Search Results

Noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or order and arm circumference range between 9" to 14" (23cm to 36cm).

The EASY X 800 (R/L) and EASY 900 (R/L) are blood pressure monitors to non-invalied. The devices of The EAST X 600 (102) and EXS P 500 (102) The devices employ oscillometric method. The devices are airsuing microprocessor-controlled and include an air pump, an electronic valve to regulate deflation and controlled of microprocessor-controlled and included and in and in and in the many of LCD(EASY X 900) display of systolic and diastolic pressure readings and heart rate, and push buttons. Systom and dastone proboard roading of the designed to detect, filter, filter, process, and store The devices employ a probation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy. The EASY X 800 (R/L) and EASY X 900 (R/L) are AC adapter-powered.

The Jawon Medical Automatic Blood Pressure Monitor, Models EASY X 800 (R/L) & EASY X 900 (R/L), is intended for noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or older and arm circumference range between 9" to 14" (23cm to 36cm).

The device's acceptance criteria and performance are based on compliance with the ANSI/AAMI SP10 standard. The submission indicates that the modified devices (EASY X 800 (R/L) and EASY X 900 (R/L)) were deemed substantially equivalent to the predicate devices (FT-500 (R/L) and FT-700 (R/L)) due to similarities in intended use, technology, and software/pressure detection hardware. No new clinical trials were conducted for the modified devices.

Here's a breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Note: The document only specifies compliance with standards as the acceptance criteria, and the reported performance is the device meeting these standards. Specific numerical performance metrics (e.g., mean difference and standard deviation between device and reference measurements) as typically found in AAMI validation studies are not explicitly detailed in this summary, but are implicitly met if the device complies with the standard.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The modified devices... are not clinically tested because the devices use the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate." This implies that no new test set was used for the modified devices for clinical performance evaluation. The substantial equivalence relies on the established performance of the predicate devices. The document does not provide details of the predicate device's test set or data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As no new clinical testing was performed for the modified devices, this information is not applicable to the current submission for the EASY X 800 (R/L) & EASY X 900 (R/L) devices. The ground truth for the predicate devices would have been established through clinical validation studies, likely involving trained healthcare professionals, but these details are not provided in this summary.

4. Adjudication Method for the Test Set

Since no new clinical testing was conducted for the modified devices, the adjudication method for a new test set is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No (N/A). This type of study investigates the improvement of human readers with AI assistance. The device in question is an automatic blood pressure monitor, which does not involve human readers interpreting images or data for diagnosis, therefore, an MRMC study is not relevant.

6. Standalone Performance Study

Yes, implied. The statement "The modified devices... meet the requirements of ANSI/AAMI SP10, IEC 60601-1-2, and EN 60601-1" suggests that the standalone performance of the device (or its predicate) was evaluated against these recognized standards for automated sphygmomanometers. ANSI/AAMI SP10 outlines requirements for accuracy of automated blood pressure devices compared to a reference standard. However, detailed results of such a standalone study for the modified devices are not provided, as they relied on the predicate's performance.

7. Type of Ground Truth Used

For blood pressure monitors, the "ground truth" for clinical validation (as required by standards like ANSI/AAMI SP10) is typically established using simultaneous auscultatory measurements by trained observers (experts) using a mercury sphygmomanometer or another validated reference method. This is the standard method for establishing the accuracy of automated blood pressure devices.

8. Sample Size for the Training Set

The document explicitly states that the modified devices use "identical software codes and pressure detection related hardware as the predicate devices." This means there was no separate training set for algorithm development for these modified devices, as the algorithm was already developed and validated with the predicate devices. The details of the training set (if any, as traditional machine learning "training" might not apply in the same way to this type of device at that time) for the predicate devices' algorithm are not provided.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, there was no separate "training set" for these modified devices. For the predicate devices, if an algorithm involved learning, its ground truth would have been established through clinical measurements against a reference standard, as described in point 7. However, the exact methods or criteria for establishing ground truth for any potential algorithm training for the predicate devices are not detailed in this summary.

Ask a specific question about this device