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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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IL Test™ ContrIL Spectrum is an in vitro diagnostic quality control material equilibrated with specific concentrations of carbon dioxide and oxygen and with a known level of sodium, potassium, calcium, chloride and glucose and available in three levels to simulate clinically significant conditions of acid base, electrolytes and glucose balance and oxygenation status. The following parameters can be monitored with IL Test™ ContrIL Spectrum: pH/pCO2/pO2/Na+/ K+/Ca++/Cl-/Glucose/THb/O2Hb/COHb/MetHb/RHb.

IL Test™ ContrIL Spectrum is an in vitro diagnostic quality control material equilibrated with specific concentrations of carbon dioxide and oxygen and with a known level of sodium, potassium, calcium, chloride and glucose and available in three levels to simulate clinically significant conditions of acid base, electrolytes and glucose balance and oxygenation status. The following parameters can be monitored with IL Test™ ContrIL Spectrum: pH/pCO2/pO2/Na+/ K+/Ca++/Cl-/Glucose/THb/O2Hb/COHb/MetHb/RHb.

The provided document is a 510(k) summary for the IL Test™ ContrIL Spectrum, an in vitro diagnostic quality control material. It describes the device's intended use and presents performance data. However, the document does not establish explicit "acceptance criteria" in the form of predefined performance thresholds that the device must meet.

Instead, the study presented is primarily a performance summary demonstrating the consistency and expected values of different analytes within the quality control material at various levels. The "acceptance" is implicitly based on showing that the control material consistently yields quantifiable results for the listed parameters with acceptable precision (indicated by %CV, Coefficient of Variation) across different levels. The 510(k) clearance process focuses on substantial equivalence to predicate devices, and the performance data supports this claim by showing similar performance characteristics.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria (e.g., "pH must be within X% of target" or "CV must be less than Y%") are not stated in the provided document. The table below presents the reported device performance for the IL Test™ ContrIL Spectrum for each measured parameter at three different levels. The "acceptance criteria" for a quality control material would typically relate to its ability to consistently produce specific, known values within a small range of variability, which is what the "Grand Mean" and "Within Run %CV" data demonstrate.

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of runs, number of vials, number of measurements) used to generate the "Within Run %CV" data. It reports "Grand Mean" and "Within Run %CV" for each parameter at three levels, which implies a series of measurements were taken, but the exact N is not provided.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a 510(k) submission from Instrumentation Laboratory Company based in Lexington, MA, USA, suggesting the study likely took place in the US or was overseen by the US-based company.

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

• This device is a quality control material for laboratory instruments, not a diagnostic device that interprets patient data. Therefore, the concept of "experts establishing ground truth" in the context of clinical interpretation (like radiologists for imaging) does not apply here.
• The reported "Grand Mean" values are derived from analytical measurements using laboratory instruments. The "ground truth" for the test set is established by the analytical methods and instrumentation used to determine the values and assess the precision of the control material. There is no mention of human experts in this context.

4. Adjudication Method for the Test Set

• Since the "ground truth" is established by analytical measurements rather than expert human interpretation, there is no adjudication method described as would be relevant for subjective assessments (e.g., 2+1, 3+1). The "Grand Mean" and "Within Run %CV" are statistical calculations from direct measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI Assistance

• No. This is a quality control material for laboratory instrumentation, not an AI-powered diagnostic device. Therefore, an MRMC comparative effectiveness study with human readers (with or without AI assistance) is not applicable and was not performed.

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

• This is a laboratory quality control material, not an algorithm or AI device. Therefore, the concept of "standalone algorithm performance" is not applicable. The performance presented relates to the analytical capabilities of the quality control material itself when measured by laboratory instruments.

7. The Type of Ground Truth Used

• The "ground truth" for this quality control material is established through analytical measurements using laboratory instruments. The "Grand Mean" for each parameter represents the assigned value for that specific level of control material, determined by rigorous laboratory procedures and validated instrumentation. The "Within Run %CV" indicates the precision around this established mean. It is essentially an "assigned value" based on a reference method or highly controlled measurement process.

8. The Sample Size for the Training Set

• This device is a physical quality control material, not a machine learning model. Therefore, the concepts of a "training set" and "training set sample size" are not applicable. The data presented are performance characteristics of the manufactured control material.

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

• Since there is no "training set" for a machine learning model, this question is not applicable. The determination of the "Grand Mean" values for the quality control material would have been established during its manufacturing and characterization process, likely through extensive testing and calibration against reference standards, to ensure each lot has consistent and known values for the listed analytes.

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