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510(k) Data Aggregation
(37 days)
to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX 3 System
CO2 Alkaline Buffer, Procedure Number C7683
Here is an analysis of the provided text based on your request, focusing on the acceptance criteria and study details for the Sigma Diagnostics CO2 Alkaline Buffer:
This 510(k) premarket notification describes a new device (Sigma Diagnostics CO2 Alkaline Buffer) and demonstrates its substantial equivalence to a predicate device (Beckman CO2 Alkaline Buffer Kit). The study's primary goal is to show that the new device performs as safely and effectively as the existing one.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Sigma Diagnostics CO2 Alkaline Buffer) |
|---|---|---|
| Substantial Equivalence | Demonstrated substantial equivalency to Beckman CO2 Alkaline Buffer Kit | Achieved |
| Correlation | Correlation coefficient with predicate device | 0.992 |
| Regression Equation | Regression equation with predicate device | y = 0.95x + 1.54 |
| Within-run Precision (%CV) | %CV < 6.5% | < 6.5 % |
| Total Precision (%CV) | %CV < 6.5% | < 6.5 % |
| Linearity Range | Linear from 5.0 to 40.0 mmol/L | Linear from 5.0 to 40.0 mmol/L |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "In comparison studies, a correlation coefficient of 0.992 and a regression equation of y = 0.95x + 1.54 was obtained with serum samples."
- Sample Size: The specific number of serum samples used for the comparison studies is not explicitly stated in this document.
- Data Provenance: The country of origin of the data is not specified. The samples are described as "serum samples," implying they were clinical specimens, but whether they were retrospective or prospectively collected is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes an in vitro diagnostic (IVD) device for measuring CO2 concentration. The "ground truth" for evaluating such devices is typically established through direct comparison with a validated method or a predicate device.
- Number of Experts: Experts are not directly applicable in the context of establishing ground truth for quantitative chemical measurements in this manner. The ground truth is intrinsically linked to the measurement provided by the reference (predicate) method.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human interpretation of medical images or subjective assessments are involved. This is an in vitro diagnostic device measuring chemical concentrations.
- Adjudication Method: Not applicable to this type of study. The comparison is objective and quantitative.
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
This document describes the validation of an in vitro diagnostic device using a quantitative chemical assay. It is not an AI-assisted diagnostic or imaging device study.
- MRMC Study: No, an MRMC comparative effectiveness study was not done.
- Effect Size of Human Readers Improvement with/without AI: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an in vitro diagnostic device, and its performance is inherently standalone in the sense that the assay itself generates the result without real-time human interpretation influencing the measurement. The SYNCHRON CX 3 System is an automated analyzer.
- Standalone Performance: Yes, the performance described is that of the assay kit (Sigma Diagnostics CO2 Alkaline Buffer) when used on the SYNCHRON CX 3 System, generating a numerical output. This is a standalone performance of the diagnostic test itself.
7. The Type of Ground Truth Used
The ground truth for this study is based on the measurements obtained from the predicate device (Beckman CO2 Alkaline Buffer Kit). The comparison studies establish how well the new device's measurements correlate with those of the established, equivalent device.
- Type of Ground Truth: Measurements from a validated predicate device (Beckman CO2 Alkaline Buffer Kit).
8. The Sample Size for the Training Set
This document describes a performance validation study for an IVD device, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable here.
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML study, the concept of a "training set" and establishing its ground truth in that context is not relevant. The "ground truth" for the comparison study was derived from the predicate device's measurements on the "serum samples."
- How Ground Truth for Training Set Was Established: Not applicable.
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