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Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
There are 4 levels of QC encompassed in this request. Levels 1,2,3 cover the Low Mid High of the clinical range for the analytes included in the QC. Level 4 is to check at High O2 level.
Mission Controls are intended for six systems: AVL Scientific, Ciba-Coming/Bayer, IL, NOVA, Radiometer, Medica, Shapparelli, Medarini.
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for pH/Blood Gas = (pr). pCO2, pO2), and Licolorito - (No, N, Ol, St, L. ( St, S.) = S. ( = ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.

Mission Controls are used for pH/Blood Gas and Electrolyte Analyzers to estimate test . imprecision and to detect systematic deviations that may occur because of instrument or reagent variation.
Mission Controls are aqueous based tonometered controls .
Mission uses a similar composition, description and packaging as that used by the predicate Mission uses a similar oompoomon, assistion of this submission.

The provided text describes a 510(k) submission for "Mission Diagnostic Reagents on pH/Blood Gas &/or Electrolyte Analyzers" (Mission Controls™). Here's an analysis of the acceptance criteria and study information contained within the submission:

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

The submission mentions "Stability studies were done per SOP23-01-03" and "Stabilities studies support a 3 year shelf life." However, specific quantitative acceptance criteria for performance parameters (e.g., accuracy, precision, bias, stability limits) and the reported numerical device performance results are not provided in the excerpt. The submission focuses on substantial equivalence to a predicate device.

The intended use of the Mission Controls is to "estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation" on pH/Blood Gas and Electrolyte Analyzers. The acceptance criteria would likely be related to the ability of the controls to maintain their specified values within certain limits over their shelf-life and under various storage/use conditions, and to perform comparably to the predicate device.

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

This information is not explicitly provided in the excerpt. The statement "Stability studies were done per SOP23-01-03" indicates that a study was conducted, but details about the sample size (e.g., number of control lots tested, number of replicates, duration of testing points), data provenance (e.g., where the study was performed), or whether it was retrospective or prospective are absent.

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)

This is not applicable as the device is a quality control material for analytical instruments, not a diagnostic device requiring expert interpretation of results to establish "ground truth" in the clinical sense. The "ground truth" for a quality control material is its assigned value, which is determined through a rigorous analytical process, typically by the manufacturer, rather than by human experts in the context of interpretation.

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

This is not applicable for a quality control material for analytical instruments. Adjudication methods are typically used in clinical studies where human interpretation of medical images or data is involved and discrepancies need to be resolved.

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 is not applicable as the device is a quality control material, not an AI-powered diagnostic tool requiring human-in-the-loop assessment or human reader improvement studies.

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

This is not applicable as the device is a quality control material, not an algorithm.

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

For quality control materials, the "ground truth" is typically established through:

• Assigned Values: These are the expected values of the analytes within the control materials. These values are determined by the manufacturer using highly accurate and precise reference methods, often traceable to international standards, and verified through multiple measurements on various accredited instruments.
• Statistical Analysis: A comprehensive statistical analysis of multiple measurements across different instruments and laboratories is used to establish the mean and range for each analyte within the control. This forms the basis for the control's expected performance and the limits for acceptable variation.

The document implicitly refers to this type of ground truth by stating the controls are used to "estimate test imprecision and to detect systematic deviations." The controls themselves have pre-defined "true" values that analytical instruments are expected to measure within a certain range.

8. The sample size for the training set

This is not applicable. Quality control materials like Mission Controls™ do not involve training sets in the machine learning sense. Their performance is established through analytical validation and stability studies.

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

This is not applicable for the reasons stated above.

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