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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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Indications : The ABL800 FLEX with RADIANCE v2.5 modification 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 paramenters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids.

RADIANCE v2.5 is a Windows-based software application that runs on an independent server and, when added to ABL800 FLEX, enables remote data entry and control of compatible blood-gas analyzers connected to a laboratory information system (LIS) and/or a hospital information system (HIS).

This 510(k) summary (K050869) describes a software modification (RADIANCE v2.5) to an existing blood gas analyzer (ABL800 FLEX). The submission claims substantial equivalence to the predicate device (ABL800 FLEX K041874) based on having the "same intended use and the same fundamental scientific technology," with "Design control information" ensuring substantial equivalence.

This document package does not contain information about acceptance criteria or specific studies to prove that the device meets acceptance criteria. It is a software modification to an existing device, and the primary focus of the 510(k) notice is on functionality, rather than new performance claims that would require extensive clinical studies. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This implies that the device is considered equivalent based on its technical specifications and intended use matching a previously cleared device, rather than new, independent performance studies demonstrating specific acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and detailed study information because that information is not present in the provided text.

Specifically, the following information is not present in the provided document:

1. A table of acceptance criteria and the reported device performance: This document does not describe measurable acceptance criteria for the RADIANCE v2.5 software or present performance data against such criteria.
2. Sample size used for the test set and the data provenance: Not applicable as a performance study for the software itself is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multicase (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, as this is a blood gas analyzer software, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

The submission is for a software update that enables remote data entry and control of compatible blood-gas analyzers, expanding the functionality of an already cleared device. The "Design control information" is cited as the basis for ensuring substantial equivalence, suggesting that internal validation and verification activities, rather than large-scale clinical performance studies, were deemed sufficient for this type of modification.

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The ABL800 FLEX with FLEXQ Module 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) as well as for in vitro testing of samples of expired air for the parameters pO2 and pCO2.

The ABL800 FLEX with FLEXQ Module is an ABL800 FLEX Analyzer with the added optional capability of automatic sampling from of up to three blood samplers. Thus, the analyzer part of the ABL800 FLEX with FLEXQ is identical to the analyzer part of the ABL800 FLEX. As with the ABL800 FLEX, the ABL800 FLEX with FLEXQ Module consists of several models of the same analyzer for the measurement of blood gas, electrolyte, metabolite and co-oximetry. The FLEXQ module is designed to work with the vented arterial blood sampler, safePICO (subject of a separate 510(k) application).

In the sampler barrel the safePICO includes a magnetic steel ball that may be activated by the FLEXQ module for automatically mixing the sample before measurement. On the outside of the barrel, each safePICO sampler has a unique barcode that may be read by the FLEXQ module. The safePICO sampler is delivered with a new vented tip cap that allows the sampler to be vented after the appliance of the tip cap to the sampler. The sample is introduced into the analyzer by the inlet probe of the ABL800 FLEX Analyzer penetrating the top of the tip cap and entering the sampler.

Installing a FLEXQ module into an existing ABL800 FLEX Analyzer includes physically installing the module and loading upgraded software, which controls the function of the FLEXQ module. The FLEXQ module comprises a sampler tray with three slots for holding up to three samplers simultaneously. Each slot has an optical switch detecting the presence of a sampler. The FLEXQ module has a barcode reader, which can read out the barcode of the samplers. Further, the FLEXQ module includes a rotating magnet system located under the sampler tray, which interacts with the steel ball in the sampler barrel and thus automatically mixes the sample prior to measuring.

The provided text describes the ABL800 FLEX with FLEXQ Module, an in vitro diagnostic device, and its intended use. However, it does not include specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.

The document states: "Comparison tests verifying that the ABL800 FLEX with FLEXQ Module performs equivalent to the predicate devide ABL800 FLEX (K041874) will be performed." This indicates that a performance study was planned or conducted, but no results, methodology, or acceptance criteria from this study are presented in the provided text.

Therefore, many of the requested sections below cannot be populated from the given information.

1. Table of acceptance criteria and the reported device performance

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document states "Comparison tests... will be performed," implying a prospective study, but no details are given.

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

• This information is not applicable as the device measures objective quantities (blood gas, electrolytes, etc.) rather than relying on expert interpretation for ground truth.

4. Adjudication method for the test set

• Not applicable as ground truth is not established through expert 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

• This is not applicable. The device is an automated blood gas, co-oximetry, electrolyte, and metabolite analyzer. It does not involve human readers interpreting images or data in the context of AI assistance.

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

• Yes, the device is inherently a standalone algorithm/system for measuring parameters from blood samples. The FLEXQ module automates sample handling, mixing, and introduction to the analyzer. The analysis itself is performed by the instrument's electrochemical and optical systems.

7. The type of ground truth used

• For this type of device, ground truth would typically be established through reference methods (e.g., laboratory gold standard instruments, certified reference materials) for the various analytes (pH, pO2, pCO2, ions, glucose, lactate, bilirubin, hemoglobin fractions). However, the specific ground truth methods used in the comparison tests are not detailed in the provided text.

8. The sample size for the training set

• This information is not provided. As an in vitro diagnostic device performing direct measurements rather than using a complex machine learning model requiring extensive training data in the AI sense, a "training set" in the traditional machine learning context may not be directly applicable, or its details are not disclosed. Device calibration and internal quality control would involve internal data, but specific "training set" sizes are not mentioned.

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

• Not specified. As with the test set, ground truth for any internal calibration or validation (which might loosely be considered a "training" equivalent for non-AI devices) would likely be established using reference methods, but the document does not detail this.

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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.

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.

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