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510(k) Data Aggregation
(224 days)
The S-Test Carbon Dioxide Reagent is intended for the quantitative determination of carbon dioxide concentration in serum or heparin plasma using the S40 Clinical Analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Carbon dioxide (CO2) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CO2 in serum or heparin plasma based on a photometric test measuring the formation of an enzymatic cofactor in a coupled enzymatic reaction. The S-Test CO2 Reagent is contained in a bi-reagent cartridge. Reagent 1 contains water and a preservative. Reagent 2 contains phosphoenolpyruvate, nicotinamide adenine dinucleotide analog (reduced), phosphoenol pyruvate carboxylase, and malate dehydrogenase.
The provided text describes the 510(k) summary for the S-Test CO2 Reagent cartridge, used with the S40 Clinical Analyzer, for the quantitative in vitro diagnostic determination of CO2 in serum or heparin plasma.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format. Instead, it presents performance data used to demonstrate substantial equivalence. The reported performance is summarized below:
| Performance Metric | Reported Device Performance | Acceptance Criteria (Implicit) |
|---|---|---|
| Precision (Within-run CV) | In-house (21 days, 3 CO2 levels): 1.7% to 3.0% | Not explicitly stated, but results are assumed to be acceptable for clinical use and substantially equivalent to predicates. |
| POL sites (5+ days, 3 CO2 levels): 1.3% to 6.6% | Not explicitly stated, but results are assumed to be acceptable for clinical use and substantially equivalent to predicates. | |
| Precision (Total CV) | In-house (21 days, 3 CO2 levels): 5.7% to 6.7% | Not explicitly stated, but results are assumed to be acceptable for clinical use and substantially equivalent to predicates. |
| POL sites (5+ days, 3 CO2 levels): 2.0% to 6.6% | Not explicitly stated, but results are assumed to be acceptable for clinical use and substantially equivalent to predicates. | |
| Accuracy (Correlation with comparison method) | Correlation Coefficient: 0.984 (across 94 samples, 6.0 to 41.8 mEq/L) | Not explicitly stated, but typically a correlation coefficient close to 1 (e.g., >0.95 or >0.975) is considered excellent for clinical correlation studies. The value of 0.984 is very strong. |
| Standard Error Estimate: 1.1 | Not explicitly stated. | |
| Confidence Interval Slope: 0.940 to 1.029 | Not explicitly stated, but a slope covering 1.0 indicates good agreement. | |
| Confidence Interval Intercept: -0.6 to 1.5 | Not explicitly stated, but an intercept covering 0 indicates good agreement. | |
| Accuracy (Patient correlation at POL sites) | Correlation Coefficients: 0.937 to 0.980 | Not explicitly stated, but generally indicative of good correlation. |
| Standard Error Estimates: 1.40 to 2.65 | Not explicitly stated. | |
| Confidence Interval Slopes: 0.880 to 1.080 | Not explicitly stated, but generally covering 1.0 indicating good agreement. | |
| Confidence Interval Intercepts: -1.73 to 2.03 | Not explicitly stated, but generally covering 0 indicating good agreement. | |
| Sensitivity (Detection Limit) | 5 mEq/L | Not explicitly stated, but typically this is compared to the clinical requirements for detecting low levels of CO2. |
2. Sample size used for the test set and the data provenance
- Sample Size for Accuracy/Correlation Study: 94 samples.
- Sample Size for Precision Studies: Not explicitly stated as a number of individual samples, but conducted at "three CO2 levels" for 21 days for in-house and "three separate Physician Office Laboratory (POL) sites" over "five or more days" for POL precision. This implies multiple measurements per level/site.
- Data Provenance: The studies were conducted "in-house" and at "three separate Physician Office Laboratory (POL) sites." The country of origin is not specified but is implied to be within the United States, given the FDA submission. The nature of the studies (precision, accuracy, sensitivity) suggests they are prospective evaluations of the device's performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for accuracy was established by a "comparison method" and at "POL sites using the S40 Clinical Analyzer and a comparative method." This implies that the ground truth was derived from a previously validated or predicate method/device, rather than expert consensus on individual samples.
4. Adjudication method for the test set
Not applicable. There is no mention of independent interpretation or adjudication of results by multiple individuals. The performance data is based on quantitative measurements.
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 device is a diagnostic reagent cartridge used with an analyzer, not an imaging or AI-assisted diagnostic device that involves human readers interpreting diagnostic outputs in the way an MRMC study would assess.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is essentially a standalone (algorithm/device-only) performance study, as the device measures CO2 quantitatively. The stated performance metrics (precision, accuracy, sensitivity) reflect the device's direct analytical capability.
7. The type of ground truth used
The ground truth for the accuracy study was established by a "comparison method" or "comparative method." This typically refers to a well-established, validated, and often predicate or reference method for CO2 measurement. It is not pathology, expert consensus, or outcomes data in this context.
8. The sample size for the training set
Not applicable. This is a chemical reagent and analyzer system, not a machine learning or AI-based device that typically requires a "training set" in the computational sense. The device's operational parameters would have been developed and validated through laboratory testing and optimization, but not referred to as a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a "training set" in the context of this device.
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