Search Results

The device measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in an outpatient setting.

The Reizen Talking Blood Pressure Monitor SF860T measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in another outpatient setting. It has the same technological characteristics as the predicate device.

The Reizen Talking Blood Pressure Monitor, Model SF860T, met its acceptance criteria by demonstrating conformance to established international and national standards for blood pressure measurement devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:
The provided 510(k) summary does not specify the exact sample size used for testing against the ANSI/AAMI SP10 standard, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective). The other certifications (ISO, EU MDD) relate to quality management systems and general compliance, not specific device performance on a human data set for accuracy.

3. Number of Experts and Qualifications:
The summary does not mention the use of experts to establish ground truth for testing against the ANSI/AAMI SP10 standard. Conformance to this standard typically involves technical testing and, if clinical validation is performed, it would involve comparison to reference methods (e.g., auscultatory measurements by trained observers), but the role and number of "experts" in the context of clinical ground truth establishment are not detailed here.

4. Adjudication Method:
The adjudication method for any clinical testing against the ANSI/AAMI SP10 standard is not specified in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. This type of study is typically associated with AI-powered diagnostic devices, where the effect of AI assistance on human reader performance is evaluated. The Reizen Talking Blood Pressure Monitor is a stand-alone measurement device, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance:
Yes, a standalone performance assessment was conducted, as indicated by the device passing testing to show conformance with the ANSI/AAMI SP10 Standard. This standard specifically addresses the performance requirements for automated sphygmomanometers, implying that the algorithm's (oscillometric method) accuracy was tested independently.

7. Type of Ground Truth Used:
For the ANSI/AAMI SP10 standard, the "ground truth" for blood pressure measurements is typically established through a reference measurement method. Historically, this has involved auscultation by trained observers using a mercury sphygmomanometer (or a validated aneroid manometer) in accordance with standardized protocols. The device's readings would then be compared against these reference measurements.

8. Sample Size for the Training Set:
The provided document does not mention a training set sample size. This is a conventional medical device whose core technology (oscillometric method) is well-established, rather than a machine learning or AI device that requires a distinct "training set" for model development.

9. How Ground Truth for Training Set was Established:
As there is no mention of a training set for a machine learning model, the concept of establishing ground truth for a training set is not applicable in the context of this 510(k) summary. The oscillometric algorithm itself is developed based on established physiological principles and extensive validation over time across the medical device industry.

Ask a specific question about this device

Ask a specific question about this device