(195 days)
The FORA P20 Blood Pressure Monitor /U-RIGHT TD-3132 Blood Pressure Monitor is intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.
The TD-3132 is an arm type blood pressure monitor. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and arm cuff. The symbols displayed on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse rate, pulse symbol, blood pressure unit, battery display, error symbol, and memory record.
Here is an analysis of the provided text regarding the FORA P20 Blood Pressure Monitor / U-RIGHT TD-3132 Blood Pressure Monitor:
Acceptance Criteria and Device Performance Study
The provided document describes the non-clinical and clinical performance of the device against the SP10 standard. This standard typically refers to the ANSI/AAMI/ISO 81060-2 standard for non-invasive sphygmomanometers, which specifies the clinical validation requirements for accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on SP10 Standard for Non-Invasive Sphygmomanometers) | Reported Device Performance (TD-3132) |
|---|---|
| Accuracy Standard 1: Mean difference (bias) | Conformed to SP10 standard. |
| For systolic and diastolic blood pressure, the mean difference between the device and the reference method should be ≤ ± 5 mmHg. | |
| Accuracy Standard 2: Standard deviation of differences | Conformed to SP10 standard. |
| For systolic and diastolic blood pressure, the standard deviation of the differences between the device and the reference method should be ≤ 8 mmHg. | |
| Additional Criteria (Implied by SP10 conformance) | Conformed to SP10 standard. |
| Meets requirements for specific age groups (though in this document, it specifies "over 18 years of age and over"). | |
| Meets requirements for various cuff sizes (implied during validation). | |
| Meets general safety and effectiveness requirements. | Satisfactory performance (safety and effectiveness). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for the clinical test set. It only mentions "The clinical test results of the TD-3132 showed the functions of the device met the criteria in the SP10 standard." The SP10 standard (ANSI/AAMI/ISO 81060-2) typically requires a minimum of 85 participants for a clinical validation study to assess accuracy.
- Data Provenance: The document does not specify the country of origin of the data. However, the submitter's address is in Taipei County, Taiwan, which could potentially be the location of the clinical study, but this is not explicitly stated. The study is prospective, as it's a "clinical test" designed to validate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document does not explicitly state the number of experts used. For a clinical validation according to the SP10 standard, typically three independent observers (often trained clinicians or technicians) are involved in performing the reference measurements.
- Qualifications of Experts: The document does not explicitly state the qualifications of the experts. In the context of the SP10 standard, these observers would be trained and certified to perform auscultatory blood pressure measurements using a mercury sphygmomanometer or validated equivalent. They would undergo specific training and demonstrate minimal inter-observer variability.
4. Adjudication Method for the Test Set
- Adjudication Method: The document does not explicitly describe an adjudication method. In SP10 clinical validations, if multiple observers are used, their measurements are typically averaged or analyzed in comparison to the device's readings. There isn't typically a "2+1" or "3+1" adjudication method in the sense of resolving discrepancies, but rather parallel measurements taken by trained observers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is usually conducted for imaging devices where human readers interpret images (e.g., radiologists reading X-rays), often comparing AI-assisted vs. unassisted human performance. For a blood pressure monitor, the performance metric is direct measurement accuracy, not interpretive performance.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes, the "clinical performance" described in the document is essentially a standalone study of the device's algorithm. The TD-3132's oscillometric method and its calculation of systolic, diastolic, and pulse rates are evaluated directly against reference measurements (the "ground truth" as derived from experts). There isn't a human-in-the-loop component being evaluated for a blood pressure monitor's core function.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used for these types of blood pressure monitor validations is typically expert auscultatory measurements (often using a mercury sphygmomanometer or a validated equivalent) performed simultaneously or near-simultaneously with the device's readings. This is the standard reference method outlined in the SP10 standard.
8. Sample Size for the Training Set
- Sample Size: The document does not mention a training set sample size. Blood pressure monitors using the oscillometric method are typically developed and calibrated through extensive engineering and testing, which might involve internal datasets for algorithm refinement. However, the regulatory submission usually focuses on the validation (test set) rather than the development/training process.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: As no specific training set is discussed or required to be reported in this context, the method of establishing ground truth for any internal development/calibration datasets is not mentioned in the document. It would similarly involve reference blood pressure measurements.
§ 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).