(171 days)
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm.
The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.
Microlife Wrist Watch Blood Pressure Monitor, Model BP3MO1-3P is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a capacitor pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
The device can detect electrical signals while inflating. And the device has Irreqular Heartbeat Detection (IHD) function. It detects the appearance of irreqular heartbeat during measurement and the irregular heart beat symbol "44 " is displayed on the LCD screen if any irreqular heart beat signal has been detected. ' In addition, the device has traffic light function.
The provided text does not contain detailed acceptance criteria and a study that proves the device meets specific performance criteria. Instead, it describes a 510(k) summary for a blood pressure monitor, focusing on its substantial equivalence to predicate devices and general non-clinical testing.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states that a repeated clinical test in accordance with the standard ANSI/AAMI SP10 was not necessary because the subject device (BP3MO1-3P) is technically identical to a predicate device (BP3MK1-3) and internal testing demonstrated that design changes did not affect clinical accuracy.
Therefore, specific numeric acceptance criteria and reported device performance from a dedicated clinical study against those criteria are not available in this document. The "Performance" is indirectly reported by the claim of substantial equivalence and no impact on accuracy from internal testing.
| Acceptance Criteria (Inferred from industry standards) | Reported Device Performance (as stated in the document) |
|---|---|
| Blood pressure detection accuracy (e.g., mean difference and standard deviation from reference method as per ANSI/AAMI SP10) | "The internal clinical test on BP3MO1-3P demonstrates that the clinical accuracy in terms of blood pressure detection and normal use of this device is not affected by change of signal detection technology to IMT technology. The other differences (traffic light function and medication alarm function) have no impact on the clinical accuracy in terms of blood pressure detection." |
| Irregular Heartbeat Detection (IHD) function performance | Device "detects the appearance of irregular heartbeat during measurement and gives a warning signal." (No specific accuracy metrics provided). |
| Pulse rate detection accuracy | Implied to be accurate and unaffected, similar to blood pressure. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions an "internal clinical test on BP3MO1-3P," but it does not specify the sample size for this test. It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document provides no information on the number of experts used or their qualifications for establishing ground truth for any internal clinical testing mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for the test set.
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:
The document describes a medical device (blood pressure monitor), not an AI algorithm. Therefore, no MRMC comparative effectiveness study involving human readers and AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a standalone blood pressure monitor. The performance described is its inherent function of measuring blood pressure and detecting irregular heartbeats. However, the document does not use the term "standalone performance" in the context of an algorithm. The entire device's performance is standalone as per its function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For blood pressure monitors, the "ground truth" for accuracy is typically established by simultaneous measurements using a reference standard auscultatory method (e.g., using a mercury manometer and stethoscope by trained observers), often following protocols like those outlined in ANSI/AAMI SP10. While not explicitly stated, this is the standard practice for such devices.
8. The sample size for the training set:
The document does not mention a training set in the context of an AI algorithm or machine learning. The device operates based on the "oscillometric method," which is a well-known and established technique, not one that typically requires a large-scale "training set" in the modern AI sense.
9. How the ground truth for the training set was established:
As no training set is mentioned in the context of AI/ML, this information is not applicable/provided.
§ 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).