(33 days)
iHealth View BP7S Wireless Blood Pressure Wrist Monitor is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm-22cm.
iHealth View BP7S Wireless Blood Pressure Monitors are designed and manufactured according to IEC 80601-2-30. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. The new devices achieves its function by an iOS or Andriod devices.
The provided document is a 510(k) summary for a medical device called the "iHealth View Wireless Blood Pressure Wrist Monitor (BP7S)". It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailing a specific study proving the device meets acceptance criteria. As such, information on specific acceptance criteria and a study to prove them is limited.
However, I can extract the available information related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a tabular format alongside device performance for a specific study. Instead, it refers to performance standards that the device conforms to. The closest information is under "Accuracy" in the technological characteristics comparison table.
| Performance Metric | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Pressure Accuracy | IEC 80601-2-30 (implied by "Same as predicate" for accuracy) | ± 3mmHg |
| Pulse Accuracy | IEC 80601-2-30 (implied by "Same as predicate" for accuracy) | ± 5% |
2. Sample Size and Data Provenance for Test Set
The document does not specify a sample size for a test set or the data provenance (country of origin, retrospective/prospective). The non-clinical tests mentioned are adherence to electrical safety and electromagnetic compatibility standards, and performance characteristics according to a blood pressure monitor standard. These are general compliance tests for the device, not a specific clinical performance study with a test set of patient data.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The tests mentioned are compliance tests against established engineering and medical device standards.
4. Adjudication Method for Test Set
Not applicable. There is no mention of a test set requiring adjudication in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
Yes, implicitly. The "Non-clinical Tests" and "Performance summary" sections indicate that the device's performance was evaluated against recognized standards (IEC 80601-2-30 for "Safety and performance characteristics"). While not a dedicated "standalone performance study" in the context of AI algorithms, these tests assess the device's functionality and accuracy independently.
7. Type of Ground Truth Used
The ground truth for the device's accuracy claims (pressure ± 3mmHg, pulse ± 5%) would typically be based on reference measurements from a validated, calibrated standard or method, as outlined in the IEC 80601-2-30 standard for automated sphygmomanometers. This standard specifies clinical investigation requirements for blood pressure device accuracy. The document states the device "conforms to" this standard, implying that the ground truth methodology prescribed by the standard was followed for these accuracy claims.
8. Sample Size for Training Set
Not applicable. This device is a traditional medical device (blood pressure monitor) governed by engineering and performance standards, not an AI/machine learning algorithm requiring a "training set" in the computational sense.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).