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The A-PULSE CASPro/CASPal Monitors are intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic systolic pressure (CASP) and other waveform indices.

Cardiovascular disease remains among the leading causes of death worldwide. Hypertension assessment is one of the primary factors in the evaluation of cardiovascular disease. Assessment of CASP may improve the stratification and management of patients with elevated cardiovascular risk.

The A-PULSE CASPro/CASPal Monitors are compact standalone monitors that combine two methods of blood pressure measurement:

Conventional oscillometric blood pressure via a brachial cuff on the upper arm, and
Radial arterial pulse acquisition via a wrist-mounted tonometer sensor.

The A-PULSE CASPro/CASPal Monitors first measure systolic and diastolic blood pressure and pulse rate via the oscillometric method, and then acquire the radial arterial pulse waveform to derive the Central Aortic Systolic Pressure (CASP) non-invasively.

The A-PULSE CASPro monitor has a graphical display that displays the arterial pulse waveform as well as a range of other pulse indices. The A-PULSE CASPal monitor has a numeric display. Both models have a nonvolatile memory to store and recall measurements.

Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPro/CASPal Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

The A-PULSE CASPro/CASPal Monitors are intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician or other licensed practitioner.

Device Description

HealthSTATS A-PULSE CASPro/CASPal Monitors are standalone noninvasive blood pressure monitors which are designed to measure (1) conventional oscillometric blood pressure with a brachial cuff and (2) Central Aortic Systolic Pressure (CASP) and other indices based on arterial tonometry at the radial artery of the wrist.

The CASPro/CASPal Monitors are comprised of four main elements:

Integrated oscillometric blood pressure module for calibration . (identical to the BPCalibrator [listed device K041546]).
. Wrist sensor module based on the technology of the BPro® monitor device [listed device K060315].
Software algorithm for radial arterial blood pressure measurement . and calculation of CASP based on the A-PULSE PC Software [listed device K072593].
A-PULSE CASPro®, A-PULSE CASPal® main processing unit. .

Two functionally equivalent monitors are offered in this 510(k), the A-PULSE CASPro Monitor and the A-PULSE CASPal Monitor:

. The CASPro Monitor device is equipped with a full featured color TFT LCD panel to display blood pressure readings and radial arterial pulse waveforms. The device also has a real time calendar clock for time-stamped stored readings.
The A-PULSE CASPal Monitor device is equipped with a simplified . monochrome LCD panel to provide numeric blood pressure readings and a pulse bar to display radial arterial pulsations.

The operation sequence of both A-PULSE CASPro and CASPal Monitors is the same and both devices use identical hardware and software alqorithms to measure and report conventional systolic and diastolic blood pressure readings (BP), Central Aortic Systolic Pressure (CASP), and pulse rate (PR).

AI/ML Overview

The provided text describes the HealthSTATS A-PULSE CASPro/CASPal Monitors, which are non-invasive blood pressure monitors designed to measure conventional oscillometric blood pressure, Central Aortic Systolic Pressure (CASP), and other indices based on arterial tonometry.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the A-PULSE CASPro/CASPal Monitors were "clinically tested in comparison with listed devices for the measurement of central aortic systolic pressure (CASP). Test results demonstrate CASP measurements that are consistent with the predicate devices within the stated accuracy claims." However, the specific numerical acceptance criteria for CASP accuracy or other measurements (e.g., conventional blood pressure, pulse rate) are not detailed in the provided text. Therefore, a complete table cannot be constructed with specific numerical acceptance criteria.

Metric	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Central Aortic Systolic Pressure (CASP) Measurement Accuracy	Consistent with predicate devices.	Consistent with predicate devices within stated accuracy claims.
Conventional Oscillometric Blood Pressure Measurement Accuracy	(Assumed to be consistent with predicate devices and standards for BP monitors, but not explicitly stated or detailed.)	(Implied to meet relevant standards, as the oscillometric module is identical to a listed predicate device.)
Pulse Rate Measurement Accuracy	(Assumed to be consistent with predicate devices, but not explicitly stated or detailed.)	(Implied to meet relevant standards.)

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

The document states that the A-PULSE CASPro/CASPal Monitors were "clinically tested," but does not specify the sample size used for the test set.

The data provenance (country of origin, retrospective or prospective) is not mentioned in the provided text.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The clinical testing was performed "in comparison with listed devices" for CASP measurement, suggesting that the predicate devices' measurements were used as a reference, rather than independent expert ground truth establishment.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. The testing was a comparison against predicate devices.

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

A multi-reader multi-case (MRCM) comparative effectiveness study was not explicitly mentioned or described. The testing focused on the device's measurements relative to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was performed. The device, an "A-PULSE CASPro/CASPal Monitor," is described as a "standalone noninvasive blood pressure monitor" that uses "software algorithm for radial arterial blood pressure measurement and calculation of CASP." The clinical tests evaluate the accuracy of these measurements directly against predicate devices, indicating a standalone performance assessment.

7. Type of Ground Truth Used:

The ground truth for the clinical tests was established by comparison with measurements obtained from predicate devices. The text states, "The A-PULSE CASPro/CASPal Monitors were clinically tested in comparison with listed devices for the measurement of central aortic systolic pressure (CASP)." This implies that the measurements from the predicate devices served as the reference standard.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. The focus is on the clinical testing against predicate devices. It is possible that the software algorithms used in the device were developed using internal data that is not disclosed in this summary, or that the algorithms are based on established methods from the predicate devices without requiring a separate "training set" in the context of this submission.

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

Since no training set information is provided, the method for establishing its ground truth is not mentioned.

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