(88 days)
The ABL800 FLEX is intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX includes an AutoCheck Module to perform automated analysis of quality control fluids.
The ABL800 FLEX is an automatic analyzer for in vitro testing of blood gases, electrolytes, metabolites and co-oximetry parameters in samples of whole blood. The ABL800 FLEX includes the capability (FLEXMODE) of automatically measuring a reduced number of parameters when there is not enough sample to measure the desired number of parameters. The analyzer further includes a new inlet supporting test tubes and has a new software platform, which makes the user interface fully customizable.
The provided document describes the Radiometer ABL800 FLEX blood gas, co-oximetry, electrolyte, and metabolite analyzer. The study conducted to demonstrate substantial equivalence to predicate devices focuses on precision, reproducibility, and linearity/assay reportable ranges. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria for specific parameters (e.g., pH, pO2) or their corresponding device performance values like bias or imprecision in a structured table. Instead, it states a general acceptance criterion related to "substantial equivalence" and reports overall study findings.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (ABL700 Series Upgrade and ABL700 with AutoCheck Module) in terms of repeatability, bias, and test range. | "The result of the non-clinical test showed that when looking at repeatability, bias, test range etc. the ABL800 FLEX performed substantially equivalent to the predicate devices." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Test Set): A total of approximately 4,700 measurements were performed on the ABL800 FLEX. These measurements were compared against corresponding ABL735 reference values.
- Data Provenance: The study was an "in-house study" conducted by Radiometer Medical ApS (Denmark). The document does not specify the country of origin of the samples themselves, but the manufacturer is Danish. The study was "non-clinical." It is a retrospective study as all measurements were done at once without any further changes to the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of "experts" to establish a ground truth for the test set in the context of diagnostic accuracy. Instead, it used a reference device (ABL735 analyzers) for comparison. The ABL735 analyzers were used as the reference standard.
4. Adjudication Method for the Test Set
Not applicable. The study utilized comparison against a reference device (ABL735 analyzers) rather than expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is typically relevant for image-based diagnostic systems where multiple readers interpret cases with and without AI assistance. The ABL800 FLEX is an automated analyzer for in vitro testing of blood samples, not an imaging device that requires human interpretation in the same way.
6. Standalone (Algorithm Only) Performance
Yes, the study describes the performance of the ABL800 FLEX analyzer in a standalone capacity, comparing its measurements directly to a reference device (ABL735). The "algorithm" in this context refers to the device's inherent measurement technologies rather than a separate AI component for interpretation.
7. Type of Ground Truth Used
The ground truth was established by another medical device, the ABL735 analyzers, which served as the reference standard for the comparative study.
8. Sample Size for the Training Set
The document does not explicitly describe a separate "training set" as would be common for machine learning or AI models developed through training. This study appears to be a traditional validation study for a medical device's measurement accuracy and precision. If there was any internal development or calibration, the details are not provided in this submission to the FDA.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no separate training set or ground truth establishment process for a machine learning model is described. The study focuses on evaluating the performance of the final device against a predicate.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.