(51 days)
The A&D Medical UB-543 family digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
UB-543 uses an inflatable cuff which is wrapped around the patient's wrist. After the user pushes the "START" button, cuff is inflated automatically by an internal pump once the condition of the CPG (correct position guidance) algorithm is met. Measurement starts and the systolic and diastolic blood pressures are determined by oscillometric method. 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. UB-543 will not inflate the cuff higher than 300mmHg. UB-543 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.
The provided document is a 510(k) summary for a digital blood pressure monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a standalone performance study.
Therefore, many of the requested details about acceptance criteria studies, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance metrics, are not available in this document. The document describes changes from predicate devices and emphasizes that the fundamental scientific technology and intended use have not changed, implying that the established performance of the predicate devices should apply.
Here's a summary of the information that can be extracted from the provided text, along with a statement where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate) | Reported Device Performance (Modified Device UB-543) |
|---|---|---|
| Accuracy (BP) | +/- 3mmHg or +/- 2% of measured value, whichever is greater | +/- 3mmHg |
| Accuracy (Pulse) | +/- 5% | +/- 5% |
| Measurement Range (BP) | 20 to 280 mmHg | 0 to 299 mmHg |
| Measurement Range (Pulse) | 40 to 200 pulse/min | 40 to 200 pulse/min |
| Maximum Pressure Safety Setting | Up to 300mmHg (implied) | 300mmHg |
| Inflation Mechanism | Automatic internal pump | Automatic internal pump |
| Deflation Method | Quick exhaust valve | Quick exhaust valve |
Note: The accuracy criteria for UB-543 are provided as +/- 3mmHg and +/- 5% for pulse. For the predicate, the BP accuracy is +/- 3mmHg or +/- 2%, whichever is greater. While the UB-543 states +/- 3mmHg, it doesn't explicitly state the "whichever is greater" clause, but given the substantial equivalence claim, it's highly likely to adhere to the same underlying standard implying consistency with the predicate. The measurement range for BP is slightly expanded for UB-543 (0-299mmHg vs 20-280mmHg).
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document. Given that it's a 510(k) for a modified device claiming substantial equivalence, it's possible that clinical data was not required for the modifications, and performance was inferred from the predicate device and internal testing.
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.
4. Adjudication method for the test set
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a blood pressure monitor, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. Blood pressure monitors are standalone devices where the algorithm (oscillometric method) determines the blood pressure and pulse rate without human intervention beyond initiating the measurement. The document states: "Measurement starts and the systolic and diastolic blood pressures are determined by oscillometric method."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but for blood pressure monitors, the "ground truth" or reference standard for accuracy is typically direct intra-arterial measurement or a validated auscultatory method performed by trained personnel according to established protocols (e.g., AAMI, ISO standards). The document refers to "Accuracy: BP : +/- 3mmHg" which indicates a comparison against a reference.
8. The sample size for the training set
- Not applicable/specified. This device uses a traditional oscillometric algorithm, not a machine learning model that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable/specified (see #8).
§ 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).