(14 days)
The Boehringer Mannheim Elecsys CalCheck FSH is used to verify the calibration assignment for the Boehringer Mannheim Elecsys FSH assay.
The Boehringer Mannheim Elecsys CalCheck FSH are manufactured using human serum albumin, follicle stimulating hormone, and stabilizers. 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 the Enzymun® FSH assay kit calibrators (prepared using a similar procedure).
The provided 510(k) summary for the Boehringer Mannheim Elecsys CalCheck FSH is a premarket notification for a calibration verification material, not a diagnostic device with an AI algorithm. Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance in the context of AI (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth types like pathology or outcomes data) are not applicable to this type of submission.
The summary focuses on verifying the calibration assignment for an FSH assay. The "performance characteristics" section describes evaluation for "value assignment and stability" of the calibration material itself.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
Based on the provided text, the device is a calibration verification material, not a diagnostic device. The "performance characteristics" describe the evaluation of the calibration material itself, not the performance of an AI algorithm against a diagnostic outcome. Therefore, a table in the requested format for acceptance criteria related to AI performance cannot be generated.
| Acceptance Criteria (Inferred for a calibration material) | Reported Device Performance |
|---|---|
| Value assignment accuracy for FSH levels | Evaluated |
| Stability of CalCheck FSH over time | Evaluated |
(Note: The specific quantitative acceptance criteria or detailed results for "value assignment" and "stability" are not provided in this summary.)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is not a study of a diagnostic device or AI algorithm on patient data. It's about a calibration material.
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):
Not applicable. Ground truth as typically defined for diagnostic or AI studies (e.g., expert consensus on medical images or pathology) is not relevant for a calibration material. The "ground truth" for a calibration material would be its manufacturing specifications and analytical verification against reference methods/calibrators.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a calibration material.
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 not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a calibration material, the "ground truth" for the declared analyte levels or characteristics would be established through:
- Manufacturing specifications: Carefully prepared solutions with known concentrations.
- Analytical verification: Comparison against a reference method or highly characterized calibrators (as suggested by "quality controlled against the Enzymun® FSH assay kit calibrators").
8. The sample size for the training set:
Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI algorithm.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.