(26 days)
The Boehringer Mannheim Elecsys® CalCheck™ Prolactin is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Prolactin assay.
The Boehringer Mannheim Elecsys CalCheck Prolactin is manufactured using human serum albumin and human Prolactin. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled.
The provided text describes a calibration verification material (Elecsys CalCheck Prolactin), not a medical device in the typical sense that would involve performance metrics like sensitivity or specificity for diagnosing a condition. Therefore, many of the requested categories for device performance and study design are not applicable.
Here's an analysis based on the information provided for this specific submission, focusing on what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Verification of calibration assignment (intended use) | Evaluated for value assignment and stability |
| Substantial equivalence to predicate device (Tosoh Medics AIA-Pack FSH Calibration Verification Test) | Found to be substantially equivalent based on intended use and similar function |
Note: The document doesn't explicitly state "acceptance criteria" but rather describes the intended use and the evaluation performed. The core "performance" for a calibration verification material is its ability to verify calibration and its stability, which were evaluated.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is for a calibration verification material, not a diagnostic or screening device that would typically involve a "test set" from patients or human subjects for performance evaluation (e.g., sensitivity, specificity). The evaluation was focused on the material's properties (value assignment, stability) in relation to its intended use in verifying an assay.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to a calibration verification material. The "ground truth" for this product would be the assigned value of the prolactin levels in the CalCheck material itself, established through robust laboratory processes (e.g., reference methods, internal validation). The document doesn't detail how these assigned values were established or by whom.
4. Adjudication method for the test set:
- Not Applicable. As there's no "test set" of patient data for diagnostic accuracy, there's no need for an adjudication method.
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 is a calibration verification material, not an AI-powered diagnostic device, and therefore no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical calibration material, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.
7. The type of ground truth used:
- For the Elecsys CalCheck Prolactin, the "ground truth" would be the assigned concentration values of human Prolactin within the material. This is established through laboratory methods and internal quality control, not typically through pathology, expert consensus on patient outcomes, or clinical outcomes data in this context. The document states it was "evaluated for value assignment and stability," indicating these intrinsic properties were the focus of the evaluation.
8. The sample size for the training set:
- Not Applicable. This product is a physical reagent (calibration verification material), not a machine learning algorithm, so there is no "training set" in the computational sense.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an algorithm, 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.