(267 days)
The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications for ambulatory blood pressure monitoring.
Ambulatory Blood Pressure Monitor
This FDA 510(k) clearance letter for the Meditech ABPM-06 (BP6) does not provide the detailed information required to fill out the table regarding acceptance criteria and study results. This document is a clearance letter, which confirms that the device has been found substantially equivalent to a predicate device, but it does not typically contain the raw study data or a detailed breakdown of the performance validation study.
The letter only states:
- Device Name: Meditech ABPM-06 (BP6)
- Intended Use: "automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications for ambulatory blood pressure monitoring."
- Regulation Name: Noninvasive Blood Pressure Measurement System
- Regulatory Class: Class II
- Product Code: DXN
To answer your request, one would typically need access to the full 510(k) submission, which would include the performance study reports.
However, based on the information provided and general knowledge of blood pressure device validation, I can make some inferences about typical acceptance criteria for non-invasive blood pressure monitors, but these are not explicitly stated in the provided document.
Here is what would typically be expected, but not found in the provided text:
Inferred Acceptance Criteria and Reported Device Performance (Typical for BP Monitors)
| Acceptance Criteria (Inferred/Typical) | Reported Device Performance (Not found in document) |
|---|---|
| Accuracy (Mean Difference to Reference Standard) | This information is not provided in the FDA clearance letter. A typical standard like ISO 81060-2 requires a mean difference (device vs. reference) of ≤ ±5 mmHg for both systolic and diastolic, with a standard deviation of ≤ 8 mmHg. |
| Accuracy (Standard Deviation of Differences) | This information is not provided in the FDA clearance letter. A typical standard like ISO 81060-2 requires a standard deviation of differences (device vs. reference) of ≤ 8 mmHg for both systolic and diastolic. |
| Bias (e.g., AAMI/ISO Standard requirements for absolute differences within certain ranges) | This information is not provided in the FDA clearance letter. For example, AAMI/ISO standards often require that specific percentages of differences fall within certain mmHg ranges (e.g., 60% within ±5 mmHg, 85% within ±10 mmHg, 95% within ±15 mmHg). |
| Clinical Performance (e.g., successful measurements, cuff fit, patient comfort in ambulatory setting) | This information is not provided in the FDA clearance letter. The intended use mentions "ambulatory circumstances," implying that the device was likely tested for usability and performance in a real-world, mobile setting. However, specific metrics are not given. |
| Safety (e.g., absence of adverse events, pneumatic system pressure limits) | This information is not provided in the FDA clearance letter, beyond the general statement of clearance. Safety testing is inherent in device approval, but specific criteria and results are not detailed here. |
| Technical Performance (e.g., battery life, data storage, communication with software) | This information is not provided in the FDA clearance letter. While implied by "preprogrammed by the adjoining software," specific performance metrics are absent. |
| Software Validation (e.g., correct data acquisition, storage, and transfer consistent clinical decision support, user interface functionality) | This information is not provided in the FDA clearance letter. As the device uses "adjoining software," software validation would have been a part of the submission, but its specific acceptance criteria and results are not detailed here. The letter only broadly mentions "preprogrammed by the adjoining software." |
Based on the provided document, the following details are not available:
- Sample size used for the test set and the data provenance: Not mentioned. Such studies typically involve a clinical trial with a specified number of subjects (e.g., 85 subjects as per ISO 81060-2).
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned. For blood pressure monitors, ground truth is typically established by trained human observers using a mercury or auscultatory sphygmomanometer according to standardized protocols.
- Adjudication method for the test set: Not mentioned. The ground truth for BP devices is usually a consensus or average of multiple simultaneous auscultatory measurements by trained observers.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable to a standalone blood pressure monitor (it's not an AI-assisted diagnostic imaging device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone measurement device. Its performance is evaluated against an independent reference standard, typically human auscultation.
- The type of ground truth used: Not explicitly stated, but for blood pressure monitors, it's typically auscultatory measurement by trained observers or a validated reference device.
- The sample size for the training set: Not applicable as this is a non-AI hardware device that uses an "oscillometric method." There isn't a "training set" in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA clearance letter is a regulatory document confirming substantial equivalence and does not contain the detailed technical and clinical study results that would provide answers to most of your specific questions. That information would be found in the original 510(k) submission.
§ 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).