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The i15 Blood Gas and Chemistry Analysis System (including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge) is a portable, automated system that measures pH and blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl-) and hematocrit in arterial and venous whole blood samples with lithium heparin or calcium balanced heparin. The system is intended for in-vitro diagnostic use only by trained health care professionals in a laboratory environment, near patient or point-of-care settings.

pH, pCO2, pO2: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base and/or oxygenation disturbances.
Hct: Whole blood measurements of the packed cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red blood cells)
Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
K+: Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels
Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ca++: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The EDAN i15 Calibrant Fluid Pack is intended for the calibration of pH, pO2, pCO2, Na+, K+ Ca++, Cl-, and Hct as part of the EDAN i15 Blood Gas and Chemistry Analysis System.

The EDAN i15 Blood Gas and Electrolyte Controls are external multi-analyte quality control material intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Electrolyte Analyze, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of pH, blood gases (pCO2 pO2), and electrolytes (Na+, K+, Ca++, and Cl').

The EDAN i15 Hematocrit Controls are intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Chemistry Analysis System, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of hematocrit.

The EDAN i15 Blood Gas and Chemistry Analysis System, including the Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge, and Quality Controls) is a system for in-vitro analysis of whole blood, delivering quantitative results for panels of tests determined by the Test Cartridge type used in the measurement. The Analyzer incorporates a large graphical user interface with a large color touch screen interfacing the analyzer electronic, Test Cartridge (containing the sensors) and Calibrant Fluid Pack. The sensors, flow path and waste are integrated into a single-use Test Cartridge. The calibration solution is contained in the Calibrant Fluid Pack which is available in versions for 50 or 100 tests. The product, consumables, installation instructions and packaging are designed for easy customer installation and operation.

The EDAN i15 Analyzer accepts lithium- or calcium-balanced heparinized whole blood samples from syringes and capillary tube. The minimum volume for samples from both syringe and capillary tube is 140 µL.

As with the predicate device, the EDAN i15 Blood Gas and Chemistry Analysis System is microprocessor-based and incorporates traditional sensor technology for measurement.

• pH, pCO2, Na*, K*, Cl , and Ca** (potentiometric measurement) .
• pO2 (amperometric measurement)
• Hct (conductivity measurement) ●

The Test Cartridge is available in three (3) versions, with different test panels, but with identical sample paths and calibration fluid:
BG8: pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct
BG3: pH, pCO2, pO2
BC4: Na+, K+, Cl-, Ca++, Hct

The Test Cartridge aspirates the sample directly from a syringe, or capillary fitted with an adaptor, and requires a minimum sample volume of 140 µL.

The provided text describes the performance testing and acceptance criteria for the EDAN i15 Blood Gas and Chemistry Analysis System.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Linearity Studies: 7 levels of modified whole blood samples were used for each measurand. The data provenance is "Whole, venous blood samples collected from healthy volunteers" and samples were modified to achieve different concentration levels.
• Imprecision in External Controls: 80 replicates for each level of blood gas and electrolyte control, and 80 replicates for each level of hematocrit control.
• Precision in Whole Blood (Hct): 6 levels, with 10 replicates per level on 3 analyzers (total 30 results per level), from "heparinized venous whole blood samples collected from eight volunteers".
• Precision in Whole Blood (Other analytes): 3 levels (implicitly, as 3 healthy volunteers mentioned), each run in 10 replicates on each of 3 analyzers (total 30 results). Samples were "venous whole blood collected from 3 healthy volunteers".
• Comparison of Syringe and Capillary Measurement: 180 samples (derived from 6 levels of blood, each with 10 replicates on 3 instruments), using "Whole blood venous samples from healthy volunteers".
• Specificity / Interference Testing: 7 replicates of both spiked and unspiked samples were tested.
• Method Comparison: 488 (pH), 483 (pCO2), 486 (pO2), 486 (Na+), 487 (K+), 484 (Cl-), 485 (Ca++), 487 (Hct) patient samples from 4 Point-of-Care (POC) sites and 3 laboratory sites. Samples were "discarded patient samples collected into either B-D Vacutainer lithium heparin tubes or B-D balanced heparin arterial sampling syringes". This indicates retrospective data. Data provenance (country of origin) is not explicitly stated.
• Determination of Detection Limits for ionized Calcium: 120 measurements for LoB, and 120 measurements for LoD and LoQ, using zero-level and low-level whole blood samples.

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)

The document primarily relies on comparisons to reference methods or predicate devices to establish ground truth for the performance of the EDAN i15 system.

• Linearity studies: Ground truth for linearity was established by various reference methods or comparative measurements:
  • Electrolyte values: "compared to those calculated from serial dilution of high and low concentration blood samples".
  • pCO2 and pO2: "against those determined by tonometry".
  • pH: "compared against parallel measurement on a Radiometer ABL 800".
  • Hematocrit: "compared the PCV% obtained by microhematocrit centrifuge". These are technical reference standards, not human experts.
• Method Comparison: The predicate device, Siemens RapidPoint 400 System, was used as the comparator for patient samples. The quality control materials used (RNA Medical QC823 and QC900) also have assigned values. These are established reference methods and devices, not human subject matter experts.
• Clinical Site Testing: The study involved "11 persons fulfilling the minimum requirements for education and training to perform moderately complex testing in accordance with CLIA." These are operators, not experts establishing ground truth via consensus.

Therefore, no information on human experts establishing the ground truth for the test set using a consensus approach is provided; instead, instrumental or established reference methods/devices were used.

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

No information on an adjudication method involving multiple readers or experts is provided in the document. The ground truth was established by comparison to reference methods or a predicate device.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was done. This document describes the performance of a blood gas and chemistry analysis system, which is an automated device, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

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

Yes, the device evaluated is a standalone automated blood gas and chemistry analysis system (EDAN i15). The performance metrics provided (linearity, imprecision, interference, method comparison) are indicative of the algorithm's (device's) performance without human interpretation or intervention in the measurement process itself, beyond sample introduction and operation.

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

The ground truth used was based on:

• Reference Methods/Standards: For linearity, this included calculations from serial dilution, tonometry for blood gases, measurement by Radiometer ABL 800 for pH, and microhematocrit centrifuge for Hct.
• Predicate Device: For method comparison, the Siemens RapidPoint 400 System was used as the comparator, representing an established and cleared device.
• Assayed Control Materials: For imprecision studies, external quality control materials (EDAN i15 Blood Gas and Electrolyte Control and EDAN i15 Hematocrit Control) with assigned values were used.

8. The sample size for the training set

The document does not explicitly state a "training set" size. As this is a medical device for in-vitro diagnostics and not a machine learning algorithm that undergoes traditional "training," the concept of a training set in the AI sense does not directly apply. The development of such a device involves internal verification and validation, but specific "training set" details are not provided in this regulatory summary.

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

As noted in point 8, the concept of a "training set" in the AI sense is not directly applicable here. The device's performance characteristics (e.g., calibration, measurement principles, stability) are established through rigorous engineering, chemical, and biological testing during its development and validation. The "ground truth" for the device's operational parameters and calibration solutions (e.g., Calibrant Fluid Pack) is established by using primary and secondary standards traceable to NIST or other recognized standards (as detailed in the "Traceability" section, page 23). For the EDAN i15 Controls, value assignment is performed by parallel testing against existing, validated lots and applying bias to determine acceptable ranges (page 24-25).

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