(113 days)
The FORA P100 Blood Pressure Monitoring System is intended to measure 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. Do not use this system on babies, young children or persons who cannot express their consent.
FORA P100 Blood Pressure Monitoring System (Model: P100) can be operated by the device itself to assist in blood pressure testing, recording, tracking and monitoring in easy.
The TD-3130 in report is an internal model and FORA P100 is the marketing name for this system.
The FORA P100 Blood Pressure Monitoring System was validated by tests conducted according to IEC 80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009.
1. Table of Acceptance Criteria and Reported Device Performance:
| Standard/Requirement | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| IEC 80601-2-30:2009 | Met requirements | Met requirements |
| ANSI/AAMI/ISO 81060-2:2009 | Met requirements | Met requirements |
| Electrical Safety (IEC/EN 60601-1) | Met requirements | Met requirements |
| EMC (IEC/EN 60601-1-2) | Met requirements | Met requirements |
| Shock and Vibration (IEC/EN 60601-1-11) | Met requirements | Met requirements |
| Biocompatibility (ISO 10993-5, 10993-10) | Met requirements | Met requirements |
| Software Validation | Functionally works | Verified and validated |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample size used for the specific tests in the performance characteristics section, nor does it detail the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the device was validated by specific international standards.
3. Number of Experts and Qualifications:
The document does not provide information about the number of experts used to establish a ground truth or their qualifications. The validation relies on adherence to established international standards for medical devices, which typically involve standardized testing protocols rather than expert consensus on individual readings for ground truth in the context of blood pressure monitoring devices.
4. Adjudication Method:
The document does not mention an adjudication method for a test set. This type of method is usually associated with studies involving human interpretation (e.g., radiology images) rather than the direct measurement and algorithmic calculation performed by a blood pressure monitor.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The device's validation is based on its performance against recognized industry standards for accuracy and safety, rather than comparing human readers with and without AI assistance.
6. Standalone Performance:
The performance characteristics described (validation against IEC 80601-2-30:2009 and ANSI/AAMI/ISO 81060-2:2009) implicitly refer to the standalone performance of the FORA P100 Blood Pressure Monitoring System, as these standards assess the accuracy and functionality of the device itself. The device uses an oscillometric method to determine blood pressure and pulse rate.
7. Type of Ground Truth Used:
For blood pressure monitors, the "ground truth" for accuracy studies (such as those conforming to ANSI/AAMI/ISO 81060-2) typically involves direct comparison with a reference method, often auscultation by trained observers using a mercury sphygmomanometer or another validated reference device, under strictly controlled conditions. The document states validation was done "according to IEC 80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009," which implies this type of ground truth was used for accuracy assessment.
8. Sample Size for the Training Set:
The document does not explicitly mention a training set or its sample size. This information is typically relevant for machine learning models, and while the device uses a "software algorithm," the document doesn't provide details on an explicit training phase for that algorithm within the context of the submission. The algorithm for blood pressure measurement based on the oscillometric method is well-established.
9. How Ground Truth for the Training Set Was Established:
Since no explicit training set is mentioned in the document, there is no information on how its ground truth might have been established.
§ 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).