(173 days)
The Electronic Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique at medical facilities or at home.
JPD-HA120 and JPD-HA121 Electronic Blood Pressure Monitor is a battery powered automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The proposed JPD-HA120 and JPD-HA121 Electronic Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm. The main differences are product appearance. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use.
The provided document is a 510(k) premarket notification for an Electronic Blood Pressure Monitor (models JPD-HA120 and JPD-HA121). The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or, if there are differences, that these differences do not raise new questions of safety and effectiveness.
The document focuses on comparing the new device to a predicate device and detailing the non-clinical and clinical testing performed to support substantial equivalence.
Here's an analysis addressing your specific questions, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly present a pre-defined table of acceptance criteria with corresponding performance results in the way you might expect for a typical scientific study's results section. Instead, for blood pressure monitors, accuracy is defined by industry standards like ISO 81060-2. The acceptance criteria are implicitly met if the device complies with the accuracy requirements of this standard.
The general acceptance criteria for a non-invasive blood pressure monitor would be its accuracy in measuring systolic and diastolic blood pressure, and pulse rate. The document states the device's accuracy specifications:
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Standard Compliance) | Reported Device Performance (Claimed Accuracy) |
|---|---|---|
| Static Pressure | Per ISO 81060-2:2013 (implicit) | ± 3 mmHg |
| Pulse Rate | Per ISO 81060-2:2013 (implicit) | ± 5% |
It is explicitly stated that the system complies with ISO 80601-2-30:2009 (for performance effectiveness) and ISO 81060-2:2013 (for clinical validation), meaning it met the requirements set forth in those standards. The accuracy stated in the "Comparison" table (Page 4) reflects the accuracy specifications of the device, which are the same as the predicate device and are presumed to meet the standard's requirements.
Study Details
2. 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: "Clinical testing is conducted per ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
- Sample Size: The ISO 81060-2 standard specifies the minimum number of subjects required for clinical validation (typically 85 subjects with specific age/sex/BP distribution). While the document does not explicitly state the sample size used in this specific study, it implies compliance with the standard's requirements.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Clinical validation studies for medical devices are almost always 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)
For blood pressure monitor validation studies adhering to ISO 81060-2:2013, ground truth (reference blood pressure) is established using auscultation by trained observers. The standard typically requires two or three independent trained observers:
- Number of experts: ISO 81060-2:2013 requires measurements from two trained observers simultaneously using a mercury sphygmomanometer or validated alternative. A third observer might be used for adjudication if the first two differ significantly.
- Qualifications of experts: These are typically medical professionals or trained technicians who are specifically trained and certified in the auscultation method for blood pressure measurement, following strict protocols outlined in the standard. The document doesn't specify their direct qualifications, but compliance with the standard implies they met these criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
For clinical validation following ISO 81060-2:2013, the ground truth is established by simultaneous auscultatory measurements often by two observers. If their readings differ by more than a specified amount, a third observer might be involved or the measurement discarded. The standard itself outlines the specific methodology for comparing automated device readings to reference readings. The document does not explicitly state the adjudication method beyond "Clinical testing is conducted per ISO 81060-2: 2013".
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, an MRMC study was not done. This type of study (MRMC) is typically performed for diagnostic imaging AI algorithms where AI is assisting human interpretation. Blood pressure monitors are automated devices that provide a direct measurement; there's no human "reader" whose performance needs to be improved by AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in effect, a standalone performance evaluation was done. The device itself is an automated measurement system. When it undergoes clinical validation per ISO 81060-2, its performance is evaluated as a standalone system against a reference standard (auscultation). There isn't a "human-in-the-loop" once the device is initiated for a measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for blood pressure measurement in clinical validation studies for oscillometric devices is typically established by simultaneous, independent auscultatory measurements performed by trained human observers using a standardized reference method (e.g., mercury sphygmomanometer). This can be considered a form of "expert consensus," specifically expert measurement.
8. The sample size for the training set
- The document does not specify a training set size. For blood pressure monitors, the "algorithm" is the oscillometric method itself, which is well-established. While the device's internal algorithm might have been tuned or developed using performance data, this is not typically disclosed as a distinct "training set" in a 510(k) unless a novel, data-driven AI algorithm is at its core. This device likely relies on a standard oscillometric algorithm.
9. How the ground truth for the training set was established
- As a training set is not explicitly mentioned or suggested for a novel AI algorithm, the method for establishing ground truth for a training set is not applicable/provided in this 510(k) submission. The underlying principles of oscillometry are based on established physiological responses, not on training a machine learning model on a specific dataset.
§ 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).