for resolving discrepancies if the initial two observers differ beyond a defined threshold. The standard specifies statistical analysis methods (e.g., Bland-Altman plots, mean difference, standard deviation) to assess agreement.

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

Not applicable. This is a standalone diagnostic device for blood pressure measurement, not an AI-assisted diagnostic tool that aids human readers in interpreting complex medical images or signals.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a sense. Blood pressure monitors operate largely as "standalone" automated devices. The performance evaluation (compliance with ISO 81060-2) assesses the device's accuracy in measuring blood pressure values independently, which are then displayed to the user. There isn't an "algorithm only" vs. "human-in-the-loop" distinction in the same way as for, say, an AI diagnostic aid. The device itself is the "algorithm" providing the measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for non-invasive blood pressure monitors, as defined by ISO 81060-2, is typically simultaneous auscultatory measurements performed by trained and certified observers using a calibrated sphygmomanometer and stethoscope. This is considered the clinical gold standard for non-invasive blood pressure.

8. The sample size for the training set

Not applicable in the traditional sense of AI/ML training sets. Blood pressure monitors use established algorithms based on oscillometric principles, not machine learning algorithms trained on large datasets. The device's underlying algorithm is developed and refined by the manufacturer, but there isn't a "training set" like there would be for an AI model.

9. How the ground truth for the training set was established

Not applicable for the same reasons as point 8. The "ground truth" for the development of the oscillometric algorithm itself would be based on fundamental physiological principles and extensive engineering validation, likely drawing from datasets of pressure waveforms, but not a "training set" in the context of expert-labeled data for an AI model.

Ask a specific question about this device