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Thermo Scientific MAS® Omni•CORE™ is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include MAS® Omni•CORE with patient serum specimens when assaying for any of the constituents. Assay values are provided for the specific systems listed. The user can compare observations with their expected ranges as a means of assuring consistent performance of reagent and instrument.

Omni•CORE is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various animal extracts and non-protein materials including drugs, drug metabolites and purified chemicals. Amylase, ALT/GPT, CK and Lipase are obtained from porcine tissue; alkaline phosphatase and GGT are from bovine tissue; LDH is from avian tissue. Preservatives and stabilizers are added to maintain product integrity.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MAS® Omni•CORE device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K110738) is a 510(k) summary for a Quality Control Material (QCM), not a diagnostic device or an AI-powered system that would typically have performance metrics like sensitivity, specificity, or accuracy. Therefore, the concept of "acceptance criteria" and "reported device performance" as applied to accuracy/effectiveness for an AI or diagnostic device does not directly apply here in the traditional sense.

Instead, the "acceptance criteria" for a QCM generally revolve around its intended use, matrix, form, control levels, storage, shelf life, and the analytes it covers, ensuring it is substantially equivalent to existing QCMs. The "reported device performance" is essentially the description of MAS® Omni•CORE's characteristics that demonstrate this equivalence.

Here's how we can frame it based on the available information:

Study Proving Device Meets Acceptance Criteria:

The "study" presented here is a substantial equivalence comparison to legally marketed predicate devices. The document explicitly states: "As summarized, Omni-CORE is substantially equivalent to the previously [cleared] chem-TRAK H (K09205) and MAS Immunology (K960824) Controls."

This type of submission primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics as the predicates, and that any differences do not raise new questions of safety or effectiveness. For a quality control material, this typically involves:

• Analytical Performance Studies: While not detailed in this summary, a QCM would undergo internal testing to establish the target values and acceptable ranges for each analyte across various common laboratory instruments and methods. These studies demonstrate that the control material performs as expected for its intended use (i.e., that it provides stable, known-concentration samples for monitoring assay conditions).
• Stability Studies: To support the claimed shelf life and open-vial stability.
• Homogeneity Studies: To ensure uniform concentration throughout the batch.
• Value Assignment Studies: To determine the assayed values for various instruments and methods.

The summary provided does not contain the detailed data from these studies. Instead, it presents the conclusion drawn from such studies, which is the affirmation of substantial equivalence based on matching or similar characteristics.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not explicitly stated in the 510(k) summary. For a quality control material, the "test set" would refer to the number of individual control vials or batches tested during value assignment, stability, and homogeneity studies. This information is typically found in the full submission, not the summary.
• Data Provenance: Not explicitly stated. For internal validation studies of a quality control material, the data would typically be generated in-house by the manufacturer (Thermo Fisher Scientific / Microgenics Corporation) in their own laboratories. It is not patient data, but rather data generated from testing the control material itself. Therefore, concepts like "country of origin of the data" (in terms of patient demographics) or "retrospective/prospective" (in relation to patient enrollment) are not directly applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to a Quality Control Material like MAS® Omni•CORE.

• "Ground truth" for a QCM is established through rigorous analytical chemistry and metrology. The "true" concentration of an analyte in the control material is determined through highly accurate reference methods, often by multiple independent analyses or by comparison to certified reference materials. It does not involve human expert interpretation of images or clinical data.
• Therefore, there were no "experts" in the sense of clinicians or radiologists establishing a subjective "ground truth." The ground truth for analyte concentrations is objectively determined experimentally.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for analyte concentrations in a QCM is determined objectively through analytical methods, not subjective interpretation requiring adjudication.

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 device is a quality control material for laboratory assays, not an AI-powered diagnostic device that assists human readers. No MRMC study was performed.

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

Not applicable. This device is a laboratory reagent, not an algorithm or software device.

7. The Type of Ground Truth Used

The ground truth for the MAS® Omni•CORE (target values for each analyte) would be established through a combination of:

• Reference Methods: Using highly accurate and precise analytical methods (often recognized reference methods) to determine the concentration of each analyte in the control material.
• Comparison to Certified Reference Materials: Where available, direct comparison or traceability to certified reference materials.
• Consensus from Multiple Assays/Instruments: For assayed controls, values are often assigned based on analysis across multiple common laboratory instruments and reagent systems, generating a consensus or assigned range.

It is not based on expert consensus (clinical opinion), pathology (histology), or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The materials used to produce the control (human serum base, animal extracts, purified chemicals, etc.) are raw materials, not a training set in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no "training set" for an AI algorithm, there is no ground truth established for it in this context. The "ground truth" for the actual control material, as described in point 7, is established through analytical testing.

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