(76 days)
The Dade Indirect IMT system with TCQ2 electrode performs four in vitro diagnostic tests: sodium (Na), potassium (K), chloride (CI) and total carbon dioxide (TCO2).
The sodium, potassium and chloride (Na/K/CI) methods use a sample which is diluted automatically on-board the Dimension® XL or RxL clinical chemistry system. The diluted sample is then processed in a multisensor cartridge which uses Integrated Multisensor Technology (IMT) to develop an electrical potential proportional to the activity of each specific ion in the sample. The total carbon dioxide (TCQ2) method uses a Severinghaus electrode designed to measure the liberated CO2 from a diluted, acidified sample.
Here's an analysis of the provided text regarding the Dade Indirect IMT System with TCO2 Electrode, structured to address your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text doesn't explicitly state "acceptance criteria" in a numerical format that would typically be seen for medical device performance. Instead, it presents the results of a comparison study against a predicate device. For the purpose of this analysis, I will infer that the reported slope, intercept, and correlation coefficient from the comparison study serve as the performance metrics intended to demonstrate substantial equivalence to the predicate device, which implicitly defines the "acceptance criteria" in this context.
| Analyte (Serum/Plasma) | Acceptance Criteria (Implicit: Close to Reference) | Reported Device Performance (Slope) | Reported Device Performance (Intercept) | Reported Device Performance (Correlation Coefficient) | Range of Samples |
|---|---|---|---|---|---|
| Na | Slope ~1.0, Intercept ~0.0, Corr Coeff ~1.0 | 1.03 | -4.8 | 0.983 | 98-160 |
| K | Slope ~1.0, Intercept ~0.0, Corr Coeff ~1.0 | 1.00 | 0.06 | 0.996 | 2.3-9.5 |
| Cl | Slope ~1.0, Intercept ~0.0, Corr Coeff ~1.0 | 1.05 | -0.3 | 0.968 | 71-119 |
| TCO2 | Slope ~1.0, Intercept ~0.0, Corr Coeff ~1.0 | 1.00 | 0.3 | 0.945 | 10.6-41.5 |
| Analyte (Urine) | Acceptance Criteria (Implicit: Close to Reference) | Reported Device Performance (Slope) | Reported Device Performance (Intercept) | Reported Device Performance (Correlation Coefficient) |
|---|---|---|---|---|
| Na | Slope ~1.0, Intercept ~0.0, Corr Coeff ~1.0 | 0.91 | 5 | 0.997 |
| K | Slope ~1.0, Intercept ~0.0, Corr Coeff ~1.0 | 0.93 | 0.2 | 0.998 |
| Cl | Slope ~1.0, Intercept ~0.0, Corr Coeff ~1.0 | 1.03 | 2.0 | 0.979 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Total samples evaluated: n = 270
- Breakdown: 149 serum samples and 121 plasma samples.
- Specific analyte sample sizes: Na = 100, K = 95, Cl = 105. (It's unclear if these N values for specific analytes apply to serum, plasma, or a combination for each, or if they represent the total number of measurements for that analyte across all sample types.)
- Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study is described as a "split sample comparison study," which typically means samples were split and analyzed by both the investigational device and the predicate device within the same laboratory environment. The text does not specify if the data was retrospective or prospective, although comparison studies for device validation are often prospective to ensure proper sample handling and analysis by both systems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device performs in-vitro diagnostic tests for chemical analytes (sodium, potassium, chloride, TCO2). The "ground truth" for such measurements is typically established by comparing the device's results against a well-validated reference method or a predicate device that is already considered accurate, rather than through expert interpretation of images or clinical data. In this case, the ground truth is implicitly defined by the results obtained from the "Beckman SYNCHRON CX63 clinical system."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective expert interpretation (e.g., radiology reads) to resolve discrepancies. For objective chemical measurements, adjudication is not performed in the same manner. The comparison is quantitative against a reference method.
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 an in vitro diagnostic device for measuring chemical analytes, not an AI-powered diagnostic imaging or clinical decision support tool that assists human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Essentially, yes. The performance metrics presented (slope, intercept, correlation coefficient) reflect the performance of the Dade Indirect IMT System itself, in comparison to the Beckman SYNCHRON CX63 system. This is a "standalone" evaluation of the device's analytical performance, as it's not described as having an AI component or a human-in-the-loop interaction for result generation. The human interaction would involve operating the instrument and interpreting the numerical output, but the measurement itself is automated.
7. The Type of Ground Truth Used
The ground truth was established by comparison to a predicate device/reference method: the Beckman SYNCHRON CX63 clinical system. This system's measurements are considered the reference against which the novel device's performance is gauged for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of an analytical instrument for chemical measurements, not a machine learning or AI model that requires a training set. The device operates based on established chemical and electrical principles (Integrated Multisensor Technology and Severinghaus electrode), not on learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.