(14 days)
PG-800A Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm.
The proposed device, PG-800A Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. The device has the data storage function. It has an bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
Here's a breakdown of the acceptance criteria and study information for the PG-800A Electronic Blood Pressure Monitor, based on the provided text:
Acceptance Criteria and Device Performance
The provided document states that "Performance and Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006" was conducted. This standard outlines acceptance criteria for non-invasive automated sphygmomanometers. While the specific numerical acceptance criteria for mean difference and standard deviation are not explicitly listed in the provided text, the successful completion of the test per this standard implies that the device met its requirements. The "reported device performance" would be the results obtained from this clinical verification test; however, these specific numerical results (e.g., mean difference and standard deviation of blood pressure measurements) are not detailed in the provided document.
Therefore, I can present the information as follows, indicating where details are inferred or missing:
| Acceptance Criteria (ANSI/AAMI SP10:2002+A1:2003+A2:2006) | Reported Device Performance (Implied by meeting standard) |
|---|---|
| Blood Pressure Measurement Accuracy | |
| Mean difference between device and reference method | Met the specified limits (exact values not provided) |
| Standard deviation of differences | Met the specified limits (exact values not provided) |
| Pulse Rate Accuracy | (Not explicitly detailed, but usually part of performance verification) |
| Mean difference between device and reference method | Met the specified limits, if applicable (exact values not provided) |
| Standard deviation of differences | Met the specified limits, if applicable (exact values not provided) |
Study Details
Based on the provided text:
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Sample size used for the test set and the data provenance: The document states that a "Clinical Verification Test per ANSI/AAMI SP10:2002+A1:2003+A2:2006" was performed. This standard typically mandates a minimum number of subjects (e.g., 85 subjects with specific demographic and blood pressure distribution) for clinical testing. However, the exact sample size used for the test set is not explicitly stated in the provided 510(k) summary. The data provenance (country of origin, retrospective/prospective) is also not specified.
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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 monitors, the "ground truth" is typically established by trained observers taking auscultatory measurements using a mercury sphygmomanometer or another validated reference method. The ANSI/AAMI SP10 standard specifies requirements for these observers (e.g., being blinded, trained according to specific protocols). However, the number of experts and their specific qualifications are not explicitly stated in this document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: For blood pressure measurement validation studies, ground truth is often established by multiple observers (e.g., two observers taking simultaneous measurements, with a third observer for adjudication if there's a discrepancy). While this is common practice for AAMI SP10 studies, the specific adjudication method used is not detailed in the provided text.
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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: This device is an electronic blood pressure monitor, not an AI-assisted diagnostic tool for imaging or complex data interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable to this type of device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the described "Performance and Clinical Verification Test per ANSI/AAMI SP10" is a standalone performance test for the device (algorithm only), assessing its accuracy against a reference standard without human-in-the-loop interaction for interpretation, beyond the initial cuff placement and operation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for blood pressure measurement accuracy studies conforming to ANSI/AAMI SP10 is established through simultaneous auscultatory measurements taken by trained expert observers using a validated reference mercury sphygmomanometer (or an equivalent validated oscillometric device).
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The sample size for the training set: This device is a traditional electronic medical hardware device based on an oscillometric technique, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense of AI development. Therefore, the concept of a "training set" and its sample size is not applicable to this device.
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How the ground truth for the training set was established: As the concept of a "training set" is not applicable, establishing ground truth for a training set is also not applicable. The device's measurement principle is based on established oscillometric algorithms, which are determined through physical and mathematical modeling, not empirical data training in the AI sense.
§ 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).