(76 days)
HL868BF Measures automatically 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 this over-the-counter device is for over the age of 18 with arm circumference ranging from 9 inches to 17 inches (23 cm to 43 cm) and for home use.
When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. And this device can let the memory data be transferred to the connected personal computer (PC) via USB cable.
HL868BF automatically measures 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 this over-the-counter device is for over the age of 18 with arm circumference ranging from 9 inches to 17 inches (23 cm to 43 cm) and for home use.
The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Also, user can save and manage the measurement data by transferring the measured readings of blood pressure to the connected personal computer (PC) via USB cable.
Additionally, the device will display a symbol of ****ordes, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat during the measurement.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study
The primary study cited for the device's performance is compliance with the ANSI/AAMI SP-10:2002+A1:2003+A2:2006 Standard for Manual, electronic, or automated sphygmomanometers. This standard dictates the acceptance criteria for accuracy of blood pressure and pulse rate measurements.
1. Table of Acceptance Criteria and Reported Device Performance
The direct acceptance criteria and reported device performance from the provided text are as follows:
| Acceptance Criteria (from ANSI/AAMI SP-10 Standard) | Reported Device Performance (HL868BF) |
|---|---|
| Blood Pressure Accuracy: Not explicitly stated, but implied by compliance to standard. The ANSI/AAMI SP-10 standard typically requires: |
- Mean difference between device and reference standard: ≤ ±5 mmHg
- Standard deviation of the differences: ≤ 8 mmHg | Pressure: +/- 3mmHg |
| Pulse Accuracy: Not explicitly stated, but implied by compliance to standard. The ANSI/AAMI SP-10 standard typically requires: - No specific numeric criteria provided in the document for pulse, but compliance to the standard implicitly means the device meets its pulse accuracy requirements. | Pulse: +/- 5% |
Note: The reported device performance values (+/- 3mmHg and +/- 5% pulse) are explicitly stated in the "Product Specification Comparison Table" as the "Accuracy" for both the HL868BF and its predicate device. This implies these are the performance metrics tested against the standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that compliance testing was performed in accordance with the ANSI/AAMI SP-10 standard. The ANSI/AAMI SP-10 standard itself specifies requirements for subject recruitment (demographics, blood pressure ranges, etc.) and sample size (typically at least 85 subjects for accuracy validation). However, the specific details for this device are not provided in the 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. In compliance with the ANSI/AAMI SP-10 standard, ground truth for blood pressure measurements is typically established by comparing the automated device readings with simultaneous readings taken by trained observers using a mercury sphygmomanometer or another validated reference method. The standard outlines requirements for multiple trained observers.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used. For ANSI/AAMI SP-10 compliance, it is common to have at least two trained observers taking simultaneous readings, and if their readings differ beyond a certain threshold, a third observer or a predefined adjudication process is typically involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of how human readers improve with AI vs without AI assistance. This device is a standalone blood pressure monitor and does not involve AI assistance for human readers in the context of diagnostic interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The device, HL868BF, itself is a standalone device that automatically measures blood pressure and heart rate. The entire compliance study to ANSI/AAMI SP-10 assesses the performance of the device without human intervention beyond proper cuff placement and initiation of the measurement. The "Accuracy" metrics provided (Pressure +/- 3mmHg, Pulse +/- 5%) are directly from the device's standalone operation.
7. Type of Ground Truth Used
The type of ground truth used is implied by the compliance to the ANSI/AAMI SP-10 standard. This standard typically relies on reference measurements obtained simultaneously by trained human observers using a validated reference method (e.g., mercury sphygmomanometer or equivalent). This is a form of expert consensus or highly standardized measurement.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This type of device (traditional oscillometric blood pressure monitor) is typically developed and validated using engineering and clinical studies. While there are algorithms involved, it's not a machine learning or AI device that would have a distinct "training set" in the modern sense. The "training" or development process would involve iterative design and testing against a set of physiological data to optimize the oscillometric algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" with established ground truth in the context of modern machine learning is not applicable here. The development of the oscillometric algorithm would involve calibrating and refining it against a range of actual blood pressure recordings, likely using simultaneous reference measurements from established methods (e.g., intra-arterial catheter readings or auscultatory measurements by trained clinicians) to ensure accuracy across different patient populations and blood pressure ranges.
§ 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).