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The CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction.

The Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the rapid diagnosis of heart disease, for example, acute myocardial infarction.

For in vitro diagnostic use. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

The AQT90 FLEX is a cartridge-based immunoassay analyzer, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.

This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups – no liquids other than the sample itself together with the assay buffer are required.

The provided document is a 510(k) premarket notification from Radiometer Medical ApS for their AQT90 FLEX CKMB Test Kit, AQT90 FLEX Myo Test Kit, and the AQT90 FLEX analyzer. The submission is to seek clearance for modifications to the existing AQT90 FLEX system devices.

The document does not describe a study involving an AI model or a human-in-the-loop performance study. Instead, it describes analytical performance studies of in-vitro diagnostic assays (Myoglobin and CKMB) on a laboratory analyzer. Therefore, many of the requested elements pertaining to AI models, human experts, ground truth adjudication, MRMC studies, and training datasets are not applicable to this document.

However, I can extract information related to the acceptance criteria (implicitly, the performance metrics evaluated) and the studies conducted to prove the device meets these criteria in the context of an in-vitro diagnostic device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Performance Metrics) and Reported Device Performance

For an in-vitro diagnostic device, acceptance criteria are typically related to analytical performance characteristics such as linearity, limits of detection/quantitation, method comparison (agreement with a predicate), and precision. The reported device performance is the outcome of the studies conducted for these characteristics.

AQT90 FLEX Myo Test Kit

AQT90 FLEX CKMB Test Kit

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

• Linearity (Myo & CKMB): 11 sample levels for linearity series, measured with 10 replicates each. This is an in vitro analytical study, not patient data.
• LoB/LoD/LoQ (Myo & CKMB):
  • LoB: Four blank samples measured with 5 replicates on 3 days, using 2 test kit lots and 2 analyzers. Total 60 measurements per test kit lot.
  • LoD/LoQ: 10 samples per matrix (lithium heparin whole blood and plasma).
• Method Comparison (Myo & CKMB):
  • Myo: n=103 lithium heparin plasma samples.
  • CKMB: n=107 lithium heparin plasma samples.
• Matrix Comparison (Myo & CKMB):
  • Myo: n=125 for most comparisons (e.g., Liph/Pl vs Liph/WB), some n=127. Paired lithium heparin and EDTA specimens.
  • CKMB: n=106 for Liph/Pl vs Liph/WB, others n=104, 103, 101. Paired lithium heparin and EDTA specimens.
• Precision (Myo & CKMB):
  • Whole Blood: 3 lithium heparin whole blood samples, measured 5 times five replicates (total 25 measurements per sample level).
  • Plasma: 3 lithium heparin plasma pools, measured across 20 test days, twice a day with 2 replicates (total 80 measurements per sample level).

Data Provenance: The studies were conducted "at one internal test site" for method comparison and "at three hospital laboratory sites" for matrix comparison. This indicates domestic (likely Denmark, where the manufacturer is located) or potentially international clinical laboratory settings. The data are prospective in the sense that they were generated specifically for these validation studies using prepared samples (diluted native specimens, spiked specimens, blank samples). They are not patient-outcome data or retrospective chart reviews.

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

• Not Applicable. For an in-vitro diagnostic device measuring analytes (myoglobin, CK-MB), the "ground truth" isn't established by human experts in the same way as, for example, image interpretation. The ground truth for these studies is the reference measurement from the original (predicate) device or the known concentration of prepared analytical samples.

4. Adjudication Method for the Test Set:

• Not Applicable. No human interpretation or adjudication is involved in determining the concentration of analytes in a blood sample by an immunoassay method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation. This document describes the analytical performance of an in-vitro diagnostic device that quantitatively measures biochemical markers. There are no human readers or AI assistance involved in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

• Yes, in the context of an IVD. The performance data presented (linearity, LoD/LoQ, method comparison, precision) are all "standalone" in the sense that they demonstrate the analytical performance of the AQT90 FLEX system (analyzer and test kits) independent of human interpretation or intervention beyond proper sample handling and instrument operation. This isn't an "algorithm only" in the AI sense, but rather the performance of analytical machines.

7. The Type of Ground Truth Used:

• Reference Measurement/Known Concentration:
  • For Linearity, LoB/LoD/LoQ, and Precision: The ground truth is established by preparing samples with known or precisely characterized concentrations of the analytes (e.g., diluted native specimens, spiked specimens, blank samples).
  • For Method Comparison: The ground truth is the measurement obtained from the predicate device (the previously cleared version of the AQT90 FLEX system devices). The goal is to show agreement between the modified device and the predicate.

8. The Sample Size for the Training Set:

• Not Applicable. This document describes the validation of an in-vitro diagnostic device, not an AI model. Therefore, there's no "training set" in the machine learning sense. The device performs a chemical reaction and optical measurement based on established immunoassay principles, not a learned algorithm trained on data.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

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The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial 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.

ABL90 FLEX PLUS:
The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyzer that quantitatively measures neonatal bilirubin in heparinized capillary, venous and arterial whole blood.
The ABL90 FLEX PLUS 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 PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are two models of the same portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO-, pCO3, potassium, sodium, calcium, chloride, glucose, lactate, neonatal bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO-Hb, FCOHb, FMetHb, FHHb and FHbF).
The manufacturer of the ABL90 FLEX and ABL90 FLEX PLUS is Radiometer Medical ApS.
The ABL90 FLEX and ABL90 FLEX PLUS consist 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 two models differing in the number of tests available.
Technology:
The ABL 90 FLEX and ABL90 FLEX PLUS electrochemical sensors are miniaturized, manufactured by film technology and integrated in a common sensor cassette. Likewise, the ABL90 FLEX and ABL90 FLEX PLUS optical oxygen sensor is integrated in the sensor cassette. A 256-pixel array spectrophotometer is used for the co-oximetry parameters and bilirubin.
Clinical Utility ctBil:
For newborns up to an age of one month the method's reportable range covers the entire reference range. Neonatal Bilirubin test is intended for use to aid in assessing the risk of kernicterus in newborns.

The provided document is a 510(k) Premarket Notification from the FDA regarding the ABL90 FLEX and ABL90 FLEX PLUS devices for measuring neonatal bilirubin. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria as typically done for novel AI/ML medical devices.

Therefore, many of the requested points related to acceptance criteria, ground truth establishment, expert consensus, MRMC studies, and training sets are not applicable to this type of submission. This 510(k) is for an in-vitro diagnostic device that measures a chemical parameter (bilirubin) using established spectrophotometric technology, not an AI/ML-driven diagnostic or image analysis tool. The "performance" being evaluated is the analytical performance (accuracy, precision, linearity) of the device against a known predicate and reference methods, not the diagnostic performance of an algorithm.

However, I can extract the relevant information from the document that pertains to its performance evaluation.

Overview of Device Performance Evaluation (Not AI/ML focused)

The ABL90 FLEX and ABL90 FLEX PLUS analyzers are in vitro diagnostic devices designed to quantitatively measure neonatal bilirubin in heparinized capillary, venous, and arterial whole blood. The submission aims to extend the indicated sample types for neonatal bilirubin measurement to include arterial and venous whole blood, leveraging performance data already established for capillary whole blood in a previous 510(k) (K132691).

The core of the performance study for this specific submission is demonstrating method comparison (correlation) against a predicate device (ABL800 FLEX or ABL835 FLEX, which is part of the ABL800 FLEX family) for the new sample types.

Relevant Performance Information and Analysis (from the provided document):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds in this document for the method comparison study. The goal is to demonstrate "substantial equivalence" based on the correlation characteristics (slope, intercept, R-squared) to the predicate device. The implicit acceptance is that the correlation is strong (R-squared close to 1) and the linear relationship is close to y=x (slope close to 1, intercept close to 0), indicating comparable performance to the predicate. The FDA's determination of substantial equivalence implies these criteria were met.

   • Reported Device Performance (from Table 1: Neonatal bilirubin linear regression data for ABL90 FLEX measurements compared to ABL835 FLEX measurements):

     Parameter	Units	Slope	Intercept (mg/dL)	R²	Sy.x (mg/dL)
     ctBil All (combined samples)	mg/dL	0.97	-0.38	1.00	0.60
     ctBil Arterial All	mg/dL	0.98	-0.54	0.97	0.53
     ctBil Venous All	mg/dL	0.98	-0.32	0.98	0.62
     ctBil site 1	mg/dL	0.96	-0.18	1.00	0.57
     ctBil site 2	mg/dL	0.98	-0.71	1.00	0.58

   Interpretation: The R-squared values are very high (0.97 to 1.00), indicating a very strong linear correlation between the ABL90 FLEX and the predicate ABL835 FLEX. The slopes are close to 1 (0.96-0.98) and intercepts are close to 0 (-0.18 to -0.71 mg/dL), suggesting good agreement (i.e., minimal proportional or constant bias) between the new device and the predicate.

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

   • Test Set Sample Sizes:
     • 44 arterial blood samples
     • 42 venous blood samples
     • 17 spiked cord blood samples
     • Total N = 103 samples (44 arterial + 42 venous + 17 spiked)
   • Data Provenance: The study was conducted at "two point-of-care sites." The document does not specify the country of origin of the data. It is a prospective method comparison study where new measurements were taken for the purpose of this submission.

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

   • Not applicable in the context of an AI/ML algorithm. For this in vitro diagnostic device, the "ground truth" for the method comparison is the measurement obtained from the predicate device (ABL835 FLEX), which is itself a validated diagnostic instrument. This is an analytical performance study, not a diagnostic performance study relying on expert interpretation.

4. Adjudication method for the test set:

   • Not applicable. This study involves direct quantitative measurements of a chemical analyte, not qualitative assessments or interpretations that would require adjudication.

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. This is an in vitro diagnostic device measuring a chemical substance, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

   • This is inherently a "standalone" device in its measurement function. The device itself performs the measurement and provides a numerical output. Human involvement is in operating the device and interpreting the numerical result in a clinical context, but not in assisting an algorithm to produce the measurement.

7. The type of ground truth used:

   • The "ground truth" (or reference method for comparison) was measurements obtained from another legally marketed device (predicate device, ABL835 FLEX), which is widely considered a reliable method for bilirubin measurement. For in vitro diagnostics, this is a standard approach to demonstrating substantial equivalence – showing comparable performance to an established method.

8. The sample size for the training set:

   • Not applicable. This device uses established spectrophotometric technology and is not an AI/ML device that requires a training set in the conventional sense. The "training" here would be the design and calibration of the instrument based on chemical and optical principles.

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

   • Not applicable. As above, no training set in the AI/ML sense.

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The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood.

The ABL90 FLEX PLUS 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 PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.

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): qlucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoqlycemia, 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 oxyhemoqlobin and oxyhemoglobin plus reduced hemoqlobin.

FO2Hb: oxyhemoqlobin as a fraction of total hemoqlobin.

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 hemoqlobin 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 PLUS 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 FO-Hb, FCOHb, FMetHb, FHHb and FHbF).

The manufacturer of the ABL90 FLEX PLUS is Radiometer Medical ApS.

The ABL90 FLEX PLUS 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 two models differing in the number of tests available.

The provided text describes the ABL90 FLEX PLUS analyzer, an in vitro diagnostic device. The submission is for a design change to an existing device, the ABL90 FLEX, with the introduction of the ABL90 FLEX PLUS which includes a mechanized inlet module (AutoInlet) and a Short Probe Mode.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the performance evaluation is a "Method comparison of ABL90 FLEX PLUS Short Probe mode versus ABL90 FLEX syringe mode with inlet clip" and "Imprecision" studies. The reported device performance is that all acceptance criteria were met.

Method Comparison Acceptance Criteria & Performance:

Imprecision Acceptance Criteria & Performance:

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

• Method Comparison Test Set: "more than 40 samples (N) per parameter"
• Data Provenance: Samples were "heparinized, leftover whole blood samples (analyzed 2-3 hours post draw)." The specific country of origin is not explicitly stated, but the submission is from Radiometer Medical ApS in Denmark, suggesting the study likely occurred in a European context or by their internal methods. The study is retrospective as it uses "leftover whole blood samples".

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

Not applicable to this type of in vitro diagnostic device and study. The ground truth for this device is based on measurements from a predicate device (ABL90 FLEX) or a reference instrument, not expert consensus.

4. Adjudication method for the test set

Not applicable. The study compares quantitative measurements between two devices, not subjective interpretations requiring adjudication.

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. This is an in vitro diagnostic device for quantitative measurements, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

Yes, the performance studies described (Method Comparison and Imprecision) evaluate the standalone analytical performance of the ABL90 FLEX PLUS device (ABL90 FLEX PLUS Short Probe mode and ABL90 FLEX PLUS for imprecision). The comparisons are against a predicate device or reference instrument, not involving human interpretation.

7. The type of ground truth used

• Method Comparison: The predicate device, ABL90 FLEX syringe mode with inlet clip, served as the comparative "truth". The study assessed if the new ABL90 FLEX PLUS Short Probe mode yields equivalent results to this established method.
• Imprecision: "The total imprecision for all parameters except neonatal bilirubin was calculated as the imprecision of the bias towards a reference value determined for each sample on an ABL90 FLEX reference instrument." For neonatal bilirubin, the ground truth source is not explicitly defined beyond "aqueous solutions," but implies a known concentration.

8. The sample size for the training set

Not explicitly stated. For in vitro diagnostic devices, "training set" is not a standard term as it is in machine learning. The studies described are performance verification studies for a medical device. If there was an internal development phase for calibration or algorithm adjustment, that data is not detailed here.

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

Not applicable directly as this is not an ML/AI model with a "training set" in the conventional sense. For the performance studies, ground truth (or reference values) for comparison were established by:

• Method Comparison: Measurements from the predicate device (ABL90 FLEX syringe mode with inlet clip).
• Imprecision: Measurements on an "ABL90 FLEX reference instrument" for most parameters, and "aqueous solutions" for neonatal bilirubin (implying known concentrations).

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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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This Hematocrit and Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.

Analytes are: cGlucose, cLactate, Hct

Hematocrit and Metabolite QUALICHECK is a two-level quality control system consisting of:

• Hematocrit and Metabolite QUALICHECK, Level 1 (S7170), 944-039
• Hematocrit and Metabolite QUALICHECK, Level 2 (S7180), 944-040

The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution.

The quality control solution is an aqueous solution containing an organic buffer, acid, salts, metabolites, and a preservative.

The provided text describes the Hematocrit and Metabolite QUALICHECK, a quality control system, and its substantial equivalence to a predicate device. However, the document does not contain the specific acceptance criteria, study details proving meeting these criteria, or most of the requested information about test and training sets, expert involvement, or comparative effectiveness studies.

This device is a quality control material, not a diagnostic or prognostic medical device that would typically involve AI, human-in-the-loop performance, or extensive clinical trials with patient data and expert ground truth establishment in the manner usually associated with the questions asked. The performance is assessed by comparing its measured values to established reference values and demonstrating stability.

Therefore, many of your requested points cannot be answered from the provided text. I will answer what is available and indicate when information is not present.

Acceptance Criteria and Device Performance (Limited Information Available)

The document states: "All study results met the acceptance criteria," but it does not explicitly list the acceptance criteria in a table or otherwise. It also does not report device performance data in a quantitative manner against specific criteria. The closest information available is in the "Stability" section, which mentions:

• Stability Claim: Control solutions are stable for 2 years at 2 °C to 25 °C.
• Performance against "Acceptance Criteria" (unspecified): "All study results met the acceptance criteria."

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set:
  • Hct: For value assignment, 30 ampoules were sampled from the batch (5 from each of 6 trays) and 30 ampoules were sampled from a reference batch. Measurements were repeated 5 times per ABL555 analyzer (60 total measurements for each set of ampoules across 2+ analyzers).
  • Glucose and Lactate: Similar sampling: 30 ampoules from the batch and 30 from a reference batch. Measurements were repeated 5 times per EML105 analyzer (60 total measurements for each set of ampoules across 2+ analyzers).
• Data Provenance: Not explicitly stated, but the company (Radiometer Medical ApS) is based in Denmark. The study is part of the regulatory submission process for a medical device quality control, suggesting it is a controlled, prospective study for regulatory purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable or not specified. Ground truth for quality control materials for analytes like glucose, lactate, and hematocrit is established through highly calibrated reference methods and analyzers, not typically by human expert consensus or interpretation in the same way as imaging or diagnostic assessments.
• Qualifications of Experts: Not applicable/not specified. The "ground truth" (referred to as "true value" in the document) is determined by "validated ABL555" and "validated EML105" analyzers and "validated algorithms" in an Excel spreadsheet.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. The ground truth is established by instrumental measurements and calculations, not human adjudication.

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

• MRMC Study: No. This device is a quality control material for analytical instruments, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Yes, in a sense. The "performance" of this device is its inherent accuracy and stability as a quality control material, which is assessed instrumentally without human in-the-loop performance altering its "reading." The device itself doesn't have an "algorithm" in the AI sense; its function is to provide known analyte concentrations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground Truth Type: "True value" established through measurements on validated reference analyzers (ABL555 for Hct, EML105 for Glucose and Lactate) and validated algorithms for calculation. This is an analytical ground truth based on reference methods.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a quality control material, not an AI algorithm that requires a "training set." The materials are manufactured, and then their "true values" and stability are verified.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set." The "true values" for the device itself (which are the reference for other instruments using it for quality control) are established as described in point 7.

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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.

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.

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:

• 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 = 0.9878
  Capillary 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) |

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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.

Indications for use:

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 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 oxyhemoqlobin plus reduced hemoglobin.

FO2Hb: oxyhemoqlobin as a fraction of total hemoglobin.

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

FMetHb: methemoqlobin 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 hemoqlobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).

This document describes modifications to the ABL90 FLEX device, specifically software changes to suppress glucose results under certain low pO2 conditions. The following is a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The results are valid under the conditions that:

• all glucose results are suppressed when the pO2 level of the sample is below 10 mmHg.
• all glucose results are suppressed when pO2 level of the sample is between 10 mmHg and 25 mmHg and the glucose level is above 270 mg/dL.
  All acceptance criteria are met: Bias 90 mmHg | 18.1 | 0.1 | 0.7 | 4.1 | 240 |
  | Glu Mid $98.7 \pm 9 mg/dL$ | 10 mmHg | 101.7 | 1.1 | 3.8 | 3.7 | 240 |
  | | 30 mmHg | 101.0 | 0.7 | 3.3 | 3.3 | 240 |
  | | >90 mmHg | 101.2 | 0.5 | 3.3 | 3.2 | 240 |
  | Glu High $270 \pm 6 mg/dL$ | 10 mmHg | 254.1 | 1.6 | 10.8 | 4.2 | 240 |
  | | 30 mmHg | 262.3 | 1.1 | 8.8 | 3.4 | 240 |
  | | >90 mmHg | 271.9 | 1.7 | 7.4 | 2.7 | 240 | | Passed |
  | 48/Unacceptable bias on Glucose results obtained from samples with pO2 levels above 25 mmHg | (Covered by Interference Study) | (Covered by Interference Study) | (Covered by Interference Study) | Passed |
  | (General Performance) Method Comparison | Method comparison study versus a comparative analyzer (ABL735). | Slope: 0.9 - 1.1
  Intercept: 0
  Correlation Coefficient: ≥ 0.95 | Linear regression of the pooled data gives a slope of 0.9206, intercept of 0.084 and an R² ≥ 0.95. | Passed |

2. Sample Sizes and Data Provenance

Interference Study (Test Set):

• Sample Size:
  • 6 different pO2 levels (including a control at ≥90 mmHg)
  • 7 different glucose levels
  • 3 analyzers
  • 6 tests of each sample on each analyzer
  • 2 runs
  • Total: 1512 measurements
• Data Provenance: Fresh heparinized whole blood samples. The document does not specify the country of origin but implies an in-house study ("Radiometer Medical ApS"). The samples are likely prospective as they are "fresh heparinized whole blood samples" and "untreated donor samples in combination with spiked donor blood."

Precision Study (Test Set):

• Sample Size:
  • 20 days
  • 3 different pO2 levels
  • 3 different glucose levels
  • 2 tests of each sample each day
  • 2 runs
  • Total: 2160 measurements
• Data Provenance: Serum pool sample of glucose. The document does not specify the country of origin but implies an in-house study ("Radiometer Medical ApS"). likely prospective.

Method Comparison Study:

• Sample Size: A total of 52 different donors and approximately 500 samples.
• Data Provenance: In-house study using untreated donor samples in combination with spiked donor blood where necessary. Likely prospective.

3. Number of Experts and Qualifications for Ground Truth

The studies described are for an in vitro diagnostic device measuring blood analytes. The ground truth for such devices is typically established through a reference method or comparator device, not clinical expert consensus in the way image analysis or clinical diagnosis algorithms would.

• Interference Study: The ground truth for bias calculation was established by comparing results to a "control" pO2 level (≥90 mmHg). This relies on the established accuracy of the glucose measurement at optimal pO2.
• Precision Study: The ground truth is inherent in the known concentrations of glucose levels in the serum pool samples used.
• Method Comparison Study: The ground truth was established by comparison to results from a "comparative analyzer (ABL735)," which is a predicate device.

Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in the context of clinical interpretation (e.g., radiologists for images) is not applicable here. The ground truth is based on laboratory-defined reference measurements or a well-established predicate device.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used for subjective assessments where multiple human readers disagree (e.g., interpreting medical images or clinical notes). This document describes performance studies for an in vitro diagnostic device, where results are quantitative measurements. Discrepancies would be resolved through re-testing, calibration, or investigation of instrument malfunction, not clinical adjudication by experts. Therefore, no formal adjudication method of this type is mentioned or expected.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on human reader performance, typically in diagnostic imaging or similar fields where human interpretation is central. This document focuses on the analytical performance of an in vitro diagnostic device, specifically the impact of a software modification on glucose measurement accuracy under certain pO2 conditions. The comparisons are between the device's results and reference methods/predicate devices, not between human readers with and without AI.

6. Standalone Performance

Yes, standalone performance was done. The entire submission describes the standalone analytical performance of the ABL90 FLEX device, particularly its glucose measurement under varying pO2 conditions, after the proposed software modification. The studies (Interference, Precision, Method Comparison) evaluate the device's inherent measurement capabilities and the impact of the software suppression logic without human intervention in the continuous measurement process. The modification itself involves the device automatically suppressing results based on pO2 and glucose levels.

7. Type of Ground Truth Used

• Interference Study: The ground truth for bias calculation was primarily reference measurements at optimal pO2 (≥90 mmHg) and the known concentrations of spiked glucose.
• Precision Study: The ground truth was based on the known concentrations of glucose in the serum pool samples used.
• Method Comparison Study: The ground truth was established through comparison with a predicate device (ABL735) and likely involved reference methods for its initial validation.

In essence, the ground truth for these analytical performance studies is rooted in established reference values, comparator devices, and controlled experimental conditions where "true" concentrations or performance characteristics are either known or determined by a validated reference standard.

8. Sample Size for the Training Set

The document does not explicitly state a separate "training set" sample size. This is common for analytical performance studies of this nature, especially when the modification is primarily a software rule change based on understanding of the underlying chemistry (glucose oxidase co-reaction with oxygen). The "training" in such cases might involve development and initial testing against known samples to define the suppression rules, which is not typically formalized as a distinct "training set" in the context of a 510(k) submission for IVDs. The "test set" described above (1512 measurements for interference, 2160 for precision) serves as the primary validation data.

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

As noted above, a formal "training set" with ground truth establishment in the machine learning sense is not explicitly described or necessarily applicable here. The software modification (suppression rules) likely emerged from:

• Understanding of the underlying scientific principle: The document states, "The linearity of the glucose is dependent on the oxygen tension of the sample. This dependence is due to the co-reaction of glucose and oxygen by the enzyme glucose oxidase." This foundational knowledge guides the need for suppression.
• Prior internal R&D data/experiments: Radiometer would have conducted extensive internal studies to characterize the glucose sensor's performance across various pO2 and glucose concentrations to determine the thresholds (e.g., 270 mg/dL) at which accuracy is compromised. This data, if it exists, would have informed the development of the suppression logic.

Therefore, the "ground truth" for developing these rules would be based on analytical measurements from controlled experiments using samples with known glucose and pO2 concentrations, helping to define the performance boundaries.

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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.

Indications for use:
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 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 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 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 modification consists of Data Management software called AQURE system. The software enables display of test results, receivable of data from connected devices at the point-of-care or laboratory, transfer of test results to the HIS/LIS and initiation of device actions.

This document describes the software modification (AQURE system) for the ABL90 FLEX device, rather than a new device or a clinical study evaluating its performance. The bulk of the text focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert involvement, and comparative effectiveness studies is not available in the provided text. The document explicitly states:

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

This means that a new study to prove the device meets acceptance criteria for its clinical performance was not conducted, as the modification was to the data management software and not the core measurement capabilities of the ABL90 FLEX analyzer. The submission relies on the performance data of the predicate devices.

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

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

The change consists of an update to the Intralipid correction algorithm for Oxi parameters. The purpose of this update is to improve the suppression of Intralipid interference.

Here's a breakdown of the acceptance criteria and the study details for the ABL90 Flex with the improved Intralipid correction algorithm, extracted from the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Size: "between 76 and 282 samples per parameter spanning the measuring range."
   • Data Provenance: "In-house method comparison study" and "existing performance verification data obtained in-house." This suggests the data was generated internally by Radiometer Medical ApS, likely in Denmark. The data is prospective in nature as it's a verification study against a new algorithm.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: Not explicitly stated. The study references "medical decision points" and "existing claims" but does not detail the involvement or qualifications of experts in establishing the ground truth for these.

3. Adjudication Method for the Test Set: Not explicitly stated. Given that the study compared the "new algorithm" against the "previous algorithm" and "existing claims," it implies a comparison to a established reference, but the method of adjudication (e.g., expert consensus) for that reference is not detailed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The study focuses on the analytical performance of the device's algorithm.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: Yes, this appears to be a standalone (algorithm only) performance study. The focus is on the performance of the "Improved Intralipid correction algorithm for Oxi parameters" and its impact on measurements, without human interaction with the algorithm's output as part of the primary evaluation.

6. Type of Ground Truth Used: The ground truth used for performance evaluation was based on the "previous algorithm" (predicate device's algorithm) and "existing claims" for analytical performance (bias, imprecision, linearity, LOQ). This can be categorized as a comparative analytical truth against a previously validated method, rather than a clinical ground truth like pathology or patient outcomes.

7. Sample Size for the Training Set: Not explicitly stated. The document describes a "new correction" and an "improved Intralipid correction algorithm," implying development and training, but the sample size used for this training is not provided in this 510(k) summary.

8. How the Ground Truth for the Training Set Was Established: Not explicitly stated. The document describes the verification of the new algorithm against the old one and existing claims, but it does not detail how the ground truth was established for the training of the new algorithm itself.

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This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pO2, ctHb, cGlucose, cLactate

High Metabolite QUALICHECK is a single level quality control system consisting of: High Metabolite QUALICHECK (S7570). The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution. The quality control solution is an aqueous solution containing a biological buffer, salts, metabolites, and a preservative.

The provided documentation describes the High Metabolite QUALICHECK, a quality control system. As such, the concept of "acceptance criteria" and "device performance" is focused on its ability to serve as a reliable control for other diagnostic devices, rather than directly diagnosing a condition. The "study" described is a value assignment study to establish the accepted control ranges for the device.

Here's a breakdown of the information requested:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a quality control material are typically the established target ranges for its analytes, determined through a rigorous value assignment process. The "reported device performance" refers to the specific values found for the analytes within the control solution, which then form these target ranges.

Note: The document states "Target ranges are calculated based on the mean ±2SD" but does not explicitly list the numerical target ranges or the actual performance values. This information would typically be found in the device's insert.

Study Details

This section focuses on the value assignment study for the High Metabolite QUALICHECK.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 72 ampoules (12 ampoules sampled from each of 6 trays). Additionally, a "reference batch" was used, though its size is not explicitly stated in terms of ampoules. A total of 144 measurements were performed for each parameter.
   • Data Provenance: Not explicitly stated, but assumed to be generated in a controlled laboratory environment by the manufacturer (Radiometer Medical ApS, Denmark) as part of the product development and validation for regulatory submission. This is a prospective study for establishing control values.

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

   • Number of Experts: Not applicable in the traditional sense for this type of device. The "ground truth" for a quality control material is established through precise and extensive instrumental measurements on a well-characterized batch.
   • Qualifications of Experts: The measurements were performed on "a minimum of 3 validated ABL7xx series" instruments. The expertise lies in the calibration, validation, and operation of these high-precision instruments and the personnel trained to use them for quality control value assignment.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. The "ground truth" (target ranges) is established statistically from a large number of instrumental measurements (144 measurements per parameter) from established and validated analyzers, rather than through expert consensus or adjudication of subjective interpretations.

4. 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:

   • MRMC Study: No. This device is a quality control material for in vitro diagnostic instruments, not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant.

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

   • Standalone Performance: Not applicable. This is a physical quality control solution, not an algorithm. Its "performance" is its ability to provide stable and accurate reference values when measured by compatible analyzers. The value assignment study itself is a standalone evaluation of the control solution's inherent characteristics.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Type of Ground Truth: The ground truth is established through reference method measurements or highly precise, validated instrumental measurements on a large, representative sample of the quality control material. Specifically, it's based on the statistical analysis (mean ± 2SD) of 144 measurements from validated ABL7xx series analyzers.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context refers to the initial production of the control material according to specifications.

8. How the ground truth for the training set was established:

   • Ground Truth for Training Set: Not applicable. There is no training set for this type of device in the machine learning sense. The "ground truth" (i.e., the target values) for the product is established through the value assignment process described in point 6 above for the manufactured batches.

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