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510(k) Data Aggregation
(82 days)
Model CH-432 Blood Pressure Meter intended use is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the Citizen Watch Company's Blood Pressure Meter, Model CH-432.
This letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework and responsibilities of the manufacturer. It does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, you would typically need to refer to the full 510(k) submission document or a summary thereof, which often includes details of performance testing and comparison to predicate devices, but these specifics are not present in the provided FDA letter.
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