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AVL OPTI-check assayed control is intended to be used to monitor the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in the AVL OPTI Critical Care Analyzer, as well as other devices measuring the same parameters and ionized calcium and chloride.

For In Vitro Diagnostic Use

The determination of acid-base status, and concentration of carbon dioxide, oxygen, electrolytes, total hemoglobin and oxygen saturation is an important adjunct to patient monitoring for a variety of clinical conditions described in the labeling for those devices used for these purposes. Since therapeutic regimes are often determined by the results obtained in patient samples, the instruments used for these analyses must meet stringent requirements for accuracy and precision of measurement. It should be the goal of the quality control program in institutions performing these analyses to determine the instrumentation is working properly before the analysis and report of patient specimens, or after any suspicious results have been obtained.

OPTI-check is a specially formulated aqueous liquid material intended to for use to monitor all analytes measured by the OPTI. It contains a stable suspension of polystyrene microbeads which reflect and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb and SO2 in exactly the same manner as these analytes are determined in whole blood by the AVL OPTI Critical Care Analyzer. The three control levels contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples. OPT-check provides a convenient method of performing daily QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.

While the product is optimized for performance on the AVL OPTI Critical Care Analyzer, it may be used to monitor the measurement of blood gas and electrolyte values in conventional instrumentation. OPTI-check contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, and suitable concentrations of microbeads to simulate clinically relevant values of tHb and oxygen saturation.

The provided document describes the AVL OPTI-check Control, a multi-analyte control solution. The acceptance criteria and the study proving the device meets these criteria are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of the "Implied" nature: The document does not explicitly state numerical acceptance criteria. Instead, it concludes that the device's performance "was within manufacturer's stated claims" for precision and showed "no significant difference (P < 0.05)" in correlation studies with predicate devices. This implies that the manufacturer's stated claims and the statistical significance threshold of P < 0.05 were the acceptance criteria for these aspects.

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

• Sample Size: The document mentions that for precision studies, two runs per day with 2 replicates per run were conducted for 20 days. This translates to a total of 80 measurements per analyte for each AVL OPTI Critical Care Analyzer used in the precision study (2 runs/day * 2 replicates/run * 20 days). For correlation studies, the number of patient specimens collected is not explicitly stated, but they were "remnant from patient specimens of both whole blood and serum collected for routing analysis."
• Data Provenance: The document does not specify the country of origin. The test data for correlation studies came from "remnant from patient specimens... collected for routing analysis on existing instrumentation," indicating a retrospective or opportunistic use of clinical samples. The precision studies were conducted internally on AVL OPTI Critical Care Analyzers.

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

• The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the device's performance. The "ground truth" for the correlation studies would be the results obtained from the "predicate devices" or "existing instrumentation" in a clinical setting.
• The personnel operating the instrumentation for the clinical correlation studies were "trained to perform and report these analyses." Their specific qualifications (e.g., radiologist, lab technician with X years of experience) are not detailed.

4. Adjudication Method for the Test Set:

• No adjudication method is described. The comparison was made against results from existing instrumentation (predicate devices).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No MRMC comparative effectiveness study was done as this device is a control solution, not an interpretive diagnostic tool that involves human readers.

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

• This device is a control solution for analyzers, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm does not apply in this context. The described studies evaluate the control solution's performance in ensuring the accuracy and precision of the analytical instruments.

7. The Type of Ground Truth Used:

• For precision studies, the "ground truth" is typically the expected value of the control solution itself, as established by the manufacturer, against which the measured variance is compared.
• For correlation studies, the "ground truth" was the measurements obtained from "predicate devices" or "existing instrumentation" using patient specimens. This could be considered a form of "reference method" comparison, which is close to "outcomes data" in the sense that it reflects real-world clinical measurements. However, it's more specifically a comparison to established, legally marketed devices.

8. The Sample Size for the Training Set:

• The document does not explicitly describe a "training set" in the context of machine learning or AI. This product is a control solution, and its development would likely involve formulation and stability studies, rather than a data training pipeline.

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

• As there's no mention of a "training set" in an AI/machine learning context, this question is not applicable. The control levels in the solution "contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples" and "clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride." These concentrations would be established during the product's development and manufacturing process based on clinical relevance and analytical needs.

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