(301 days)
The Arm Blood Pressure Monitor is intended to measure the systolic pressure and diastolic pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
AOJ-33series arm blood pressure monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or Kpa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use. All the models included in this submission follow the same software, same measurement principle and same specifications. The main differences are color of the face shell and keys, which will not affect the safety and effectiveness of the device. AOJ-33B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for AOJ-33A.
The provided text describes the acceptance criteria and the study that proves the Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B, meets these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The core performance acceptance criteria for blood pressure monitors are typically defined by international standards like ISO 81060-2. The document states that the device was tested to ISO 81060-2:2018.
| Acceptance Criteria (from ISO 81060-2:2018; implicitly accepted by FDA clearance) | Reported Device Performance (from Clinical Study on AOJ-33A) |
|---|---|
| Mean error and standard deviation of differences for systolic pressure within specified limits of ISO 81060-2:2018 | Met: "All data's mean error and standard deviation of differences for systolic... pressure is not over the limits of ISO 81060-2:2018." |
| Mean error and standard deviation of differences for diastolic pressure within specified limits of ISO 81060-2:2018 | Met: "All data's mean error and standard deviation of differences for ...diastolic pressure is not over the limits of ISO 81060-2:2018." |
| Blood pressure measurement range: ± 3 mmHg | Met: "± 3 mmHg" (This is listed under "Accuracy" in the comparison table, implying it's the expected accuracy). |
| Heart rate measurement accuracy: ± 5% of reading | Met: "± 5% of reading" (This is listed under "Accuracy" in the comparison table). |
2. Sample size used for the test set and the data provenance
- Sample Size: 100 adult subjects (49 female, 51 male).
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a clinical validation study performed on AOJ-33A, implying it was a prospective study conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document refers to a "Same Arm Sequential Method" clinical validation study in accordance with ISO 81060-2:2018. This standard typically involves multiple trained observers (experts) taking sequential measurements using a reference sphygmomanometer. However, the document does not specify the exact number of experts or their qualifications.
4. Adjudication method for the test set
The document states "The Same Arm Sequential Method was chosen." This method, as described in ISO 81060-2, involves comparing the automated device measurements to those taken by trained observers using a reference manual sphygmomanometer on the same arm. While it implies a comparison against expert readings, the document does not explicitly detail an adjudication method (e.g., 2+1, 3+1). The standard outlines procedures for obtaining reference measurements, which inherently involve a form of expert consensus or highly standardized measurement to establish ground truth.
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
This question is not applicable as the device is an automated blood pressure monitor and not an AI-assisted diagnostic tool for human readers. It directly measures and displays blood pressure and pulse rate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The clinical validation study described is for the device (AOJ-33A) functioning independently to measure blood pressure and pulse rate, without human interpretation or assistance during the measurement process.
7. The type of ground truth used
The ground truth for the clinical study was established by comparison with established reference measurements, likely from a manual sphygmomanometer operated by trained observers, as per the ISO 81060-2:2018 standard for non-invasive sphygmomanometers. This effectively represents a validated, expert-derived measurement.
8. The sample size for the training set
The document does not specify a separate training set sample size. The clinical data mentioned (100 adult subjects) refers to the testing or validation set for the device's performance against the standard. For medical devices like blood pressure monitors, the "training" (i.e., calibration and algorithm development) often occurs internally during the device design phase, and explicit "training set" data for regulatory submission in the same way as an AI algorithm is typically not detailed.
9. How the ground truth for the training set was established
As there is no explicit mention of a separate "training set" in the context of data for regulatory submission (beyond the device's inherent design and calibration), this information is not provided in the document. The general principle for developing such devices involves engineering and clinical testing to ensure accurate readings, which implicitly leverages previous data and established hemodynamic principles to calibrate the oscillometric algorithm.
§ 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).