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CONNEOT PULSE is a non-invasive blood pressure measurement system that provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively using a technique in which an inflatable cuff is wrapped around the upper arm. Additionally, the CONNEQT PULSE automatically provides brachial systolic and diastolic blood pressures and heart rate. The measurement range of the cuff circumference is 8.6''-12.6''(22cm-32cm) and 12.6''- 16.5''(32cm-42cm).

The CONNEQT PULSE is designed and manufactured according to IEC 80601 -2-30:2019and consists of the following two parts:

• 1. Brachial systolic and diastolic blood pressure measurements:
     The operational principle is based on the oscillometric method and silicon integrated pressure sensor technology for determining the brachial systolic and diastolic blood pressure. These blood pressure measurement results are classified for hypertension according to the American Heart Association (AHA) guidelines. The user is also alerted if an irregular heartbeat is detected.
• 2. Central blood pressure and cardiovascular indices measurement using Pulse Wave Analysis (PWA):
     The central blood pressure measurement and calculation of corresponding central blood pressure parameters are a subset of the central blood pressure parameters provided by the predicate Atcor SphygmoCor XCEL (K122129).
     The CONNEQT PULSE can be used on its own or with the optional CONNEQT App on the user's smartphone or CONNEQT PRO App on the healthcare provider's portal. Both Apps are used to transmit patient data from the device using paired Bluetooth Low Energy communication for the purpose of storing and displaying the daily blood pressure data and historical trends. Patient data can also be transmitted from the user's smartphone to their HCP to enable HCP monitoring of the user's cardiac health.

Here's a breakdown of the acceptance criteria and the study details for the CONNEQT PULSE device, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to established standards for non-invasive sphygmomanometers and clinical agreement with a cleared reference device.

2. Sample Sizes and Data Provenance

• Test Set for Brachial Blood Pressure:
  • Sample Size: 90 adult subjects (54 female, 36 male)
  • Data Provenance: Not explicitly stated, but clinical studies for FDA clearance are typically conducted in a controlled, prospective manner. The text does not specify the country of origin, but "clinical testing" implies a prospective study.
• Test Set for Central Blood Pressure Parameters:
  • Sample Size: 41 subjects (20 female, 21 male)
  • Data Provenance: Not explicitly stated, but described as an "internal protocol" for validation, suggesting a prospective clinical study. The country of origin is not specified.
• Training Set: Not specified in the provided document. The document focuses on the clinical validation of the device, not the development or training of its underlying algorithms.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Brachial Blood Pressure: The ISO 81060-2:2018 standard typically specifies the use of trained observers for reference measurements (e.g., auscultatory) against which automated devices are compared. The exact number and qualifications of these observers are not detailed in this summary but would be specified within the standard's methodology.
• Central Blood Pressure Parameters: The SphygmoCor CvMS (K070795) device served as the comparator/reference standard. This device itself is cleared, and its output is considered the ground truth for this comparison. The summary doesn't mention human experts establishing ground truth for individual cases; rather, it relies on the output of a previously cleared device.

4. Adjudication Method (Test Set)

• Brachial Blood Pressure: The ISO 81060-2:2018 standard guides observer measurements for ground truth. This often involves multiple observers and a specific protocol to ensure accuracy and minimize bias (e.g., alternating observers, blind measurements). The summary does not provide specific details on the adjudication method used within that study, other than stating it conformed to the ISO standard.
• Central Blood Pressure Parameters: Adjudication is not applicable in the traditional sense here, as the comparison was against a device (SphygmoCor CvMS) rather than against expert human readings that might require adjudication.

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

• No MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The CONNEQT PULSE is a device that provides blood pressure measurements and central arterial indices. It is not an AI-assisted diagnostic imaging or interpretation tool where human reader performance is typically evaluated.

6. Standalone Performance Study

• Yes, a standalone study was conducted for the CONNEQT PULSE device. The entire clinical testing section (Section 9.0) describes the validation of the device's accuracy for both brachial blood pressure and central blood pressure parameters as an algorithm/device-only system, without human interpretation being part of the primary measured outcome for its clearance.
  • For brachial blood pressure, its measurements were validated against the ISO 81060-2:2018 standard.
  • For central blood pressure parameters, its measurements were validated against the SphygmoCor CvMS device.

7. Type of Ground Truth Used (Test Set)

• Brachial Blood Pressure: Reference standard measurements as defined by ISO 81060-2:2018 (typically auscultatory measurements by trained observers or an intra-arterial reference).
• Central Blood Pressure Parameters: Measurements from a previously 510(k) cleared comparator device (SphygmoCor CvMS), which serves as the established reference for these parameters.

8. Sample Size for the Training Set

• The document does not provide information regarding the sample size for the training set. This summary focuses on the clinical validation of the final device for regulatory submission, not the developmental phase or the data used to train the underlying algorithms.

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

• The document does not provide information on how the ground truth for the training set was established, as the training set details are not included in this 510(k) summary.

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