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510(k) Data Aggregation
(23 days)
The Oxyhemoglobin Control for CO-Oximetry is intended for use to monitor CO-oximetry measurements of hemoglobin and hemoglobin fractions in instruments which measure the optical absorption characteristics of whole blood at specific wavelengths.
To make possible verification of instrument performance at different points for each analyte, the Control has different clinically significant values for total hemoglobin, oxyhemoglobin, carboxyhemoglobin and methemoglobin.
This product is for In Vitro Diagnostic Use only.
The measurement of the concentrations of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, and methemoglobin can serve to monitor tissue oxygenation and therefore the various metabolic factors which effect oxygen transport of blood. Since therapeutic regimes are often determined by the result obtained in patient samples, the instruments used for these analyses must meet clinical requirements for precision and accuracy. The use of control materials are designed to verify test results and assist in identifying instrument calibration or operating problems.
Oxyhemoglobin CO-Oximeter Control is prepared by purifying bovine blood to different to different concentrations of hemoglobin. The solution is then treated with oxygen, carbon dioxide and carbon monoxide to provide different defined values for the hemoglobin fractions of oxyhemoglobin, carboxyhemoglobin and methemoglobin. The solution is packaged in sealed glass ampuls to assure the integrity of all control values. The material contains no human based materials.
Here's a breakdown of the acceptance criteria and study information for the Bionostics Oxyhemoglobin CO-Oximeter Control, based on the provided text:
Acceptance Criteria and Device Performance
The provided text does not contain a specific table of numerical acceptance criteria (e.g., specific thresholds for accuracy, precision, or bias) or direct reporting of the device's performance against such criteria. Instead, the general conclusion is that the device provides "sufficient accuracy and precision" and "suitable" performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy and Precision | Expected to ensure the device is suitable for monitoring performance of CO-oximeters and provides values for total hemoglobin and hemoglobin fractions. To be comparable to predicate devices. | The Oxyhemoglobin CO-Oximeter Control "provides sufficient accuracy and precision in measurements of total hemoglobin and hemoglobin fractions to be suitable for monitoring the performance of CO-oximeters." |
| Suitability for different CO-oximeter models | Expected to work across various CO-oximeter models despite differing operating methodologies. | "The test results show suitable [performance] of the product for use on different CO-oximeter models, each of which employ slightly differing operating methodology." |
| Substantial Equivalence | Performance should be substantially equivalent to predicate products with similar intended uses. | "The data collected shows the product has substantially equivalent performance to the predicate products which have similar intended uses." |
| Intended Use Fulfillment | Ability to monitor CO-oximetry measurements of hemoglobin and hemoglobin fractions. | The testing verified the control material's ability to fulfill its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The exact sample size (number of control ampuls tested or number of measurements/replicates) is not explicitly stated. It mentions "The Oxyhemoglobin CO-Oximeter Control was tested for performance as a quality control material on 8 of CO-oximeter instrument models." This suggests testing across different instrument types rather than just a large volume of the control material on a single instrument.
- Data Provenance: The testing "took place in both the Bionostics' lab as models. well as in clinical laboratories." This indicates both internal testing and external validation in real-world clinical settings. There is no specific country of origin mentioned beyond "Bionostics, Inc" in Acton, MA, USA, and "Instrumentation Laboratory, Lexington, MA" for the predicate device. The study appears to be prospective in nature, as it describes the testing of a newly developed control material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The concept of "experts" establishing ground truth in the context of a quality control material like this is not directly applicable in the same way it would be for diagnostic imaging or clinical interpretation studies.
For a CO-Oximeter control, the "ground truth" or reference values are established through the precise formulation and characterization of the control material itself, using validated analytical methods. The text describes: "The solution is then treated with oxygen, carbon dioxide and carbon monoxide to provide different defined values for the hemoglobin fractions of oxyhemoglobin, carboxyhemoglobin and methemoglobin." These defined values are the ground truth for the control. The "experts" in this context would be the analytical chemists and laboratory personnel who developed and characterized the control, ensuring the accuracy of these defined values. Their specific number or qualifications are not provided in the summary, but it's implicit that they are qualified in analytical chemistry and quality control manufacturing.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of data (e.g., medical images) requires consensus. This concept is not applicable to the evaluation of a laboratory quality control material. The performance of the control is judged by its analytical measurements on instruments, not by human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was performed. MRMC studies are used to evaluate the impact of a device on human reader performance, typically in diagnostic tasks. This device is a quality control material, not a diagnostic tool that a human "reads" or interprets to make a clinical decision. Its purpose is to monitor instrument performance.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done. The "BIONOSTICS Oxyhemoglobin CO-Oximeter Control" is the device, and its performance as a standalone quality control material was evaluated. The study assessed how reliably its defined values could be measured by various CO-oximeters and how consistently it performed. Its "performance" refers to its stability and its ability to yield expected results when measured by an instrument.
7. Type of Ground Truth Used
- Defined, manufactured values: The ground truth for the control material itself is based on the precise chemical preparation and characterization of the bovine blood solution, where specific concentrations of hemoglobin fractions are "defined" by the manufacturing process. The material is "treated with oxygen, carbon dioxide and carbon monoxide to provide different defined values for the hemoglobin fractions..." These defined values serve as the reference against which the CO-oximeters' measurements are compared.
8. Sample Size for the Training Set
- Not Applicable / Not Provided. This device is a chemical control material, not an AI or machine learning algorithm that requires a "training set." The concept of a training set is relevant for devices that learn from data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this type of device, this question is not relevant.
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