(12 days)
The Elecsys CalCheck Myoglobin is intended for use in periodic verification of the calibration of the Elecsys Myoglobin assay.
The Boehringer Mannheim Elecsys CalCheck Myoglobin is manufactured using bovine serum albumin, human Myoglobin, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.
The provided document is a 510(k) summary for the Boehringer Mannheim Elecsys CalCheck Myoglobin, a calibration verification material. This type of submission focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes. It does not contain information about the clinical efficacy or performance of a diagnostic device in the way a study for a new AI-powered diagnostic might.
Therefore, many of the requested categories for describing acceptance criteria and a study to prove a device meets those criteria are not applicable to the information provided in this 510(k) summary. I can, however, extract relevant details about the device's "performance characteristics" as described in the approval.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
Based on the 510(k) summary, the device is a calibration verification material. Its "performance characteristics" revolve around its ability to accurately verify calibration and its stability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Value assignment (accurate Myoglobin concentration) | "The Elecsys® CalCheckTM Myoglobin was evaluated for value assignment" (Specific results not detailed in this summary) |
| Stability (maintaining concentration over time) | "The Elecsys® CalCheckTM Myoglobin was evaluated for... stability" (Specific results not detailed in this summary) |
| Intended Use | "Used to verify the calibration assignment for the Boehringer Mannheim Elecsys Myoglobin assay." |
| Concentration levels | Low (near lower detection limit), Mid (middle/clinically critical point), High (near upper limit). |
Regarding the study that proves the device meets the acceptance criteria:
The document states: "The Elecsys® CalCheckTM Myoglobin was evaluated for value assignment and stability."
However, the 510(k) Summary does not provide the detailed results of this evaluation or the specific study design. It only mentions that an evaluation was performed. For a calibration verification material, typical studies would involve:
- Value Assignment: Multiple runs on the target analyzer using reference methods or highly accurate assays to determine the assigned concentration for each level (low, mid, high).
- Stability: Testing samples at various time points and storage conditions (e.g., refrigerated, frozen, room temperature) to ensure the assigned values remain within acceptable limits over the claimed shelf life and in-use stability period.
The following requested categories are NOT applicable or detailable from the provided 510(k) summary because it's for a calibration verification material, not a diagnostic AI device, and the summary itself is high-level:
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided. The summary does not provide details on sample sizes for value assignment or stability testing, nor does it specify data provenance.
- 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)
- Not Applicable/Not Provided. For a calibration verification material, "ground truth" for concentration would typically be established through highly accurate analytical methods, not expert human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. This relates to human expert review, which is not relevant for the performance evaluation of a calibration verification material.
- 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 specific to AI-powered diagnostic devices involving human readers. This device is a calibration material.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Likely Analytical Reference Methods/Certified Standards (Not explicitly stated but implied by "value assignment"). For a calibration verification material, ground truth for analyte concentration is established through precise analytical techniques, often traceable to international reference materials.
- The sample size for the training set
- Not Applicable. This device is not an AI algorithm requiring a training set.
- How the ground truth for the training set was established
- Not Applicable. This device is not an AI algorithm requiring a training set.
§ 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.