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Thermo Scientific MAS® Omni•CARDIO™ is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.

Each MAS® Omni•CARDIO control kit is packaged in a plastic clamshell container with a product insert and value sheet. Each vial contains 3 mL of the control level in an amber glass bottle with black sterile caps. Kits are stored frozen at -20°C. MAS® Omni CARDIO control levels are provided in liquid form and are to be stored at -20°C until the expiration date on the label. The control levels are prepared from human serum and contain the following constituents: Beta-Human Chorionic Gonadotropin (ß-HCG), B-Type Natriuretic Peptide (BNP), Creatine Kinase-MB (CK-MB), D-Dimer, Digitoxin, Homocysteine, High Sensitivity C-Reactive Protein (hsCRP), Human Chorionic Gonadotropin (HCG), Myeloperoxidase (MPO), Myoglobin, N-Terminal Prohormone of Brain Natriuretic Peptide (NTproBNP), Procalcitonin (PCT), Total Creatine Kinase (CK), Troponin I, Troponin T.

Here's the analysis of the acceptance criteria and study information for the MAS® Omni•CARDIO device, based on the provided 510(k) summary:

Device: Thermo Scientific MAS® Omni•CARDIO

Intended Use: Intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly define distinct "test sets" in the way a clinical study would for a diagnostic device. Instead, the testing described relates to the manufacturing and characterization of the control material itself.

• Stability Studies (Accelerated & Real-time): "evaluation lots" were used. The specific number of vials/samples tested per lot, per analyte, per temperature/timepoint is not provided.
• Open and Closed Vial Testing: "evaluation lots" were used. Vials were opened/unopened daily (work days) and assayed at "multiple timepoints." Specific numbers are not provided.
• Value Assignment Testing: "Evaluation lots were sent to multiple sites, typically 2 or 3 lots per instrument platform, and assayed over 5 days in duplicate."
  • Data Provenance: The document does not specify the country of origin of the data. It mentions "multiple sites" for value assignment, suggesting it could be multi-site data. The studies are prospective in nature, as they involve testing newly manufactured lots of the control material under defined conditions.

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

• This device is an assayed control serum, not a diagnostic device that interprets patient data. Therefore, the concept of "ground truth" established by experts in the context of diagnostic device validation (e.g., radiologist consensus on images) does not directly apply here.
• The "ground truth" for this control material is its assigned values and stability properties. These are established through rigorous laboratory testing using various analytical instruments and methods, following established protocols (e.g., averaging data from multiple sites, determining failure points via linear regression).
• The "experts" involved would be clinical laboratory professionals, assay developers, and quality control specialists, responsible for designing and executing these validation studies and analyzing the results according to scientific and regulatory standards. Specific numbers or qualifications of these individuals are not provided in this summary.

4. Adjudication Method for the Test Set

• Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for diagnostic devices where human readers interpret patient data and discrepancies need to be resolved.
• For this control material, adjudication, if it occurred, would likely be in the form of discrepancy resolution during the laboratory testing, where any unexpected results or outliers would be investigated, re-tested, and potentially discussed among the testing team or quality control personnel to ensure data integrity and accuracy of the assigned values and stability claims. This process is implicit in good laboratory practice but not explicitly detailed as a formal adjudication method in this summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done.
• This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) use the device to interpret cases, and the study compares human performance with and without AI assistance.
• The MAS® Omni•CARDIO is a quality control material, not a diagnostic device, and therefore does not involve human readers interpreting cases for diagnosis. Its purpose is to monitor the performance of analytical instruments.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, in essence, standalone performance was assessed.
• The stability and value assignment studies for MAS® Omni•CARDIO are conducted in a "standalone" manner in the sense that they evaluate the inherent properties of the control material (its value, stability over time) independent of a "human-in-the-loop" interpretation process. The control material serves as a fixed, known standard against which analytical instruments are measured. The evaluation of its performance criteria (stability, assigned value accuracy) is a direct measurement of the product itself.

7. Type of Ground Truth Used

• The "ground truth" for the MAS® Omni•CARDIO control material is established through analytical testing and consensus of assay results across multiple instruments and sites.
• For Value Assignment: The ground truth for the assigned values (e.g., BNP 32 at 56 pg/mL for Level UL) is the grand mean derived from assaying the evaluation lots over 5 days in duplicate on "multiple sites, typically 2 or 3 lots per instrument platform."
• For Stability: The ground truth for stability claims (e.g., 36 months frozen) is derived from analytical measurements at various timepoints and conditions (accelerated and real-time testing), with "point of failure determined by linear regression analysis of the data."

8. Sample Size for the Training Set

• This device is a quality control material, not an AI or machine learning algorithm that requires a "training set" in the conventional sense.
• Therefore, the concept of a "training set" as described for AI devices (e.g., for model development) does not apply to the MAS® Omni•CARDIO. The data described in the summary is for product characterization and validation.

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

• As stated in point 8, the concept of a "training set" does not apply to this device.
• The ground truth for the characterization and validation data (which some might loosely compare to a "training" or "development" phase for product features) was established as described in point 7: through analytical measurements, grand mean calculations across multiple instrument platforms and sites, and linear regression analysis for stability.

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