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Liquichek™ Blood Gas Plus Co-Oximeter Control (IL Synthesis Series) is an assayed quality control intended for use in monitoring the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis Co-Oximetry instrumentation.

Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) is a dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen and glucose.

This document describes the safety and effectiveness of the "Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series)" and seeks to establish its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device and the stability studies conducted. The goal is to demonstrate that the new device performs similarly to the predicate device and meets its stated stability claims.

2. Sample Size and Data Provenance (for test set)

The document states that "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series)." It also mentions that "All supporting data is retained on file at Bio-Rad Laboratories."

• Sample Size: The specific sample sizes (number of vials, replicates, lots, or dates during stability studies) used for the stability testing (which serve as the "test set" for the performance claims) are not explicitly stated in the provided text.
• Data Provenance: The data provenance is from Bio-Rad Laboratories, the submitter of the device. The study is a prospective stability study conducted on the new device, designed to support its stated claims. The country of origin for the data is implicitly the United States, as Bio-Rad Laboratories is based in Irvine, California, and the submission is to the FDA.

3. Number of Experts and Qualifications (for ground truth of test set)

This device is an assayed quality control material for laboratory instruments. The "ground truth" for its performance is typically established through analytical methods and instrument readings, not expert human interpretation. Therefore, the concept of "experts" in the traditional sense (e.g., radiologists) for establishing ground truth is not applicable here.

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method (for test set)

Since the ground truth is established through analytical measurements and a comparison to predefined stability limits and performance metrics, an adjudication method for human interpretation is not applicable. The performance is assessed against established measurement procedures and statistical analysis of the stability data.

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

• Was an MRMC study done? No.
• Effect Size: Not applicable, as this is an in-vitro diagnostic control material, not a diagnostic imaging aid for human readers.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone study done? Yes, to the extent that "standalone" refers to the device itself being tested independently to determine its inherent performance characteristics (stability, analyte values on compatible instruments). The stability studies are effectively a standalone performance assessment of the control material's behavior over time and under different conditions. The "Summary of Performance Data" directly reports on the outcomes of these studies.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

• Analytical Measurements/Instrument Readings: The stability studies involve repeatedly measuring the analytes (pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions) in the control material using specified instrumentation (IL Synthesis CO-Oximetry instrumentation) over time and under various storage conditions.
• Defined Chemical/Physical Properties: The control material is designed with predetermined levels of oxygen, carbon dioxide, nitrogen, and glucose, and its matrix is a buffered bicarbonate and electrolyte solution. The expected values for the analytes are what the device is "controlling" against.
• Comparison to Predicate Device: Substantial equivalence claims heavily rely on demonstrating that the new device's performance is comparable to the legally marketed predicate device, implying that the predicate's established performance serves as a reference point for acceptable ground truth.

8. Sample Size for the Training Set

This device is a quality control material, not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable. The manufacturing process for the control material involves precise formulation and quality checks, but not algorithmic training.

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

As there is no "training set" for this type of device, this question is not applicable.

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The IL Synthesis™ is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers that was cleared for market by K963800. A new measured co-oximeter parameter is being added on the IL Synthesis™ for the semiquantitative determination of total bilirubin in whole blood from neonates. Elevated bilirubin levels in the blood of newborns is used to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

The IL Synthesis™ is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers that was cleared for market by K963800. A new measured co-oximeter parameter is being added on the IL Synthesis™ for the semiquantitative determination of total bilirubin in whole blood from neonates.

Here's a breakdown of the acceptance criteria and study details for the IL Synthesis™ Bilirubin parameter, as presented in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific numerical thresholds for slope, intercept, or correlation coefficient. Instead, it describes what the results "showed" and concludes that they are "statistically similar" to the predicate device. For precision, specific acceptance criteria (e.g., maximum allowable SD) are not provided, only the observed SD values.

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

• Sample Size: 309 whole blood samples.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It only mentions "In a comparative performance study" and "whole blood samples."

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

• This device is an in-vitro diagnostic (IVD) device measuring a biomarker (bilirubin). The "ground truth" for the comparative study was established by another analytical method (the predicate device, Sigma's Bilirubin, Total and Direct on a spectrophotometer), not by clinical experts making diagnoses based on the results.
• Therefore, the concept of "experts establishing ground truth" as it would apply to image interpretation or clinical decision-making is not directly applicable here. The predicate device itself acts as the reference method.

4. Adjudication Method for the Test Set

• Not applicable. The study compares the new device's measurements against a reference method (the predicate device) directly. There is no human interpretation or adjudication involved in establishing the "ground truth" values for the bilirubin levels.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of an IVD device measuring a biomarker, not on human interpretation of images or data.

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

• Yes, this study is inherently a standalone performance evaluation of the device. The IL Synthesis™ analyzes samples automatically, and the performance data presented (comparative and precision) reflects the device's output without human intervention in the measurement process itself.

7. The Type of Ground Truth Used

• Comparative Ground Truth: The "ground truth" or reference for the comparative study was the measurement results from the predicate device: Sigma's Bilirubin, Total and Direct on a spectrophotometer. This is a form of reference method comparison or method comparison validation.
• Precision Ground Truth: For the precision study, the ground truth is simply the intrinsic variability of the device measuring the same sample multiple times.

8. The Sample Size for the Training Set

• The document describes a 510(k) submission for an already existing device (IL Synthesis™) with the addition of a new measured parameter (Bilirubin). It does not provide information about a "training set" in the context of machine learning. IVD device development typically involves analytical validation studies rather than machine learning training sets.
• If we interpret "training set" as the data used to initially develop and optimize the bilirubin measurement method for the IL Synthesis™, that information is not provided in this summary. The 309 samples described are for performance validation against the predicate.

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

• As noted above, the concept of a "training set" and its "ground truth" in the machine learning sense is not applicable or detailed in this 510(k) summary for an IVD device. The summary focuses on the validation of the new parameter's performance against a legally marketed predicate device.

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The IL Synthesis (hardware, software, and reagents) is for the quantitative in vitro diagnostic determination of pH, pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen), sodium (Na+), potassium (K+), calcium (Ca++), chloride (C1-), glucose (Glu), and Hematocrit (conductivity) in whole blood or pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen) in expired gases by direct ion selectrode (ISE) petentiometry. Sodium and potassium results are used to monitor electrolyte balance. Note that the number of electrodes is limited and any given instrument will only contain two of the three functions: calcium (Ca++), chloride (Cl-) and Glucose (Glu).

The IL Synthesis (hardware, software, and reagents) also permits the quantitative in vitro diagnostic determination of five forms of hemoglobin in whole blood samples, total hemoglobin (tHb), oxyhemoglobin (%O2Hb), carboxyhemoglobin (%COHb), methemoglobin (MetHb) and reduced hemoglobin, also called deoxyhemoglobin (%RHb) and will also calculate the following parameters: oxygen content of hemoglobin (O ct) oxygen binding capacity (O2 cap) and oxygen saturation (sO2m).

The IL Synthesis is designed for laboratory use to provide both measured and calculated results for blood gases, electrolytes, substrates, and co-oximeters on blood and gas samples.

The IL Synthesis is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers. Its technology combines that of the IL BGElectrolytes Analyzer (IL 1400/1430) and the IL BGGE Blood Gas with Glucose Analyzer (IL 1660) with an integrated co-oximeter module - The IL Synthesis will be available in several different configurations of blood gas, electrolytes. co-oximeter, and glucose.

Here's an analysis of the provided text regarding the IL Synthesis device, categorized by your requests.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific performance thresholds that the device must meet (e.g., pH %CV must be

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