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The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating equivalent OEM Analyzers.

The Calibrators for the OEM Instruments are aqueous reagents with salts (chemical constituents) added to obtain desired analyte levels to provide the desired calibration.

The provided text describes performance characteristics for various calibrating materials. The acceptance criteria are implicitly defined by establishing "substantial equivalence" of the Mission Diagnostics calibrators to OEM calibrating materials. The studies aim to demonstrate that the Mission Diagnostics devices perform "equally" to the predicate OEM devices.

Here's an analysis of the provided information for the devices where detailed performance data is given:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for all studies is that the Mission Diagnostics calibrator performs "equally" to the OEM calibrator. This is demonstrated through comparative studies, where the performance of the Mission device, when used to calibrate an instrument, results in QC and sample recoveries that correlate strongly with, and are comparable to, the recoveries obtained when the OEM device is used for calibration. This "equally" is quantified by high correlation coefficients ($r^2$) and low standard errors of the estimate (S(y.x)) in linear regression analysis, alongside comparable %CV values for precision.

Let's focus on three specific devices for which detailed performance data is provided: CD-105670D (Hct Slope), CD-471818D (634 Ca/pH Slope Standard), and CD-473692D (pH Blood Gas Slope).

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

The studies are designed as comparative performance evaluations between the Mission Diagnostics calibrators and the OEM calibrators.

• CD-105670D (Hct Slope):

  • Test Set Sample Size: n=96 individual QC observations for regression analysis (derived from 7 days, 2 runs each for Mission and OEM, with 2 QC samples measured in duplicate for each run, so 7 days * 2 runs/day * 2 QC samples * 2 duplicates = 56 for Mission and same for OEM, which might imply n=112 total measurements, or 96 for the regression points between Mission and OEM).
  • Data Provenance: Not explicitly stated, but the context of an in vitro diagnostic device for clinical analyzers implies laboratory testing, likely prospective. Country of origin not specified.

• CD-471818D (634 Ca/pH Slope Standard):

  • Test Set Sample Size:
    • Serum samples: n=69 for regression analysis.
    • QC samples (Ca): n=33 for regression analysis.
    • QC samples (pH): n=33 for regression analysis.
    • QC precision studies: 12 replicates for each of 3 QC levels for both Mission and OEM for both Ca and pH (total 1232*2 = 144 measurements for QCs alone).
  • Data Provenance: Not explicitly stated, but implies laboratory testing using spiked/diluted serum samples and QC materials. Likely prospective. Country of origin not specified.

• CD-473606D (654 Lithium Slope Solution 2.50 mmol/L):

  • Test Set Sample Size:
    • Serum samples: n=28 for regression analysis.
    • QC precision studies: 20 replicates for each of 3 QC levels for both Mission and OEM for Na, K, and Li (total 2032*3 = 360 measurements for QCs alone).
  • Data Provenance: Not explicitly stated, but implies laboratory testing using spiked/diluted serum samples and QC materials. Likely prospective. Country of origin not specified.

• CD-473692D (pH Blood Gas Slope):

  • Test Set Sample Size:
    • QC samples: n=113 for pH regression analysis, n=113 for pO2 regression analysis.
    • Precision studies: N varies by analyte and level (e.g., pH Level 1 has 36 observations for Mission, 37 for OEM). Total observations for QC precision for pH, pCO2, pO2 across 3 levels over 5 days, 2 runs/day with 4 replicates per run (implied n=8 per QC sample per day for each calibrator) = (36+38+40) + (37+40+39) = 230 for pH. Similar counts for pCO2 and pO2.
  • Data Provenance: Not explicitly stated, but implies laboratory testing using QC materials. Likely prospective. Country of origin not specified.

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

Not applicable. These studies do not involve human expert interpretation of results to establish ground truth. The "ground truth" (or reference values) for quality control materials and serum samples in these types of in vitro diagnostic studies are typically established by certified reference methods, inter-laboratory comparisons, or assigned values by the manufacturer of the QC materials, under a strict quality management system in a laboratory setting. The predicate device (OEM calibrator) acts as the comparative standard.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication process described, as the evaluation is based on quantitative analytical results comparing the performance of two calibrators.

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. These are studies for in vitro diagnostic calibrators, not AI-assisted human reader studies.

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

Yes, these are standalone performance studies of the calibrator materials in conjunction with the specified automated analyzers. The calibrators themselves are not an "algorithm" in the typical sense, but rather a chemical reagent. The performance is determined by how well the analytical system (instrument + calibrator) performs compared to the system calibrated with the OEM device. The results (e.g., QC recoveries, analyte concentrations) are measured directly by the instrument.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth or reference standard is the performance achieved when the respective analyzer is calibrated using the OEM calibrator. The study's objective is to show that the Mission Diagnostics calibrator produces equivalent results to the OEM calibrator, implying that the OEM calibrator's performance represents the acceptable "truth" or standard. Additionally, the QC samples used have established target values (though not explicitly stated as "ground truth" in the text, it is implied as a reference for assessing accuracy and precision). For serum samples, the "ground truth" is typically the reference values established through the OEM calibration.

8. The Sample Size for the Training Set

Not applicable. These are not machine learning (AI) models that require a training set. The "training" in this context refers to the calibration of the analyzer, which uses the calibrator material itself, not a separate data set.

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

Not applicable, as there is no training set for an AI model. The calibrators "train" (calibrate) the instrument by providing known reference points for the instrument to adjust its measurement scale. The values of these calibrators are established by the manufacturer, Mission Diagnostics, and are designed to be equivalent to the OEM's calibrators.

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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. 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 Mission Fluid Packs (PN = ME-XXXXD or IL-XXXXD or MN-XXXXD) are equivalent to the Medica EasyLyte Solutions Packs or IL Test™ Solutions Packs or Menarinin Spotlyte™ Packs. They are a self-contained closed reagent package containing all the calibrating and wash reagents. The Solutions Packs slide into the front of the instrument for operation. The Calibrators for the OEM Instruments are aqueous reagents with salts (chemical constituents) added to obtain desired analyte levels to provide the desired calibration.

Here's an analysis of the provided text, outlining the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mission Diagnostic Fluid Packs are implicitly established by demonstrating "substantial equivalence" to the predicate devices (Medica Fluid Packs). This is shown through precision and correlation studies. While explicit numerical acceptance criteria for precision (e.g., maximum allowable %CV difference) or correlation (e.g., minimum R-squared, acceptable slope/intercept range) are not directly stated in the summaries, the data presented aims to show that the Mission reagents perform similarly to the predicate.

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

• Test Set Description:
  • Precision Data: Three levels of control materials were analyzed. Each level was tested a minimum of two runs per day, with each run being part of a dataset of N=12 measurements for each analyte at each level, for both Mission and Medica reagents. The provenance of the control materials is not specified (e.g., commercial control, in-house), nor is the country of origin of this data. It appears to be prospective testing conducted for the 510(k) submission.
  • Correlation Data: Samples consisted of human serum samples for Na, K, Cl, Ca, and Li. These were "spiked to yield varying concentrations" of each analyte.
    • N = 55 for Na, K, Cl.
    • N = 15 for Li.
    • The country of origin for these human serum samples is not specified. The study appears to be prospective, designed specifically for this submission.

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

This type of device (reagents for an electrolyte analyzer) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI would. The "ground truth" for the test set is derived from the measurements obtained by the predicate device (Medica Fluid Packs) itself. The predicate device's measurements are considered the reference against which the Mission Fluid Packs' measurements are compared. Therefore, no human experts as clinicians/radiologists were used to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a comparison study against a predicate device's measurements, not an expert-adjudicated clinical study involving interpretation of results.

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 a human-in-the-loop AI device; it is a laboratory reagent. No MRMC study was conducted.

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

Yes, in a way. The performance studies for the Mission Diagnostic Fluid Packs (precision and correlation) represent the standalone performance of the reagents on the Medica analyzers. The "algorithm" here would be the chemical reactions and physical detection performed by the analyzer when using these reagents. The studies compare this standalone performance against the standalone performance when using the predicate reagents.

7. The Type of Ground Truth Used

The ground truth for the correlation study was the measurements obtained from the predicate device (Medica Fluid Packs) when running the same human serum samples. For the precision study, there isn't a direct "ground truth" in the same sense; rather, the "truth" is the internal consistency and reproducibility of the measurements, which are then compared between the new and predicate reagents.

8. The Sample Size for the Training Set

Not applicable. These are diagnostic reagents, not a machine learning model that requires a training set. The "development" process for these reagents would involve chemical formulation and quality control, not data training.

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

Not applicable, as there is no training set for this type of device.

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