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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 < 0.1%). Instead, it presents performance data (imprecision) from an internal study conducted on the IL Synthesis™. The reported device performance is shown in the tables below, representing the "Between Day Imprecision" for various parameters.

Blood Gas and Electrolyte Imprecision (pH, pCO2, pO2, Na, K, Ca, Cl, Glu, Hct)

CO-Oximeter Imprecision (tHb, %O2Hb, %COHb, %MetHb)

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

• Blood Gas, Electrolytes, Glucose:
  • Sample Size: For pH, pCO2, pO2, Na, and K, 60 replicates (5 replicates/day for 12 days) were run on each of three IL Synthesis instruments. For Ca, Cl, and Glu, 60 replicates were run on each of two IL Synthesis instruments.
  • Data Provenance: "The data were collected during in-house studies." This indicates the data is retrospective from internal company testing, likely conducted in the US (given the Lexington, MA address).
• Hematocrit:
  • Sample Size: 12 replicates (2 levels of Hct CHECK, run for 12 days) on each of three instruments.
  • Data Provenance: "The data were collected during in-house studies." (Retrospective, likely US).
• CO-Oximeter:
  • Sample Size: 15 replicates (5 replicates/day for 3 days) for each parameter at each of three levels, on each of three IL Synthesis instruments.
  • Data Provenance: "The data were collected during in-house studies." (Retrospective, likely US).

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

This document describes performance testing of a diagnostic laboratory instrument rather than an AI/ML device relying on human expert labels for ground truth. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here.

For this type of device, the "ground truth" is typically established by:

• The known, certified values of the quality control materials used (Contrill Plus, Hct CHECK, dye-based controls).
• The inherent accuracy and precision of the analytical methods themselves, which are validated against reference methods or certified standards during the development process.

The document does not specify the qualifications of individuals performing these imprecision tests, but they would be laboratory technicians or scientists familiar with operating and calibrating the instruments and handling QC materials.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/ML device whose output requires clinical interpretation or consensus among experts, there is no adjudication method described or needed. The performance is based on direct measurement outputs compared against the known values of control materials.

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 laboratory diagnostic instrument, not an AI/ML device intended to assist human readers or clinicians in interpreting complex data like images. Therefore, an MRMC study is not relevant to its evaluation.

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

The performance data presented IS standalone performance of the device (i.e., the instrument's intrinsic ability to measure parameters on control materials) without human intervention in the interpretive process. The "algorithm" here refers to the instrument's internal measurement and calculation processes. There is no explicit "human-in-the-loop" component for performance evaluation beyond operating the device and analyzing the raw numerical results.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the performance study (imprecision) was established using certified quality control materials (Contrill Plus, Hct CHECK, dye-based controls) with known target values for the measured parameters. This is a common and accepted method for assessing the analytical performance of in vitro diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. The IL Synthesis™ is a traditional in vitro diagnostic instrument, not an AI/ML device that requires a training set. Its internal logic and calibration are based on established physicochemical principles and engineering, not machine learning from a data set.

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

Not applicable, as there is no "training set" for this type of device. The ground truth for the development and calibration of such instruments is typically based on:

• Reference materials with known, traceable values.
• Physical principles of measurement (e.g., ion-selective electrode chemistry, spectrophotometry).
• Rigorous analytical validation against other established methods.

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