(338 days)
The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood. The ABL90 FLEX 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 (cK+): 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 (cCa2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride (cCl-): 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 idiopathion. 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 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 hemoglobin.
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 system consists of a modular analyzer Incorporating a user interface module with a large colour touch screen interfacing the analyzer electronic and fluidic modules. The user interface module contains the analyzer CPU and all of the required electronic interfaces for external communication and data storage.
Sensors that measure pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose and lactate are contained in a sensor cassette that connects to the sample inlet. This cassette attaches to the front of the instrument.
An oximetry module measures ctHb, sO2, FO2Hb, FCOHb, FMetHb and FHHb. This module consists of a spectrometer, an ultrasonic hemolyzer and thermostatic components integrated into the instrument.
The system also includes a solution pack for the calibration and automatic quality control of the sensor and oximetry system. The solution pack includes calibration and quality control reagents individually packaged in sealed foil pouches.
The instrument and consumables incorporate "smart chip" technology for unique identification and lot-specific calibration and quality control data.
The provided text describes the ABL90 FLEX Analyzer, but it primarily focuses on its device description, intended use, and substantial equivalence to predicate devices. It lists categories of performance data generated but does not provide the acceptance criteria or the study results that prove the device meets these criteria.
Therefore, I cannot populate the requested table and answer many of the questions based solely on the provided text. The document refers to "Performance Data" but does not detail the specific criteria or the results of those studies.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Cannot be created. The document lists types of performance data generated (Method Comparison, Precision, Linearity/Assay Reportable Range, Limit of Quantitation, Calibration/Quality Control, Analytical Specificity Interferences, User Testing, Stability) but does not provide the actual acceptance criteria or the corresponding measured performance values for the ABL90 FLEX.
2. Sample size used for the test set and the data provenance:
- Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text. The device is an automated analyzer for chemical measurements, not an imaging or diagnostic AI system that typically relies on expert interpretation for ground truth.
4. Adjudication method for the test set:
- Not specified in the provided text.
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:
- Not applicable/Not specified. This is an automated diagnostic analyzer, not an AI-assisted interpretation system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The ABL90 FLEX is an automated analyzer designed to provide measurements independently. Its performance data (e.g., precision, linearity) would inherently be a standalone assessment of the algorithm/instrument. However, the specific results of these standalone tests are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but implied for an automated analyzer. For devices measuring analytes, ground truth is typically established through reference methods, certified standards, or highly accurate laboratory techniques.
8. The sample size for the training set:
- Not applicable/Not specified. This is a hardware-based analyzer with embedded firmware/algorithms, not a machine learning model that undergoes a distinct "training" phase with a separate training set in the typical sense. Calibration and internal quality control would be part of its ongoing operational validation.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. See point 8.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.