(27 days)
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
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- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay).
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- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
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- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided text describes a 510(k) pre-market notification for VITROS Immunodiagnostic Products Testosterone Range Verifiers and NTx Range Verifiers. The submission aims to demonstrate substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, a detailed study proving performance against acceptance criteria, or most of the requested information about test sets, expert adjudication, or training sets for a device utilizing AI.
The device in question is a "Range Verifier," which is used to verify the calibration range of an immunodiagnostic system. This is a quality control product, not an AI-powered diagnostic device. Therefore, the questions related to AI-specific performance, human reader improvement, and extensive data set details are not applicable or not present in the provided text.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) because it is a range verifier, not a diagnostic test. Its performance is demonstrated by its "substantial equivalence" to a predicate device based on its characteristics and intended use.
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Intended Use | For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include Testosterone and NTx. (Matches predicate in function, differs in specific analytes verified) |
| Matrix of Range Verifiers | A base matrix of freeze-dried human plasma or buffered matrix spiked with analyte (Testosterone, NTx). (Similar to predicate: freeze-dried human plasma spiked with human pituitary FSH) |
| Range Verifier levels | Low and high (Matches predicate) |
| Safety and Effectiveness | The data presented provides a reasonable assurance that the VITROS Testosterone and NTx Range Verifiers are safe and effective for the stated intended use, demonstrated through comparison to a legally marketed predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided for this type of device. The document mentions "data presented in the pre-market notification" but does not detail a specific test set, its size, or provenance for performance evaluation in the context of sensitivity/specificity that would be relevant for a diagnostic or AI device. The equivalence is primarily based on device characteristics and intended use comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. The device is a range verifier, not a diagnostic interpretation tool, so "ground truth" in the clinical diagnostic sense with expert review is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided.
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 device is a quality control product for an immunoassay system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated in terms of a clinical ground truth. The "ground truth" for a range verifier would be its ability to correctly verify the expected range of the VITROS Immunodiagnostic System. This would be established by the manufacturer through internal quality control and analytical validation, ensuring the spiked analytes are at known concentrations and that the verifier performs consistently within established tolerance limits for its intended purpose. The document primarily focuses on demonstrating equivalence to another verifier product.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.