Search Results

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.

Ask a specific question about this device

The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.

The ABL700 Series Analyzer with the AutoCheck module is an ABL700 Analyzer with the added capability of performing automated analysis of quality control fluids. The AutoCheck module is designed to work with a quality control fluid system named AutoCheck 5+. The AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids in AutoCheck 5+ correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135).

The AutoCheck 5+ ampoules comprise a cap on the top of the ampoules designed to break the top of an ampoule when it is to be used. Furthermore, each ampoule has a bar code containing information on the specific level and lot of the quality control fluid.

Installing an AutoCheck module into an existing ABL700 Series Analyzer includes physically installing the module and loading upgraded software which controls the function of the AutoCheck module. The AutoCheck module comprises an ampoule carrousel carrying 20 ampoules of quality control fluid and further comprises a bar code reader for reading the bar code located on each ampoule. When installed into the ABL700 Series Analyzer, the AutoCheck module automatically performs the quality control of the analyzer. Thus, when a quality control is due, the analyzer warns the user and if the user accepts, the quality control is performed. The software selects the appropriate ampoule, the AutoCheck module opens the ampoule by pressing the cap through the top of the ampoule, the quality control fluid is automatically introduced into the analyzer inlet and the measurements are performed. The upgraded software controls all steps. If required, a manual quality control may be performed as well.

The provided text describes a medical device, the ABL700 with AutoCheck Module, and its 510(k) submission for market clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the statistical metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in such a study report.

The document focuses on:

• Product Description: How the AutoCheck module adds automated quality control functionality to the ABL700 analyzer.
• Intended Use: The parameters measured (pH, pCO2, pO2, etc.) and the types of samples (human arterial/venous and capillary whole blood).
• Technological Characteristics vs. Predicate Device: Stating it's "Similar to the ABL700 Series."
• Substantial Equivalence: Claiming it's substantially equivalent to the existing ABL700 Series (K980130).

The mention of "automated analysis of quality control fluids" is the closest it comes to a performance claim, but no specific performance targets or results are presented.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's an attempt to answer based on the available information, noting where data is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The document refers to "automated analysis of quality control fluids" but does not detail a specific test study with a defined sample size of these fluids.
• Data Provenance: Not specified.

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

• Number of Experts: Not applicable/Not specified. Ground truth for automated quality control measurements on a device would typically be established by comparing against known reference values of the quality control fluids, not expert consensus.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not specified.

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 is not an MRMC study. The device is an automated blood gas analyzer with an automated quality control module. It does not involve human readers interpreting medical images or data that would be assisted by AI.

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

• Standalone Performance: Yes, implicitly this device operates in a standalone manner for its quality control function. The AutoCheck module "automatically performs the quality control of the analyzer." However, specific performance metrics for this standalone function are not provided.

7. The type of ground truth used

• Type of Ground Truth: For quality control fluids, the ground truth would typically be the known, certified values of the analytes (pH, pCO2, pO2, etc.) within the quality control solutions themselves. The document mentions "AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids...correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135)," indicating the use of commercial quality control materials with established values.

8. The sample size for the training set

• Sample Size (Training Set): Not specified. The device is an analyzer for blood gases and electrolytes, not an AI/ML algorithm that would typically have a "training set" in the conventional sense of machine learning. The "upgraded software" mentioned controls the automated quality control process, but the document does not describe its development in terms of a training set.

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

• Ground Truth Establishment (Training Set): Not applicable/Not specified, as this is not a traditional AI/ML training context for which a ground truth for a training set would be established. The "ground truth" for the device's functionality would be the accuracy and precision of its measurements against known standards, including those provided by the quality control fluids.

Ask a specific question about this device

Per 21 CFR, 682.2160, the ALCYON Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The analyzer with the optional Ion-Selective Electrode (ISE) Module measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.

The ALCYON Analyzer is an automated open system for quantitative analysis of clinical chemistries. The ALCYON Analyzer has an optional Ion-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.

This document describes the 510(k) submission for the Abbott ALCYON™ Analyzer, a clinical chemistry analyzer. The submission demonstrates substantial equivalence to previously cleared devices through performance characteristics, specifically correlation analysis, linearity, and precision.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ALCYON Analyzer are established by demonstrating substantial equivalence to predicate devices. This is primarily shown through correlation analysis, where the ALCYON Analyzer's results for various assays are compared to those of the predicate devices. While explicit "acceptance criteria" are not numerically stated as thresholds, the high correlation coefficients and acceptable linearity and precision values demonstrate that the device performs comparably to established analyzers.

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

The document does not explicitly state the specific sample sizes used for the correlation analysis, linearity studies, or precision studies. It mentions "representative methods" and "normal and abnormal controls" for precision, implying a set of samples were run for each.
The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text.

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

This type of information is not applicable to the evaluation of a clinical chemistry analyzer in this context. The "ground truth" for the performance of such a device is typically established by comparing its analytical results to those of a predicate device, which itself is an established and validated analytical instrument. There is no mention of human experts interpreting results for the purpose of establishing ground truth for the device's performance.

4. Adjudication Method for the Test Set

Not applicable. The evaluation of a clinical chemistry analyzer generally involves direct analytical comparison to predicate devices, not human adjudication of results in the traditional sense of image or clinical interpretation.

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 a clinical chemistry analyzer, not a diagnostic imaging or AI-assisted diagnostic device that involves human readers interpreting results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented (correlation, linearity, precision) are all standalone performance evaluations of the ALCYON Analyzer. The device is designed for automated quantitative analysis, and its performance is assessed based on its ability to accurately and precisely measure analytes compared to established methods.

7. The Type of Ground Truth Used

The ground truth for the performance of the ALCYON Analyzer is the analytical results obtained from predicate devices. For example, in the correlation analysis, the results from the ALCYON Analyzer are compared to results obtained from "the Roche® Cobas® Mira Plus" and other predicate analyzers mentioned for electrolytes. The assumption is that these predicate devices provide an accepted and validated "ground truth" for analyte concentrations or activity.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional automated clinical chemistry analyzer, not an AI/ML device that requires a distinct "training set" in the context of machine learning. The term "training set" is generally used when an algorithm learns from data; for this type of device, calibration materials are used to "train" the instrument to accurately measure analytes, but this is a different concept than an AI training set.

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

Not applicable in the AI/ML sense. For traditional clinical chemistry analyzers, "training" involves calibration using materials ("calibrators") with known concentrations. These known concentrations are the "ground truth" for establishing the instrument's calibration curve or response function. The text states:

• "For analytes, all three analyzers determine the concentration of unknown samples from a standard curve generated with known analyte concentrations."
• "All analyzers are calibrated with known concentration calibrator material."

Ask a specific question about this device