(27 days)
The Elecsys SHBG 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 SHBG quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
The Elecsys SHBG CalCheck 5 is a lyophilized product consisting of SHBG in human and equine (horse) serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's an analysis of the provided text regarding the Elecsys SHBG CalCheck 5, focusing on acceptance criteria and study details:
The provided documents primarily constitute a 510(k) summary for the Elecsys SHBG CalCheck 5. This type of submission to the FDA focuses on establishing substantial equivalence to a predicate device, rather than proving a device's effectiveness through extensive clinical trials with specific acceptance criteria like those commonly seen for diagnostic AI/ML products.
Therefore, the information regarding acceptance criteria and study design for validating diagnostic performance (like sensitivity, specificity, accuracy against a gold standard) is not present in the provided text, as this is not the nature of a 510(k) for a quality control material.
The data provided describes the evaluation of the CalCheck 5 for value assignment and performance characteristics stability, which are internal validation steps for a quality control product, not a diagnostic device.
Here's an attempt to answer your questions based on the available information, noting the limitations:
Acceptance Criteria and Study Details for Elecsys SHBG CalCheck 5
Given that the Elecsys SHBG CalCheck 5 is an assayed control for calibration verification, its "acceptance criteria" are intrinsically linked to its intended use: to accurately verify the assay range and calibration of the Elecsys SHBG quantitative assay. The studies conducted are internal validations of the control material itself, rather than diagnostic performance studies.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria (e.g., within certain percentage of target value, stability limits) are not detailed. The "reported device performance" is described as the evaluation for "value assignment and Performance Characteristics stability," but the specific outcomes or thresholds are not presented in this summary.
| Characteristic | Acceptance Criteria (Not explicitly stated in summary) | Reported Device Performance (Implied from the study purpose) |
|---|---|---|
| Value Assignment | (Likely: Values fall within specific target ranges for each check level) | Evaluated for value assignment. (Specific data not provided.) |
| Stability | (Likely: Maintains stated concentrations over specified storage conditions and timeframes) | Evaluated for Performance Characteristics stability. (Specific data not provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. For a quality control material, this typically refers to the number of lots produced and tested, or the number of replicates in internal validation studies.
- Data Provenance: Not specified. Given it's an internal validation for a quality control material, the data would likely originate from Roche Diagnostics' manufacturing and R&D facilities. The nature would be prospective, as it involves testing newly manufactured product.
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)
This question is not applicable to this type of device. As a quality control material, "ground truth" doesn't involve clinical diagnosis by expert human readers. The "truth" for this device would be its assigned SHBG concentration, which is determined through rigorous analytical methods by the manufacturer.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) where disagreement among experts needs resolution. For a quantitative analytical control, the "truth" is analytically derived, not adjudicated 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
This question is not applicable.
- This device is not an AI/ML diagnostic tool; it's a quality control material for an immunoassay.
- It does not involve human "readers" in the context of interpretation, nor does it involve AI assistance.
- Therefore, an MRMC comparative effectiveness study is not relevant to its validation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is not an algorithm, but a physical reagent (lyophilized control material).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Elecsys SHBG CalCheck 5 is its assigned concentration of SHBG. This is established through highly precise and accurate analytical methods (e.g., using reference methods, internal standards, and extensive characterization studies) by the manufacturer, Roche Diagnostics. It is not based on expert consensus, pathology, or outcomes data, as those relate to clinical diagnosis, not the characterization of a control material.
8. The sample size for the training set
This question is not applicable in the context of an algorithm or AI model. For a quality control material, there isn't a "training set" in this sense. The development of the control material involves formulation, stability studies, and value assignment, but not an algorithm training process.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as point 8. The "ground truth" (assigned SHBG concentrations) for the control material is established through internal analytical validation and quality control procedures during manufacturing, not through a "training set" for an algorithm.
§ 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.