(90 days)
All five models automatically measures human's Systolic, Diastolic blood pressure and pulse rate, and output in one LCD Panel.
The intended use of Models PH168A, PH168E and PH168W is for age 16 and above.
The intended use for the Models PHC888JA and PH888HA is for adult patients whose arm circumference is between 24-32cm (approx. 8.7" to 12.6").
Not Found
The provided document is a 510(k) summary for a blood pressure monitor, which primarily focuses on regulatory approval rather than providing detailed study results that would typically include acceptance criteria and performance data. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and a study proving device performance in the way you've outlined.
The document states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence determination is the core of a 510(k) clearance, meaning the new device performs as safely and effectively as a legally marketed predicate device.
Without the actual study report for the Proton Digital Blood Pressure Monitor, it is impossible to populate the table and answer the specific questions. However, I can infer what typical acceptance criteria and study designs look like for blood pressure monitors based on general FDA guidelines and international standards (like ISO 81060-2).
Here's how I would answer your request, assuming the device followed common validation protocols for blood pressure monitors. Please note that the specific numbers and details below are illustrative of a typical study and NOT directly from the provided FDA letter.
Inferred Acceptance Criteria and Hypothetical Device Performance (Illustrative)
Since the provided document is an FDA 510(k) clearance letter and not a detailed study report, the specific acceptance criteria and detailed device performance are not available within this document.
However, for non-invasive blood pressure monitors, acceptance criteria are typically based on recognized standards such as ISO 81060-2:2018 (Non-invasive sphygmomanometers – Part 2: Clinical investigation of automated measurement type).
Hypothetical Acceptance Criteria and Reported Device Performance (Illustrative, not from the provided document):
| Acceptance Criteria (Based on ISO 81060-2) | Reported Device Performance (Hypothetical) |
|---|---|
| Criterion 1: Mean Difference | |
| The mean difference (device reading minus reference reading) for both systolic and diastolic blood pressure shall be within ±5 mmHg. | Systolic Blood Pressure: |
| Mean Difference: +0.8 mmHg | |
| Standard Deviation: 7.2 mmHg | |
| Diastolic Blood Pressure: | |
| Mean Difference: -0.5 mmHg | |
| Standard Deviation: 6.8 mmHg | |
| (Meets Criterion: Both mean differences are within ±5 mmHg) | |
| Criterion 2: Standard Deviation | |
| The standard deviation of the blood pressure differences (device reading minus reference reading) for both systolic and diastolic blood pressure shall be within 8 mmHg. | Systolic Blood Pressure: |
| Mean Difference: +0.8 mmHg | |
| Standard Deviation: 7.2 mmHg | |
| Diastolic Blood Pressure: | |
| Mean Difference: -0.5 mmHg | |
| Standard Deviation: 6.8 mmHg | |
| (Meets Criterion: Both standard deviations are within 8 mmHg) | |
| Criterion 3: Absolute Difference Distribution |
- At least 60% of all absolute differences (device reading minus reference reading) for both systolic and diastolic blood pressure shall be ≤ 5 mmHg.
- At least 85% of all absolute differences shall be ≤ 10 mmHg.
- At least 95% of all absolute differences shall be ≤ 15 mmHg. | Systolic Blood Pressure:
≤ 5 mmHg: 68%
≤ 10 mmHg: 92%
≤ 15 mmHg: 98%
Diastolic Blood Pressure:
≤ 5 mmHg: 71%
≤ 10 mmHg: 94%
≤ 15 mmHg: 99%
(Meets Criterion for both systolic and diastolic) |
| Criterion 4: Discrepancy per subject
For each subject, the mean of the three device-reference differences must meet specific thresholds (not detailed in this table for brevity, but crucial in ISO 81060-2 assessments). | (Hypothetically met, as this is part of the overall ISO 81060-2 validation process leading to the above statistics) |
Additional Information (Hypothetical, as not available in the provided document):
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Sample size used for the test set and the data provenance:
- Sample Size: Typically, according to ISO 81060-2, a minimum of 85 subjects is required for clinical validation (with specific demographic requirements for age, gender, and blood pressure distribution).
- Data Provenance: Prospective, multi-center clinical study conducted in a specific country (e.g., USA, Europe, or a combination for broader generalizability).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For blood pressure monitor validation, ground truth is established by highly trained and certified observers using a calibrated auscultatory sphygmomanometer according to a standardized protocol.
- Number of Experts: Two independent, trained observers are typically used for each measurement, blinding them to each other's readings. A third observer might be used in case of significant discrepancies.
- Qualifications: Observers trained and certified in auscultatory blood pressure measurement, often healthcare professionals (e.g., nurses, technicians) with experience in clinical trials. They would undergo specific training and testing to ensure inter-observer agreement.
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Adjudication method for the test set:
- Typically, the average of the two independent observers' readings is taken as the reference standard (ground truth), provided their readings are within a pre-defined tolerance (e.g., 4 mmHg).
- If the difference between the two observers' readings exceeds the tolerance, a third observer's reading might be obtained, or the measurement discarded. Sometimes, the mean of the two closest readings (if three are taken) is used.
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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 is generally not applicable or performed for a standalone blood pressure monitor. Blood pressure monitors measure a physiological parameter directly; they do not involve human "readers" interpreting images or data where AI assistance would improve diagnostic performance. The device is a direct measurement tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the primary evaluation of a blood pressure monitor is a standalone performance study. The device itself generates the blood pressure readings, and its accuracy is compared against an expert-derived reference standard. There isn't typically a "human-in-the-loop" once the device is initiated for a measurement, beyond placing the cuff and starting the measurement.
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The type of ground truth used:
- Expert Consensus (Auscultatory Reference): The ground truth for blood pressure monitor validation is the auscultatory measurement performed by trained human observers using a mercury or an equivalent validated non-invasive sphygmomanometer and a stethoscope, following a strict protocol.
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The sample size for the training set:
- Not applicable for this type of device validation in the context of the 510(k) pathway. Blood pressure monitors are typically validated using a clinical study comparing their measurements to a reference standard. While the firmware or algorithm within the device might have been developed and tested internally, details of that internal development "training set" are usually proprietary and not part of the external clinical validation submitted for a 510(k). The 510(k) focuses on the performance of the final device.
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How the ground truth for the training set was established:
- Not applicable for external validation as performed for 510(k). If considering internal engineering development, the "ground truth" for training an internal algorithm might involve similar auscultatory measurements obtained during the R&D phase, often on a much smaller scale or with simulated data, to refine the device's measurement accuracy before formal clinical validation.
§ 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).