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510(k) Data Aggregation
(112 days)
HL158TB 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.
HL158TB 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 user tracking their blood pressure level.
HL158TB 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 ♥*~, 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.
The provided text describes the submission for a medical device called the "Full Automatic (NIBP) Blood Pressure Monitor, Model HL158TB." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (HL158TA, K160336).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document states that the subject device (HL158TB) and the predicate device (HL158TA, K160336) have the "same method of measurement, measure type, critical components (ex. air pump, sensor...) and algorithm." Therefore, the acceptance criteria and performance are implicitly aligned with the predicate device. The performance specifications are given in comparison to the predicate device.
| Item | Acceptance Criteria (based on Predicate Device HL158TA) | Reported Device Performance |
|---|---|---|
| Accuracy | Pressure ± 3mmHg | Same as predicate |
| Pulse ± 5% | Same as predicate | |
| Range of measurement | Cuff Pressure: 0~300mmHg | Same as predicate |
| Determination: 40~280mmHg (Blood Pressure) | Same as predicate | |
| Pulse: 40~199 Beats/minute | Same as predicate | |
| Inflation | Automatic Inflation (Air Pump) | Same as predicate |
| Deflation | Automatic Air Release Control Valve | Same as predicate |
| Pressure Changed Rate | 2~5mmHg/sec. | Same as predicate |
| Display | Liquid Crystal Digital | Same as predicate |
| Power Supply | 2 "AAA(LR03)(1.5V)" Alkaline Batteries | Same as predicate |
| Storage/Transport | -25°C~70°C, ≤93% R.H. | Same as predicate |
| Operating environment | 5°C ~ 40°C, 15% ~ 93% R.H., 700~1060 hPa | Same as predicate |
| Material | ABS housing and ABS keys | Same as predicate |
| Memory | 1*60, total 60 sets | Same as predicate |
| Cuff size | Wrist circumference approx. 135 ~ 195 mm | Same as predicate |
| Irregular Heartbeat | Yes (detection) | Same as predicate |
Note: While the "Risk Category Indicator" and "Error icon" have been updated, the core accuracy and measurement parameters remain the same, implying the HL158TB meets the same performance acceptance criteria for blood pressure and pulse accuracy as the predicate.
2. Sample size used for the test set and the data provenance:
The document states: "In ISO 81060-2 Second Edition 2013-05-01 Non-invasive sphygmomanometers-Part 2: Clinical validation of automated measurement type, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met."
However, this statement refers to the predicate device (K160336). The document explicitly says, "clinical study results can be transferred from the K160336 predicate to the subject device." Therefore, the clinical validation for the subject device relies on the predicate's study.
- Sample size: Not specified for the predicate device's clinical validation study, only that it followed ISO 81060-2 which has specific patient number requirements (e.g., typically at least 85 subjects with specific age and blood pressure distributions).
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not detailed in the provided text for the clinical study of the predicate device. The ISO 81060-2 standard typically involves trained observers for ground truth measurements (using auscultation), but their specific number and detailed qualifications are not provided here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not detailed in the provided text. ISO 81060-2 outlines a specific methodology for collecting reference blood pressure measurements (often including multiple observers), but the specific adjudication method (e.g., 2+1) is not explicitly mentioned here.
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:
This is not applicable. The device is a "Full Automatic Blood Pressure Monitor" which automatically measures blood pressure. It does not involve "human readers" or "AI assistance" in the context of interpreting medical images or complex diagnostic data. Its primary function is a direct measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the device is standalone. It is a "Full Automatic (NIBP) Blood Pressure Monitor." The clinical validation, transferred from the predicate device that followed ISO 81060-2, assessed the device's accuracy against reference measurements, which is an assessment of its standalone performance. The ISO 81060-2 standard is for the validation of automated sphygmomanometers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For blood pressure monitors validated according to ISO 81060-2, the ground truth is typically established by cuff auscultation (e.g., by trained observers using a mercury sphygmomanometer), considered the gold standard for non-invasive blood pressure measurement in clinical validation studies.
8. The sample size for the training set:
This information is not provided. The document discusses clinical validation, which is an evaluation of the device's performance, not the training of an algorithm in the machine learning sense. While the device utilizes an oscillometric algorithm, details about its development or any training data used are not disclosed. The primary claim for HL158TB's performance relies on the transfer of clinical study results from its predicate, which shares the "same... algorithm."
9. How the ground truth for the training set was established:
This information is not provided. As mentioned above, details about algorithm development or training data are not available in this document.
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