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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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