(46 days)
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.
ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes two in vitro diagnostic devices, ELICAL 2 (a calibrator) and ELITROL I / ELITROL II (controls), and their comparison to predicate devices for 510(k) clearance.
However, the documentation provided does not contain information related to an AI/ML-based device. It describes traditional in vitro diagnostic devices, specifically a multi-analyte calibrator and multi-analyte controls based on human serum.
Therefore, I cannot provide an answer that includes details typical of an AI/ML device study, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or a table of acceptance criteria and reported device performance for an AI/ML model.
The document focuses on demonstrating substantial equivalence of the new calibrator and control devices to existing predicate devices based on attributes like intended use, format, levels, handling, traceability, and stability. The "performance data" mentioned in the Conclusion likely refers to the analytical performance characteristics (e.g., stability) that were tested to show the new devices perform comparably to the predicates, rather than the performance of an AI algorithm.
To answer your request thoroughly, I need information about an AI/ML device study. The current document does not provide the necessary details.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.