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The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinised capillary 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. Bilirubin measurements on the ABL90 FLEX analyzer are intended to aid in assessing the risk of kernicterus in neonates.

Device Description

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, neonatal bilirubin and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). The ABL90 FLEX consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available. The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test load are available. The solution pack is available in one model. The ABL 90 FLEX electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ABL90 FLEX device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Precision (Repeatability & Device/Method Precision)	Acceptable precision in POC and laboratory settings, and in both capillary and syringe mode.	Aqueous Solutions (20-day pooled):- Capillary mode: Total %CV from 1.4% to 3.8%- Syringe mode: Total %CV from 1.3% to 4.6%Spiked Adult Whole Blood (1-day pooled):- Capillary mode: Total %CV from 1.6% to 14.0%- Syringe mode: Total %CV from 1.0% to 8.7%Spiked Adult Whole Blood & Cord Blood (1-day lab):- Capillary mode: Total %CV from 1.1% to 7.7% for adult, 0.9% to 7.4% for cord.
Method Comparison (vs. Predicate ABL800 FLEX)	Good correlation with the predicate device and very good agreement between the two modes.	Syringe mode (pooled): Slope = 0.9903 (95% CI: 0.975-1.005), Intercept = 0.6574, R² = 0.9878Capillary mode (pooled): Slope = 0.9760 (95% CI: 0.961-0.991), Intercept = 0.7741, R² = 0.9861
Linearity	Linear over the entire measuring range and fulfills requirements for allowable error due to non-linearity.	Linear (first order) over the entire measuring range. R² = 0.9996 for Bilirubin: ABL90 vs. Sample Conc.
Interference (Non-Significant)	< ± 10% interference	Evans Blue: 5 mg/LIntralipid: 1000 mg/dLHbF: 82%Hemolysis: 20% (approx. 3 g/dL hemoglobin)Triglyceride: 500 mg/dL
Interference (Significant)	Significant interference is ≥ ± 10%. Dose-response studies determine highest levels free from significant interference.	Fluorescein: 1.5 mg/L (at 5 mg/dL Bilirubin), 4 mg/L (at 15 mg/dL Bilirubin)Patent Blue V: 1.5 mg/L (at 5 mg/dL Bilirubin), 2.5 mg/L (at 15 mg/dL Bilirubin)Methylene Blue: 0.75 mg/L (at 5 mg/dL Bilirubin), 2 mg/L (at 15 mg/dL Bilirubin)Cardio Green: 3 mg/L (at 5 mg/dL Bilirubin), 10 mg/L (at 15 mg/dL Bilirubin)SHb: 1.1% (at 5 mg/dL Bilirubin), 1.6% (at 15 mg/dL Bilirubin)Hydroxocobalamin Hydrochloride: 0.19 g/L (at 5 mg/dL Bilirubin), 0.5 g/L (at 15 mg/dL Bilirubin)Cyanocobalamin: 0.2 g/L (at 5 mg/dL Bilirubin), 0.7 g/L (at 15 mg/dL Bilirubin)pH: No significant interference in range 6.8 – 7.9.
Limits of Blank (LoB)	Not explicitly stated, but determined.	1.1 mg/dL (18 µmol/L)
Limits of Detection (LoD)	Not explicitly stated, but determined.	1.60 mg/dL (27.4 µmol/L)
Limits of Quantitation (LoQ)	Not explicitly stated, but determined.	1.60 mg/dL (27.4 µmol/L)

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

Precision Studies:
- Aqueous Solutions (20-day): 240 samples (pooled data for capillary and syringe modes) across three point-of-care (POC) sites.
- Spiked Adult Whole Blood (1-day): 75 samples (pooled data for capillary and syringe modes) across three POC sites.
- Spiked Adult Whole Blood and Cord Blood (1-day laboratory): 25 samples per category (Adult Blood Samples 1, 2, 3 and Cord Blood Samples 1, 2, 3) for both capillary and syringe modes an additional sample for adult blood for syringe and capillary, making it 150 samples just for adult blood samples and 150 for cord blood samples.
Method Comparison:
- Syringe Mode: 210 samples (pooled from 74, 51, and 85 samples from three sites).
- Capillary Mode: 224 samples (pooled from 77, 56, and 91 samples from three sites).
Linearity: The specific number of samples is not explicitly stated, but data points appear to cover a range shown in the figure.
Interference: The specific number of samples per interferent tested is not explicitly stated.
LoB, LoD, LoQ: The specific number of samples used for these determinations is not explicitly stated.
Data Provenance: Studies were conducted at three point-of-care (POC) sites and Radiometer's laboratory facility. The country of origin for the data is not specifically mentioned, but the manufacturer is based in Denmark. The studies appear to be prospective as they were specifically conducted to evaluate the device's performance.

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

The ground truth for this device (Bilirubin measurement) is established by quantitative measurement against a reference method (the predicate device) or known concentrations (aqueous solutions, spiked blood).
Therefore, the concept of "experts" to establish a ground truth for a diagnostic measurement device like this (unlike image-based diagnostic AI) is not directly applicable in the same way. The accuracy is determined by comparing its measurements to established, validated methods or known standards.

4. Adjudication Method for the Test Set:

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective interpretation by multiple readers is involved (e.g., radiologists reviewing images).
For a quantitative in vitro diagnostic device measuring a biomarker, the "adjudication" is inherent in the reference method used for comparison (e.g., the ABL800 FLEX predicate device in the method comparison study, or the gravimetric methods for preparing known concentrations in precision and linearity studies). There is no explicit expert adjudication process described for the quantitative measurements themselves.

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.
This device is an in vitro diagnostic analyzer that quantitatively measures neonatal bilirubin, not an AI-assisted diagnostic tool that aids human readers in interpreting clinical data or images. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to this device.

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

Yes, this entire study is a standalone performance evaluation.
The ABL90 FLEX analyzer is an automated device designed to provide a direct readout of neonatal bilirubin. The performance data presented (precision, method comparison, linearity, interference, LoB/LoD/LoQ) all represent the performance of the device itself, without human intervention in the measurement process after the sample is introduced. Human users are involved in operating the device and interpreting its results within a clinical context, but the measurements themselves are fully automated.

7. The Type of Ground Truth Used:

Reference Method / Known Concentrations:
- For Precision, the ground truth was established by aqueous samples and spiked adult whole blood samples with known concentrations of bilirubin.
- For Method Comparison, the ground truth was the measurements obtained from the predicate device (ABL800 FLEX analyzer).
- For Linearity, the ground truth was samples with known target values of bilirubin concentration.
- For Interference, the ground truth was the expected bilirubin value in the presence of varying concentrations of potential interferents.
- For LoB, LoD, LoQ, the ground truth would be based on statistical analysis of samples with very low or no analyte present, often using a highly sensitive reference method to confirm absence or very low levels.

8. The Sample Size for the Training Set:

This is a traditional in-vitro diagnostic device, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. The device's spectrophotometric multi-component analysis method is based on established scientific principles and calibrated using known standards. Therefore, the concept of a "training set" as it applies to AI models is not relevant here. The device is developed and validated, not "trained."

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

As mentioned above, there is no "training set" for this type of device in the AI sense. The principle behind the device's measurement (spectrophotometric multi-component analysis) relies on fundamental physics and chemistry, with calibration done using solutions of known concentrations. This calibration process ensures accuracy, but it's not "training" an algorithm to learn from data.

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