(60 days)
The Elecsys® C-Peptide CalSet is used for calibrating the quantitative C-Peptide assay on the Elecsys immunoassay systems.
The Elecsys® C-Peptide CalSet is a lyophilized product consisting of synthetic human C-Peptide in a buffered horse serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
This is a 510(k) premarket notification for the Elecsys® C-Peptide CalSet, a calibrator used with an immunoassay system. As such, the concept of "device performance" in terms of clinical accuracy, sensitivity, or specificity as typically understood for diagnostic devices is not directly applicable. Instead, the performance relates to its function as a calibrator, specifically its value assignment and stability.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported performance data for the Elecsys® C-Peptide CalSet beyond a general statement that it was "evaluated for value assignment and stability." For calibrators, acceptance criteria typically involve demonstrating that the assigned values are accurate and that the calibrator remains stable over its claimed shelf life and in-use period, ensuring reliable calibration of the assay.
| Acceptance Criteria (Implied for Calibrators) | Reported Device Performance (Summary from Document) |
|---|---|
| Accurate value assignment | The Elecsys® C-Peptide CalSet was evaluated for value assignment. |
| Stability over claimed shelf life | The Elecsys® C-Peptide CalSet was evaluated for stability. |
| Unopened: Store at 2-8°C until expiration date. | |
| Reconstituted: -20°C for 1 month (freeze only once). | |
| Reconstituted: On the analyzers, use only once. |
Note: The document only provides a summary that these evaluations were performed, not the specific quantitative results or defined acceptance limits. This is common in a 510(k) summary, where detailed study reports are typically submitted separately.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the value assignment or stability testing, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective). For calibrator studies, the "sample size" would refer to the number of lots of calibrator tested, the number of measurements taken, and potentially the number of instruments used in the evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to a calibrator. Ground truth for a calibrator's value assignment would typically be established through a reference measurement procedure and/or comparison to a higher-order reference material, not by expert consensus in the same way clinical ground truth is established for diagnostic devices evaluating patient conditions.
4. Adjudication method for the test set
Not applicable to a calibrator's value assignment or stability testing. These are analytical performance studies.
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 calibrator for an immunoassay system, not an AI-powered diagnostic device involving human readers or interpretation of clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a calibrator. The "performance" of a calibrator is inherent to its physical and chemical properties and how it functions within the immunoassay system to assign values. There isn't an "algorithm-only" performance in the sense of a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For calibrators, the "ground truth" for value assignment is typically established through:
- Reference measurement procedures: Highly accurate and precise analytical methods.
- Reference materials: Certified reference materials (CRMs) with known analyte concentrations traceable to international standards.
- Gravimetric or volumetric preparation: For primary calibrators, the concentration might be known by precise preparation.
The document does not specify the exact method used to establish the "ground truth" for the Elecsys® C-Peptide CalSet's value assignment, but it would align with the principles above.
8. The sample size for the training set
Not applicable. This device is a calibrator, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a calibrator device.
§ 862.1150 Calibrator.
(a)
Identification. A 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. (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.