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510(k) Data Aggregation
K Number
K193005Device Name
DIMI RRT SystemManufacturer
Date Cleared
2020-08-28
(305 days)
Product Code
Regulation Number
876.5860Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
Not Found
AI/ML Overview
This document is an FDA 510(k) clearance letter for a medical device called the "DIMI RRT System," which is a high permeability hemodialysis system. It does not contain information about the acceptance criteria or the study that proves the device meets the acceptance criteria. The common data points you asked for, such as sample size for test and training sets, expert qualifications, and specific performance metrics, are not included in this type of regulatory correspondence.
Therefore, I cannot provide the requested information based on the input text.
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