(118 days)
The Elecsys HCG+B 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 HCG+B reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys HCG+$\beta$ CalCheck 5 is a lyophilized product consisting of HCG in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
This document describes the Elecsys HCG+β CalCheck 5, an assayed control for use in calibration verification and verification of the reportable range of Elecsys HCG+β reagent on Elecsys and cobas e immunoassay analyzers.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device for market clearance. It does not contain detailed information about acceptance criteria or a comprehensive study report with the level of detail requested for AI/ML device evaluations. The device described here is a control material for laboratory assays, not an AI/ML diagnostic device. Therefore, many of the requested fields, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "stand-alone study," "type of ground truth," and "sample size for training/test sets" as understood in the context of AI/ML, are not applicable to this type of medical device.
The provided text focuses on comparing the new device (Elecsys HCG+β CalCheck 5) to a predicate device (Elecsys HCG+β CalCheck) to establish substantial equivalence.
Here's an attempt to answer the questions based on the available information, noting where information is not present or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance data in a results table format as would be expected for an AI/ML device. Instead, performance is generally described within the context of substantial equivalence to the predicate.
| Characteristic | Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Intended Use | Equivalent to predicate for calibration verification; extended to include verification of reportable range and additional analyzers. | Met: Intended use includes calibration verification and verification of reportable range on indicated Elecsys and cobas e immunoassay analyzers. |
| Levels | Not explicitly stated beyond "Three" for predicate. | Met: Increased levels from 3 (predicate) to 5. |
| Format | Identical to predicate (Lyophilized). | Met: Lyophilized. |
| Handling | Similar reconstitution process, specific volumes for each check. | Met: Similar reconstitution process, specific 1.0 mL for all 5 checks. |
| Stability | Equivalent to predicate (Unopened: Store at 2-8°C until expiration date; Reconstituted: 20 – 25°C : 4 hrs). | Met: Same stability as predicate. |
| Matrix | Identical to predicate (Human serum matrix). | Met: Human serum matrix. |
| Value Assignment | (Implicitly, values should be appropriately assigned and traceable) | Evaluated: "The Elecsys HCG+β CalCheck 5 was evaluated for value assignment..." (No specific data provided in this summary). |
| Stability | (Implicitly, stability should be maintained for the stated periods) | Evaluated: "...and stability." (No specific data provided in this summary). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not provided in the 510(k) summary. For a control material, "test set" would typically refer to the number of batches produced and tested, or the number of runs performed during validation.
- Data Provenance: This information is not provided. The studies would have been conducted by Roche Diagnostics, likely in their labs. The document does not specify if data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as this is a medical device (calibration control), not an AI/ML diagnostic system requiring expert interpretation of complex inputs to establish ground truth. The "ground truth" for a control material would be its manufacturing specifications and assigned values, verified through analytical methods.
4. Adjudication method for the test set
- This question is not applicable as there is no interpretative "test set" requiring adjudication by multiple readers for this type of device.
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 is a control material, not an AI/ML diagnostic device that interacts with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is a control material, not an algorithm.
7. The type of ground truth used
- The "ground truth" for a calibrator/control material like Elecsys HCG+β CalCheck 5 would be assigned values based on a traceable reference method and/or reference materials, established during the manufacturing and characterization process. It is about the physicochemical properties and concentration of HCG in the control, not an interpretative diagnosis.
8. The sample size for the training set
- This question is not applicable. This is a control material, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
- This question is not applicable.
§ 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.