(15 days)
The PG-800A Series 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 Series Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which 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. User can select the unit of the measurement: mmHg or KPa. All the models included in this submission follow the same measurement principle and same specifications. The main differences are appearance and data storage. These two differences will not affect the safety and effectiveness of the device.
Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Criterion (Claimed) | Reported Device Performance |
|---|---|---|
| BP Accuracy | ± 3 mmHg | ± 3 mmHg |
| BP Range | 30 ~ 280 mmHg | 30 ~ 280 mmHg |
| PR Range | 40-199 bpm | 40-199 bpm |
Study Details:
The provided document describes non-clinical bench tests conducted to verify that the proposed device (PG-800A Series Electronic Blood Pressure Monitor) met all design specifications and was Substantially Equivalent (SE) to the predicate device (Electronic Blood Pressure Monitor PG-800A, K102920).
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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 that "Bench tests were conducted." It does not specify the sample size for human subjects or the number of measurements taken during these bench tests that would be considered a "test set" in the context of clinical performance. It also does not specify the origin of any data, if human data was used, nor if it was retrospective or prospective. The tests mentioned are primarily for compliance with standards.
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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):
- This information is not provided in the document. The document refers to "bench tests" and compliance with standards like AAMI SP10, which typically involves comparison to a reference standard, not a panel of experts establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as the study described is non-clinical bench testing for compliance. Clinical adjudication methods are not relevant here.
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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. The device is an automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The presented data is the standalone performance of the device's measurement accuracy against the claimed specifications and relevant standards. The "bench tests" confirm the device's ability to measure blood pressure and pulse rate accurately according to the stated ranges and accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "BP Accuracy" and "PR Range" acceptance criteria, the implicit "ground truth" for the bench tests would be a highly accurate reference measurement device or method, as specified by the AAMI SP10 standard (e.g., using a mercury sphygmomanometer or highly calibrated electronic reference). The document states compliance with AAMI SP10:2002/(R) 2008 & A1:2003, which sets out requirements for accuracy testing against a reference standard.
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The sample size for the training set:
- This information is not applicable as the device described is an electronic blood pressure monitor, not an AI/ML device that requires a "training set" in the conventional sense of machine learning. Its operation is based on an oscillometric principle.
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How the ground truth for the training set was established:
- This information is not applicable for the reasons stated above.
§ 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).