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The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate. The device is intended for use at home or in doctor's office settings on patients who are eighteen (18) years and older and who do not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. The arm circumference range shall be between 8.3 inches (21 cm) and 16.5 inches (42 cm).

The BPCalibrator™ MC3000 has a communication port that enables blood pressure and pulse rate readings to be transmitted to other electronic devices designed to communicate with it.

Blood pressure and pulse rate readings obtained using the device are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate at home or in clinical settings.

A cuff is applied to the upper arm before measurement. When a measurement is initiated, the cuff is inflated to a pressure higher than the systolic pressure and then deflated. Pressure pulses measured from the cuff during deflation are used to calculate blood pressure and pulse rate using the oscillometric method.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was clinically tested in accordance with AAMI-SP10: 1992, Electronic or Automated Sphygmomanometers, and that the "requirements of the standard were met." While the specific numerical acceptance criteria from AAMI-SP10:1992 are not explicitly detailed in the provided text, the standard generally sets forth requirements for accuracy in blood pressure measurements.

Therefore, the table can be structured as follows, with the understanding that "Met AAMI-SP10: 1992 requirements" implies compliance with the standard's accuracy and performance thresholds.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the clinical test set. It only mentions that "The BPCalibrator™ MC3000/MC3100 was clinically tested in accordance with AAMI-SP10: 1992, Electronic or Automated Sphygmomanometers."

• Sample Size for Test Set: Not explicitly stated in the provided text. AAMI-SP10: 1992 typically recommends a minimum of 85 subjects for clinical validation.
• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective). Clinical testing conforming to AAMI-SP10 is usually prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number of experts used or their qualifications for establishing ground truth. AAMI-SP10: 1992 typically requires simultaneous auscultatory measurements by trained observers (often two) as the reference standard (ground truth).

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. In AAMI-SP10: 1992, if two observers are used for ground truth, their readings are averaged or a consensus is reached if there are significant discrepancies, but a formal adjudication process beyond that is not typically described as a standalone method.

• Adjudication Method: Not explicitly stated.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers.

• MRMC Study: No.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The entire premise of the clinical testing section is to validate the device itself (the BPCalibrator™ MC3000/MC3100) as a standalone blood pressure monitor, without human intervention in the measurement process other than placing the cuff and initiating the reading. The device calculates blood pressure and pulse rate using its internal oscillometric algorithm.

• Standalone Study: Yes.

7. The Type of Ground Truth Used

The ground truth used for the clinical testing would have been expert consensus (auscultation). AAMI-SP10: 1992 requires comparison of the automated device's readings against simultaneously obtained auscultatory measurements performed by trained observers using a mercury sphygmomanometer as the reference standard.

• Type of Ground Truth: Expert consensus (auscultatory measurements).

8. The Sample Size for the Training Set

The document does not mention or imply a "training set" in the context of machine learning or AI. This is a traditional medical device (oscillometric blood pressure monitor), not a device that uses AI algorithms requiring a distinct training phase. The device's algorithm for calculating blood pressure from oscillometric pulses is fixed and pre-programmed, not "trained" in the AI sense.

• Sample Size for Training Set: Not applicable/not mentioned, as this is not an AI/ML device in the context of typical "training sets."

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of AI/ML, this question is not applicable to the provided information.

• How Ground Truth for Training Set was Established: Not applicable.

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