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The BPro® BT Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of a BPro BT wrist-mounted tonometric monitor, a BPCalibrator MC3100+ oscillometric blood pressure monitor for calibration, and BProSOft BT software, a PC-based computer program.

Before each measurement session, the wrist device is calibrated using the oscillometric monitor. Once calibrated, the BPro wrist device is capable of recording and displaying up to 96 measurements of systolic and diastolic blood pressure and pulse rate over a period of 24 hours.

BProSOft BT PC software is used to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 24-hour period.

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

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

HealthSTATS BPro® BT Ambulatory Blood Pressure Monitoring System with BProSOft 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 BT wrist-mounted tonometric monitor.
• BProSoft BT report management software, a PC-based computer program.
• BPCalibrator MC3100+ oscillometric blood pressure monitor [listed device, K131788] for calibration of BPro BT monitor.

Once the BPro BT 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. Blood pressure measurements obtained over the 24 hour period are transferred wirelessly by the BProSoft BT PC software for storage, display, and reports.

This FDA 510(k) summary provides information for the HealthSTATS BPro® BT Ambulatory Blood Pressure Monitoring System with BProSOft BT PC Software. However, it explicitly states "No clinical tests have been submitted - the blood pressure measurement is unaffected by the device modification, which is limited to the device display change to color, wireless data transmission of blood pressure records, and the addition of an internal rechargeable battery."

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets those criteria, as no new clinical study was conducted for this specific 510(k) submission (K173028). The device's equivalency is based on modifications to an existing predicate device (K060315), and the assumption that the core blood pressure measurement functionality remains unchanged.

However, I can extract the information provided about the non-clinical tests and the product's general characteristics:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical study was submitted for K173028, there are no specific numerical acceptance criteria for blood pressure accuracy or reported performance metrics from a new clinical study. The device's performance is assumed to be equivalent to its predicate.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable, as no new clinical test data was submitted.
• Data Provenance: Not applicable.

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

Not applicable, as no new clinical test data was submitted.

4. Adjudication method for the test set

Not applicable, as no new clinical test data was submitted.

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

Not applicable. This device is a blood pressure monitor, not an AI-assisted diagnostic tool that involves human readers.

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

Not applicable for a new study. The device's core blood pressure measurement algorithm is inherited from the predicate device, and its performance is assumed to be equivalent.

7. The type of ground truth used

Not applicable for a new study. For the predicate device, standard reference methods for blood pressure measurement would have been used as ground truth.

8. The sample size for the training set

Not applicable, as no new clinical study was conducted for this submission. The device modifications did not involve changes to the blood pressure hardware sensor or software algorithms (implying the measurement algorithm was not retrained).

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

Not applicable, as no new clinical study was conducted for this submission. For the predicate device, the ground truth for any initial algorithm development would have been established through comparison with established reference blood pressure measurement methods.

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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 A-PULSE CASPal+ and MC3100+ Monitors are intended for use on patients who are eighteen (18) years and older, and for the CASPal+, have a palpable radial pulse.

Brachial Blood pressure, CASP and pulse rate readings obtained using the A-PULSE CASPal+ and MC3100+ Monitors are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

The HealthSTATS A-PULSE CASPal® and MC3100™ 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 CASPal®+ Monitor is comprised of four main elements:

• System embedded processing unit.
• Integrated oscillometric blood pressure module for calibration (identical to the BPCalibrator [listed device K041546], also cleared iin CASPal device K101002).
• Wrist sensor module for acquistion of central aortic systolic pressure (CASP) via radial arterial tonometry at the wrist [cleared accessory and method K101002].
• Bluetooth® wireless communications module.

The MC3100™* is a reduced feature set of the CASPal®* which only offers the oscillometric blood pressure measurement and not the CASP measurement, but is otherwise identical. my-BP™ PC software may be used with either device to store and display blood pressure and pulse rate measurements on a suitably equipped computer.

The provided 510(k) summary does not contain the information necessary to fully describe the acceptance criteria and the study that proves the device meets those criteria, particularly as it relates to AI/machine learning performance studies.

This document describes a blood pressure monitor (HealthSTATS A-PULSE CASPal®+ and MC3100™+ Monitors) and associated software. The "Clinical Tests Submitted" section explicitly states that no new clinical data was submitted for this specific 510(k) submission (K131788). Instead, it relies on clinical testing performed on a cleared predicate device (A-PULSE CASPal) because the current devices are considered "functionally and physically identical" except for the addition of Bluetooth wireless data transmission.

Therefore, many of the requested details about acceptance criteria, test set characteristics, expert involvement, and ground truth establishment are not present in this document, as they would have been part of the predicate device's clearance.

However, I can extract what is stated:

Summary of Acceptance Criteria and Device Performance (based on provided text):

The document frames "acceptance criteria" through the lens of substantial equivalence to predicate devices, focusing on safety and effectiveness.

Study Details (based on provided text):

Since this submission relies on a predicate device's clearance for clinical data, the details of the original clinical study are not provided in this document. The following points represent what can be inferred or are explicitly absent:

1. A table of acceptance criteria and the reported device performance: See table above. Specific numerical clinical performance metrics (e.g., mean difference and standard deviation of BP readings compared to a reference) are not provided in this summary, as clinical data was not submitted anew for this device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in this document. This information would have been part of the predicate device's submission.
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): Not applicable/provided. For a blood pressure monitor, the "ground truth" is typically established by concomitant measurements using a validated reference method (e.g., auscultation by trained observers using a mercury sphygmomanometer, intra-arterial catheterization for CASP, or another FDA-cleared device with established accuracy), not by human experts adjudicating images or reports. The document does not describe the specifics of the clinical study method for the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided. As per point 3, this is not a study type where human adjudication of results would typically occur.
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: No. This is not an AI/machine learning device that assists human readers. It's a medical device for measuring blood pressure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device measures blood pressure automatically, so its performance is inherently "standalone" in that sense. It does not involve a human in a decision-making loop that an AI would typically augment. The performance of the measurement algorithms themselves would have been evaluated in the predicate device’s clinical study against reference methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure measurement, the ground truth is typically a reference measurement from a validated standard method (e.g., intra-arterial catheter, or manual auscultatory measurement by trained personnel according to a standard protocol). The specific method used for the predicate device's clinical study is not detailed in this 510(k) summary.
8. The sample size for the training set: Not applicable. This device is not described as utilizing a machine learning algorithm that has a "training set." Its function is based on established physiological principles and signal processing, not a trained AI model.
9. How the ground truth for the training set was established: Not applicable. (See point 8).

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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.

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).

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.

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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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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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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The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate. The device is intended for use at home or in doctor's office settings on patients who are eighteen (18) years and older and who do not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. The arm circumference range shall be between 8.3 inches (21 cm) and 16.5 inches (42 cm).

The BPCalibrator™ MC3000 has a communication port that enables blood pressure and pulse rate readings to be transmitted to other electronic devices designed to communicate with it.

Blood pressure and pulse rate readings obtained using the device are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

The BPCalibrator™ MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate at home or in clinical settings.

A cuff is applied to the upper arm before measurement. When a measurement is initiated, the cuff is inflated to a pressure higher than the systolic pressure and then deflated. Pressure pulses measured from the cuff during deflation are used to calculate blood pressure and pulse rate using the oscillometric method.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was clinically tested in accordance with AAMI-SP10: 1992, Electronic or Automated Sphygmomanometers, and that the "requirements of the standard were met." While the specific numerical acceptance criteria from AAMI-SP10:1992 are not explicitly detailed in the provided text, the standard generally sets forth requirements for accuracy in blood pressure measurements.

Therefore, the table can be structured as follows, with the understanding that "Met AAMI-SP10: 1992 requirements" implies compliance with the standard's accuracy and performance thresholds.

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

The document does not explicitly state the sample size used for the clinical test set. It only mentions that "The BPCalibrator™ MC3000/MC3100 was clinically tested in accordance with AAMI-SP10: 1992, Electronic or Automated Sphygmomanometers."

• Sample Size for Test Set: Not explicitly stated in the provided text. AAMI-SP10: 1992 typically recommends a minimum of 85 subjects for clinical validation.
• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective). Clinical testing conforming to AAMI-SP10 is usually prospective.

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

The document does not provide details on the number of experts used or their qualifications for establishing ground truth. AAMI-SP10: 1992 typically requires simultaneous auscultatory measurements by trained observers (often two) as the reference standard (ground truth).

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. In AAMI-SP10: 1992, if two observers are used for ground truth, their readings are averaged or a consensus is reached if there are significant discrepancies, but a formal adjudication process beyond that is not typically described as a standalone method.

• Adjudication Method: Not explicitly stated.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers.

• MRMC Study: No.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The entire premise of the clinical testing section is to validate the device itself (the BPCalibrator™ MC3000/MC3100) as a standalone blood pressure monitor, without human intervention in the measurement process other than placing the cuff and initiating the reading. The device calculates blood pressure and pulse rate using its internal oscillometric algorithm.

• Standalone Study: Yes.

7. The Type of Ground Truth Used

The ground truth used for the clinical testing would have been expert consensus (auscultation). AAMI-SP10: 1992 requires comparison of the automated device's readings against simultaneously obtained auscultatory measurements performed by trained observers using a mercury sphygmomanometer as the reference standard.

• Type of Ground Truth: Expert consensus (auscultatory measurements).

8. The Sample Size for the Training Set

The document does not mention or imply a "training set" in the context of machine learning or AI. This is a traditional medical device (oscillometric blood pressure monitor), not a device that uses AI algorithms requiring a distinct training phase. The device's algorithm for calculating blood pressure from oscillometric pulses is fixed and pre-programmed, not "trained" in the AI sense.

• Sample Size for Training Set: Not applicable/not mentioned, as this is not an AI/ML device in the context of typical "training sets."

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

As there is no mention of a "training set" in the context of AI/ML, this question is not applicable to the provided information.

• How Ground Truth for Training Set was Established: Not applicable.

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