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The AMPLIFE Upper Arm Blood Pressure Monitor, Model M100, is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.

The AMPLIFE Upper Arm Automatic Blood Pressure Monitor, Model M100 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

This 510(k) summary provides limited information regarding the clinical study.

Here's a breakdown of the available information and areas where details are missing or unclear based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified. The document only states "We have performed the clinical test on AMPLIFE Upper Arm Blood Pressure".
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not specified.
• Qualifications: Not specified. For blood pressure monitors, ground truth is typically established by trained observers using a mercury sphygmomanometer or validated reference device. The qualifications of these observers (e.g., trained technicians, physicians) are not mentioned.

4. Adjudication Method for the Test Set

• Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is not typically relevant for a standalone blood pressure monitor, which measures a physiological parameter directly rather than requiring human interpretation of complex images or data.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance assessment was effectively done. The AMPLIFE Upper Arm Blood Pressure Monitor is a standalone device that measures blood pressure using an "oscillometric method" algorithm without human intervention in the measurement process itself. The clinical test described refers to the performance of this device in making those measurements.

7. Type of Ground Truth Used

• Ground Truth: The document states the clinical test was performed according to the "ANSI/AAMI -- SP-10 Standard, Section 4.4.2". This standard typically requires comparison of the device's measurements against a reference method, such as direct intra-arterial measurement or, more commonly for non-invasive devices, simultaneous auscultatory measurements performed by trained observers using a validated reference device (e.g., mercury sphygmomanometer). While not explicitly stated, it is implied that a reference method was used to establish the ground truth.

8. Sample Size for the Training Set

• Not applicable/Not specified. For a traditional blood pressure monitor using the oscillometric method, the "algorithm" is based on established physiological principles and signal processing, rather than a machine learning model that requires a separate "training set" in the common sense. The algorithm parameters might be refined or calibrated, but this isn't typically referred to as "training" in the same way as for AI/ML algorithms.

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

• Not applicable/Not specified for the reasons stated above.

In summary:

The provided 510(k) summary indicates that a clinical test was performed in accordance with the ANSI/AAMI SP-10 Standard, which is the relevant standard for validating the accuracy of automated sphygmomanometers. However, the summary lacks specific details regarding the clinical study's methodology, such as the exact acceptance criteria, the number of subjects (sample size), the ground truth measurement details, or the specific performance results (e.g., mean differences and standard deviations) that demonstrated compliance with the standard. It only provides a general statement that the device met the requirements of the standard.

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