(26 days)
The ProBP 2400 is a non-invasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic blood pressures, pulse rate and mean arterial pressure (MAP) for use in pediatric and adult populations with arm cuff circumference sizes ranging from 14 - 52 cm.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.
ProBP 2400 Digital Blood Pressure Device is designed to measure systolic and diastolic blood pressure, pulse rate and mean arterial pressure (MAP) of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.The device has 1x, 3x, and MANUAL measurement modes and has irreqular heartbeat detection function. inflation pressure setting function, measurement intervals setting function etc.
The 1x mode is selected to perform single blood pressure measurement of patients.
The 3x mode is selected to complete a fully-automated triple measurements. Taking fewer than three measurements can be stopped by pressing the Start/Stop button.
The MANUAL mode is selected for blood pressure measurement of patients to confirm if a patient is suitable for the oscillometric method.
Here's an analysis of the provided text regarding the ProBP 2400 Digital Blood Pressure Device, structured to address your specific questions.
Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, it often references previous studies rather than presenting entirely new, exhaustive clinical trials for every aspect. Where specific details are not explicitly stated, it will be noted.
Acceptance Criteria and Device Performance
The primary acceptance criteria for blood pressure devices are typically defined by recognized standards such as AAMI/ANSI SP10, EN 1060-1, EN 1060-3, and ANSI/AAMI/ISO 81060-2. These standards outline requirements for accuracy (mean difference and standard deviation between device and reference measurements) and other performance metrics. The provided document states that the device passed these standards but does not provide a table of the specific acceptance criteria thresholds or the exact reported performance numbers for the ProBP 2400. It simply states "Results were passing."
However, based on the reference to ANSI/AAMI/ISO 81060-2 (2013), we can infer the typical acceptance criteria for accuracy. For adult populations, this standard generally requires:
- Mean difference: ≤ ±5 mmHg for both systolic and diastolic blood pressure.
- Standard deviation of the differences (SD): ≤ 8 mmHg for both systolic and diastolic blood pressure.
Since the document does not provide the specific performance data for the ProBP 2400, a table of acceptance criteria and reported performance cannot be fully constructed from this text. It only states that "Results were passing."
Inferred Table of Acceptance Criteria (based on ANSI/AAMI/ISO 81060-2) and Reported Device Performance:
| Performance Metric | Acceptance Criteria (e.g., ANSI/AAMI/ISO 81060-2) | Reported Device Performance (ProBP 2400) |
|---|---|---|
| Systolic BP: Mean Difference (device - reference) | ≤ ±5 mmHg | "Passing" (specific value not reported) |
| Systolic BP: Standard Deviation of Differences | ≤ 8 mmHg | "Passing" (specific value not reported) |
| Diastolic BP: Mean Difference (device - reference) | ≤ ±5 mmHg | "Passing" (specific value not reported) |
| Diastolic BP: Standard Deviation of Differences | ≤ 8 mmHg | "Passing" (specific value not reported) |
| (Additional metrics as per standard, e.g., heart rate if applicable) | (Varies by standard) | "Passing" (specific value not reported) |
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document states: "A clinical validation was conducted in accordance with ISO 81060-2 testing."
- Sample Size: The exact sample size used for the ISO 81060-2 clinical validation is not specified in this document for the subject device. However, ISO 81060-2 (2013) typically requires a minimum of 85 participants for accuracy validation in a standard adult population.
- Data Provenance: Not explicitly stated. The study for the subject device was a clinical validation. The language "clinical validation was conducted" suggests a prospective study for that component.
- For the "pregnancy and pre-eclampsia" claim, the document states: "The clinical test report referenced in K143341 supporting measurement accuracy in pregnancy and pre-eclampsia use is applicable to our subject device." This implies the data for this specific population was from a previous study associated with the predicate device (K143341), meaning it could be retrospective to the current submission, but was likely prospective when originally conducted for the predicate.
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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):
- For blood pressure validation studies according to ISO 81060-2, the "ground truth" (reference blood pressure measurements) is established by two trained observers (experts) using a standardized auscultatory method, often with a double-stethoscope setup.
- Qualifications of Experts: The standard requires trained observers who are blinded to the device's readings. Specific experience levels (e.g., "radiologist with 10 years of experience") are not typically detailed in 510(k) summaries for blood pressure studies, but they are expected to be competent and trained in auscultatory blood pressure measurement.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For ISO 81060-2, the reference measurements are typically taken by two independent observers. If their readings differ significantly (e.g., by more than a predefined threshold, commonly 4 mmHg or 5 mmHg), a third observer or a re-measurement procedure is often employed, which implies a form of 2+1 adjudication or a similar conflict resolution mechanism, though the exact method isn't specified in this summary. The standard requires the average of the two observers' readings or a specific procedure for discrepancies.
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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 standalone blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI assistance. Therefore, there is no "effect size of how much human readers improve with AI."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The entire clinical validation described for the ProBP 2400 (and its predicate) is a standalone performance assessment of the oscillometric algorithm against a well-established reference measurement (auscultation by human observers). The device's measurement is entirely algorithmic, without a human "in-the-loop" to modify its output for a single measurement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth used for the clinical validation was expert consensus (of two trained observers performing auscultatory blood pressure measurement). This is often referred to as the "reference measurement" in blood pressure validation standards.
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The sample size for the training set:
- Not specified. 510(k) summaries for devices of this type typically do not detail the training set size for the underlying algorithm, especially when substantial equivalence to a predicate is the primary claim. The "oscillometric method" is a well-established technique used by many devices, and the core algorithm would have been developed and "trained" (or calibrated) using extensive data over time, but these details are not part of the current submission.
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How the ground truth for the training set was established:
- Not specified. Similar to the training set size, the method for establishing the ground truth for an algorithm's internal training/calibration is not typically disclosed in a 510(k) summary. It would likely involve a large dataset of comparative measurements against a recognized reference standard (e.g., invasive arterial pressure or auscultatory measurements by experts) during the device's original development cycle.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).