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510(k) Data Aggregation
(136 days)
HL158UB automatically measures human's Systolic 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.
HL158UB 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.
HL158UB 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. Besides, HL158UB 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 HL158UB Full Automatic (NIBP) Blood Pressure Monitor and its compliance with regulatory requirements, including clinical and non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 81060-2:2013) | Reported Device Performance (HL158UB) |
|---|---|
| Accuracy: Pressure: ± 3 mmHg | Accuracy: Pressure: ± 3 mmHg |
| Accuracy: Pulse: ± 5% | Accuracy: Pulse: ± 5% |
| Clinical Study Compliance: Fulfillment of ISO 81060-2:2013 requirements for wrist-type blood pressure monitors for accuracy specification and performance. | "The clinical validation result demonstrates the subject blood pressure monitor fulfills the acceptance criteria therefore the accuracy specification and performance of the subject device is judged fully comply with the requirements of ISO 810601-2." |
| Usability Goals and Design Considerations: Conformity to usability goals and design considerations and risk criteria of medical devices in risk management procedures. | "The HL158UB demonstrates conformity to the usability goals and design considerations and risk criteria of medical device in risk management procedure by alleviating potential use errors and risk derived from real world experience. This ensures HL158UB is not only safe to use but also offers usability." |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study (Accuracy Test):
- Sample Size: 100 valid subjects.
- Data Provenance: Retrospective, conducted at Lohas Clinic in Taipei, Taiwan (R.O.C.), 2015-16.
- Usability Validation (Human Factors Test):
- Sample Size: 60 valid subjects (recruited across four target groups).
- Data Provenance: Prospective, conducted at Health & Life Co., Ltd. in Taipei, Taiwan (R.O.C.), 2018.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical accuracy test. It only mentions that the clinical study was conducted at Lohas Clinic and assessed compliance with ISO 81060-2:2013, which typically involves a comparison to a reference standard (e.g., auscultatory method by trained observers). However, no details on these observers are provided.
For the usability validation, the ground truth was based on observing user interactions and assessing if the device met usability goals and risk criteria as per IEC 62366-1, IEC 60601-1-6, and IEC 60601-1-11. This involves human factors engineers or usability specialists, but specific numbers and qualifications are not mentioned.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for the clinical accuracy study or the usability validation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a blood pressure monitor, not an AI-assisted diagnostic imaging tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the primary evaluation for the HL158UB blood pressure monitor (an algorithm-driven device) is inherently a standalone performance assessment. The "clinical study" described evaluates the device's accuracy against a recognized standard (ISO 81060-2:2013), which is a measure of its standalone performance in blood pressure measurement. The usability study also assesses the device's performance in interaction with users, without explicitly comparing it to human readers.
7. The Type of Ground Truth Used
- For Clinical Accuracy: The ground truth for blood pressure measurement accuracy would typically be established by a reference standard, such as auscultation (manual sphygmomanometry) performed by trained observers, as specified by standards like ISO 81060-2. While the document mentions compliance with ISO 81060-2, it does not explicitly state the specific ground truth method used beyond "clinical validation result."
- For Usability: The ground truth was based on observing user interactions and assessing the effectiveness, efficiency, ease of user learning, and user satisfaction against pre-defined usability goals and risk criteria. This is a form of empirical user performance data and expert evaluation.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set. The HL158UB is compared to its predicate device, HL158UA, and states that it uses the "same... algorithm." This suggests that the core algorithm may have been developed and "trained" (in a broader sense, if it involves any machine learning components, which is not explicitly stated for a blood pressure monitor) prior to this submission, possibly in the development of the predicate device or a similar platform. No specific training set data is mentioned for the HL158UB itself in this document.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned for the HL158UB, there is no information on how its ground truth would have been established. Given that it's a blood pressure monitor based on the oscillometric method, the "training" of such algorithms typically involves extensive physiological data, calibration, and validation against a gold standard for blood pressure measurement. However, this is not detailed in the provided text.
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