(305 days)
Bokang Digital Blood Pressure Monitor, Model BK6001, Model BK6002 and Model BK6023 are non-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate by using an inflating cuff which is wrapped around the upper arm or wrist. The device is indicated for use in adults only.
Non-invasive blood pressure (NIBP) monitors which use a standard oscillometric measurement method and intend for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate for adults only.
Model BK6001 is a semi-auto digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by a manual air pump.
Model BK6002 is an automatic digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated automatically by an electrical air pump.
Model BK6023 is a wrist automatic digital non-invasive blood pressure monitors which respectively use an inflation cuff wrapped around the wrists. The cuff is inflated automatically by a electrical air pump.
The systolic, diastolic 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 rapidly and automatically released by a electric valve at a constant rate after the measurement. The measurement results including diastolic, systolic pressure and heart pulse rate are displayed on the LCD. Besides the real-time display, the blood pressure and pulse values are also averaged, stored, and recalled from the last data.
The provided 510(k) summary for the Bokang Digital Blood Pressure Monitors (Models BK6001, BK6002, BK6023) indicates that the devices were tested to meet the requirements of the ANSI/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure Monitor Guidance."
Here's an attempt to break down the information, acknowledging that specific numerical acceptance criteria and a detailed study report are not explicitly provided in the given text. The document states that clinical studies were performed and "evaluated clinical bias, clinical uncertainty and clinical repeatability per the Bokang Clinical Test Protocol outline and meet the requirement of AAMI SP10." However, the exact performance values like accuracy (mean difference and standard deviation) or sensitivity/specificity are not presented.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Based on AAMI SP10):
While not explicitly stated in the document with specific numerical thresholds, the AAMI SP10 standard for non-invasive sphygmomanometers typically requires:
- Mean Difference (Bias): For systolic and diastolic blood pressure, the mean difference between the device and a reference standard (e.g., auscultation by trained observers) should be within ±5 mmHg.
- Standard Deviation (Precision): For systolic and diastolic blood pressure, the standard deviation of the differences should be no greater than 8 mmHg.
Reported Device Performance:
The document states that the devices "meet the requirement of AAMI SP10" and that "clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability." However, the actual numerical values for bias, standard deviation, clinical uncertainty, or repeatability are not provided in this summary. Therefore, a table with specific performance numbers cannot be created from the given text.
| Performance Metric | Acceptance Criteria (Typically AAMI SP10) | Reported Device Performance (from document) |
|---|---|---|
| Systolic BP | ||
| Mean Difference | ≤ ±5 mmHg | "meets the requirement of AAMI SP10" (No specific numerical bias reported) |
| Standard Deviation | ≤ 8 mmHg | "meets the requirement of AAMI SP10" (No specific numerical SD reported) |
| Diastolic BP | ||
| Mean Difference | ≤ ±5 mmHg | "meets the requirement of AAMI SP10" (No specific numerical bias reported) |
| Standard Deviation | ≤ 8 mmHg | "meets the requirement of AAMI SP10" (No specific numerical SD reported) |
| Pulse Rate | Typically ≤ ±5% or similar | Not specified beyond general statement of meeting AAMI SP10 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: "Controlled human clinical studies were conducted." The country of origin for the studies is not explicitly stated, but the company is located in Wenzhou, China, suggesting the studies were likely conducted there. The studies were prospective as they are described as "controlled human clinical studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document implies that the ground truth for blood pressure measurements in clinical studies would have been established by trained medical professionals (e.g., physicians or nurses) using a reference standard (such as auscultation). However, the number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not mentioned in the provided 510(k) summary.
4. Adjudication Method for the Test Set
- The specific adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth in the clinical studies is not described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done as described for typical AI device evaluations. This document describes a traditional medical device (blood pressure monitor) validation, not an AI system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance assessment was effectively done. The Bokang Digital Blood Pressure Monitors are standalone devices designed to automatically measure and display blood pressure and pulse rate. The clinical studies evaluated the device's performance without human intervention in the measurement process itself (beyond applying the cuff and initiating the measurement), comparing its output to a reference standard. The results of these tests, by demonstrating compliance with AAMI SP10, reflect the standalone performance of the algorithm.
7. The Type of Ground Truth Used
- The ground truth used for validating blood pressure monitors in clinical studies compliant with AAMI SP10 is typically reference blood pressure measurements obtained through auscultation (e.g., by a trained observer using a stethoscope and sphygmomanometer), often with multiple readings and potentially averaged. This is a form of expert standard or clinical gold standard rather than pathology or outcome data.
8. The Sample Size for the Training Set
- This device is a traditional non-invasive blood pressure monitor, not an AI/machine learning algorithm that requires a "training set." Therefore, the concept of a separate training set is not applicable to this device. The development and calibration would typically involve engineering tests and internal validation, but not a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, the concept of a "training set" and associated ground truth establishment is not applicable to this traditional medical device.
§ 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).