(73 days)
OSTAR USB Blood Pressure Monitor Upper Arm Type : P200 and Wrist Type : M100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressure 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 or upper arm.
The cuff circumference is limited to be 5.5'~7.8'(14 cm ~20 cm) for wrist type, and 9'~13'(24cm ~32cm) for Upper Arm Type.
Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on.
OSTAR USB Blood Pressure Monitor Upper Arm Type : P200 and Wrist Type : M100 use the Oscillometric method to measure blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to ise the stethoscope, as in the traditional measuring method, to monitor the Korothkov sound when deciding the systolic and 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 stop decreasing. In addition, the heart beat rate will be also measured and displayed on LCD as part of measurement result.
For P200 Upper Arm Type, all the measuring circuit, measuring devices, measuring and display software are all mounted on the device housing. It can be operated individually or be operated by the PC installed with measurement software through USB connection port to control and transfer the measuring records, and then stored the records in device.
For M100 Wrist Type. all the measuring circuit, measuring devices, software are all mounted on the device housing except for the measurement control keys and display. It can be operated only by the PC installed with measurement software through USB connection port to control and transfer the measuring records, and then stored the records in device.
The provided text describes the Ostar USB Blood Pressure Monitor and details its classification, intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. However, it does not explicitly state acceptance criteria or provide a study with detailed performance metrics against those criteria. The document states that the device is compliant with certain standards, including ANSI/AAMI, SP 10-2002/A 1:2003, for blood pressure monitors. These standards typically contain detailed accuracy requirements that would serve as acceptance criteria. Without explicit mention of those criteria in the document or the results against them, I can only indicate general compliance.
Here's the information based on the provided text, with limitations noted due to the absence of specific acceptance criteria and detailed study results:
1. Table of Acceptance Criteria and Reported Device Performance
The document states compliance with ANSI/AAMI SP 10-2002/A 1:2003. This standard dictates accuracy requirements for automated sphygmomanometers.
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Acceptance Criteria (Based on ANSI/AAMI SP 10-2002/A 1:2003 for automated sphygmomanometers) - Inferred, not explicitly stated in the document:
- Mean difference between device and reference standard: ≤ ±5 mmHg
- Standard deviation of the difference: ≤ 8 mmHg
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Reported Device Performance:
The document states: "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
This broadly confirms that the device meets the necessary performance standards, including those for accuracy as defined by ANSI/AAMI SP 10-2002/A 1:2003, but specific numerical results are not provided in this summary.
| Acceptance Criteria (Inferred from ANSI/AAMI SP 10-2002/A 1:2003) | Reported Device Performance (Summary Statement) |
|---|---|
| Mean difference between device and reference standard ≤ ±5 mmHg; Standard deviation of the difference ≤ 8 mmHg | "Verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." (Indicates compliance with relevant standards) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "verification and validation tests."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts or their qualifications for establishing ground truth. For blood pressure measurements, ground truth would typically come from auscultatory measurements by trained observers using a reference sphygmomanometer, often with mercury.
4. Adjudication method for the test set
The document does not describe any adjudication method used 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
This is not applicable as the device is a blood pressure monitor, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the blood pressure monitor is a standalone device that measures blood pressure using an oscillometric method. Its performance is inherent to the device's algorithms and hardware, without requiring human interpretation for the measurement itself.
7. The type of ground truth used
The type of ground truth for blood pressure monitors, while not explicitly stated in the document, is universally established by comparison to a reference standard, typically auscultatory measurements performed by trained clinicians using a mercury sphygmomanometer or an equivalent validated non-invasive method.
8. The sample size for the training set
The document does not provide information about a "training set." This term is usually associated with machine learning or AI models, which is not directly applicable to the functional description of this blood pressure monitor. The oscillometric method is an established physiological measurement technique.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The device relies on established oscillometric principles and internal calculations.
§ 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).