(142 days)
Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.
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 upper arm. The cuff circumference is limited to 22cm-30cm.
Fully Automatic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy requirements of ANSI/AAMI SP10-2002 | The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002. |
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 or prospective). It only mentions that "Clinical tests were performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focused on the device's accuracy against a standard (ANSI/AAMI SP10-2002), not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The clinical tests were performed to assess the "Fully Automatic Electronic Blood Pressure Monitor" against the accuracy requirements of ANSI/AAMI SP10-2002. This implies an evaluation of the device's algorithmic performance in measuring blood pressure and pulse rate without human-in-the-loop adjustments during the measurement.
7. Type of Ground Truth Used
The ground truth used was the accuracy requirements of ANSI/AAMI SP10-2002. This standard defines the acceptable error limits for non-invasive blood pressure measurement devices.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. Given the context of a 510(k) for a blood pressure monitor, the "training set" concept (as understood in machine learning) might not be directly applicable in the same way. The device's underlying algorithm is likely developed based on established oscillometric principles rather than being "trained" on a large dataset in the modern AI sense.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth for a training set was established. (See the explanation in point 8 regarding the applicability of the "training set" concept here). The device's accuracy is evaluated against a pre-defined industry standard.
§ 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).