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The BPro system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.

The BPro system is intended only for measurement, recording, and display. It makes no diagnosis.

HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System with BProSOft CASP® PC software is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements:
. BPro wrist-mounted tonometric monitor (listed device K060315),
. BProSoft CASP report management software, a PC-based computer program (new/added measurement function).
. BPCalibrator MC3000 oscillometric blood pressure monitor [listed device, K051546] for calibration of BPro monitors.

Once the BPro is calibrated using the BPcalibrator oscillometric device, it is capable of measuring and recording systolic pressure, diastolic pressure and pulse rate over a period of 24 hours. Arterial pulse waveforms obtained over the 24 hour period are used by the BProSoft CASP PC software to calculate central aortic systolic pressure (CASP).

This document describes the HealthSTATS BPro® Ambulatory Blood Pressure Monitoring System with BProSOft CASP® PC software.

Here's an analysis of the provided text to answer your questions:

Acceptance Criteria and Device Performance

The document states that the BProSOft CASP PC Software's accuracy was confirmed against a predicate device. However, it does not provide a specific table of acceptance criteria with quantitative performance metrics (e.g., mean difference, standard deviation of difference) for CASP measurement. It only states that the "Test results confirm the accuracy of the BProSOft CASP measurement consistent with the predicate device measurements within the stated accuracy claims."

Without specific numerical acceptance criteria, a direct comparison table cannot be provided. The general acceptance criterion implied is equivalence in accuracy to the predicate device for CASP measurement.

Study Information

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size: Not explicitly stated. The document mentions "clinically studied" but does not give the number of participants.
• Data Provenance: Not explicitly stated. The document indicates the submission is from Singapore but does not specify where the clinical study data originated. It does not mention if the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Number of experts: Not explicitly stated.
• Qualifications of experts: Not explicitly stated. The ground truth (predicate device measurements) is established by another device rather than human experts for the CASP comparison study.

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

• Adjudication Method: Not explicitly stated. The study compares the BPro with a predicate device, implying the predicate device's measurements serve as the reference.

5. 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:

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not explicitly mentioned. This device measures physiological parameters and calculates CASP, rather than providing interpretations that human readers would then review. The focus is on the accuracy of the device's measurements relative to a predicate device, not on improving human reader performance.

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

• Standalone Performance: Yes, the clinical study for the BProSOft CASP PC Software appears to be a standalone performance study. It compares the CASP measurements generated by the software (algorithm) with those from a predicate device. The BPro system itself is stated to be "intended only for measurement, recording, and display. It makes no diagnosis," further supporting a standalone assessment of its output.

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

• Ground Truth: The ground truth for the CASP measurement comparison was the measurements from a listed predicate device. The document states, "BProSOft CASP PC Software has been clinically studied with the BPro monitor in comparison to a listed predicate device for the derivation of central aortic systolic pressure (CASP)."

8. The sample size for the training set:

• Training Set Sample Size: Not explicitly stated. The document mentions the software "calculates central aortic systolic pressure (CASP)" but does not detail any machine learning or AI training process, nor any specific training datasets.

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

• Training Set Ground Truth Establishment: Not explicitly stated. Given the description, it's unclear if a traditional "training set" in the machine learning sense was used for the CASP calculation algorithm. If it was, the method for establishing ground truth for such a set is not provided. The focus is on the validation of the calculation against a predicate.

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The BPro system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.

The BPro system is intended only for measurement, recording, and display. It makes no diagnosis.

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

• BPro/BPal wrist-mounted tonometric monitor.
• BProSoft report management software, a PC-based computer program.
• BPCalibrator MC3000 oscillometric blood pressure monitor [listed . device, K051546] for calibration of BPro/BPal monitors.

Once the BPro is calibrated using the BPcalibrator oscillometric device, it is capable of measuring and recording systolic pressure, diastolic pressure and pulse rate over a period of 24 hours.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample size used for the clinical test set. It only states that the BPro system "was clinically tested in accordance with AAMI-SP10."

The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not explicitly mentioned.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth. For blood pressure monitoring, "ground truth" typically refers to reference measurements taken by trained personnel using a validated method against which the device's readings are compared.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For a blood pressure monitoring device, the "adjudication" would typically involve comparing the device's readings to reference readings obtained by the standard method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This device is a blood pressure monitor, not an AI for image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance assessment was effectively done. The clinical tests evaluated the accuracy of the BPro system (which includes its underlying algorithms for measurement) against a standard, without requiring active human interpretation of its outputs beyond what's typically involved in blood pressure measurement (e.g., ensuring proper device placement, initiating measurement). The device's output is directly a blood pressure reading.

7. The Type of Ground Truth Used:

For blood pressure monitoring device validation against standards like AAMI-SP10, the ground truth is typically established by simultaneous measurements using a recognized reference method, often involving auscultation by trained observers or another validated oscillometric device, especially during the "stationary" and "ambulatory" tests. The document implies this by stating conformity to AAMI-SP10.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set size. This is common for devices like this that primarily rely on established physical measurement principles and calibration rather than complex machine learning models that require extensive "training" data.

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

Since a training set is not mentioned or implied for this type of device, the method for establishing its ground truth is not applicable and not provided in the document.

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