(50 days)
HL858TA 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 upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.
HL858TA 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.
HL858TA 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 upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 17 inches (approx.23 cm to 43 cm) and for home use.
The device will display a symbol ( 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.
The provided document describes the K161156 premarket notification for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858TA. This device is a non-invasive blood pressure measurement system.
Here's the breakdown of the acceptance criteria and study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The key performance acceptance criteria for non-invasive blood pressure monitors are typically defined by recognized standards like ISO 81060-2. The document explicitly states compliance with ISO 81060-2. This standard specifies limits for the mean difference and standard deviation between the device's measurements and reference measurements.
While the exact numerical thresholds specified by ISO 81060-2 are not explicitly listed in this FDA summary document, the summary states:
| Acceptance Criteria (Based on ISO 81060-2) | Reported Device Performance (HL858TA) |
|---|---|
| Required limits for mean difference and standard deviation (between device & reference measurement) for blood pressure and pulse rate (as per ISO 81060-2) | Fulfilled by the subject device HL858TA |
In addition to the clinical validation, the device also meets the following technical performance criteria, which are often derived from predicate device performance and relevant standards:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pressure Measurement Range: 0-300mmHg | Same (0-300mmHg) as predicate device |
| Pulse Measurement Range: 40-199 Beats/minute | Same (40-199 Beats/minute) as predicate device |
| Pressure Accuracy: ± 3mmHg | Same (± 3mmHg) as predicate device |
| Pulse Accuracy: ± 5% | Same (± 5%) as predicate device |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 105 subjects (used for the clinical investigation compliant with ISO 81060-2).
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Clinical validation studies for these types of devices are typically prospective in nature, as they involve actively taking measurements on subjects under controlled conditions to compare against a reference method.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth. However, for a clinical validation compliant with ISO 81060-2, the ground truth is established by simultaneous measurements using a reference standard, usually by trained operators (e.g., medical professionals using a mercury sphygmomanometer or an equivalent calibrated method). The standard specifies the requirements for these reference measurements and the personnel performing them.
4. Adjudication method for the test set
The document does not mention an adjudication method in the context of human readers or image interpretation, as this device measures physiological parameters directly. For blood pressure measurements, the "adjudication" is inherent in the direct comparison against a reference standard measurement, often performed simultaneously by a trained human operator.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic imaging devices where human interpretation is involved. The HL858TA is a direct measurement device and does not involve human interpretation of complex images aided by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the algorithm without human interaction. For this device, the "algorithm" is the oscillometric method and its processing of the pressure signals to determine BP and heart rate. The clinical validation described in the document (ISO 81060-2) directly assesses the performance of this algorithm in a standalone manner (albeit with a human applying the cuff and initiating the measurement), comparing its output to a reference standard. Therefore, a standalone performance assessment was done.
7. The type of ground truth used
The ground truth used was simultaneous measurements by a validated reference method (e.g., mercury sphygmomanometer) as per the requirements of ISO 81060-2. This is a form of direct physiological measurement ground truth, not pathology, outcomes data, or expert consensus (in the sense of interpreting subjective data).
8. The sample size for the training set
The document does not specify the sample size for a training set. This is because the device is not based on machine learning in the conventional sense (where a model is "trained" on a large dataset). It uses an established oscillometric method. Its calibration and internal algorithms are based on fundamental principles of blood pressure measurement, rather than a data-driven training process that requires a distinct "training set."
9. How the ground truth for the training set was established
As there is no "training set" in the machine learning sense, there is no ground truth established for it. The device's underlying principles are based on established biophysics and engineering, validated through rigorous clinical testing on a test set (as described in point 2).
§ 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).