(127 days)
The AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. At the end of each measurement, the results will be displayed on LCD. AViTA BPM656ZB through its Bluetooth wireless communication port can also transfer the measurement results to other electronic devices, such as a PC , a PDA or a printer.
The device is indicated for adult in home use. The arm circumference range shall be between 9 inches (23 cm) to 17 inches (43 cm). The end users should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation.
The AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is designed to measure the systolic and diastolic blood pressure, and pulse rate (heart of an individual).
The device uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff. The measurement results are displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point.
The provided text describes a 510(k) submission for the AViTA Bluetooth Blood Pressure Monitor. However, it does not contain the specific information required to complete the detailed acceptance criteria and study analysis table as requested.
The document primarily focuses on:
- Identifying the submitter and device.
- Classifying the device and its predicate.
- Stating the intended use.
- Giving a brief device description.
- Concluding that the device is substantially equivalent to the predicate based on intended use, technological characteristics, and bench testing (without detailing the bench testing results or criteria).
- The FDA's official acceptance letter.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a response based on the available information, with explanations for what is missing:
Acceptance Criteria and Device Performance Study Analysis
The provided 510(k) summary for the AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) states that the device conforms to applicable standards, including EN-1060-1, EN-1060-3, and ANSI/AAMI SP-10. These standards define the acceptance criteria for non-invasive sphygmomanometers. However, the specific reported device performance against these criteria is not detailed in the provided document. The 510(k) simply concludes that "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (from EN-1060-1, EN-1060-3, ANSI/AAMI SP-10) | Description (General Standard Requirement) | Reported Device Performance (Specific values from study) |
|---|---|---|
| Accuracy (Mean Difference) | Sphygmomanometer must have a mean difference between device and reference measurement within ±5 mmHg. | Not specified in provided text. |
| Accuracy (Standard Deviation) | Sphygmomanometer must have a standard deviation between device and reference measurement within ≤8 mmHg. | Not specified in provided text. |
| Cuff Pressure Display Accuracy | Pressure display accuracy within ±3 mmHg. | Not specified in provided text. |
| Repeatability/Reproducibility | Consistency of measurements over multiple trials. | Not specified in provided text. |
| Safety & EMC | Conformance to IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility). | Conforms to IEC 60601-1 and IEC 60601-1-2. |
| Operating Specifications | Conformance to EN-1060-1 and EN-1060-3 (non-invasive sphygmomanometers). | Conforms to EN-1060-1 and EN-1060-3. |
| Software/Hardware Performance | Performance of the oscillometric method, display, and Bluetooth transmission. | Not specified in provided text beyond functional description. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "bench testing contained in this submission" as the basis for performance claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. For blood pressure devices, reference measurements are typically taken by trained technicians, often using auscultation with a calibrated mercury or aneroid sphygmomanometer, according to standard protocols (e.g., AAMI/ISO standards). The "ground truth" for blood pressure accuracy studies is usually these simultaneous, expert-performed reference measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. This typically refers to how discrepancies in expert readings are resolved, which would be relevant if multiple experts were performing initial ground truth measurements.
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:
- MRMC Study: No, this is not applicable for a standalone blood pressure monitor. MRMC studies are typically for image analysis or diagnostic support systems where human readers interpret data with or without AI assistance. This device simply provides blood pressure readings.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the device operates in a standalone mode, measuring and displaying blood pressure and heart rate. The performance indicated by conformance to standards like ANSI/AAMI SP-10 refers to the algorithm's accuracy in determining blood pressure from the oscillometric pulsations, without human interpretation of the underlying data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Most likely, the ground truth for accuracy testing would be simultaneous, highly accurate measurements performed by a trained observer using a validated reference method (e.g., auscultatory measurements by a trained observer using a mercury sphygmomanometer) in accordance with the relevant international standards (e.g., ANSI/AAMI SP-10, ISO 81060-2). The expert's reading acts as the comparator.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/Not specified. For a traditional oscillometric blood pressure monitor, there isn't a "training set" in the machine learning sense. The device's algorithm is based on physiological principles and pre-defined mathematical models, rather than being "trained" on a dataset. The development and calibration would involve engineering and clinical validation rather than machine learning training.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As mentioned above, there isn't a training set in the machine learning context for this type of device. The algorithm's fundamental principles are established through engineering design and physiological understanding.
§ 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).