(15 days)
The Boehringer Mannheim Elecsys CalCheck DIGOXIN is used to verify the calibration assignment for the Boehringer Mannheim Elecsys DIGOXIN assay.
Elecsys® CalCheck™ DIGOXIN calibration verification solutions comprise three levels - low, mid, and high - each with a defined DIGOXIN concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® CalCheck™ DIGOXIN is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent.
The Elecsys® CalCheck™ DIGOXIN is a three level single analyte set of stable liquid, bovine based materials. They are assayed in triplicate and the results compared to the target values.
The provided document is a 510(k) summary for the Elecsys® CalCheck™ DIGOXIN, a calibration verification material. This type of device is used to check the calibration assignment of an in vitro diagnostic assay, not to produce diagnostic results directly from patient data. Therefore, the concepts of acceptance criteria as typically applied to diagnostic performance (e.g., sensitivity, specificity, AUC) and the detailed study elements you've requested (like sample size for test sets/training sets, expert ground truth, MRMC studies) are not directly applicable or are not detailed in this type of submission for this specific device.
Instead, the "performance" of such a device primarily relates to its ability to verify the calibration of the associated assay. The acceptance criteria would typically involve demonstrating that the CalCheck material, when run on the Elecsys® DIGOXIN assay, produces results that are consistent with its assigned target values, thereby verifying the assay's calibration over its measuring range.
Here's an attempt to address your questions based on the available information and the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of ranges or tolerance limits for the CalCheck™ DIGOXIN material. However, its intended use implies that when tested, the measured values should fall within an acceptable range of its assigned target values.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Implied from Intended Use) |
|---|---|---|
| Primary Function | The Elecsys® CalCheck™ DIGOXIN should accurately verify the calibration assignment of the Elecsys® DIGOXIN assay. | The device is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent. This implies it met performance expectations during validation. |
| Concentration Levels | Must comprise three distinct levels (low, mid, high) with defined DIGOXIN concentrations. | Low solution: near the lower detection limit. Mid solution: in the middle or at the clinically critical point. High solution: near the upper limit of the measuring range. |
| Stability | Must be a stable liquid material. | Described as a stable liquid, bovine-based material. |
| Matrix Type | Suitable for matrix match with the assay, or validated for its matrix effects. | Bovine serum (different from the predicate's horse serum, which was deemed acceptable). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. For a calibration verification material, the "test set" would typically refer to the number of replicates or runs performed during the characterization and validation of the product, both for assigning its own values and for demonstrating its ability to verify the associated assay. The document states it is "assayed in triplicate," which likely refers to the method for determining its target values, but not necessarily the full validation sample size. The provenance of this data (e.g., country of origin) is also not specified. It is a Boehringer Mannheim product, likely developed and tested in a regulated environment relevant to its manufacturing locations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable or not provided for a calibration verification material. The "ground truth" for such a device is typically its assigned concentration, which is determined through a rigorous analytical process using reference methods and materials, not by expert consensus in a clinical sense.
4. Adjudication Method for the Test Set
This is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data, which is not the function of this device classification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that are interpreted by human readers (e.g., radiologists, pathologists) and aims to assess the impact of AI assistance on their performance. The Elecsys® CalCheck™ DIGOXIN is a laboratory reagent, not an imaging or interpretive diagnostic AI device, so such a study is not relevant to its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device's function involves an "algorithm" in the sense of the chemical reaction and measurement process of the Elecsys® DIGOXIN assay, the concept of "standalone performance" as typically discussed for AI devices (algorithm only without human-in-the-loop performance) is not applicable here. The CalCheck material itself does not have an "algorithm" in that AI sense; its performance is linked to its assigned values and its interaction with the Elecsys® DIGOXIN assay.
7. The Type of Ground Truth Used
The "ground truth" for the Elecsys® CalCheck™ DIGOXIN is its assigned DIGOXIN concentration values. These values are established through an analytical process, likely calibrated against internationally recognized reference materials or methods to ensure accuracy and traceability. It is not based on expert consensus, pathology, or patient outcomes data, as these are clinical endpoints.
8. The Sample Size for the Training Set
This information is not applicable or not provided. The concept of a "training set" is relevant for machine learning algorithms that learn from data. This device is a chemical reagent, not a learning algorithm. Its "manufacture" involves established chemical and production processes, not data training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" in the context of this device. The assigned values of the CalCheck material (its "ground truth" for verification purposes) would be established through:
- Reference methods.
- Assaying against known primary standards.
- Interlaboratory studies.
- Statistical analysis of repeated measurements (e.g., "assayed in triplicate" mentioned in the description).
In summary, the provided 510(k) pertains to a calibration verification material, not a clinical diagnostic device that interprets patient data or uses AI. Therefore, many of the requested study details like test set size, expert consensus, MRMC studies, and training set information are not relevant or typically found in submissions for this class of product. The "study" that proves the device meets its acceptance criteria involves analytical validation demonstrating that the material performs as intended to verify the calibration of the associated Elecsys® DIGOXIN assay.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.