(73 days)
KD-7961 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.
KD-7961 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches. It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. The LCD backlight, the touch key button and the voice function make it more convenient to use.
The Andon Health Co., Ltd. KD-7961 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to the ANSI/AAMI SP10 standard for manual, electronic, or automated sphygmomanometers. This standard sets the acceptance criteria for devices measuring blood pressure non-invasively through an oscillometric method.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for accuracy (e.g., mean difference and standard deviation from a reference measurement) or the reported device performance in this format. However, compliance with AAMI SP10 implies meeting its accuracy requirements.
AAMI SP10 typically requires:
- Mean difference: ≤ ±5 mmHg
- Standard deviation: ≤ 8 mmHg
The submission states that the device "conforms to the following standards: ... AAMI SP10:2002..." This conformity implies that the device met these performance criteria, although specific values from the testing are not presented in this summary.
| Acceptance Criteria (from AAMI SP10, implied) | Reported Device Performance |
|---|---|
| Mean difference ≤ ±5 mmHg (Systolic) | (Implied to meet AAMI SP10 standards, specific data not provided in summary) |
| Standard deviation ≤ 8 mmHg (Systolic) | (Implied to meet AAMI SP10 standards, specific data not provided in summary) |
| Mean difference ≤ ±5 mmHg (Diastolic) | (Implied to meet AAMI SP10 standards, specific data not provided in summary) |
| Standard deviation ≤ 8 mmHg (Diastolic) | (Implied to meet AAMI SP10 standards, specific data not provided in summary) |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). However, AAMI SP10 typically requires a clinical validation study on a sufficient number of subjects (usually at least 85 with a specified distribution of blood pressures) to demonstrate accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth. For AAMI SP10 validation, ground truth is typically established by trained observers (often two or three) using a auscultatory reference method (e.g., mercurial sphygmomanometer).
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For AAMI SP10 studies using multiple observers for ground truth, a common method is to average their readings or use a defined adjudication rule if there are discrepancies (e.g., removing outliers or consulting a third observer).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or described. This study type is typically relevant for interpretative devices (e.g., AI for medical imaging) to assess how AI assistance affects human reader performance. This blood pressure monitor is a direct measurement device rather than an interpretative one.
6. Standalone (Algorithm Only) Performance Study
The device itself is a standalone (algorithm only, without human-in-the-loop performance) blood pressure monitor. The conformity to AAMI SP10 implies that a standalone performance study was conducted to validate its accuracy against a reference method. The summary does not provide the results of this standalone performance study, but states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," thus implying the device met the AAMI SP10 requirements in a standalone capacity.
7. Type of Ground Truth Used
Based on the explicit mention of AAMI SP10 compliance, the ground truth used would be auscultatory blood pressure measurements taken by trained observers using a reference sphygmomanometer (e.g., merchanism blood pressure device) on the same subjects, simultaneously or in quick succession, with the device being tested.
8. Sample Size for the Training Set
The document does not specify any training set sample size. Blood pressure monitors based on oscillometric principles are typically engineered and calibrated rather than "trained" in the machine learning sense. The underlying algorithm is based on physiological principles and validated through clinical studies. If there were any machine learning components, details are not provided.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the machine learning sense is described, information on how its ground truth was established is not applicable or not provided. The device's calibration and validation would rely on the clinical study outlined in point 7.
§ 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).