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The ABL 80 FLEX is a portable, automated system that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of- care setting.

These tests are only performed under a physicians order:

pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/Blood gas measurement.

pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.

pCO2: pCO2is a direct reflection of the adequacy of alveclar ventilation in relation to the metabolic rate.

Potassium (cK*): The potassium level is the predominant intracellular cation. It is fundamental for correct neuromuscular activity

Sodium (cNa"): The sodium ion is the most abundant cation in plasma. It is the foremost agent involved in maintenance of osmolality and body fluid volumes.

Calcium (cCa2): The calcium ion is the most abundant mineral element in the human body and is involved in numerous enzymatic processes, blood coagulation, cell growth, and membrane transport mechanisms as well as plays an important role in nervous impulse conduction, neuromuscular transmission, and muscular contraction and relaxation.

Chloride (cCl): The chloride ion is the main extracellular anion and plays an important role in maintaining electrical neutrality.

Hematocrit (Hct): The hematocrit measurement is the ratio of the volume of red blood cells in whole blood in comparison to the total volume.

Glucose (cGlu): The glucose measurements are used to screen for, diagnose and monitor glycemic levels in potential pre-diabetic, diabetic, hypoglycemic patients.

The ABL80 FLEX System consists of a modular analyzer incorporating a user interface module with a large color touch screen interfacing to analyzer electronic and fluidic modules. The user interface module contains the analyzer CPU and all of the required electronic interfaces for external communication and data storage. The system also includes a reagent cartridge for the calibration and automatic quality control of the analyzer and sensor system. The calibration and quality control reagents are packaged in sealed foil pouches, similar to the existing ABL 77 cal pack. The analyzer and consumables incorporate "smart chip" technology for unique identification and lot specific calibration data.

The ABL80 FLEX System is a portable, automated system that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood.

The following information describes the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and data provenance:
   The document does not specify the exact sample size for the test set. The provenance of the data (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
   This information is not provided in the document. The ground truth was established by comparison to other analytical methods/devices rather than expert consensus.

4. Adjudication method for the test set:
   Not applicable, as the performance testing involved method comparisons against established standards or predicate devices, rather than expert adjudication of results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
   No, an MRMC comparative effectiveness study was not done. The device is an automated system for measuring analytes, not an imaging or diagnostic AI system requiring human reader performance studies.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:
   Yes, the performance data described is a standalone evaluation of the ABL80 FLEX System's analytical performance (algorithm only) compared to reference methods and predicate devices. There is no mention of human-in-the-loop performance in the context of this device's validation.

7. The type of ground truth used:
   The ground truth used was based on established analytical methods and reference devices:

   • For pH, sodium, potassium, calcium, and chloride: The measurement standard was the ABL™700, and method comparison was conducted against 2 ABL725 analyzers.
   • For blood gases (pCO2 and pO2): Target tonometry levels, with values calculated from certified tonometry gas mixtures traceable to NIST.
   • For glucose: Serum standard per NCCLS Publication RS1-A.
   • For hematocrit: Micro-hematocrit method using centrifugation per CLSI standard H7-A3.

8. The sample size for the training set:
   This information is not specified in the document. The ABL80 FLEX System is a medical device for analyte measurement, and the concept of a "training set" in the context of machine learning is not directly applicable to its analytical validation as described. The system's design and performance are based on established electrochemical and spectrophotometric principles, likely calibrated during manufacturing.

9. How the ground truth for the training set was established:
   Not applicable, as the document does not describe a training set in the context of machine learning. The ground truth for the performance evaluation was established through comparison with established analytical methods and reference devices, as detailed in point 7.

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