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Device intended as an aid in monitoring the performance of DPC's IMMULITE ACTH assay. DPC's IMMULITE ACTH Control Module is an assayed, bi-level control intended for use with DPC's IMMULITE ACTH assay. It is intended strictly for in vitro diagnostic use.

DPC's IMMULITE ACTH Control Module is an assayed, bi-level control intended for use with DPC's IMMULITE ACTH assay. It is intended strictly for in vitro diagnostic use.

The provided document is a 510(k) summary for a medical device called "IMMULITE ACTH Control Module." This device is described as a Quality Control Material intended to aid in monitoring the performance of DPC's IMMULITE ACTH assay.

Based on the nature of this device (a quality control material) and the content of the summary, the request for acceptance criteria, study details, and related performance metrics is largely not applicable in the way it would be for a diagnostic algorithm or an AI-powered device.

Here's a breakdown based on the provided information and the typical understanding of a quality control material:

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

   • Acceptance Criteria: For a quality control material, acceptance criteria would typically relate to its stability, homogeneity, and its ability to produce expected results (e.g., falling within a specified range) when run with the intended assay. These are not defined in this summary.
   • Reported Device Performance: The document explicitly states "Clinical Studies: Not applicable" and "The conclusions drawn from the nonclinical tests demonstrate that the device is safe and effective." This indicates that a performance study of the control module itself by running it against clinical samples or a ground truth from patients was not performed or deemed necessary for this type of device. Its "performance" is tied to its intended use as a monitor of an assay, not as a diagnostic tool in and of itself.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable. No "test set" in the context of diagnostic performance was used for this quality control 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. No ground truth for a diagnostic test was established for this device.

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

   • Not applicable.

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-powered device or a diagnostic reader-dependent device.

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

   • Not applicable. This is a physical control material, not an algorithm.

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

   • Not applicable. No ground truth in the diagnostic sense was used for this device. Its "ground truth" would be the expected range of the analyte it controls, which is established by the manufacturer of the assay it monitors, not by itself.

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable.

In summary, the provided document describes a quality control material, not a diagnostic or AI-powered device that would typically undergo the types of studies and evaluations outlined in your request. The "Clinical Studies: Not Applicable" statement is crucial here, indicating that the device's safety and effectiveness for its intended purpose were established through non-clinical means (likely manufacturing quality, stability testing, and consistency checks) rather than clinical performance trials against a diagnostic ground truth.

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