(30 days)
HL158UA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx. 135 mm to 195 mm) and for home use.
HL158UA detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.
HL158UA automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging from 5.3 inches to 7.7 inches (approx.13.5 cm to 19.5 cm) and for home use.
The device will display a symbol wor ma, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, HL158UA has a built-in Wrist Position Guide. By holding START/STOP button, the display will illuminate with different icons that are designed to guide you move your wrist.
The provided text describes the 510(k) premarket notification for the Full Automatic (NIBP) Blood Pressure Monitor model HL158UA. While it mentions clinical and non-clinical tests were performed and met acceptance criteria, it does not provide a detailed breakdown of the acceptance criteria nor the specific results of a study to prove the device meets these criteria in the format requested.
The text focuses on demonstrating substantial equivalence to a predicate device (HL158VA K160557) by comparing specifications and listing standards the device complies with.
Here's a breakdown of what can be extracted and what information is missing from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device is compliant with ISO 81060-2: Second Edition 2013-05-01 "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type." This standard defines the acceptance criteria for clinical accuracy of automated sphygmomanometers. However, the document does not explicitly list the acceptance criteria from this standard in a table, nor does it present the specific performance results from the clinical validation study against those criteria.
It only states: "All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."
Based on the ISO 81060-2 standard, typical acceptance criteria for blood pressure monitors involve:
- Mean difference: The average difference between the device's readings and reference measurements (e.g., from a mercury sphygmomanometer).
- Standard deviation: The variability of these differences.
The typical acceptance criteria from ISO 81060-2 are:
- Mean difference ± Standard Deviation: ≤ ±5 mmHg for both systolic and diastolic blood pressure.
- Individual differences: Not more than 5 mmHg for a high percentage of measurements (e.g., 60% or 80%), and not more than 15 mmHg for nearly all measurements (e.g., 95%).
Since the document does not provide the specific reported device performance, I cannot fill in the "Reported Device Performance" column with actual numbers.
| Metric (based on ISO 81060-2) | Acceptance Criteria (from ISO 81060-2) | Reported Device Performance (Not provided in text) |
|---|---|---|
| Mean Difference (Systolic) | ≤ ±5 mmHg | Not provided |
| Standard Deviation (Systolic) | ≤ 8 mmHg | Not provided |
| Mean Difference (Diastolic) | ≤ ±5 mmHg | Not provided |
| Standard Deviation (Diastolic) | ≤ 8 mmHg | Not provided |
| Pulse Accuracy | ± 5% | Same as left (from comparison table) |
2. Sample size used for the test set and the data provenance
The document states compliance with ISO 81060-2 for clinical validation. This standard typically requires a minimum of 85 participants for clinical testing, covering a range of blood pressures and demographic characteristics.
- Sample size for the test set: Not explicitly stated, but inferred to be compliant with the minimum requirements of ISO 81060-2 (typically 85 subjects).
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). Clinical studies conforming to ISO standards are generally prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ISO 81060-2 standard requires that reference blood pressure measurements, which serve as the ground truth, be taken by two trained observers (experts) using auscultation with a mercury sphygmomanometer or an equivalent validated device. These observers must be trained and blinded to each other's readings and the results of the automated device.
- Number of experts: Not explicitly stated, but inferred to be at least two (as per ISO 81060-2).
- Qualifications of experts: Not specified (e.g., "radiologist with 10 years of experience"), but implied to be trained observers in blood pressure measurement as required by the ISO standard.
4. Adjudication method for the test set
The ISO 81060-2 standard specifies a method for comparing the automated device's readings with reference measurements taken by two trained observers. It typically involves averaging the two observers' readings or comparing discrepancies. If there's a significant difference between the two observers, a third observer might be involved, or the measurement discarded.
- Adjudication method: Not explicitly stated, but inferred to follow the methodology outlined in ISO 81060-2 for comparison against two independent observers' readings.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret images with or without AI assistance. The device in question is a non-invasive blood pressure monitor, and its validation revolves around direct measurement accuracy, not interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical validation described as compliant with ISO 81060-2 is inherently a standalone performance test for the device's algorithm. The standard assesses the device's ability to accurately measure blood pressure readings independently against a reference standard. While a human initiates the measurement, the accuracy evaluation focuses on the automated device's output.
7. The type of ground truth used
The ground truth for blood pressure monitors validated to ISO 81060-2 is established by expert auscultation measurements using a reference standard like a mercury sphygmomanometer. This involves trained observers listening to Korotkoff sounds.
- Type of ground truth: Expert auscultation measurements (reference standard blood pressure readings).
8. The sample size for the training set
The document does not provide information on a training set sample size. This is typical for a medical device cleared via substantial equivalence, especially for a blood pressure monitor. While the device's development likely involved internal data for calibrating the oscillometric algorithm, the 510(k) summary only focuses on the validation against established standards. The ISO 81060-2 standard is for clinical validation, not algorithm training.
9. How the ground truth for the training set was established
As no training set information is provided in the document, this cannot be answered. If a training set were used for algorithm development, its ground truth would typically be established similarly to the validation set—i.e., through expert auscultation or other highly accurate reference methods.
§ 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).