(70 days)
The Optilite IgA CSF Kit is intended for the quantitative in vitro measurement of IgA in cerebrospinal fluid (CSF) using the Optilite analyser.
The Optilite IgA CSF Kit comprises the following reagents: Latex Reagent, Calibrator and Controls, and Reaction Buffer.
The provided text describes the performance characteristics of the Optilite IgA CSF Kit. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision (Total CV%) | Not explicitly stated, but generally 0.95, slope near 1, intercept near 0) | Correlation coefficient 0.984; Passing Bablok: y = 1.05x - 0.02 (Slope 95% Cl: 1.03 to 1.07, Intercept 95% Cl: -0.07 to 0.05) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision/Reproducibility: 4 different samples were used. The number of runs (two per day for 5 days) and analysts (two) suggest multiple measurements for each sample. Data provenance is not explicitly stated but is implicitly from an internal laboratory study (prospective).
- Linearity: One serially diluted sample was used. Data provenance is implicitly from an internal laboratory study (prospective).
- Analytical Specificity: A CSF sample close to the medical decision point and an elevated CSF sample were tested. Data provenance is implicitly from an internal laboratory study (prospective).
- Method Comparison: 130 CSF samples (including 40 samples with analyte levels within the reference interval) were used. Data provenance is not explicitly stated, but it's likely from a collection of clinical samples. It is retrospective in nature as these are "samples" analyzed, not patients prospectively enrolled.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker. The "ground truth" for the test set is established by the reference methods or the true concentration of the analyte, not by expert interpretation in the same way an imaging or pathology device would involve human experts.
- For precision, the ground truth is the true concentration of IgA in the sample, measured repeatedly to assess variation.
- For linearity, the ground truth is the expected concentration based on the serial dilution.
- For traceability, the ground truth is the value assigned by the international reference material (ERM-DA470k/IFCC).
- For method comparison, the ground truth is the measurement obtained from the alternative commercially available assay (predicate device).
Therefore, the concept of "number of experts used" or their "qualifications" for establishing ground truth is not directly applicable in the context of this type of quantitative IVD performance study.
4. Adjudication Method for the Test Set
Not applicable. As a quantitative IVD, the results are numerical values, and adjudication by experts is not a standard practice for assessing performance metrics like precision, linearity, or method correlation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on human performance. The Optilite IgA CSF Kit is a standalone automated quantitative assay, not an AI-assisted interpretation tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the performance studies described are intrinsically standalone performance evaluations of the Optilite IgA CSF Kit (the "algorithm/device only" in this context) without human-in-the-loop performance. The device provides a quantitative measurement directly.
7. The Type of Ground Truth Used
- Precision and Linearity: The ground truth is based on the known or reference concentrations of the samples used in the study.
- Traceability: The ground truth is the value assigned by the international reference material (ERM-DA470k/IFCC).
- Method Comparison: The ground truth for comparative purposes is the result obtained from an alternative commercially available assay (predicate device).
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This device is an in vitro diagnostic kit based on immunoturbidimetry, which is a chemical/biological reaction and measurement system, not a machine learning model that requires a training set. The term "training set" is not applicable here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).