(165 days)
The SDI CA480 Clinical Chemistry System includes a discrete, random access, microprocessor controlled clinical chemistry analyzer and dedicated reagents intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum. Other various chemistry assays are adaptable to the analyzer.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. BUN measurements are use in the diagnosis and treatment of certain renal and metabolic diseases. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and are used in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The SDI CA480 is a discrete, random access, microprocessor controlled photometric analyzer with the capability to perform 300 clinical chemistry tests per hour with an additional 180 ISE tests per hour for a total throughput of 480 tests per hour.
The analyzer is comprised of three main components: sample system, reagent system, and measurement system. The analyzer utilizes hardware controlled robotics for pipetting, transport, dispensing and stirring of reagents and samples, The measurement system features a halogen lamp, filter wheel and photodiode for optical detection and reusable quartz reaction cuvettes which are automatically washed and dried between samples. The integrated ISE module allows for Na/K/Cl electrolyte tests.
The provided document describes the SDI CA480 Clinical Chemistry System, a device designed for in-vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium, and Chloride in serum. The study presented aims to demonstrate the substantial equivalence of the SDI CA480 to its predicate devices, the Ciba Corning Model 550 Express Clinical Chemistry Analyzer and the Model 664/FAST 4 System.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the "Summary of Substantial Equivalence" which states that the SDI CA480 is "substantially equivalent" to the predicate devices in design, intended use, and technology. The performance aspects of this substantial equivalence are quantitative, focusing on the agreement between measurements made by the new device and the predicate devices. This agreement is expressed through slope, intercept, and correlation coefficient derived from method comparison studies.
| Assay | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Slope) | Reported Device Performance (Intercept) | Reported Device Performance (Correlation Coefficient) |
|---|---|---|---|---|
| ISE Sodium Electrode | Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation) | 0.998 | -1.26 | 0.9905 |
| ISE Potassium Electrode | Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation) | 0.977 | 0.06 | 0.9946 |
| ISE Chloride Electrode | Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation) | 1.02 | -2.34 | 0.9761 |
| Urea Nitrogen (BUN) | Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation) | 0.933 | 0.94 | 0.9988 |
| Glucose HK | Close to 1 (Slope), Close to 0 (Intercept), Near 1 (Correlation) | 0.980 | 1.34 | 0.9998 |
The reported performance values for slope are all close to 1, intercepts are close to 0, and correlation coefficients are all very close to 1, indicating strong agreement with the predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 60 real patient samples were used for the method comparison study.
- Data Provenance: The samples are described as "real patient samples," suggesting a clinical setting. The country of origin is not specified, nor is whether the data was retrospective or prospective. Given the medical device submission context, it is highly likely these were prospectively collected clinical samples for the purpose of the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of diagnostic device (clinical chemistry analyzer) does not typically rely on human expert interpretation of results for ground truth in the same way imaging devices do. Instead, the "ground truth" for method comparison is usually established by using an existing, legally marketed, and accepted predicate device. No human experts are directly used to establish a subjective "ground truth" for each sample's measurement values. The predicate devices themselves serve as the reference.
4. Adjudication method for the test set
Not applicable. As described above, this study compares the performance of a new instrument against established predicate instruments. There is no 'adjudication' process involving human experts to resolve discrepancies in measurement values, as the predicate device's measurement is taken as the reference for comparison.
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 fully automated clinical chemistry analyzer, not an AI-assisted diagnostic tool requiring human reader interpretation or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was conducted. The "Method Comparison Data" section details the performance of the SDI CA480 itself by comparing its measurements to those of the predicate devices. This is an evaluation of the algorithm/instrument's performance without human intervention in the measurement process (beyond initial sample loading and instrument operation).
7. The type of ground truth used
The ground truth for this method comparison study is the measurements obtained from the legally marketed predicate devices (Ciba Corning Model 550 Express and Model 664/Fast 4 System). These predicate devices are presumed to provide accurate and reliable measurements based on their prior 510(k) clearances.
8. The sample size for the training set
Not applicable explicitly. For this type of clinical chemistry system, there isn't a "training set" in the machine learning sense. The device's internal algorithms and calibration are established during its development and manufacturing. The data used in this submission is for validation and demonstration of substantial equivalence, not for training a model.
9. How the ground truth for the training set was established
Not applicable. As mentioned above, a "training set" with established ground truth as in machine learning is not described or typically relevant for the 510(k) clearance of an automated clinical chemistry analyzer based on chemical reactions and photometric detection. Device calibration and internal parameters are set through manufacturing and quality control processes based on known standards and reference materials.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.