(572 days)
TM-2440 and TM-2441 blood pressure monitors are designed to monitor systolic and diastolic pressure, and pulse rate of adults who are twelve (12) years and older by using the oscillometric method.
TM-2441 has four environmental functions to measure activity monitoring (3-axis accelerometer), ambient temperature monitoring, barometric pressure monitoring, and waveform capability. These functions are not observed by patients form the device display and can only be used by the medical professionals.
TM-2440 & TM-2441 Digital Blood Pressure Monitors have the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. The blood pressure measurement starts with the inflation process by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method during the deflation process. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released immediately. There is a maximum pressure safety setting at 299 mmHg. TM-2440 & TM-2441 Digital Blood Pressure Monitors will not inflate the cuff higher than 299 mmHg. TM-2440 & TM-2441 will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the OLED and transmitted via Bluetooth wireless module to the connected app. The cuff is also deflated automatically to 0 mmHg at the same time. If the monitor receives no further action from the user for 1 minute, it will automatically turn off by itself and waiting for the next measurement timing.
We can break down this request based on the information provided in the given text.
The device in question is the A&D Medical TM-2440 & TM-2441 Digital Blood Pressure Monitors.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The primary performance acceptance criteria for the blood pressure monitors are based on the ISO 81060-2:2013 standard.
| Criterion | Acceptance Criteria (ISO 81060-2:2013) | Reported Device Performance (TM-2440 & TM-2441) | Result |
|---|---|---|---|
| Criterion 1: Mean value & Standard deviation (Comparison to reference values) | Mean value: ± 5mmHg or less | ||
| Standard deviation: 8mmHg or less | Mean value: SYS = -0.80 mmHg, DIA = -0.94 mmHg | ||
| Std deviation: SYS = 6.46 mmHg, DIA = 6.45 mmHg | Passed | ||
| Criterion 2: Standard deviation (Individual differences) | SYS=6.89 mmHg or less | ||
| DIA=6.88 mmHg or less | Std deviation: SYS = 5.13 mmHg, DIA = 5.86 mmHg | Passed |
Note: The reported device performance is for both TM-2440 and TM-2441 models, as they passed "all blood pressure measurement accuracy requirements."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated in the provided text. The text only mentions "The summary of the test results of ISO 81061-2 is listed below," implying a clinical validation study was conducted as per the ISO standard, which has specific sample size requirements. While the standard is cited, the actual number of subjects is not provided in this summary.
- Data Provenance: Not explicitly stated. The study was conducted as part of the regulatory submission (510(k)) in the US, but the geographic origin of the participants or clinical sites (e.g., country of origin) is not mentioned. The study is assumed to be prospective as it's a clinical validation study for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated in the provided text. The ISO 81060-2:2013 standard for automated sphygmomanometers typically requires comparison of the device under test to auscultatory measurements obtained by trained observers (experts) using a mercury sphygmomanometer or validated reference device.
- Qualifications of Experts: Not explicitly stated. However, given the reliance on ISO 81060-2:2013, it is implied that the ground truth (reference blood pressure values) would have been established by qualified and trained personnel according to the standard's protocol for taking reference measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. For clinical validation of blood pressure monitors, the ISO 81060-2:2013 standard outlines a specific protocol for taking "reference measurements" (ground truth). This typically involves simultaneous or closely timed measurements by multiple trained observers (e.g., two observers) to minimize measurement error and observer bias, often with a predefined method for resolving discrepancies (e.g., averaging or a third observer if differences exceed a threshold). However, the specific adjudication details are not present in this summary.
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
- MRMC Comparative Effectiveness Study: Not applicable. The device in question is a standalone digital blood pressure monitor, not an AI-powered diagnostic imaging tool or a system designed to assist human "readers" (e.g., radiologists). Therefore, this type of study is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Yes, indirectly. The ISO 81060-2:2013 clinical BP measurement study evaluates the performance of the device itself (the "algorithm only," in a sense, as it's an automated measurement device) against a reference standard. The results presented in the table (Criterion 1 & 2) directly reflect the device's accuracy without human intervention in the measurement process (beyond applying the cuff and initiating the measurement). The device is designed to operate as a standalone automated blood pressure monitor.
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert consensus applying the methodology outlined in ISO 81060-2:2013. This standard details how reference blood pressure measurements (auscultatory readings from trained observers) are obtained and averaged to form the ground truth against which the automated device's readings are compared.
8. The Sample Size for the Training Set
- Sample Size for the Training Set: Not applicable / Not mentioned. This device is a measurement instrument, not typically an AI/machine learning model that undergoes a separate "training" phase with a distinct training dataset in the conventional sense. Its underlying algorithm for oscillometric blood pressure determination is based on established physiological principles and likely developed through engineering and calibration, rather than statistical machine learning training on a large dataset. The provided text does not mention any training set or machine learning components.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, the concept of a "training set" and associated "ground truth" establishment in a machine learning context does not appear to apply to this device based on the provided information.
§ 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).