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510(k) Data Aggregation
(267 days)
Calprest®NG is a quantitative ELISA for detecting concentration of fecal calprotectin, which can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's disease and ulcerative colitis, and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.
Calprest®NG is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of antibodies against calprotectin present in the diluted sample is bound by the antibody adsorbed to the surface of the plastic well. The enzyme conjugated antibody binds to the captured antigen and subsequently the enzyme catalyzes the conversion of the substrate to a colored product. The intensity of the color is proportional to the amount of conjugate bound, and thus to the amount of captured calprotectin. Concentration of calprotectin in the samples is calculated using the provided standards.
Calprest®NG: Acceptance Criteria and Performance Study
This document outlines the acceptance criteria and performance of the Calprest®NG device, an in-vitro diagnostic ELISA for detecting fecal calprotectin to aid in the diagnosis of Inflammatory Bowel Diseases (IBD) and differentiation from Irritable Bowel Syndrome (IBS).
1. Acceptance Criteria and Reported Device Performance
The provided document details various performance characteristics. For acceptance criteria, the "Clinical Performance" and "Method Comparison" sections are most relevant, establishing performance benchmarks against a predicate device and clinical diagnoses.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (Calprest®NG) |
|---|---|---|
| Clinical Performance (Borderline values Positive) | To be substantially equivalent to predicate device performance. | Sensitivity: 94.6% (95% CI: 89.2% - 97.8%) |
| Specificity: 90.2% (95% CI: 84.1% - 94.5%) | ||
| PPV: 89.8% (95% CI: 83.4% - 94.3%) | ||
| NPV: 94.9% (95% CI: 89.7% - 97.9%) | ||
| Clinical Performance (Borderline values Negative) | To be substantially equivalent to predicate device performance. | Sensitivity: 83.1% (95% CI: 75.5% - 89.1%) |
| Specificity: 97.9% (95% CI: 94.0% - 99.6%) | ||
| PPV: 97.3% (95% CI: 92.3% - 99.4%) | ||
| NPV: 86.4% (95% CI: 80.2% - 91.3%) | ||
| Method Comparison (Borderline Value as Positive) | Positive Agreement with predicate device. | 96.6% (95% CI: 91.5% - 98.7%) |
| Negative Agreement with predicate device. | 100.0% (95% CI: 91.2% - 100.0%) | |
| Overall Agreement with predicate device. | 97.5% (95% CI: 93.9% - 99.0%) | |
| Method Comparison (Borderline Value as Negative) | Positive Agreement with predicate device. | 96.1% (95% CI: 89.0% - 98.6%) |
| Negative Agreement with predicate device. | 96.3% (95% CI: 89.7% - 98.7%) | |
| Overall Agreement with predicate device. | 96.2% (95% CI: 91.9% - 98.2%) | |
| Linearity (Matrix) | % Recovery Rate between 80-120%. | 86.91% - 112.84% |
| Linearity (Aqueous) | % Recovery Rate between 80-120%. | 93.00% - 118.68% |
| Calprotectin Recovery | Recovery % between 80-120%. | 94.8% - 112.1% |
| Interfering Substances | No significant interference observed (typically within +/- 20% deviation). | All tested interfering substances and bacteria resulted in % deviation between 90.8% and 110.4% in Table 2a, and between 90.8% and 110% in Table 2b, indicating no significant interference. |
2. Sample size and data provenance for the test set
- Clinical Performance Test Set: The "Clinical Performance" table shows a total of 273 samples were used for the clinical evaluation. The document does not explicitly state the country of origin or whether the data was retrospective or prospective.
- Method Comparison Test Set: A total of 157 samples were used for the method comparison study against the predicate device. The document does not explicitly state the country of origin or whether the data was retrospective or prospective.
3. Number of experts and their qualifications used to establish ground truth for the test set
Not applicable. This device is an in-vitro diagnostic test. "Experts" in the traditional sense of clinicians or radiologists establishing image-based ground truth is not relevant here. The ground truth for clinical performance would be an established diagnosis of IBD or IBS, likely based on a combination of clinical, endoscopic, histological, and other laboratory findings, which are considered the "gold standard" for these conditions. The document does not specify the number of clinicians or the exact method of establishing these clinical diagnoses.
4. Adjudication method for the test set
Not applicable. As this is an in-vitro diagnostic, adjudication method in the context of human interpretation of medical images is not relevant. The device output is a quantitative measurement of fecal calprotectin concentration.
5. Multi-reader multi-case (MRMC) comparative effectiveness study
Not applicable. This is an in-vitro diagnostic device that provides a quantitative measurement, not an AI-assisted diagnostic tool that humans interpret. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.
6. Standalone (algorithm only without human-in-the-loop) performance
Yes, this is a standalone device. The Calprest®NG is an ELISA system that provides a direct quantitative measurement of fecal calprotectin. Its performance is evaluated independently of human interpretation of the assay result, although a clinician will interpret the final numerical result in the context of other clinical findings. The reported sensitivity, specificity, and agreement values represent the standalone performance of the assay.
7. Type of ground truth used
- Clinical Performance: For the "Clinical Performance" study, the ground truth was clinical diagnosis of Inflammatory Bowel Disease (IBD) (Crohn's disease and ulcerative colitis) or Irritable Bowel Syndrome (IBS). This is an outcome-based ground truth, derived from standard clinical work-up which may include endoscopy, histology, imaging, and other diagnostic tests.
- Method Comparison: For the "Method Comparison" study, the ground truth was the results obtained from the predicate device, Calprest® (K130945), which serves as a comparator for substantial equivalence.
- Other performance studies (Precision, Linearity, Recovery, Interfering Substances): The ground truth for these studies are precisely prepared reference materials with known concentrations.
8. Sample size for the training set
The document does not explicitly mention a "training set" in the context of machine learning. This device is an immunoassay (ELISA), which relies on chemical and biological reactions, not a machine learning algorithm that requires a training set in the typical sense. The term "training set" is not applicable here. The assay is developed and validated through a series of analytical and clinical performance studies, rather than "training" an AI model.
9. How the ground truth for the training set was established
Not applicable. As explained in point 8, the concept of a "training set" and its associated ground truth is not relevant for this type of immunoassay device. The device's performance is established through rigorous analytical verification and clinical validation studies as described in the summary.
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