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The A-Pulse™ Arterial Pulse Waveform Analysis System consists of A-Pulse PC Software, the BPro® Blood Pressure monitor, and the BPCalibrator Oscillometric monitor.

A-Pulse PC software is used in conjunction with the HealthSTATS BPro Blood Pressure monitor to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure waveforms measured at the radial artery.

Before each measurement session, the BPro wrist-mounted tonometric device is calibrated using the BPCalibrator oscillometric monitor. Once calibrated, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device.

A-Pulse PC software is intended to measure systolic and diastolic blood pressure and pulse rate, and to utilize the radial pulse waveform to derive central aortic pressure (CAP), radial augmentation index (rAl), and a range of other indices.

A-Pulse PC Software is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.

HealthSTATS BPro® is a noninvasive arterial waveform analysis system system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements:

• A-Pulse PC Software for radial arterial pulse waveform analysis, a PC-. based computer program [new device].
• BPro® wrist-mounted tonometric monitor [listed device K060315]. .
• BPCalibrator MC3000 oscillometric blood pressure monitor [listed . device, K051546] for calibration of the BPro monitor ..

Once calibrated using the BPCalibrator oscillometric device, A-Pulse PC Software is capable of acquiring and displaying arterial blood pressure waveforms from the BPro wrist device.

The BPro monitor is applied to the wrist with a pressure transducer placed over the radial artery. The monitor has a size and weight similar to a sports type wrist watch. An embedded microcontroller supervises the actions of the monitor including scheduled measurements, on-demand measurements, and serial data communication with the host PC.

The A-Pulse PC Software measures arterial waveforms in real time, calculates blood pressure parameters and indices on selected waveforms. and stores and prints reports.

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document is a 510(k) summary for a medical device. This summary often provides high-level information and may not contain all the detailed data found in the full submission, such as specific acceptance criteria thresholds or comprehensive study methodologies.

Acceptance Criteria and Device Performance

Based on the provided K072593 510(k) summary, the device is being compared to predicate devices for its ability to derive certain physiological indices. The summary states: "Test results confirm reliable indices that are consistent with the predicate device measurements within the stated accuracy claims." However, specific numerical acceptance criteria (e.g., a defined threshold for agreement or difference) are not explicitly stated in this summary document. Thus, the performance is reported qualitatively as "consistent" and "reliable."

Study Details to Prove Acceptance Criteria

The document mentions "Clinical Tests Submitted" and "Conclusions from Tests" to demonstrate equivalence.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified in the provided summary. It doesn't mention country of origin, nor whether the study was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the summary. The study is described as a comparative clinical test against predicate devices, implying the predicate device measurements served as the reference rather than expert interpretation of raw data for ground truth establishment.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • None is explicitly mentioned or implied. The study design appears to be a direct comparison of the device's output (rAI, CAP) against the output of predicate devices.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a diagnostic measurement system that provides physiological indices (rAI, CAP) directly, rather than an AI-assisted diagnostic aid for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, in effect, a standalone comparison was done. The A-Pulse PC Software, in conjunction with the BPro monitor, derives the indices (rAI, CAP) directly. The clinical test compared these derived indices with those obtained from predicate devices. While a human uses the system and interprets the output, the calculation of rAI and CAP by the A-Pulse system itself is a standalone algorithmic process compared to the benchmark values from the predicate devices. The "standalone" performance here refers to the device's ability to consistently produce these indices compared to existing approved technology.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this study was the measurements and derived indices from legally marketed predicate devices. The summary states, "The A-Pulse Arterial Pulse Waveform Analysis System was clinically tested in comparison with the listed devices for the derivation of the indices."

7. The sample size for the training set:

   • The document primarily describes the premarket notification for a new device and its comparison to predicate devices. It does not explicitly mention a "training set" in the context of machine learning, nor does it specify any sample size for such. It's possible the device uses algorithms that were developed and "trained" on internal data, but this information is not part of the provided 510(k) summary.

8. How the ground truth for the training set was established:

   • As no "training set" is explicitly mentioned in the context of the 510(k) summary, the method for establishing its ground truth is not provided. If the device's algorithms were developed using historical data, the methods for establishing ground truth for that development would be external to this specific regulatory summary.

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