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510(k) Data Aggregation
(48 days)
The Elecsys T4 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 T4 reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys T4 CalCheck 5 is a lyophilized product consisting of T4 in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's a breakdown of the acceptance criteria and study information for the Elecsys T4 CalCheck 5, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device (Elecsys T3 CalCheck 5) rather than explicitly stating specific numerical acceptance criteria for the Elecsys T4 CalCheck 5. However, the performance characteristics section mentions "value assignment and stability" as evaluation points. From the comparison table with the predicate, we can infer some targets or expected ranges for "Check Target Values" and "Assay Measuring Range".
| Characteristic | Acceptance Criteria (Inferred from Predicate/Device Spec.) | Reported Device Performance (Assumed to meet, since cleared) |
|---|---|---|
| Intended Use | Assayed control for calibration verification and assay range verification for Elecsys T4 reagent on Elecsys and cobas e immunoassay analyzers. | Meets the stated intended use. |
| Analyte | Thyroxine (T4) | Contains Thyroxine (T4). |
| Number of Levels | Five | Five levels provided. |
| Assay Measuring Range | 5.40 - 320 nmol/L | The device is designed to verify this range. |
| Check Target Values | Check 1: <0.78 ug/dL, <10 nmol/L | The device provides these target values. |
| Check 2: 7.77 ug/dL, 100 nmol/L | ||
| Check 3: 12.43 ug/dL, 160 nmol/L | ||
| Check 4: 19.42 ug/dL, 250 nmol/L | ||
| Check 5: 24.86 ug/dL, 320 nmol/L | ||
| Format | Lyophilized | Lyophilized. |
| Handling | Reconstitution with 1.0 mL distilled/deionized water, stand 15 min, mix gently. | Designed for this handling procedure. |
| Stability (Unopened) | Store at 2-8°C until expiration date. | Meets this stability requirement. |
| Stability (Reconstituted) | 20-25°C: 4 hours. | Meets this stability requirement. |
| Matrix | Check 1: BSA/Buffer matrix; Checks 2-5: Human serum. | Utilizes these matrices. |
| Traceability | Traceable to reference method ID-GC/MS using serum/plasma samples. | Traceable as described. |
| Value Assignment | (Implicit: Values accurately assigned for each level) | Evaluated. |
| Stability | (Implicit: Stable over specified conditions) | Evaluated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance evaluation (test set). It only mentions that the device "was evaluated for value assignment and stability."
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "traceability" section mentions "standardized against reference standards by weighing T3" for the predicate and "Thyroxine is traceable to the reference method ID-GC/MS using serum/plasma samples as reference material" for the candidate device. This suggests a more analytical approach to establishing ground truth rather than expert consensus on observational data.
4. Adjudication Method for the Test Set
Not applicable/Not mentioned. The study described is not one where human interpretation of results would require adjudication.
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 calibration and assay verification material, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This would also not be applicable in the context of this device. The device itself is the "algorithm" or control material for other assays. The performance evaluated would be of the control material itself, not an algorithm's output.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the Elecsys T4 CalCheck 5 is based on traceability to a reference method: "Thyroxine is traceable to the reference method ID-GC/MS using serum/plasma samples as reference material." This indicates that the "true" concentration of T4 in the control levels was determined using a highly accurate and precise analytical method (Isotope Dilution Gas Chromatography/Mass Spectrometry).
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning. The evaluation would have involved multiple runs or lots of the control material, but the term "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" with established ground truth is not applicable to a medical device that is a quality control material. The "ground truth" for the control material's concentrations is established through its traceability to a reference method (ID-GC/MS).
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