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510(k) Data Aggregation
(15 days)
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.
| Parameter | Grand Mean (Level 1) | Within Run %CV (Level 1) | Grand Mean (Level 2) | Within Run %CV (Level 2) | Grand Mean (Level 3) | Within Run %CV (Level 3) |
|---|---|---|---|---|---|---|
| pH | 7.59 | 0.03 | 7.41 | 0.02 | 7.13 | 0.03 |
| pCO2 (mmHg) | 20.80 | 1.98 | 37.81 | 1.81 | 64.91 | 1.43 |
| pO2 (mmHg) | 145.94 | 1.69 | 87.80 | 3.71 | 52.05 | 4.89 |
| Na+ (mmol/L) | 114.66 | 0.62 | 137.46 | 0.40 | 157.20 | 0.59 |
| K+ (mmol/L) | 2.57 | 2.93 | 4.33 | 1.65 | 5.99 | 1.04 |
| Ca++ (mmol/L) | 0.62 | 1.82 | 1.00 | 1.40 | 1.54 | 1.69 |
| Cl- (mmol/L) | 83.06 | 0.66 | 110.03 | 0.53 | 137.60 | 0.40 |
| Glu (mg/dL) | 60.74 | 3.79 | 84.49 | 2.43 | 233.29 | 2.04 |
| THb | 7.1 | 3.64 | 13.4 | 3.35 | 18.0 | 2.73 |
| % COHb | 54.1 | 0.32 | 4.0 | 1.17 | 96.6 | 0.06 |
| % O2Hb | 44.9 | 0.38 | 93.6 | 0.13 | 1.9 | 0 |
| % MetHb | 0.5 | 3.21 | 1.8 | 5.77 | 1.5 | 5.30 |
| % RHb | 0.5 | 1.85 | 0.6 | 3.86 | 0.002 | 4.40 |
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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(51 days)
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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