(90 days)
The INNOFLUOR™ Topinamate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.
The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.
Here's an analysis of the provided text regarding the INNOFLUOR™ Topiramate Control Set, focusing on the requested information.
It's important to note that this 510(k) summary is for a control set within an assay system, not a diagnostic AI device. Therefore, many of the requested categories (like "multi-reader multi-case study," "number of experts," "adjudication method," etc.) are not applicable in the context of an in-vitro diagnostic (IVD) assay comparison study. The study described focuses on analytical performance rather than diagnostic accuracy involving human interpretation.
Acceptance Criteria and Study Details for INNOFLUOR™ Topiramate Control Set
Based on the provided 510(k) summary, the device under review is the INNOFLUOR™ Topiramate Control Set, which is part of the INNOFLUOR™ Topiramate Assay System. The study described focuses on establishing the analytical performance and substantial equivalence of the overall INNOFLUOR™ Topiramate Assay System, not specifically the control set in isolation, but rather its performance in measuring topiramate.
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Table of Acceptance Criteria and Reported Device Performance
The document implies acceptance criteria through the reference to "substantial equivalence" and the presentation of a linear regression analysis. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient, maximum bias) are not stated, the demonstration of equivalency is the overarching criterion.
Acceptance Criteria (Implied) Reported Device Performance Substantial equivalence to current predicate devices/methods. The technological characteristics, performance and intended use of the INNOFLUOR™ Topiramate Assay System are substantially equivalent to the INNOFLUOR™ Phenobarbital Assay System and the Abbott Phenobarbital II Assay with the exception of the specific anticonvulsant tested for by each method. Equivalency of results between INNOFLUOR™ Topiramate Assay System and an established method (Topiramate Gas Chromatography). Demonstrated by strong correlation and acceptable linear regression parameters. Comparison of the patient sample results by linear regression analysis resulted in the regression equation: (INNOFLUOR™) = 0.985 x (GC) - 0.147, with a correlation coefficient of 0.9934, demonstrating equivalency of results. A correlation coefficient (r) of 0.9934 indicates a very strong linear relationship between the two methods. A slope of 0.985 is very close to 1, and an intercept of -0.147 is very close to 0, suggesting minimal systematic bias between the two methods. -
Sample Size Used for the Test Set and Data Provenance
- Sample Size: 117 patient samples.
- Data Provenance: The origin of the data (country) is not specified. It is prospective in the sense that samples were collected from "patients receiving topiramate therapy" and then analyzed by both methods for comparison. It is not listed as retrospective.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This study involves comparing the analytical measurement of a specific analyte (topiramate) by two different laboratory methods (fluorescence polarization immunoassay vs. gas chromatography). It does not involve human interpretation of images or other data where experts establish a diagnostic ground truth. The "ground truth" here is effectively the measurement obtained by the established reference method (Gas Chromatography).
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Adjudication Method for the Test Set
- Not applicable. See point 3.
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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
- No. This is an analytical performance study of an in-vitro diagnostic assay, not a study of an AI system for diagnostic image interpretation or similar.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, analogous to standalone. The study directly compares the results of the INNOFLUOR™ Topiramate Assay System (algorithm/assay only) against Topiramate Gas Chromatography (reference method), without any human interpretive element being evaluated in the comparison. The "performance" being assessed is the analytical output of the assay system itself.
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The Type of Ground Truth Used
- The "ground truth" for the test set was established by Topiramate Gas Chromatography (GC). GC is a well-established and highly accurate analytical method often used as a reference standard for drug quantification.
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The Sample Size for the Training Set
- Not explicitly stated in terms of a "training set" for an algorithm. For an IVD assay, method development involves internal studies (calibration, linearity, precision), but these are usually not referred to as "training sets" in the same way as machine learning. The 117 patient samples are specifically for the comparison/validation study.
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How the Ground Truth for the Training Set Was Established
- Not explicitly applicable in the machine learning sense. For an IVD assay, "ground truth" during development would be established through a carefully controlled laboratory setting, using gravimetrically prepared standards and reference materials, and verified by highly accurate reference methods (like GC or LC-MS/MS). The document does not detail the development process, only the validation comparison.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.