(13 days)
Measuring Systolic and Diastolic blood pressure and pulse rates in adult patients with arm circumferences between 5½~ 7½ inches using the oscillometric method
MD-880B, MD-900T models are oscillometric systems intended for measurement of blood pressure and purse rate in a home care environment.
- 1)MD-880B : MD-880B employs the oscillometric method for measurement of blood pressure and heart rate. A cuff is wrapped around the wrist and inflates to a pressure sufficient to initially interrupt blood flow. As cuff pressure is gradually reduced, a sensor inside the cuff detects the small oscillations in pressure against the cuff produced by expansion and contractions of the arteries in the wrist in response to each heart beat. The amplitude of these pressure waves is measured to monitor changes in the character of blood flow and the corresponding cuff pressure at which these changes occur is detected. The systolic and diastolic pressure in millimeters of mercury, followed by the heart rate in beats per minute, is displayed as a numerical value on the LCD.
The cuff is automatically inflated by a built-in air pump(low noise) and selected inflation level by checking heart beat signal. The inflation is automatically activated in about 1 second after power on. The three-row, 9-digit LCD displays systolic pressure(upper 3digits) and diastolic pressure(middle 3 digits) and heart rate(lower 3-digits). In addition, the date and time are displayed(8-digit).
MD-880B incorporates a constant air release valve to regulate deflation rate, within limits of 2 or 3 mmHg/sec to optimize measurement accuracy. The pressure measurement range is 20 to 285 mmHq. And keys are consisting of push-button switch instead of touch screen(MD-900T) for low cost model.
MD-880B is powered by two AAA-size batteries and are equipped with a circuit that will automatically cut off power after about 1 minutes of non-use to conserve battery charge.
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- MD-900T : MD-900T employs the oscillometric method for measurement of blood pressure and heart rate. A cuff is wrapped around the wrist and inflates to a pressure sufficient to initially interrupt blood flow. As cuff pressure is gradually reduced, a sensor inside the cuff detects the small oscillations in pressure against the cuff produced by expansion and contractions of the arteries in the wrist in response to each heart beat. The amplitude of these pressure waves is measured to monitor changes in the character of blood flow and the corresponding cuff pressure at which these changes occur is detected. The systolic and diastolic pressure in millimeters of mercury, followed by the heart rate in beats per minute, is displayed as a numerical value on the LCD.
The cuff is automatically inflated by a built-in air pump(low noise) and selected inflation level by checking heart beat signal. The inflation is automatically activated in about 1 second after power on. The three-row, 9-digit LCD displays systolic pressure(upper 3-digits) and diastolic pressure(middle 3 digits) and heart rate(lower 3-digits). In addition, the date and time are displayed(8-digit).
- MD-900T : MD-900T employs the oscillometric method for measurement of blood pressure and heart rate. A cuff is wrapped around the wrist and inflates to a pressure sufficient to initially interrupt blood flow. As cuff pressure is gradually reduced, a sensor inside the cuff detects the small oscillations in pressure against the cuff produced by expansion and contractions of the arteries in the wrist in response to each heart beat. The amplitude of these pressure waves is measured to monitor changes in the character of blood flow and the corresponding cuff pressure at which these changes occur is detected. The systolic and diastolic pressure in millimeters of mercury, followed by the heart rate in beats per minute, is displayed as a numerical value on the LCD.
MD-900T incorporates a constant air release valve to regulate deflation rate, within limits of 2 or 3 mmHg/sec to optimize measurement accuracy. The pressure measurement range is 20 to 285 mmHg.
MD-900T is powered by two AAA-size batteries and are equipped with a circuit that will automatically cut off power after about 1 minutes of non-use to conserve battery charge.
The provided text describes the regulatory clearance for the MEDITEC Wrist Type Blood Pressure Monitor (MD-880B, MD-900T). Here’s an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the information given.
1. Table of Acceptance Criteria and Reported Device Performance
The text explicitly states that the device was evaluated against the accuracy criteria established in the ANSI/AAMI SP 10-1992 standard. While the specific numerical acceptance criteria from this standard are not detailed in the provided text, the overall outcome is reported.
| Acceptance Criteria (from ANSI/AAMI SP 10-1992) | Reported Device Performance |
|---|---|
| Accuracy criteria for blood pressure measurement | "found to comply fully with the accuracy criteria established in the standard." |
| Safety and functional testing (electrical, mechanical, environmental integrity, high/low altitude, vibration/shock, life cycle, intra-device variability) | "performed with satisfactory results." |
| Biocompatibility of cuff materials | "evaluated favorably by TUV Product Service." |
| Electromagnetic interference | "found to comply with international standards." |
| Software validation | "performed and documented." |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "clinical studies conducted on accordance with ANSI/AAMI SP 10-1992," but it does not specify the sample size used for these studies or the test set.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It only refers to "clinical studies."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not specify the number of experts used to establish ground truth or their qualifications. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference device (e.g., auscultatory method with a mercury sphygmomanometer).
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This type of study is more common for diagnostic imaging devices, whereas this submission is for a blood pressure monitor.
6. Standalone Performance Study
Yes, a standalone performance study was done. The text states:
- "The measurement performances of the 2 MEDITEC systems have been evaluated in clinical studies conducted on accordance with ANSI/AAMI SP 10-1992 and found to comply fully with the accuracy criteria established in the standard."
- "Safety and functional testing including electrical characteristics, mechanical and environmental integrity under various operating and storage conditions, high and low altitude performance, resistance to vibration and shock, life cycle testing, and intra-device variability has been performed with satisfactory results."
These statements directly refer to the algorithm's (device's) performance without human intervention during the measurement process, indicating standalone studies.
7. Type of Ground Truth Used
For blood pressure monitors, the "ground truth" (or reference standard) is typically established by simultaneous measurements using a validated reference method, such as auscultation with a mercury sphygmomanometer performed by trained observers. The text refers to "clinical studies conducted on accordance with ANSI/AAMI SP 10-1992," which is the standard outlining such reference methods for validation. While not explicitly stated, this implies the use of a recognized reference standard for blood pressure measurement.
8. Sample Size for the Training Set
The provided text does not specify the sample size for any training set. As this is a medical device clearance and not an AI/ML software submission, the concept of a "training set" in the context of machine learning might not be directly applicable or explicitly detailed. The device operates based on an oscillometric method, which is a known physical principle, not necessarily a trained AI model in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Since the text does not mention a specific "training set" in the context of an AI/ML model, it does not describe how ground truth for a training set was established.
§ 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).