(64 days)
The Elecsys Toxo IgG CalCheck, as assayed calibrator control, is intended for use in the verification of the calibration established by the Elecsys Toxo IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers.
The Elecsys Toxo IgG CalCheck is a lyophilized product consisting of human anti-Toxo IgG antibodies in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided text describes a 510(k) summary for the Elecsys Toxo IgG CalCheck device. It outlines the device's intended use, comparison to a predicate device, and indicates that performance characteristics were evaluated for value assignment and stability.
However, the document does not provide specific acceptance criteria or details of a study that explicitly proves the device meets those criteria in a quantitative manner. It states that "The Elecsys Toxo IgG CalCheck was evaluated for value assignment and stability," but the results of these evaluations, including the actual performance metrics or a comparison to predefined acceptance criteria, are not presented.
Therefore, much of the requested information cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that the device was "evaluated for value assignment and stability," but it does not list any specific acceptance criteria (e.g., within-run precision, lot-to-lot consistency, stability limits) nor does it report the quantitative results of these evaluations.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. The document mentions evaluations but provides no details on sample sizes or data provenance.
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)
- Not applicable/Cannot be extracted. This device is a calibration check for an immunoassay, not an imaging or diagnostic device that typically relies on expert interpretation for ground truth. The "ground truth" for a calibrator would be its assigned value and its stability characteristics, which are determined through laboratory testing, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be extracted. Adjudication methods are relevant for studies where human interpretation is involved in establishing a ground truth or evaluating device output. This is not the type of device or study described.
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 laboratory control/calibrator, not an AI-powered diagnostic tool intended for human reader assistance. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the conventional sense. This is a laboratory reagent. Its "performance" is evaluated independently of human interpretation in its intended use. However, the document does not detail these standalone performance evaluations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. As a calibrator, its "ground truth" would be established through robust analytical methods, often traceable to reference materials, to assign its value and confirm its stability and consistency. The document does not specify these methods.
8. The sample size for the training set
- Not applicable. This device is a calibrator, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As this is not a machine learning device, there is no training set or ground truth establishment in that context.
§ 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.