(462 days)
The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is for use by medical professional or home user. The EX PLUS 1300 is a device intended to measure the systolic and diastolic blood pressure, pulse rate and mean blood pressure and inter-arm pressure difference of an adult individual by using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The cuff size is fit for arm circumference of 23-36 cm.
The EX PLUS 1300 is a blood pressure monitor to non-invasively measure blood pressures and heart rate at the brachial site(s). The device employs oscillometric method. The device is a microprocessor-controlled and includes an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, LCD display of systolic and diastolic pressure readings and heart rate, and push buttons. The device employs a pressurement algorithm designed to detect, filter, process, and store pressure readings. The electronic deflation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy. The EX PLUS 1300 is an AC adapter-powered.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Jawon Automatic Blood Pressure Monitor, Model EX PLUS 1300:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states compliance with the ANSI/AAMI Voluntary Standard, SP-10:2008. While the specific numerical acceptance criteria for blood pressure monitors according to this standard are not fully detailed in this document, the performance specifications provided are implicitly part of meeting this standard.
| Characteristic | Acceptance Criteria (Implicitly per ANSI/AAMI SP-10:2008) | Reported Device Performance (Model EX PLUS 1300) |
|---|---|---|
| Accuracy - Pressure | Typically Mean Difference ≤ 5 mmHg, Std Dev ≤ 8 mmHg (per AAMI SP-10) | +/- 2mmHg (as specified in performance table) |
| Accuracy - Heart Rate | Typically +/- 5% or 5 bpm (depending on standard criteria) | +/- 3% (as specified in performance table) |
| Measurement Range - Pressure | (Not explicitly stated, but within typical human physiological range) | 30 to 280 mmHg |
| Measurement Range - Heart Rate | (Not explicitly stated, but within typical human physiological range) | 30 to 200 bpm |
Important Note: The stated "Accuracy - pressure: +/- 2mmHg" is often interpreted as the device's inherent precision or resolution. The actual AAMI SP-10 standard for accuracy involves statistical analysis of the difference between device readings and a reference method (auscultation by trained observers), where the mean difference and standard deviation of differences are the key metrics. The document implies compliance with the standard but does not provide these specific statistical results for validation of the EX PLUS 1300 model itself.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: No new clinical test data for the EX PLUS 1300 is provided. The document explicitly states: "The EX PLUS 1300 was not clinically tested because the device uses the identical software codes and pressure detection related hardware as the predicate device to determine systolic, diastolic, and pulse rate." And "As the modified device EX PLUS 1300 comprises of two sets of EASY X 900(R/L) of which are predicate device, no clinical test was conducted."
- Data Provenance: Not applicable as no new clinical data was collected for this specific device. The clinical validation of the predicate device (EASY X 900(R/L)) would have involved data, but its provenance is not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable as no new clinical study was conducted for the EX PLUS 1300. The ground truth method for the predicate device's validation (likely expert auscultation according to AAMI SP-10) is not detailed here.
4. Adjudication Method:
- Not applicable as no new clinical study was conducted for the EX PLUS 1300.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The device's validation relies on its substantial equivalence to a predicate device and engineering/non-clinical testing.
6. Standalone Performance Study:
- A standalone clinical performance study was not done for the EX PLUS 1300. The submission argues that because the EX PLUS 1300 uses "identical software codes and pressure detection related hardware" as the predicate device (Jawon Model EASY X 900(R/L)), and is essentially "two (2) sets of model EASY X 900(R/L) in one enclosure," a new clinical test was not required. The performance specifications are given for the EX PLUS 1300, but they are based on the proven performance of the predicate device.
7. Type of Ground Truth Used:
- For the EX PLUS 1300, no new clinical ground truth was established. For the original predicate device validation (EASY X 900(R/L)), the ground truth for blood pressure measurement according to ANSI/AAMI SP-10 typically involves simultaneous auscultation by multiple trained observers using a mercury sphygmomanometer as the reference standard.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. It's an oscillometric blood pressure monitor.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable as this is not an AI/ML device requiring a training set.
§ 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).