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510(k) Data Aggregation
(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 < 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)
| Parameter | Level | n | Reported Max %CV (across instruments) |
|---|---|---|---|
| pH | 1 | 60 | 0.19 |
| 2 | 60 | 0.09 | |
| 3 | 60 | 0.08 | |
| pCO2 (mmHg) | 1 | 60 | 1.81 |
| 2 | 60 | 1.23 | |
| 3 | 60 | 1.29 | |
| pO2 (mmHg) | 1 | 60 | 0.61 |
| 2 | 60 | 1.84 | |
| 3 | 60 | 3.79 | |
| Na (mmol/L) | 1 | 60 | 0.77 |
| 2 | 60 | 0.65 | |
| 3 | 60 | 1.42 | |
| K (mmol/L) | 1 | 60 | 2.05 |
| 2 | 60 | 1.37 | |
| 3 | 60 | 2.27 | |
| Ca (mmol/L) | 1 | 60 | 1.82 |
| 2 | 60 | 2.84 | |
| 3 | 60 | 1.14 | |
| Cl (mmol/L) | 1 | 60 | 4.01 |
| 2 | 60 | 1.13 | |
| 3 | 60 | 0.58 | |
| Gluc (mg/dL) | 1 | 60 | 2.88 |
| 2 | 60 | 3.83 | |
| 3 | 60 | 3.72 | |
| Hct (%) | Low | 12 | 1.31 |
| High | 12 | 1.39 |
CO-Oximeter Imprecision (tHb, %O2Hb, %COHb, %MetHb)
| Parameter | Level | n | Reported Max %CV (across instruments) |
|---|---|---|---|
| tHb (mg/dL) | 1 | 15 | 5.42 |
| 2 | 15 | 4.68 | |
| 3 | 15 | 5.12 | |
| O₂Hb (%) | 1 | 15 | 0.34 |
| 2 | 15 | 0.08 | |
| 3 | 15 | 0.35 | |
| COHb (%) | 1 | 15 | 0.28 |
| 2 | 15 | 1.04 | |
| 3 | 15 | 0.94 | |
| MetHb (%) | 1 | 15 | 8.83 |
| 2 | 15 | 4.79 | |
| 3 | 15 | 9.72 |
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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