(39 days)
HL888V is a manual inflate type blood pressure monitor for measurement of human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).
HL868JM is a manual inflate type blood pressure monitor for measurement of human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. It is recommended for use by adults aged 18 years and older with arm circumference ranging 9~13 inches (approx.23cm-33cm).
Both HL888V and HL868JM are manual inflate type blood pressure monitors for measurement of human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of the over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 ~13 inches (approx.23cm-33cm) and for home use.
HL868JM features a Risk Category Indicator 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.
Here's a summary of the acceptance criteria and study information for the Full Automatic (NIBP) Blood Pressure Monitor, Models HL888V and HL868JM, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The devices (HL888V and HL868JM) were found to be compliant with the ANSI/AAMI SP-10:2002+ A1:2003+A2:2006 Standard for Manual, electronic, or automated sphygmomanometers. This standard likely sets the specific acceptance criteria for blood pressure monitor accuracy. The 510(k) summary references the predicate device's accuracy which is assumed to be the target for the new devices.
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (HL888V & HL868JM) |
|---|---|
| Pressure: ± 3mmHg | Fully met (compliant with ANSI/AAMI SP-10) |
| Pulse: ± 5% | Fully met (compliant with ANSI/AAMI SP-10) |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document. The statement "All the relevant activities were performed by designate individual(s)" suggests a clinical study was conducted. However, the exact number of participants is not disclosed.
- Data Provenance: Not explicitly stated. Given that the manufacturer is Health & Life Co., Ltd. from Taiwan, R.O.C., the study might have been conducted in Taiwan, but this is not confirmed. The document does not specify whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The ANSI/AAMI SP-10 standard typically involves comparison against a reference standard, often conducted by trained technicians or clinicians, but details on the number and qualifications of experts are not provided in this summary.
4. Adjudication method for the test set:
- Not explicitly stated. The ANSI/AAMI SP-10 standard outlines specific protocols for measurement and comparison, which would inherently include methods for handling discrepancies, but the specific adjudication method is not mentioned.
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:
- A MRMC comparative effectiveness study was not performed. This device is a standalone blood pressure monitor and does not involve AI assistance or human readers for diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The study was conducted to demonstrate the accuracy of the blood pressure monitor itself in accordance with the ANSI/AAMI SP-10 standard. The device's oscillometric method is an algorithm that processes pressure oscillations to determine blood pressure values without human intervention in the measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth would have been established by comparing the device's measurements against a recognized reference standard for blood pressure measurement, typically auscultatory measurement by trained observers using a mercury sphygmomanometer or an equivalent validated non-invasive method, as prescribed by the ANSI/AAMI SP-10 standard.
8. The sample size for the training set:
- Not applicable. As a medical device that does not employ machine learning or AI models with a "training set" in the computational sense, there is no training set sample size to report. The device's underlying oscillometric algorithm is a classic engineering principle, not a trained AI model.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of this device's technology.
§ 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).