(330 days)
The Aerotel Medical Systems (1998) Ltd BP-Tel Trans-Telephonic Monitoring system is intended to be used by patients to measure their blood pressure at home and transmit it to a central station by telephone. The system includes both the patient unit and a central computer program (to be used in a Personal Computer) which receives the blood pressure data, stores it in a patient's record, and prepares reports and charts showing the history of the systolic, diastolic pressures and the heart rate. The BP-Tel is not intended for patients with defibrillators.
The system includes a home blood-pressure measuring device that makes use of the oscillometric system, a means for sending the measurements over the telephone lines to a central station, and a computer program at the central station for receiving the measurements, storing them in a data base, and preparing reports.
The provided document, a 510(k) summary for the Aerotel BP-Tel Trans-Telephonic Blood Pressure Measurement System, offers limited information regarding specific acceptance criteria and the detailed study proving it. However, based on the available text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with EN 60601-1 (Medical electrical equipment safety standard) | "satisfactorily passed all tests" for EN 60601-1. |
| Software Validation | Proper functioning and reliability of the MPM software for receiving, storing, and reporting data. | "undergone extensive validation testing." |
| Clinical Performance (Accuracy of Blood Pressure Measurement) | Equivalent performance to a legally cleared blood pressure device. | "The actual blood-pressure device is a cleared device purchased for this system." |
| System Functionality (Trans-Telephonic Transmission) | Successful transmission of measurements over telephone lines to a central station. | "The entire system has been tested in a clinical test with volunteer subjects." (Implication: transmission and data handling worked as intended). |
| Equivalence to Predicate Devices | Comparable safety and efficacy to specified legally marketed predicate devices. | "The BP-Tel Blood-Pressure trans-telephonic monitoring system is equivalent in safety and efficacy to the legally-marketed predicate devices." |
2. Sample Size and Data Provenance
- Test Set Sample Size: "The entire system has been tested in a clinical test with volunteer subjects." The exact number of volunteer subjects is not specified in the document.
- Data Provenance: The study was a "clinical test." The country of origin is not explicitly stated for the clinical test, but the company is based in Israel, so it's plausible the study was conducted there or in the US (given the FDA submission). It was a prospective study as it involved testing the system in a clinical setting.
3. Number of Experts and Qualifications
- Not applicable / Not specified. The document does not mention the use of experts to establish a ground truth for the clinical test beyond the standard clinical assessment methods that would be used for blood pressure measurement. The core blood pressure device itself was a "cleared device," implying its accuracy was already established.
4. Adjudication Method
- Not applicable / Not specified. Given the nature of a blood pressure measurement device testing, an adjudication method like 2+1 or 3+1 typically applies to subjective interpretations (e.g., radiology images). For quantitative measurements like blood pressure, the ground truth is usually established through a reference standard measurement, not expert consensus on interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned as this device is for measuring and transmitting blood pressure, not for interpretation tasks that involve human readers. The clinical test involved the device's performance, not a comparison of human readers with and without AI assistance.
6. Standalone Performance Study
- Most likely, yes, for a component. The statement "The actual blood-pressure device is a cleared device purchased for this system" implies that the core blood pressure measurement algorithm (which could be considered a standalone algorithm) had undergone its own performance evaluation to achieve clearance. The current submission focuses on the system (measurement + telephonic transmission). The "extensive validation testing" for the MPM software also indicates a standalone assessment of that software component.
7. Type of Ground Truth Used
- Reference Standard Measurement (Inferred): For the blood pressure component, the ground truth would have been established by comparing the device's readings against a recognized standard method for blood pressure measurement (e.g., a mercury sphygmomanometer or another validated oscillometric device).
- System Functionality Verification: For the transmission and data handling aspects, the ground truth would be whether the data was accurately transmitted, stored, and displayed as received from the device's measurements.
8. Sample Size for the Training Set
- Not applicable / Not specified. Blood pressure monitors typically rely on established physiological principles and algorithms rather than machine learning models that require large training sets in the same way an AI diagnostic tool would. While there might be some internal calibration or algorithm development, the document doesn't mention a distinct "training set" in the context of an AI/ML algorithm. The core blood pressure device was "cleared," meaning its underlying algorithms and parameters were already validated.
9. How Ground Truth for Training Set was Established
- Not applicable / Not specified. As mentioned above, a traditional "training set" with ground truth in the AI/ML sense is not indicated for this type of device. The accuracy of the blood pressure measurement component would have been established during its original clearance, likely through comparison to gold-standard manual measurements on a diverse population.
§ 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).