(71 days)
This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
Bluetooth Blood Pressure Monitor, BPW1 is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method, including irregular heartbeats (IHB) from the wrist. The device is powered by a rechargeable Lithium battery. The device has an START/STOP button for starting the measurement and stopping the measurement at any time when measuring. The MEM button is for displaying the last measurement. The device can also connect the mobile platform with an MMA (mobile medical application) as its accessory which can start/stop the device through Bluetooth 4.0. An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
The provided text describes the submission of a 510(k) premarket notification for a "Bluetooth Blood Pressure Monitor, BPW1" and its substantial equivalence to a predicate device. It details various performance tests conducted, including safety, EMC, reliability, and biocompatibility. However, it does not contain the specific acceptance criteria for the device's performance (e.g., blood pressure accuracy in mmHg or pulse accuracy in bpm), nor does it provide the detailed study results that prove the device meets these criteria in a quantitative manner.
Instead, the document states that the device was tested according to relevant standards (e.g., IEC 80601-2-30, ISO81060-2:2013) and that it "met all relevant requirements" or "achieved the requirements." It also states "The evaluation of these results present no new issues related to safety or effectiveness." This indicates that the study was performed, and the results were deemed acceptable, but the specific numerical performance data and detailed acceptance thresholds are not included in this summary.
Therefore, for aspects requiring quantitative data (like specific accuracy tolerances and achieved performance), the information is implicitly covered by conformance to standards, but not explicitly stated.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Parameter | Acceptance Criteria (Implied by Standard) | Reported Device Performance (Summary Statement) |
|---|---|---|
| Accuracy (Static Pressure) | ± 3mmHg (from comparison table) | Met requirements of IEC 80601-2-30 |
| Accuracy (Pulse) | ± 5% reading value (from comparison table) | Met requirements of IEC 80601-2-30 |
| Safety | Conformance to IEC 60601-1, IEC 60601-1-11, IEC 62133 | Met all relevant requirements |
| EMC | Conformance to IEC 60601-1-2 | Met all relevant requirements |
| Reliability | Conformance to IEC 80601-2-30, EN 1060-3 | Met all relevant requirements |
| Radio Frequency Wireless Performance | Conformance to EN 300 328, EN 301 489-1, EN 301 489-17 | Met all relevant requirements |
| FCC Compliance | Conformance to FCC 47 CFR Part 15 Subpart B/C, 1.1307, 2.1093 | Met all relevant requirements |
| Biocompatibility | Conformance to ISO 10993-1, -5, -10 | Met all relevant requirements |
| Clinical Validation (Accuracy) | Conformance to ISO81060-2:2013 | Achieved the requirements of ISO81060-2:2013 |
| Cybersecurity Risk | Acceptable residual risk per FDA guidance | Overall residual risk is acceptable |
Note: The "Accuracy" values (Static Pressure: ± 3mmHg, Pulse: ± 5% reading value) are explicitly stated in the "Comparison of Technological Characteristics" table under the "Accuracy" row for both the predicate and modified device. This implies they are the expected performance standard and likely the acceptance criteria for those specific parameters. The broader "Reported Device Performance" for other categories is a general statement of compliance with standards, as detailed numerical results are not included.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The text clearly mentions "Clinical Validation: ISO81060-2:2013 Non-invasive sphygmomanometers —Part 2: Clinical validation of automated measurement type." This standard specifies requirements for the number of subjects and measurements for clinical validation. While the exact number of subjects is not stated in this document, it implies that the sample size adhered to the ISO 81060-2:2013 standard. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a blood pressure monitor, the ground truth for clinical validation is typically established by trained observers using a reference measurement method (e.g., auscultation with a sphygmomanometer). The ISO 81060-2 standard outlines requirements for such observers, but the specific details are not in this text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. For blood pressure clinical validation, ground truth primarily relates to the reference measurement method (e.g., mercury sphygmomanometer with trained observers), rather than expert adjudication of AI output.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is a blood pressure monitor, not an AI-based imaging diagnostic tool that typically involves human readers. Therefore, an MRMC study is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the clinical validation study conducted per ISO 81060-2:2013 is a standalone performance test of the device (its algorithm) against a reference standard. The document states, "The device has achieved the requirements of ISO18060-2:2013," which indicates its standalone performance against a clinical reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the clinical validation of the blood pressure monitor, the ground truth would be established through simultaneous or closely sequential measurements using a validated reference method, typically auscultation by trained observers with a mercury sphygmomanometer or another precisely calibrated and validated reference device, as specified by ISO 81060-2:2013. This is implicitly the "ground truth" against which the device's measurements are compared.
8. The sample size for the training set:
This device is a traditional oscillometric blood pressure monitor, not a machine learning/AI device requiring a separate "training set" in the conventional sense of AI model development. Therefore, this concept is not applicable in the context presented. The "training" for such devices is inherent in their design and calibration processes, not a distinct data set for algorithm training.
9. How the ground truth for the training set was established:
As explained in point 8, the concept of a separate "training set" with established ground truth as used in AI/ML is not applicable to this type of medical device based on the information provided.
§ 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).