(83 days)
For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to measure creatinine in whole blood, plasma or serum specimens by professionals to aid in the diagnosis and treatment of renal diseases.
CareSide™ Creatinine cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure creatinine concentration in anti-coagulated whole blood, plasma or serum specimens. The CareSide™ Creatinine cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of creatinine concentration. The film cartridge (patent pending) contains all reagents necessary to measure creatinine concentration. When used in conjunction with the CareSideTM BUN cartridge on the CareSide™ Analyzer, the analyzer calculates a BUN to creatinine ratio.
Here's an analysis of the provided text regarding the CareSide™ Creatinine device, structured according to your requested information:
CareSide™ Creatinine Device Performance Study Analysis
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining "acceptance criteria" against which to measure the device's performance in a standalone context. However, it does present comparative performance characteristics between the CareSide™ Creatinine and the predicate device (Vitros Creatinine DT Slides). We can infer "performance standards" or expected performance based on these comparisons and the predicate device's characteristics.
| Performance Metric | CareSide™ Creatinine Reported Performance | Predicate Device Performance / Implied Acceptance Criteria |
|---|---|---|
| Detection Limit | 0.2 mg/dL | Not provided for predicate (but assumed to be comparable or better) |
| Reportable Range | 0.2 to 16 mg/dL | 0.01 to 15 mg/dL (CareSide™ exceeds on high end, slightly less on low end) |
| Accuracy (Mean Recovery) | 99% | Not provided for predicate (but an implied expectation of high accuracy) |
| Precision (Total CV) | 4.2% at 9 mg/dL | 3.3% at 10 mg/dL (Predicate device shows slightly better precision) |
| Method Comparison (vs. Predicate) | CareSide™ = 1.08 (Vitros Creatinine DT) - 0.38, r=0.99 | Strongly correlated (r=0.99) with predicate, indicating substantial agreement. |
| Linearity | Mean deviation approx 4%, r>0.99 | Not provided for predicate (but implied expectation of good linearity across the reportable range) |
| Interference | No significant interference observed at tested concentration of interferents (Ammonium PO₄, Ascorbic Acid, Bilirubin, 5-fluorocytosine, Glucose, Hemoglobin, Triglycerides, Urea Nitrogen) | Not provided for predicate (but implied expectation of minimal interference for common substances) |
| Specimen Types & Anticoagulants | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. | No clinically significant difference between serum and heparin plasma. Whole blood is unsuitable for predicate. |
| Expected Values | 0.4 to 0.9 mg/dL (female); 0.6 to 1.3 mg/dL (male) (Central 95% interval) | 0.5 to 1.2 mg/dL (female); 0.7 to 1.4 mg/dL (male) (Central 95% interval) |
Study Proving Acceptance Criteria:
The document describes several "Comparative Performance Characteristics" that serve as the basis for proving the device meets the implied acceptance criteria for substantial equivalence to the predicate device. These include:
- Detection Limit: Directly reported.
- Reportable Range: Compared against the predicate.
- Accuracy: Mean recovery study reported.
- Precision: Total CV reported.
- Method Comparison: A regression analysis (CareSide™ vs. Vitros Creatinine DT) showing strong correlation (r=0.99). This is a primary study for demonstrating equivalence.
- Linearity: Reported with mean deviation and correlation coefficient.
- Interference: A study testing various common interferents at specified concentrations.
- Specimen Types & Anticoagulants: A study assessing performance across different sample types.
- Expected Values: Clinical range established.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for the various tests (e.g., accuracy, precision, method comparison, linearity, interference, specimen type studies). Similarly, the data provenance (country of origin, retrospective/prospective) is not mentioned. These details would typically be found in more comprehensive study reports or validation binders.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of experts to establish ground truth in the context of radiologists or similar clinical reviewers. This device is an in vitro diagnostic (IVD) for measuring a biochemical marker. Ground truth for such devices is typically established through a reference method, which is stated as HPLC (High-Performance Liquid Chromatography) for both the CareSide™ and the predicate device. Therefore, the "ground truth" is analytical, not based on expert consensus of interpretive results.
4. Adjudication Method for the Test Set
As the ground truth is established analytically (via HPLC) rather than by expert interpretation, an "adjudication method" in the sense of reconciling differing expert opinions (e.g., 2+1, 3+1) is not applicable or described.
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
No MRMC comparative effectiveness study was done or is applicable. This device is an automated in vitro diagnostic system for measuring creatinine levels from blood samples. It is not an AI-assisted diagnostic imaging tool that would involve human readers or interpretation of complex medical images.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this is essentially a standalone (algorithm only) device. The CareSide™ Creatinine cartridge and CareSide™ Analyzer automatically measure creatinine concentration. While a laboratory professional introduces the sample and operates the device, the measurement itself is automated and does not involve human interpretation of the analytical result (e.g., a "human-in-the-loop" for image review). The performance metrics reported (accuracy, precision, linearity, etc.) describe the standalone analytical performance of the device system.
7. The Type of Ground Truth Used
The ground truth used for performance comparison and validation is analytical measurement by High-Performance Liquid Chromatography (HPLC). HPLC is explicitly listed as the "Reference Method" (Page 13b). This is a gold standard laboratory technique for quantifying substances like creatinine.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" sample size. This is common for IVD devices of this nature from this era (1998). While the device's internal algorithms (e.g., for calculating creatinine concentration from reflectance measurements) would have been developed and optimized, the concept of a distinct, labeled "training set" in the context of modern machine learning validation protocols is not explicitly addressed here. The reported "Calibration" mentions "Calibration information bar-coded on each cartridge" and that "Calibration information may change with each lot," implying a continuous process rather than a fixed training set used for a singular AI model.
9. How the Ground Truth for the Training Set was Established
As there is no explicit mention of an identifiable "training set" in the modern AI sense, the method for establishing its ground truth is not described. For the underlying analytical methodology, calibration materials with known creatinine concentrations (traceable to a reference method like HPLC) would be used to establish the relationship between the reflectance signal and creatinine concentration.
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.