(17 days)
The Boehringer Mannheim Elecsys® CalCheck™ Folate is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Folate assay.
Elecsys CalCheck Folate calibration verification solutions comprise three levels - low, mid, and high - each with a defined Folate concentration. The low solution concentration is near the clinical deficiency range of the assay. The mid solution is in the middle point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys CalCheck Folate is intended for use in periodic verification of the calibration of the Elecsys Folate assay.
The Boehringer Mannheim Elecsys® CalCheck™ Folate is manufactured using human serum albumin, Folate, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against in-house standards.
This looks like a 510(k) premarket notification for a calibration verification material, not a medical device that diagnoses or treats patients and therefore the typical "acceptance criteria" and "device performance" in terms of clinical accuracy (sensitivity, specificity, etc.) with human-in-the-loop or standalone studies are not applicable in the same way.
Instead, the "acceptance criteria" and "device performance" for a calibration verification material like the Elecsys® CalCheck™ Folate would relate to its ability to accurately verify the calibration of an assay, its stability, and consistency of its assigned values.
However, based on the provided text, the specific acceptance criteria and the detailed study results that prove the device meets these criteria are not explicitly stated. The document mentions that performance characteristics were evaluated for "value assignment and stability" but does not provide the numerical results or the methodology in detail within the provided snippets.
Therefore, many of the requested fields cannot be fully populated. Here's what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Accurate value assignment for Folate concentration levels. | "The Elecsys® CalCheck™ Folate was evaluated for value assignment..." (Details of specific values or acceptable ranges are not provided in the given text). The device is manufactured with the analyte "appropriately spiked into the calcheck matrix to the correct calcheck concentration levels," and "in process checked and quality controlled against in-house standards." (This implies a successful value assignment, but specific performance data is missing). |
| Stability of Folate concentration over time. | "...and stability." (Details of stability duration, conditions, and acceptable deviation are not provided in the given text.) |
| Substantial equivalence to predicate device (Elecsys® CalCheck™ TSH). | The FDA found the device "substantially equivalent" to the predicate device. The document explicitly states: "The Boehringer Mannheim Elecsys® CalCheck™ Folate is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH Calibration Verification Test (K963147)." |
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 in the provided text. The evaluation report mentioned "value assignment and stability" but no sample sizes for these studies are indicated.
- Data Provenance: Not specified. It's likely internal testing performed by Boehringer Mannheim Corporation (based in Pleasanton, CA, USA), but this is not explicitly stated as the origin of the data. The study type (retrospective/prospective) is also not stated.
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 type of expert ground truth is not applicable for a calibration verification material. The "ground truth" for the a calibration verification material is the precisely known concentration of the analyte within the material, established through rigorous analytical measurement and manufacturing processes. The document mentions "in process checked and quality controlled against in-house standards."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable as it's not a diagnostic device requiring human interpretation for ground truth.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of typical diagnostic algorithms. The device itself (the CalCheck material) is a standalone product to verify an assay's performance. The "performance" assessment ("value assignment" and "stability") would inherently be a standalone evaluation of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the Elecsys® CalCheck™ Folate, the "ground truth" would be the analytically determined and assigned concentration of Folate within each of the three CalCheck levels. This is established through the manufacturing process, spiking the analyte to "correct calcheck concentration levels," and subsequent quality control processes using "in-house standards."
8. The sample size for the training set
- Not applicable for this type of device. There is no machine learning "training set."
9. How the ground truth for the training set was established
- Not applicable for this type of device.
§ 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.