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The Boehringer Mannheim Elecsys CalCheck LH is used to verify the calibration assignment for the Boehringer Mannheim Elecsys LH assay.

The Boehringer Mannheim Elecsys CalCheck LH are manufactured using human serum albumin, luteinizing hormone, 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 the Enzymun® LH assay kit calibrators (prepared using a similar procedure), which have been value assigned by comparison to a 2nd International Standard (NIBSC) 80/552.

The provided 510(k) summary for K964830, "Elecsys CalCheck LH," does not contain the detailed study information typically requested for acceptance criteria and device performance. The information is very limited and primarily focuses on the device description, intended use, and its comparison to a predicate device in a general sense.

Here's an attempt to answer your questions based only on the provided text, highlighting where information is missing:

1. A table of acceptance criteria and the reported device performance

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 for test set: Not mentioned.
• Data provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

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)

• Number of experts: Not mentioned.
• Qualifications of experts: Not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication method: Not mentioned.

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

• This device is a calibration verification material, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This device is a calibration verification material for an assay, not a standalone algorithm. Performance evaluation for such a device would typically involve analytical performance, e.g., accuracy of assigned values, stability over time, and consistency with reference methods. The summary states, "The Elecsys® CalCheck™ LH were evaluated for value assignment and stability," which implies some form of standalone evaluation of these characteristics, but no specific methodology or results are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the CalCheck LH calibrator (which the CalCheck LH is quality-controlled against) is established by comparison to a 2nd International Standard (NIBSC) 80/552. This implies that the ground truth for the value assignment of the CalCheck material itself relies on traceability to an international reference standard for Luteinizing Hormone (LH).

8. The sample size for the training set

• Sample size for training set: Not mentioned. (Note: For a calibration verification material, "training set" is not a standard concept as it would be for an AI algorithm. The relevant concept is typically manufacturing batches and quality control samples.)

9. How the ground truth for the training set was established

• As a calibration verification material, the "ground truth" for the material's concentration levels is established during its manufacturing process. The document states: "The calcheck are in process checked and quality controlled against the Enzymun® LH assay kit calibrators (prepared using a similar procedure), which have been value assigned by comparison to a 2nd International Standard (NIBSC) 80/552." This indicates that the ground truth for the CalCheck's target values is derived from, and traceable to, an international standard.

In summary, the provided 510(k) summary is very high-level and lacks the specific details on acceptance criteria, study design, sample sizes, and expert involvement that would typically be found in a more comprehensive clinical or performance study report. This is common for devices like calibration materials, where the focus in the 510(k) summary is often on analytical performance and equivalence to a predicate device rather than complex clinical outcomes or reader studies.

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