(152 days)
The UA-767F and UA-767FAC are designed to be used by users who are older than twelve (12) years at home or clinics to monitor their blood pressure (systolic and diastolic) and pulse rate. The arm circumference range shall be between 8.7 inches (22.0 cm) and 17.7 inches (45.0 cm).
UA-767F and UA-767FAC have the same design except UA-767FAC having an AC plug for an external AC adapter connection. Both devices use an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is inflated automatically by an internal pump of UA-767F and UA-767FAC. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300mmHg. UA-767F and UA-767FAC will not inflate the cuff higher than 300mmHg. UA-767F and UA-767FAC will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.
This document is a 510(k) K141201 premarket notification from A&D Engineering, Inc. for their UA-767F and UA-767FAC Digital Blood Pressure Monitors. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo clinical trial with specific acceptance criteria and detailed study results as would be found in a PMA.
Therefore, the requested information, particularly regarding a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, and detailed ground truth establishment for training and test sets, is not applicable to this type of regulatory submission and is not provided in the document. This submission primarily relies on compliance with recognized standards and a comparison of technical specifications to predicate devices.
1. Table of acceptance criteria and the reported device performance
The document doesn't explicitly define "acceptance criteria" in the context of a clinical trial for individual performance metrics, but rather references adherence to recognized standards like ANSI/AAMI/IEC 80601-2-30:2009 for "essential performance." The key performance metrics mentioned are accuracy for blood pressure and pulse rate, which align with the requirements of such standards.
| Performance Metric | Acceptance Criteria (from standard references) | Reported Device Performance (UA-767F & UA-767FAC) |
|---|---|---|
| Blood Pressure Accuracy | +/- 3mmHg (or +/- 2% of measured value for predicate) | +/- 3mmHg |
| Pulse Accuracy | +/- 5 % (pulse) | +/- 5 % |
| Measurement Range (BP) | 20 to 280 mmHg (predicate) | 0 - 299 mmHg |
| Measurement Range (Pulse) | 30 to 200 beats/min | 30 to 200 beats/min |
| Maximum Pressure Safety | N/A (implied by standard adherence) | No inflation higher than 300mmHg |
| Irregular Heartbeat Detection | More than +/-25% to the mean interval of all pulse intervals (predicate) | No change – the same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details of a specific clinical test set with sample size, data provenance, or study design (retrospective/prospective). The submission relies on "design verification and design validation activities based on the comparison... with the predicate devices" and adherence to recognized international standards. This suggests testing was likely internal and focused on meeting technical specifications rather than a full-scale clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The device is a non-invasive blood pressure monitor that directly measures physiological parameters, not an AI or imaging device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document, as it pertains to expert adjudication of ground truth for interpretive devices, which this is not.
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
No. This is not an AI-assisted device and therefore an MRMC study is not relevant or included in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone blood pressure monitor. Its performance is measured directly against reference standards (as implied by adherence to standards like ANSI/AAMI/IEC 80601-2-30), not as an algorithm's output requiring human interpretation as a separate step. The document states, "The systolic and diastolic blood pressures are determined by oscillometric method." The reported accuracy falls under the device's inherent design and measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For blood pressure monitors, "ground truth" typically refers to measurements obtained through a validated reference method (e.g., auscultation by trained observers using a mercury sphygmomanometer) as part of the testing required by standards like ANSI/AAMI/IEC 80601-2-30. The document does not explicitly state the specific method used for ground truth, but its reliance on these standards implies their methodologies were followed.
8. The sample size for the training set
This information is not applicable and not provided. This device is a hardware-based measurement device, not an AI/machine learning model that typically relies on a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no "training set" in the context of 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).