(28 days)
The Boehringer Mannheim Myoglobin Controls are used for the quality control of the Boehringer Mannheim Tinaquant Myoglobin assay.
The Myoglobin Control Set are used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant Myoglobin assay.
The Boehringer Mannheim Myoglobin Controls are manufactured using human serum albumin. Myoglobin, and stabilizers. The analyte is appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator.
The provided text describes the 510(k) summary for the Boehringer Mannheim Myoglobin Control Set, which is a control product for laboratory assays, not a diagnostic device with performance metrics like sensitivity or specificity against a disease state.
Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, and expert ground truth is not applicable in the way it would be for a diagnostic or screening device.
However, I can extract the relevant information from the provided text in the context of a control device:
1. A table of acceptance criteria and the reported device performance:
For a control device, "acceptance criteria" and "device performance" are typically related to its ability to perform its intended function of monitoring the accuracy and precision of an assay. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device for intended use and matrix. | "The Boehringer Mannheim Myoglobin Control Set is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the myoglobin controls contained in the Behring N Latex Myoglobin assay (K902154)." |
| Ability to monitor accuracy and precision of the Boehringer Mannheim Tinaquant Myoglobin assay. | "Specific data on the performance of the controls have been incorporated into the draft labeling in attachment 5." (Specific values are not provided in the excerpt, but the claim is made that it meets this.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of clinical samples or a study designed to evaluate performance against a disease state. For a control device, the "testing" would involve demonstrating its stability, value assignment, and consistent performance within the target assay. The document states:
- "Myoglobin, and stabilizers. The analyte is appropriately spiked into the control matrix to the correct control concentration levels."
- "The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator."
- "Specific data on the performance of the controls have been incorporated into the draft labeling in attachment 5."
No specific sample sizes, data provenance (country of origin), or retrospective/prospective nature of data are mentioned as these concepts are not directly applicable to the regulatory approval of a quality control product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. For a control product, the "ground truth" relates to the assigned values of the control and its stability, not a diagnosis or clinical condition evaluated by experts. The values are established through comparison to a calibrator.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as there is no "test set" needing adjudication in the clinical sense.
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 control product, not an AI or diagnostic device designed for human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a quality control product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this control device, the "ground truth" (or reference standard for value assignment) is established through a comparison to an analyte-specific (and chemistry-specific) calibrator. This is a quantitative measurement, not a qualitative assessment like expert consensus or pathology.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI 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.