(82 days)
The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults who are eighteen (18) years and older, using the oscillometric method on a cuffed arm.
The Ambulo 2400 is a compact, lightweight, non-invasive ambulatory blood monitoring system. The Ambulo 2400 can measure systolic and diastolic blood pressure, mean arterial pressure and pulse rate over a 24 hour period. It is easily configured and individually-fitted for each patient by a physician or health care professional. Measurements are automatically captured, without medical supervision, by the Ambulo 2400 and later downloaded to a computer for analysis and interpretation by a physician.
The provided text describes the Ambulo 2400 Ambulatory Blood Pressure Monitoring System and lists several standards it complies with. However, it does not contain:
- A table of acceptance criteria and reported device performance.
- Details of a specific study to prove the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, or expert involvement.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
The document primarily focuses on regulatory compliance (510(k) summary) rather than detailing a specific performance validation study.
Therefore, for the requested information, the answer is:
- 1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document lists several standards (e.g., AAMI/ANSI SP10;2002) that the device complies with, but it does not present the specific acceptance criteria derived from these standards alongside the device's measured performance for blood pressure accuracy. Compliance with AAMI/ANSI SP10 suggests the device would meet its accuracy requirements, which typically involve mean difference and standard deviation between the device and a reference measurement, but these specific values are absent.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
- 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): Not provided in the document.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
- 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: Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device that involves human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone automated blood pressure monitor. Its performance would inherently be "standalone" in how it measures blood pressure. However, specific details of a standalone algorithm validation study with accuracy metrics are not presented.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated in the document. For blood pressure monitors complying with standards like AAMI/ANSI SP10, the ground truth is typically established using simultaneous measurements by trained observers using a mercury sphygmomanometer or another validated reference method.
- 8. The sample size for the training set: Not provided in the document. (This is an established device, not undergoing AI model training as discussed in typical AI/ML submissions).
- 9. How the ground truth for the training set was established: Not provided in the document.
§ 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).