(130 days)
The Total CO2 electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of carbon dioxide in serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
ELITech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), chloride (Cl-) and carbon dioxide (Total CO2) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.
The ELITech Clinical Systems ISE Total CO2 Electrode system is comprised of the electrodes plus ISE Reference Solution, ISE Diluent, ISE Calibrators.
Here's a breakdown of the acceptance criteria and study information for the ELITech Clinical Systems ISE TotalCO2 Electrode and ISE Calibrators, based on the provided text:
Key Takeaway: This document is a 510(k) summary for a medical device (Total CO2 electrode and calibrators). It focuses on demonstrating substantial equivalence to a previously approved predicate device, not on validating novel performance claims. As such, the "acceptance criteria" and "study" described are primarily for demonstrating equivalence, especially concerning analytical performance (precision and method comparison). Given this is a 510(k), it is an analytical study, not a clinical study to diagnose disease.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the comparison to the predicate device, aiming to show performance that is either equivalent or better. Specific acceptance criteria are not explicitly stated in a quantitative form, but rather the performance data is presented for comparison.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ELITech Clinical Systems) | Predicate Device Performance (Roche Diagnostics) |
|---|---|---|---|
| Measuring Range (Total CO2) | To be comparable to predicate (0.5-50 mmol/L) | 10.8 - 43.0 mEq/L | 0.5-50 mmol/L |
| Precision (Total CO2) | To be comparable to predicate | Within run: | Within run: |
| L1 (12.1 mEq/L): CV=3.9% | L1 (18.7mmol/L): CV=0.72% | ||
| L2 (19.9 mEq/L): CV=2.3% | L2 (31.6 mmol/L): CV=0.84% | ||
| L3 (27.5 mEq/L): CV=2.3% | L3 (9.09 mmol/L): CV=1.34% | ||
| Total: | L4 (24.9 mmol/L): CV=0.67% | ||
| L1 (12.1 mEq/L): CV=6.8% | Total: | ||
| L2 (19.9 mEq/L): CV=5.4% | L1 (18.2mmol/L): CV=1.41% | ||
| L3 (27.5 mEq/L): CV=5.2% | L2 (31.2 mmol/L): CV=0.81% | ||
| L3 (8.30 mmol/L): CV=2.23% | |||
| L4 (23.7 mmol/L): CV=1.04% | |||
| Method Comparison (Total CO2) | Correlation (r) and slope (y=mx+b) comparable to predicate | $y=0.908x + 2.2 mEq/L$, r=0.985, range: 9.7 to 44.9 mEq/L | $y=1.019x - 0.19 mmol/L$, r=0.9995, range: 2.46 to 46 mmol/L |
| Interferences (Total CO2) | No significant interference within specified limits comparable to predicate | Unconjugated bilirubin: No significant interference up to 30 mg/dL (513 μmol/L). | Icterus: No significant interference up to 60 mg/dL for conjugated and unconjugated bilirubin |
| Conjugated bilirubin: No significant interference up to 29.5 mg/dL (504 μmol/L). | |||
| Hemoglobin: No significant interference up to 300 mg/dL. | Hemoglobin: No significant interference up to an H index of 1000 (approximate haemoglobin concentration 1000 mg/dL). | ||
| Turbidity: No significant interference up to 614 mg/dL (7 mmol/L). | Lipemia: No significant interference up to an L index of 2000. | ||
| Acetylsalicylate: No significant interference up to 40 mg/dL (2.2 mmol/L). Concentrations above therapeutic levels will interfere. | |||
| Ascorbic acid: No significant interference up to 16 mg/dL (0.9 mmol/L). Concentrations above therapeutic levels will interfere. | |||
| Hyperlipemia/hyperproteinemia lead to negative bias. |
Study Information
-
Sample Size used for the test set and the data provenance:
- Total CO2 Method Comparison: The range for the method comparison was 9.7 to 44.9 mEq/L. The document does not explicitly state the number of samples used for the method comparison study.
- Precision Study: For the precision study, results are reported for multiple "levels" (12.1 mEq/L, 19.9 mEq/L, 27.5 mEq/L). The number of replicates at each level is not specified, but typically "within-run" and "total" precision studies involve multiple measurements over several days.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission, these are typically prospective analytical studies performed by the manufacturer, but this is not explicitly confirmed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an analytical performance study for an in vitro diagnostic device, not a clinical diagnostic study involving image interpretation or expert consensus. Therefore, there were no "experts" in the sense of clinical specialists establishing a ground truth for diagnostically challenging cases.
- The "ground truth" or reference values for method comparison would have been established by the predicate device (Roche Bicarbonate liquid) or a recognized reference method commonly used in clinical chemistry labs. The comparison data shows a linear regression against the predicate, implying the predicate served as the reference for comparative analysis.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As noted above, this is an analytical performance study, not a clinical study requiring adjudication of diagnostic outcomes.
-
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 not an AI/imaging device and does not involve human readers for interpretation.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance characteristics (precision, method comparison, measuring range, interferences) are all for the standalone device (ELITech Clinical Systems ISE Total CO2 Electrode) without human intervention in the result generation process, beyond operating the instrument.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the results obtained from the legally marketed predicate device (Roche Diagnostics COBAS Integra Bicarbonate liquid) or a recognized clinical chemistry reference method, against which the new device's measurements are compared. The calibrators are traceable to NIST SRM (National Institute of Standards and Technology Standard Reference Materials), which serves as a metrological ground truth for concentration.
-
The sample size for the training set:
- This document describes performance validation studies, not product development or machine learning training. There is no mention of a "training set" in the context of machine learning model development. This is a traditional IVD device.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a machine learning model.
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.