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The Withings Blood Pressure Monitor, Upper Arm Type: BP-801 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures 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 upper arm. The cuff circumference is limited to be 9 to 17 inches (22cm-42cm) for Upper Arm type.

The Withings BP-801 is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 to 17 inches (22 - 42 cm) via an arm cuff. It is designed and manufactured according to IEC 80601-2-30, Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. The operational principle is based on oscillometric and silicon integrates pressure sensor technology it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator. The Withings BP-801 is a blood pressure monitor achieves its function by integrate the device with an iPhone 4S. As it does not include a LCD or other display components, it is necessary for the new device to connect to an iPhone 4S containing a support software to constitute a complete blood pressure measurement system. And the new device connects iPhone 4S through Bluetooth or USB cable.

Here's a breakdown of the acceptance criteria and study details for the Withings Blood Pressure Monitor BP-801, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 & ANSI/AAMI/IEC 80601-2-30:2009 protocols.

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

• Sample Size:
  • Patients: 108 people.
  • Determinations: 3 determinations per patient, totaling 324 determinations (N = 108 * 3).
• Data Provenance: Not explicitly stated, but the study was conducted to conform to international standards (ANSI/AAMI/ISO) which are globally recognized. It is a prospective clinical test as described in the "PERFORMANCE & CLINICAL TEST" section.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, the ground truth was established using "the reference sphygmomanometer" in accordance with the specified protocols (ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 & ANSI/AAMI/IEC 80601-2-30:2009). These protocols typically involve trained operators for manual (auscultatory) measurements for comparison.

4. Adjudication Method for the Test Set

The adjudication method is implicitly defined by the protocols:

• "The blood pressure values of a test person included in the analysis may not differ from each other by more than 12 mmHg for the systolic and 8 mmHg for test diastolic value (haemodynamic stability)"
• "Out of 4 pairs of measured values, the first 2 consecutive pairs of measured values that were conforming with the criteria of the ANSI/AAMI/ISO 81060-1:2007 & ANSI/AAMI/ISO 81060-2:2009 &ANSI/AAMI/IEC 80601-2-30:2009 protocol was included in the analysis."

This suggests a selection criterion based on consistency for including data, rather than a formal adjudication process by multiple experts reviewing discrepancies.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This study focuses on the accuracy of the automated device against a reference sphygmomanometer, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire "PERFORMANCE & CLINICAL TEST" section describes the evaluation of the Withings BP-801 (the device/algorithm) against a reference sphygmomanometer, without human interaction in the measurement by the device itself. The device automatically measures and calculates blood pressure.

7. Type of Ground Truth Used

The ground truth used was comparative measurements from a reference sphygmomanometer (referred to as "the reference sphygmomanometer") performed according to established clinical validation protocols (ANSI/AAMI/ISO 81060-1, 81060-2, and IEC 80601-2-30). This is a well-accepted method for validating automated blood pressure monitors.

8. Sample Size for the Training Set

The document does not provide information on a "training set." This type of premarket submission (510(k)) typically focuses on the clinical validation of the final device, not on the development or training of algorithms that might be part of the device (unless the algorithm itself is novel and requires specific validation). The device uses the oscillometric method, which is a well-established principle for blood pressure measurement, not necessarily a machine learning algorithm that requires a separate training set.

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

As there is no mention of a training set or a machine learning algorithm that would require one, information on how its ground truth was established is not provided.

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