(90 days)
The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in senum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxfLx® analyzer.
The INNOFLUOR™ Topiramate Assay System consists of three products that are packaged and sold separately: the INNOFLUOR™ Topiramate Reagent Set, the INNOFLUOR™ Topiramate Calibrator Set and the INNOFLUOR™ Topiramate Control Set. It is a fluorescence polarization immunoassay.
Here's an analysis of the provided 510(k) summary, aiming to extract information about acceptance criteria and the supporting study:
The provided text describes a submission for the INNOFLUOR™ Topiramate Assay System. The core of the submission revolves around demonstrating substantial equivalence to existing devices rather than defining novel acceptance criteria for a new class of device.
1. A table of acceptance criteria and the reported device performance
The submission demonstrates "equivalency of results" between the INNOFLUOR™ system and a reference method (Topiramate Gas Chromatography, GC) using linear regression. While specific predefined "acceptance criteria" for the regression parameters (slope, intercept, correlation coefficient) are not explicitly stated as numerical targets in the document, the reported results are presented as evidence of meeting an implicit standard for equivalence.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient (r) | High correlation indicating strong linear relationship | 0.9934 |
| Slope | Close to 1 (indicating proportional agreement) | 0.985 |
| Intercept | Close to 0 (indicating no systematic bias) | -0.147 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 117 patient samples.
- Data Provenance: The document states "117 patient samples from patients receiving topiramate therapy." It does not specify the country of origin, nor does it explicitly state if the data was retrospective or prospective, though the phrasing "patient samples from patients receiving topiramate therapy" often implies a retrospective collection from a patient cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device. The "ground truth" (or reference method) for the test set was established by Topiramate Gas Chromatography (GC). GC is an analytical chemistry technique, not a human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation where adjudication would be necessary. The comparison is between two analytical measurement techniques.
5. 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
Not applicable. This is not an AI-based device or an MRMC study. It's a fluorescence polarization immunoassay compared to gas chromatography.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study described is a standalone performance assessment of the INNOFLUOR™ Topiramate Assay System. It measures topiramate concentrations directly and compares them to values obtained from a reference method (GC), without human intervention in the interpretation of the results themselves. The "algorithm" here would be the immunoassay and analyzer's method for determining concentration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" was established by a reference analytical method: Topiramate Gas Chromatography (GC). This is a well-established and generally accepted method for quantitative determination of substances like topiramate.
8. The sample size for the training set
Not explicitly stated. This summary focuses on the validation of the device, implying the assay system was already developed. For an immunoassay, the "training set" would typically refer to the data used to optimize assay parameters and establish calibration curves during the development phase. This information is typically not included in a 510(k) summary focused on performance comparison.
9. How the ground truth for the training set was established
Not explicitly stated in this summary. Similar to point 8, the development process for establishing calibration curves and optimizing assay parameters (which would use standards with "known" concentrations as ground truth) is not detailed. This "ground truth" would also likely involve well-characterized reference materials or other analytical methods to assign target values to calibrators.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.