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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.

• 2. 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 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.

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.

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Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 18 and above, in a home care environment.

Three Meditec models are oscillometric systems intended for measurement of blood pressure and heart rate in a home care environment. Three models has a built-in pump for automatic inflation. Three Models include a constant air regulate deflation rate, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure and heart rate, and a memory function. Three models utilize a pressure measurement algorithm designed to detect, process, and store pressure readings. The pressure measurement range is 20 to 285 mmHg maintained within limits of 2 of 3 mmHg/sec to optimize measurement accuracy. Three models are powered by four AA-size batteries and are equipped with a circuit that will automatically cut off power after about 3 minutes of non-use to conserve battery charge.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document states "clinical studies" were conducted but does not specify the sample size of subjects used for the test set.
   • The document does not specify the country of origin of the data.
   • The document does not specify if the study was retrospective or prospective. However, typically, clinical validation studies for medical devices are prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not provide this information. The study was a clinical validation against a standard, not necessarily involving expert interpretation of data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not provide this information.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. The device is a "Fuzzy Automatic Blood Pressure Monitor" and the studies focused on its standalone accuracy against a standard, not on human-AI interaction or improvement.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance evaluation was done. The studies assessed the "measurement performance of the Meditec systems" (the devices themselves) against the ANSI/AAMI Standard SP10-1992, which is a standard for automated blood pressure devices. This inherently evaluates the algorithm's performance without human intervention in the measurement process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for blood pressure measurement accuracy was established by compliance with the ANSI/AAMI Standard SP10-1992. This standard defines reference methods for blood pressure measurement (e.g., auscultatory method with trained observers) against which automated devices are compared. The document does not go into the specifics of how the "true" blood pressure was determined during the clinical studies, but it would align with the established reference methods of SP10.

7. The sample size for the training set:

   • The document does not specify a training set size. This device is a blood pressure monitor, and while it uses a "Fuzzy" algorithm, the primary validation is against established measurement standards, not necessarily through traditional machine learning training/testing paradigms with labeled patient data in the way an AI diagnostic tool would. It's more about hardware and algorithm calibration.

8. How the ground truth for the training set was established:

   • Given the nature of the device and the standards it follows, the concept of a "training set" ground truth in the typical machine learning sense is not explicitly presented or relevant here. The device's "fuzzy" algorithm would likely have been developed and calibrated internally using a variety of blood pressure patterns, but the document does not detail this process or how the ground truth for such internal development was established. The focus of the regulatory submission is on the validation against a known standard.

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