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The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent OEM Analyzers.

The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes and rinse the sample path. Mission uses a similar composition, description and packaging as that used by the OEM in its products.

This document pertains to the 510(k) submission for Mission Diagnostic Reagents. It's important to note that this submission is for calibrating reagents used with pH/Blood Gas and Electrolyte Analyzers, not for a medical device that diagnoses or treats patients. Therefore, the typical acceptance criteria and study designs for diagnostic AI/ML models (e.g., sensitivity, specificity, reader studies, ground truth involving expert consensus or pathology) are not directly applicable here.

Instead, the "acceptance criteria" for these calibrating reagents largely revolve around demonstrating substantial equivalence to existing predicate devices (the OEM calibrators) in terms of composition and performance when used with the specified instruments. The "study" mentioned is a performance study to show this equivalence.

Here's an attempt to answer the questions based on the provided text, adapting for the nature of the device:

Acceptance Criteria and Device Performance Study for Mission Diagnostic Calibrating Reagents

The "acceptance criteria" for these calibrating reagents are implicitly tied to demonstrating substantial equivalence to the predicate OEM calibrators, specifically in terms of their ability to correctly calibrate the target instruments. The primary performance characteristic assessed is correlation and precision compared to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the device performance is evaluated through "Precision and correlation data collected per SOP23-01-02 Performance Study Protocol for 510(k) Submission 0". The reported performance is implicitly that the Mission Diagnostics reagents are substantially equivalent to the OEM equivalents, indicating that the precision and correlation achieved are acceptable for their intended use as direct replacements.

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

• Sample Size: The document does not specify a numerical sample size for the test set. It states that "Data for each instrument and each run are recorded on SOP23-03F Performance Study O Record Sheet." This suggests that multiple runs were performed on each instrument with the Mission Diagnostic calibrators.
• Data Provenance: The data appears to be prospective as it was collected specifically for this 510(k) submission as part of a "Performance Study Protocol." The country of origin of the data is not explicitly stated, but given the submitter's address is in Holliston, MA, USA, and the FDA is the reviewing body, it is highly probable the testing was conducted in the USA.

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

This section does not apply in the traditional sense of diagnostic AI/ML devices. For calibrating reagents, the "ground truth" is typically established by the known stable values of the calibrators themselves, which are manufactured to highly precise specifications. The accuracy would be assessed against these known values and the performance of the predicate calibrators. There are no "experts" establishing a ground truth in the context of clinical interpretation, but rather skilled laboratory personnel following a quality-controlled protocol.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessments that would require adjudication. The performance is objectively measured by the instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not a diagnostic device that involves human readers or interpretation of clinical cases. Therefore, an MRMC study and measures like "human readers improve with AI vs without AI assistance" are not relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

While the device itself (calibrating reagent) is "standalone" in that it performs its function without human interpretation, the concept of "standalone performance" in the context of AI/ML algorithms is not applicable here. The calibrator's performance is intrinsically linked to its interaction with the analyzer instrument. The performance study measures the calibrator's output on the instrument.

7. The Type of Ground Truth Used

The ground truth for calibrating reagents is the known, manufactured analyte concentrations/pH values of the calibrating solutions themselves. These values are established through rigorous manufacturing processes and quality control, traceable to reference standards. The performance study evaluates if the instrument, when calibrated with the Mission Diagnostics reagents, accurately measures these known values and performs comparably to when calibrated with the OEM predicate.

8. The Sample Size for the Training Set

Not applicable. These are chemical reagents, not an AI/ML algorithm that requires a "training set."

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

Not applicable as there is no training set.

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The products encompassed by this request are intended for in-vitro diagnostics use and are intended for r ne products chooling and flushing the sample flow path of the equivalent OEM Analyzers. Mission reagents are intended to serve as direct replacements to like named products manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.

The Calibrators for the OEM Instruments are aqueous reagents with salts added to obtain desired analyte levels to provide calibration of the electrodes and rinse the sample path. The reagents are intended for use on equivalent OEM Instruments. The original equipment manufacturer (OEM) of the instruments and the predicate reagents which are necessary for the continued operation and use of the instruments. Mission uses a similar composition, description and packaging as that used by the OEM in its products, as shown in the packaging section of this submission.

Here's a breakdown of the acceptance criteria and the study details for the Mission Diagnostic Reagents, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format. However, the performance is demonstrated through precision coefficent of variation (%CV) and correlation (slope and R^2) against OEM reagents. The implicit acceptance criterion for this type of device (calibrators/reagents intended as direct replacements) would be that the Mission reagents perform comparably to the OEM reagents, demonstrating "substantial equivalence."

A reasonable interpretation of the acceptance criteria, based on the presented data, would be:

• Precision (%CV): Low %CV values, indicating good repeatability. While no specific threshold is given, the reported values are generally very low (often < 1%, with a few instances up to ~10%) which are typical for clinical chemistry assays.
• Correlation (Slope and R^2): Slope near 1 and R^2 near 1, indicating a strong linear relationship and good agreement between Mission and OEM reagents. This is explicitly stated in the document: "Correlations demonstrated slopes of 1 and R^2's of 0.99, which support a claim of substantial equivalence."

Table: Acceptance Criteria (Implicit) and Reported Device Performance

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

• Sample Sizes (Test Set):

  • Precision Studies:
    • Ciba-Corning 238: N=9 per QC level for pH, pO2, pCO2.
    • Ciba-Corning 248: N=10 per QC level for pH, pO2, pCO2.
    • Ciba-Corning 348: N=20-21 per QC level for Na, K, Ca, pH.
    • Ciba-Corning 664: N=16 per QC level for Na, K, Cl, tCO2.
    • Ciba-Corning 288: N=18-25 per QC level for Na, K, Ca, pH.
  • Correlation Studies (Regression Analysis):
    • Human Serum:
      • Na (348, 288, 664): N=19-44.
      • K (348, 288, 664): N=44-49.
      • Ca (348, 288): N=35-44.
    • QC Results:
      • pH (238, 248, 348, 288): N=21-30.

• Data Provenance: The document does not explicitly state the country of origin. The studies appear to be retrospective in the sense that they are conducted on existing instruments and control/serum samples. However, the data collection, where Mission reagents are compared against OEM reagents on the same analyzer and same test days, indicates a controlled study design. The human serum samples are implicitly "prospective" for the correlation study, as they were "spiked with Human Serum Albumin to yield varying concentrations."

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

This information is not applicable as the ground truth for these medical device assays (calibrators) is established by the reference values of certified control materials or reference methods, not by expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication typically refers to expert review processes for subjective assessments (e.g., image interpretation). For analytical performance studies of calibrators, the "ground truth" or reference values are derived from quantitative chemical analysis or certified reference materials, not expert 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

This information is not applicable. This document describes an in-vitro diagnostic (IVD) calibrator, not an AI-assisted diagnostic device or a system involving human readers.

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

This information is not applicable. This document describes an in-vitro diagnostic (IVD) calibrator, not an algorithm or AI system. The "performance" refers to the analytical performance of the chemical reagents.

7. The Type of Ground Truth Used

• Precision Data: The ground truth for precision is the consistency of results obtained from the Mission reagents themselves when repeatedly measured against known control material levels. The "ground truth" or target values for the control materials (QC1, QC2, QC3) would have been established by their manufacturer.
• Correlation Data:
  • Human Serum Samples for Na, K, Cl, Ca: The ground truth for the comparison is the results obtained using the OEM reagents on the same analyzer. The values obtained with the OEM reagents serve as the reference for determining the equivalence of the Mission reagents. These samples were also "spiked with Human Serum Albumin to yield varying concentrations," indicating prepared samples with expected values.
  • QC Samples for pH: Similar to human serum, the ground truth for comparison is the results obtained using the OEM reagents on the same analyzer for the three levels of QC.

8. The Sample Size for the Training Set

This information is not applicable. This device is a chemical reagent, not an AI model that requires a training set.

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

This information is not applicable for the same reason as above.

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