(100 days)
BP-BT Kiosk is designed to measure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 6.7 inches (17.0 cm) to 16.5 inches (42.0 cm). Indication: Prescription use in medical or clinic environment only.Rx only.
BP-BT Kiosk has the same design as the predicated device with an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is first adapted to the arm size and then, 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 300 mmHg. BP-BT Kiosk will not inflate the cuff higher than 300 mmHg. BP-BT Kiosk will turn on an irregular heartbeat 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 transmitted via Bluetooth wireless module. The cuff is also deflated automatically to 0 mmHg at the same time.
The provided text describes the BP-BT Kiosk, a non-invasive blood pressure measurement system, and its clinical validation for substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BP-BT Kiosk are based on the standard IEC 80601-2-30, which pertains to automated non-invasive sphygmomanometers. The reported device performance demonstrates compliance with these standards for blood pressure and pulse rate measurement accuracy.
| Acceptance Criteria (Based on IEC 80601-2-30) | Reported Device Performance (BP-BT Kiosk) |
|---|---|
| Blood Pressure Accuracy: | |
| Average deviation of systolic pressure | 0.19 mmHg |
| Standard deviation of systolic pressure | 1.56 mmHg |
| Average deviation of diastolic pressure | 0.25 mmHg |
| Standard deviation of diastolic pressure | 1.65 mmHg |
| Pulse Rate Accuracy: | |
| Error of pulse rate | Within ±5% |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: 267 sets of data were measured for the clinical test.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions a "Clinical Test" was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the "number of experts" or their specific qualifications for establishing the ground truth. However, it indicates that the comparison was made against a "Mercury Blood pressure monitor," which is generally considered a gold standard (ground truth) for non-invasive blood pressure measurement in clinical settings, typically operated by trained medical professionals.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method like "2+1" or "3+1." The evaluation appears to be a direct comparison between the BP-BT Kiosk and a Mercury Blood Pressure Monitor.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The BP-BT Kiosk is a standalone medical device for measuring blood pressure and pulse rate, not an AI-assisted diagnostic tool that would involve human readers. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The "Clinical Test" directly assessed the accuracy of the BP-BT Kiosk's measurements (algorithm only) against a Mercury Blood Pressure Monitor. The reported performance metrics (average and standard deviations for systolic and diastolic pressure, and pulse rate error) reflect the device's standalone accuracy without human intervention in the measurement process.
7. The Type of Ground Truth Used
The type of ground truth used for the clinical test was comparison with a Mercury Blood Pressure Monitor. This is considered a gold standard method for accurate non-invasive blood pressure measurement.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. This suggests that the device's capabilities were likely developed and validated using existing methodologies for non-invasive blood pressure measurement, and the clinical test served as the primary validation of its performance against a known standard.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" is not mentioned in the context of machine learning or AI, the concept of establishing ground truth for a training set as typically understood in AI/ML development does not apply here. The device's underlying technology and algorithms for oscillometric blood pressure measurement would have been developed based on established physiological principles and engineering practices, with validation against reference methods during its design and development phases. The "Clinical Test" served as the final-stage validation for regulatory submission.
§ 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).