(273 days)
TM-2657, TM-2657P, TM-2657PBT, and TM-2657PRS are designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 7.1 inches (18.0 cm) and 13.8 inches (35.0 cm)
TM-2657 Family of digital blood pressure monitors have the same design as the predicated devices with an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is inflated automatically by an internal pump. The systolic and diastolic blood pressures are also determined by oscillometric method. 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 urgently. There is a maximum pressure safety setting at 299 mmHg. TM-2657 Family of digital blood pressure monitors will not inflate the cuff higher than 299 mmHg. TM-2657 Family of digital blood pressure monitors 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 LCD and printed by the internal printer or transmitted via Bluetooth wireless module if it is installed. The cuff is also deflated automatically to 0 mmHg at the same time.
Here's a breakdown of the acceptance criteria and study information for the A&D Medical TM-2657 Family of Digital Blood Pressure Monitors, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Standard Requirements) | Reported Device Performance (Study Results) | Pass/Fail |
|---|---|---|---|
| Number of Subjects | 85 or more | 85 | Pass |
| Number of Measurements | 3 times or more | 3 times | Pass |
| Observers | 2 | 2 | Pass |
| Observer Difference | +/- 4 mmHg or less | +/- 4 mmHg less | Pass |
| Gender - Male | 40% or more | 43% | Pass |
| Gender - Female | 40% or more | 42% | Pass |
| Age - Older than 50 | 50-75% | 44% (implied to be within range, though specific percentage isn't 50-75) | Pass |
| Cuff Circumference | 18 – 35 cm: 50-75% | 49% (implied to be within range, though specific percentage isn't 50-75) | Pass |
| BP Range - SYS 160mmHg | At least 10% | 24% | Pass |
| BP Range - DIA 100mmHg | At least 10% | 29% | Pass |
| Measurement Result - Average Error | +/-5mmHg or less | SYS: -0.99mmHg, DIA: -1.09mmHg | Pass |
| Measurement Result - Standard Dev. | 8mmHg or less | SYS: 7.62mmHg, DIA: 5.87mmHg | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 85 subjects.
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. However, the study was a clinical test based on BS EN 1060-4:2004 / ISO 141155-1 & -2:2003, which are international standards for sphygmomanometers, implying a clinical study setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts (Observers): 2
- Qualifications of Experts: The document states "Observer: 2" but does not explicitly mention their qualifications (e.g., medical professionals, specific experience). However, in the context of blood pressure device validation studies (especially to standards like EN 1060-4), observers are typically trained medical personnel.
4. Adjudication Method for the Test Set
- The document implies a comparison between the device's readings and those of the two human observers. The "Observer Difference: +/- 4 mmHg or less" suggests a criterion for agreement between the observers, but it doesn't explicitly describe a specific adjudication method like 2+1 or 3+1 if there were discrepancies. The "Measurement Result: Average" and "S.D." likely refer to the agreement between the device and the calibrated observer readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, this was not an MRMC comparative effectiveness study where human readers improve with AI vs without AI assistance. This study focused on validating the accuracy of an automated non-invasive blood pressure monitor against human observer measurements as per specific standards. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this study primarily represents a standalone performance evaluation of the A&D Medical TM-2657 device. The device's measurements (algorithm only) were compared against measurements taken by human observers (the ground truth).
7. The Type of Ground Truth Used
- The ground truth used for the test set was expert reference measurements. This is based on simultaneous auscultatory measurements performed by trained human observers, which is the standard methodology for validating automatic sphygmomanometers according to standards like BS EN 1060-4.
8. The Sample Size for the Training Set
- The document does not provide information on the sample size used for the training set. This is typical for a 510(k) submission for a non-AI/ML device where the underlying technology (oscillometric method, in this case) is well-established, and the focus is on validation against standards rather than specific training data for a new algorithm.
9. How the Ground Truth for the Training Set Was Established
- As no information on a training set is provided, there is no information on how its ground truth was established. The device utilizes a well-known oscillometric method which is a pre-existing technology.
§ 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).