(15 days)
The Abbott ARCHITECT B12 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma.
The Abbott ARCHITECT B12 Calibrators are liquid, ready-for-use materials in a buffered aqueous solution. Concentrations of the calibrator components span the dynamic range of the assay.
The provided text describes the Abbott ARCHITECT® B12 Calibrators, which are for calibrating the ARCHITECT i System for quantitative determination of vitamin B12 in human serum and plasma. The study presented is a correlation analysis between the new 6-Point Calibrators and the predicate 2-Point Calibrators.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are not explicitly stated in the provided text. However, the study aims to demonstrate that the performance of the new 6-Point Calibrators is "comparable to the performance of the predicate device." The reported performance metrics are based on a correlation analysis.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (6-Point vs. 2-Point Calibrators) |
|---|---|---|
| Correlation (r) | High correlation (e.g., close to 1) | 0.998 |
| Slope (Least Squares) | Close to 1 | 0.96 |
| Intercept (Least Squares) | Close to 0 | 22 |
| Slope (Passing-Bablok) | Close to 1 | 0.98 |
| Intercept (Passing-Bablok) | Close to 0 | 12 |
2. Sample size used for the test set and the data provenance
- Sample size used for the test set: 495 specimens
- Data provenance: Not explicitly stated, but the specimens were "serum specimens tested." The country of origin and whether the data was retrospective or prospective are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the text. The study is a comparison of two calibration methods, not a diagnostic test requiring expert ground truth in the traditional sense. The "ground truth" here is the measurement obtained by the predicate device's 2-Point Calibrators.
4. Adjudication method for the test set
This information is not applicable as it's a direct comparison of calibration methods and not a study requiring adjudication of diagnostic interpretations by experts.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a calibrator for an automated assay, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not entirely applicable in the context of a calibrator for an automated immunoassay. The device is a component that enables standalone (algorithm-only, or in this case, instrument-only) performance of the ARCHITECT i System for B12 measurement. The study directly assesses the performance of this calibrator in conjunction with the instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this study is essentially the results obtained using the predicate device's 2-point calibration assay. The new 6-point calibrators are being evaluated against the established performance of the existing calibrators.
8. The sample size for the training set
This information is not provided and is likely not relevant for this type of calibrator evaluation. Calibrators are developed based on specific chemical and manufacturing processes, not typically "trained" on large datasets in the way an AI algorithm would be.
9. How the ground truth for the training set was established
This information is not provided and is likely not applicable for the reasons stated in point 8.
§ 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.