(205 days)
The Amluck automatic digital wrist blood pressure monitor, Model AK-3000 / AK-4000, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".
AMLUCK AK-3000 / AK-4000 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Here's a breakdown of the acceptance criteria and study information for the AMLUCK BLOOD PRESSURE MONITOR AK-3000 / AK-4000, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Standard Reference | Reported Device Performance |
|---|---|---|
| Electric Safety | EN 60601-1:1990+A1+A2+A11+A12+A13 | PASS |
| EMC Conformity | EN 60601-1-2: 1993 | PASS |
| Woven Cotton Sheeting | JIS L 1096 6.39.1.2 Method B 2 | Certified by SGS UK Ltd. |
| Performance & Clinical | AAMI / ANSI SP10 | Implied to meet (no specific performance metrics reported in summary, but indicated as the standard applied) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the AAMI / ANSI SP10 clinical test or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the test was conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. For blood pressure monitors tested against AAMI/ANSI SP10, ground truth is typically established by trained observers (experts) using a reference sphygmomanometer, but the number and qualifications are not detailed here.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. For clinical validation of blood pressure monitors, an adjudication method (such as independent observers and specific error tolerance) is part of the AAMI/ANSI SP10 standard, but the specific details of its application are not included in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is relevant for imaging devices where human readers interpret data with and without AI assistance to assess diagnostic performance. This device is an automated blood pressure monitor, not an imaging device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, implicitly. The AAMI/ANSI SP10 standard defines the accuracy requirements for automated sphygmomanometers, which involves comparing the device's readings against a reference standard. This is a standalone performance assessment of the algorithm's ability to measure blood pressure. The summary indicates that the device underwent "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10."
7. The Type of Ground Truth Used
The ground truth for the "Performance & Clinical Test" (AAMI/ANSI SP10) would be established by simultaneous measurements from a trained observer using a calibrated, auscultatory reference sphygmomanometer. The AAMI/ANSI SP10 standard outlines rigorous procedures for this to ensure accurate reference measurements.
8. The Sample Size for the Training Set
The provided 510(k) summary does not provide any information about a training set size. Blood pressure monitors using the oscillometric method are typically developed and calibrated based on physiological models and empirical data, but the specific details of a "training set" in the context of machine learning (as often implied by this question) are not applicable or disclosed for this type of device and submission. The device's underlying algorithm is likely calibrated against known pressure measurements.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the machine learning sense is explicitly mentioned or relevant for this type of device in the provided summary, information on how its ground truth was established is not available. The oscillometric method itself is based on well-understood physiological principles and extensive validation in clinical settings, with ground truth established through comparative measurements against auscultatory methods.
§ 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).