(36 days)
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).
Models FT-500 and FT-700 of the Jawon system are compact, automatic sphygmomanometers intended for measurement of blood pressure at the brachial site. Models FT-500 and FT-700 employ oscillometric method. All models are microprocessor controlled and include an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure readings and heart rate, and push button controls.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance Study for Jawon Medical FT-500(R,L) and FT-700(R,L) Noninvasive Blood Pressure Measurement System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document states that the measurement performance of the Jawon systems has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-2002 and was "found to comply fully with the accuracy criteria established in the standard."
However, the specific numerical acceptance criteria (e.g., mean difference, standard deviation) from ANSI/AAMI SP10-2002 are not explicitly detailed in the provided text. The text only states that the device complies with the standard.
To illustrate, typical ANSI/AAMI SP10 criteria for accuracy usually involve:
- Mean difference: The absolute mean difference between the device reading and the reference standard should typically be less than or equal to 5 mmHg.
- Standard deviation: The standard deviation of the difference between the device reading and the reference standard should typically be less than or equal to 8 mmHg.
Since the document doesn't provide the exact numerical performance metrics of the device against these criteria, the table below reflects what is stated in the document.
| Acceptance Criteria (Based on ANSI/AAMI SP10-2002) | Reported Device Performance |
|---|---|
| Full compliance with accuracy criteria | Complies fully |
Note: Without the explicit numerical criteria from ANSI/AAMI SP10-2002 and the specific performance data from the study, a more detailed table is not possible based on the provided text.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of subjects/measurements) used in the clinical studies. It only mentions "clinical studies."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the studies were "conducted in accordance with ANSI/AAMI Standard SP10-2002."
3. Number of Experts and Their Qualifications for Ground Truth
- The document does not provide information on the number of experts used to establish ground truth or their qualifications. For blood pressure measurement, ground truth typically involves a trained observer (often a physician or specially trained technician) using a mercury sphygmomanometer with a stethoscope in a double-blinded fashion according to a standardized protocol.
4. Adjudication Method for the Test Set
- The document does not provide any information on the adjudication method used for the test set. In clinical blood pressure validation studies, ground truth is often established by multiple trained observers, and if there are discrepancies, a third observer might adjudicate. However, this is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study information is provided. The device is a non-invasive blood pressure monitor, not an imaging or diagnostic device that typically involves human readers interpreting results. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not applicable in this context.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The "measurement performance of the Jawon systems has been evaluated in clinical studies" directly assesses the algorithm's accuracy in measuring blood pressure against a reference standard. This is inherently a standalone performance evaluation of the device's core function.
7. Type of Ground Truth Used
- Based on the statement "evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-2002," the ground truth used would be simultaneous, direct auscultatory blood pressure measurements performed by trained observers using a reference standard (e.g., mercury sphygmomanometer) in a clinical setting. ANSI/AAMI SP10 is a standard for verifying the accuracy of automated sphygmomanometers, which involves comparing the device's readings against validated manual measurements.
8. Sample Size for the Training Set
- The document does not provide information on the sample size for the training set. For established medical devices like blood pressure monitors, the "training" of the internal algorithm is often a part of the initial design and development process, which may not involve a separate "training set" in the same way machine learning models do. If the device uses machine learning, this information is not disclosed.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for any training set was established. As with the training set sample size, this information is not disclosed in the provided text.
§ 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).