(96 days)
The Elecsys CEA CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CEA CalCheck quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.
The Elecsys CEA CalCheck 5 is a lyophilized product consisting of human CEA in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text is related to the 510(k) premarket notification for the Elecsys CEA CalCheck 5, an in vitro diagnostic device. It does not describe a study involving a medical device that analyzes patient data to provide diagnostic insights (e.g., an AI-powered diagnostic tool). Instead, it describes a quality control material used to verify the calibration and assay range of other in vitro diagnostic instruments.
Therefore, many of the typical acceptance criteria and study aspects you've asked for, such as sample size for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of device and are not present in the provided document.
However, I can extract the relevant information regarding the performance characteristics that were evaluated for this quality control material.
Here's the information that can be extracted from the provided text, modified to reflect the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic quality control material, the "performance" relates to its stability and its ability to have its values assigned accurately. The document mentions these as the key performance characteristics evaluated.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Value Assignment | Evaluated | While the specific numerical acceptance criteria for value assignment are not detailed, the product is an "assayed control," meaning its anticipated values are assigned during its development. The evaluation confirms this process. |
| Stability (Unopened) | Store at 2-8°C until expiration date | The device maintained its intended characteristics when stored at 2-8°C until its expiration date. |
| Stability (Reconstituted) | 20-25°C: 4 hours | The device maintained its intended characteristics for 4 hours after reconstitution when stored at 20-25°C. |
Important Note: This document is a 510(k) summary, which provides a high-level overview. Detailed performance data, including specific acceptance ranges for value assignment or the full stability study protocols, would typically be found in the manufacturer's internal documentation and the complete 510(k) submission, not necessarily in this public summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in the context of analyzing patient data. For a quality control material, "testing" involves evaluating its matrix, analyte concentration, and stability over time under various conditions. The document does not specify the number of lots or vials tested for stability or value assignment.
- The data provenance is from Roche Diagnostics, located in Indianapolis, IN, USA.
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. "Ground truth" in this context refers to the assigned values of the control material. These values are established through rigorous internal testing and calibration processes by the manufacturer, typically involving highly controlled laboratory instruments and reference methods, not clinical expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations of images or clinical data, which is not relevant for a quality control material.
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 type of study is for evaluating the impact of AI on human diagnostic performance, which is not relevant for a quality control material.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not Applicable. The device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this device, the "ground truth" (or more appropriately, the assigned values) for the control material are established through calibration against established reference materials and methods using highly precise laboratory analytical instruments. The analyte (CEA) is spiked into a human serum matrix at desired concentration levels during manufacturing.
8. The sample size for the training set
- Not Applicable. This device is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.