(16 days)
The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys Ferritin assay.
Elecsys CalCheck Ferritin calibration verification solutions comprise three levels - low, mid, and high - each with a defined Ferritin concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys CalCheck Ferritin is intended for use in periodic verification of the calibration of the Elecsys Ferritin assay.
The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheckTM Ferritin is manufactured using human serum albumin, Ferritin, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against ID-GC/MS.
The provided text describes the Elecsys® CalCheck™ Ferritin, a calibration verification material. However, it does not contain a detailed study with acceptance criteria and reported device performance in the manner requested (e.g., accuracy, sensitivity, specificity, or a comparative effectiveness study with human readers).
The document is a 510(k) summary for a calibration verification material. The "Performance Characteristics" section [1] states that the device was evaluated for "value assignment and stability," but no specific metrics, acceptance criteria, or study results are provided in the available text.
Therefore, many of the requested details about acceptance criteria and study design cannot be extracted from this document.
Here's an attempt to answer based on the available information, with specific notes where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states, "The Elecsys® CalCheck™ Ferritin was evaluated for value assignment and stability," but no specific criteria or results are given. | Not provided in the document. No specific quantitative performance metrics (e.g., accuracy, precision, bias, stability over time, or comparison to a reference method) are detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document describes the manufacturing and quality control of the calcheck material [0] but does not mention the origin or type of data used for performance evaluation beyond general "value assignment and stability."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/Not specified. This device is a calibration verification material. Its "ground truth" would likely be derived from a validated reference method or primary standard for ferritin concentration rather than expert consensus on diagnostic images or clinical cases. The text mentions "quality controlled against ID-GC/MS" during manufacturing [0], which suggests an analytical reference method for concentration assignment, but details are not provided for the test set.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. The concept of adjudication (e.g., 2+1, 3+1 for clinical diagnoses) is not relevant for a calibration verification material whose performance is assessed through analytical measurements against established values.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is typically done for diagnostic or screening devices that involve human interpretation of results (e.g., medical images). The Elecsys® CalCheck™ Ferritin is a calibration verification solution for an automated immunoassay, meaning it does not directly involve human "readers" interpreting test results in a diagnostic context.
- Effect Size of Human Reader Improvement: Not applicable.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study Done: Yes, in an analogous sense. The "value assignment and stability" evaluation of the CalCheck™ Ferritin itself would represent a standalone assessment of its analytical performance (e.g., is the assigned concentration accurate, and does it remain stable over time?). However, the specifics of this study (methods, results, acceptance criteria) are not detailed in the provided text. The device itself is "algorithm only" in the sense that its performance is purely analytical, not based on human input for interpretation.
7. Type of Ground Truth Used
- Type of Ground Truth: Analytical reference methods for ferritin concentration. The text mentions the material is "quality controlled against ID-GC/MS" [0], which is a highly accurate analytical technique (Isotope Dilution Gas Chromatography/Mass Spectrometry) often used as a reference method for determining the concentration of substances in a matrix. This suggests that the "ground truth" for the assigned ferritin values in the CalCheck material would be established through such highly accurate analytical techniques.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a calibration verification material, not an AI/ML algorithm that is "trained" on data. It is a physical product with assigned values. Its manufacturing and quality control processes are established, but there isn't a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set." The "ground truth" for the CalCheck's assigned values is established through rigorous analytical measurement processes, likely against primary reference standards using methods like ID-GC/MS, as suggested in the document [0].
§ 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.