(75 days)
Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age with cuff circumference of 13.5 - 21.5 cm.
The wrist-type Fully Automatic Digital Blood Pressure Monitor uses an inflatable cuff which is wrapped around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by "oscillometric method" and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure in the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minutes. There is a maximum pressure safety setting at 300 mmHg, the device will not inflate the pressure of cuff higher than 300 mmHg.
For BP-2220, BSP-22, 120 memories are divided into two groups as the predicate device BP-2206, with 60 memories each group. For BP-2116, BSP-21, 120 memories are for one group. For BP-2116, BP-2220, BSP-21, BSP-22, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic and pulse rate information. BP-2220 , BSP-21 , BSP-22 can calculate the average of the last three measurements as the predicate device BP-2206. BP-2220, BSP-21, BSP-22 will display an irregular heartbeat symbol "(♥)" if an irregular heartbeat was detected during the measurement process. BP-2116 cancels Irregular Heartbeat Detection and "Last 3 results average". For BP-2220, BSP-22, there are 3 optional functions and there is 2 optional functions for BSP-21 as BP-2206, and there is no optional function for BP-2116.
The devices are all designed and manufactured according to AAMI / ANSI / IEC 80601-2-30:2009, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
The document describes a 510(k) submission for the Sejoy Electronics & Instruments Co., Ltd. Wrist - Type Fully Automatic Digital Blood Pressure Monitors (models BP-2116, BP-2220, BSP-21, BSP-22). The submission aims to demonstrate substantial equivalence to a predicate device (Blood Pressure Monitor, Model BP-2206, K121355).
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that clinical tests were performed to comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.
While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in a table within this document, ISO 81060-2 outlines detailed requirements for blood pressure device accuracy. Generally, for blood pressure measurement devices, the acceptance criteria are related to:
- Mean Difference: The average difference between the device readings and reference measurements (typically auscultation with a sphygmomanometer performed by trained observers). The standard usually requires this to be within a few mmHg (e.g., ±5 mmHg).
- Standard Deviation (or Variance): The variability of these differences. The standard usually requires this to be below a certain threshold (e.g., 8 mmHg).
- Individual Differences: A certain percentage of individual differences must fall within predefined limits.
The document reports that the "Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01." This statement serves as the reported device performance, indicating that the device met the specified accuracy criteria defined by the ISO standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical validation study. ISO 81060-2, however, specifies minimum sample sizes for clinical validation (e.g., typically a minimum of 85 subjects with specific distributions across age, gender, and blood pressure ranges). The assertion of compliance implies these minimums were met.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Clinical validation studies according to ISO 81060-2 are typically prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: The document does not explicitly state the number of experts used. However, for clinical validation studies of blood pressure devices generally performed according to ISO 81060-2, at least two trained observers (experts) are required to take independent auscultatory measurements simultaneously to establish the reference blood pressure.
- Qualifications of Experts: The document does not explicitly state the specific qualifications of the experts. In the context of ISO 81060-2, these experts would typically be trained clinicians (e.g., physicians, nurses, or technicians) competent in the auscultatory method of blood pressure measurement.
4. Adjudication Method for the Test Set
- Adjudication Method: The document does not explicitly describe the adjudication method. For blood pressure validation studies using two observers, if there are significant disagreements between their readings, a third observer might be involved, or a specific predefined method for resolving discrepancies is used (e.g., averaging, excluding outliers). ISO 81060-2 provides guidelines for such situations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This document pertains to a blood pressure monitor, which is a measurement device, not an imaging interpretation tool. Therefore, an MRMC study with "human readers improve with AI vs without AI assistance" is not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the clinical validation described is essentially a standalone performance assessment of the device's accuracy against a known reference standard (auscultatory measurements). The device operates automatically without direct human intervention in the measurement process after initiation. The comparison is between the automated device's output and the expert human measurements, making it an assessment of the algorithm/device's performance on its own.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used is expert auscultatory blood pressure measurements. These are considered the gold standard for clinical validation of automated blood pressure devices according to ISO 81060-2.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not provide information about a training set size. Blood pressure monitors typically do not involve "training sets" in the same way as AI/ML algorithms that learn from data. The device's algorithm for determining blood pressure (oscillometric method) is typically pre-programmed and validated, rather than continuously "trained" on new data in the field.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: As there's no mention of a traditional "training set" in the context of an AI/ML algorithm that learns from data, this question is not applicable in the same way it would be for an AI-powered diagnostic tool. The "ground truth" for calibrating or developing the oscillometric algorithm during its initial design would have been established through controlled experimental settings and comparisons to invasive arterial measurements or highly accurate auscultatory methods. However, this document pertains to the validation of a finished device against the ISO standard, not its internal development process.
§ 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).