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The ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cC22+, cClu, cLac, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for In vitro testing of samples of expired air for the parameters p02 and for In vitro testing of pleura samples for the pH parameter.

pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.

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

pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.

Potassium (cK+): the measurements of the concentration of plasma are used to monitor the electrolyte balance.

Sodium (cNa+); the measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.

Calcium (cCa++): the measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.

Chloride (cCl-): the measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.

Glucose (cGlu): The glucose measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes and hyper and hypoglycemia.

Lactate (cLac): The lactate measure the concentration of lactate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.

Bilirubin (ctBil): The bilirubin measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.

Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.

Oxygen Saturation (sO2): sO2 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation.

Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the potential oxygen transport capacity; that is the fraction of oxyhemoglobins present (tHb) including dyshemoglobins.

Fraction of Carboxyhemoglobin (FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen.

Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.

Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.

Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consist of two a-chains and two B-chains, and has a higher oxygen affinity than adult Hb.

Creatinine (cCrea): The creatinine measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Pleural pH: The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of

ABL800 FLEX with AQURE connectivity is a stationary, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions F02Hb, FCOHb, FMetHb, FHHb and FHbF).

The modification consists of integration with the Medical Device Data System (MDDS) called AQURE system. The software enables the initiation of device actions on connected ABL800 series analyzers.

The provided text is a 510(k) summary for the Radiometer ABL800 FLEX with AQURE connectivity. This document focuses on demonstrating substantial equivalence to a predicate device and addresses a software modification (integration with the AQURE system), not a study proving the original device's performance against detailed acceptance criteria for its clinical parameters.

Therefore, the information required to fully answer your request regarding performance criteria and a study proving the device meets those criteria for the measured clinical parameters (pH, pO2, pCO2, etc.) is not present in this document. This document specifically states: "No performance characteristics are affected by the change. The performance data submitted in the original submission (K041874 as modified by K043218, K050869, K051968, K100777 and K110416) still apply."

However, I can extract information related to the software modification and its acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated for the software verification. The document mentions "test protocols" were used.
• Data Provenance: Not specified, but given it's a product from Radiometer Medical ApS in Denmark, it can be inferred that the testing likely occurred in a controlled lab or manufacturing environment. The study is retrospective in the sense that it relies on previously established performance data for the core ABL800 FLEX device and focuses on the impact of the new software integration.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The document does not mention the use of experts or ground truth establishment for the software verification. The assessment appears to be based on engineering and risk management principles (FMEA, test protocols).

4. Adjudication method for the test set

• Not applicable as this is a software modification verification, not a clinical study involving human judgment.

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, an MRMC comparative effectiveness study was not done. The device is for in-vitro diagnostic testing (blood gas, electrolytes, metabolites, oximetry), not an imaging or interpretive AI device where MRMC studies are typically performed. The software modification is for data management connectivity (MDDS), not AI-assisted interpretation.

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

• The device itself (ABL800 FLEX) is a standalone automated diagnostic system. The AQURE connectivity is a software integration to manage data and device actions. The validation of the software integration focuses on its functionality and safety, not standalone diagnostic performance, as the diagnostic performance relies on the already established ABL800 FLEX analyzer.

7. The type of ground truth used

• For the software modification, the "ground truth" would be the expected functional behavior and safety requirements defined during the design and risk analysis phases. For example, a "ground truth" might be that a specific command sent via AQURE results in the correct action on the ABL800 FLEX analyzer, or that data transfer is accurate. However, this is not a biological or clinical ground truth.

8. The sample size for the training set

• Not applicable. This is a medical device connectivity software update and risk assessment, not a machine learning or AI algorithm requiring a training set in the conventional sense.

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

• Not applicable for the same reason as above.

In summary: This 510(k) summary explicitly states that the software modification (AQURE connectivity) does not affect the performance characteristics of the ABL800 FLEX analyzer. Therefore, performance data for the clinical parameters refers back to the original submissions (K041874 and subsequent modifications), which are not detailed in this document. The provided text only describes the verification and validation activities conducted for the software change itself, primarily focusing on risk management and functional testing rather than clinical performance studies.

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