(391 days)
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:
| Parameter | Acceptance Criteria (Implied by standard compliance and predicate comparison) | Reported Device Performance (for all listed models) | Predicate Device Performance |
|---|---|---|---|
| Measurement Pressure Range | Typically defined by the standard. | 0 ~ 280 mmHg (0 kPa ~ 37.3 kPa) | 0 mmHg ~ 299 mmHg (0 kPa ~ 39.9 kPa) |
| Pressure Range Accuracy | ±3 mmHg (±0.4 kPa) or higher (as per ISO 81060-2 for mean and standard deviation) | ±3 mmHg (±0.4 kPa) | ±3 mmHg (±0.4 kPa) or 2% of reading |
| Measurement Pulse Range | Typically defined by the standard. | 40 ~ 200 beats/min | 40 ~ 180 beats/min |
| Pulse Accuracy | ±5% of reading value (as per ISO 81060-2) | ±5% of reading value | Within ±5% of reading |
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.
§ 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).