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The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer 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 physician's order.

pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Potassium (cKT): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Sodium (cNa*): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

Calcium (cCart): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Chloride (cCI¯): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoqlobin.

FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.

FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).

The implementation of the WiFi option allows wireless functionality for establishing network connectivity; all of which is supported by wired LAN connection in the existing application.

Here's an analysis of the provided text regarding the ABL90 Flex device modification for WiFi, structured to address your specific questions.

Acceptance Criteria and Study for ABL90 Flex - WiFi Modification

The submission pertains to a Special 510(k) for a device modification, specifically adding WiFi functionality to the existing ABL90 Flex. A key assertion in such submissions is that the modification does not affect the core performance characteristics of the previously cleared device. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance characteristics of the original ABL90 Flex, which the modified device is claimed to still meet.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a special 510(k) for a modification (WiFi functionality), the acceptance criteria are implicitly that the addition of WiFi does not degrade or alter the performance characteristics of the existing device's measurements. The reported device performance is that these performance characteristics remain unchanged.

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

The document explicitly states: "No performance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply."

This indicates that no new performance studies were conducted specifically for the WiFi modification to generate a new "test set" for measurement performance. The evidence relies on the existing performance data of the predicate device (K092686).

• Sample Size for Test Set: Not applicable for new performance data related to the WiFi modification, as existing data is referenced. The sample size for the original ABL90 Flex (K092686) performance studies would be relevant but is not provided in this submission summary.
• Data Provenance: Not applicable for new performance data related to the WiFi modification. The provenance for the original ABL90 Flex performance data (K092686) is not detailed in this submission summary.

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

Again, because no new performance studies are detailed for the WiFi modification, this information is not provided in the submission. The ground truth for the original ABL90 Flex (K092686) performance studies would have been established, but details are not present here.

4. Adjudication Method for the Test Set

Not applicable, as no new performance studies with specific test sets requiring adjudication were conducted for the WiFi modification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is typically performed for diagnostic imaging devices where human interpretation plays a significant role. The ABL90 Flex is an automated analytical instrument where the output is numerical measurements, not subjective human interpretation.

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

Yes, in essence. The ABL90 Flex is an automated analytical device. Its performance, as referenced from the original 510(k) (K092686), is inherently "standalone" in that it performs measurements without real-time human intervention affecting the measurement process itself. The modification (WiFi) is a connectivity feature and does not alter the core analytical algorithm or measurement capabilities.

7. The type of Ground Truth Used

For the core analytical measurements of the ABL90 Flex (pH, pO₂, electrolytes, glucose, etc.), the ground truth would typically be established through:

• Reference Methods: Highly accurate and precise laboratory methods considered the "gold standard" for specific analytes.
• Calibrated Reference Materials: Using certified reference materials or calibrators with known concentrations.
• Interlaboratory Comparison: Comparing results against other established and validated analytical devices or laboratories.

However, the specific details for the original ABL90 Flex (K092686) are not provided in this document.

8. The Sample Size for the Training Set

Not applicable. The ABL90 Flex is a chemical analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. Its "training" or calibration involves using specific calibrant solutions according to established protocols.

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

Not applicable, as there is no "training set" in the context of machine learning for this device. The calibration process involves using commercially available or internally prepared calibrants with known, traceable values (ground truth) to adjust the instrument's response.

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