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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.
Ask a specific question about this device
(287 days)
Calprest® is a quantitative ELISA for detecting the concentration of fecal calprest@can be used as an in-vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other laboratory findings.
Calprest® is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of polyclonal antibody 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.
Here's a breakdown of the acceptance criteria and study information for the CALPREST® device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CALPREST® device are not explicitly stated as distinct acceptance criteria in the document. Instead, the performance characteristics are presented as the results of the studies conducted. Therefore, I will present the reported performance, which implicitly serves as the "met acceptance criteria" based on the FDA's clearance.
Key Performance Characteristics of CALPREST®
| Performance Metric | Reported Device Performance - Borderline considered Positive | Reported Device Performance - Borderline considered Negative |
|---|---|---|
| Clinical Performance (vs. IBD) | ||
| Sensitivity | 96.9% (95% CI 91.3% - 99.4%) | 79.6% (95% CI 70.3% - 87.1%) |
| Specificity | 85.0% (95% CI 70.2% - 94.3%) | 92.5% (95% CI 79.6% - 98.4%) |
| Positive Predictive Value (PPV) | 94.1% (95% CI 87.5% - 97.8%) | 96.3% (95% CI 89.6% - 99.2%) |
| Negative Predictive Value (NPV) | 91.9% (95% CI 78.1% - 98.3%) | 64.9% (95% CI 51.1% - 77.1%) |
| Method Comparison (vs. PhiCal™ Test) | (Borderline considered Positive) | (Borderline considered Negative) |
| Positive Agreement | 94.9% (95% C.I. 87.4% - 98.6%) | 91.5% (95% C.I. 79.6% - 97.6%) |
| Negative Agreement | 98.1% (95% C.I. 89.9% - 100.0%) | 97.6% (95% C.I. 91.7% - 99.7%) |
| Overall Agreement | 96.2% (95% C.I. 91.3% - 98.7%) | 95.4% (95% C.I. 90.3% - 98.3%) |
| Deming Regression Analysis (y: Calprest, x: PhiCal) | ||
| Slope | 0.98 (0.96 to 1.01) | |
| Y-intercept | -1.85 (-3.96 to 0.96) | |
| Reproducibility/Precision | ||
| Extraction Reproducibility (% CV) | 7.0 - 13.6% | |
| Intra-assay Precision (% CV) | 3.3 - 12.4% | |
| Inter-assay Precision (% CV) | 7.7 - 12.4% | |
| Inter-lot Precision (% CV) | 3.1 - 12.4% | |
| Site-to-site Precision (% CV) | 3.1 - 10.4% | |
| Linearity | ||
| Matrix Linearity (R^2) | 0.9946 | |
| Aqueous Linearity (R^2) | 0.9990 | |
| % Recovery Rate | 87.0% to 113.2% (Matrix); 95.2% to 109.3% (Aqueous) | |
| Calprotectin Recovery | 100.5% - 113.4% | |
| LoB and LoD | LoB = 3.04 mg/kg; LoD = 3.98 mg/kg | |
| Interference Testing | No interferences observed (for tested substances) |
2. Sample Sizes and Data Provenance
- Clinical Performance Test Set:
- Sample Size: 138 samples (98 IBD positive, 40 IBD negative).
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it's a diagnostic test comparing against an established diagnosis.
- Method Comparison Test Set (vs. PhiCal™ Test):
- Sample Size:
- "Borderline considered Positive" comparison: 131 samples (78 positive, 53 negative by PhiCalTM). This implies 75 Calprest positive and 56 Calprest negative.
- "Borderline considered Negative" comparison: 131 samples (47 positive, 84 negative by PhiCalTM). This implies 45 Calprest positive and 86 Calprest negative.
- Data Provenance: Not explicitly stated. Likely retrospective samples used for a comparative study.
- Sample Size:
- Other Studies (reproducibility, linearity, recovery, interference): Sample sizes vary by study (e.g., 3 samples for extraction reproducibility, multiple pools for linearity and interference, 8 samples for intra/inter-assay precision, 7 samples for recovery), but detailed provenance is not specified.
3. Number of Experts and Qualifications (Ground Truth)
- Clinical Performance: Not explicitly stated in the document. For "aid in the diagnosis of Inflammatory Bowel Diseases (IBD...)" and "differentiate IBD from Irritable Bowel Syndrome (IBS)", the ground truth (IBD vs. non-IBD) would typically be established by clinical diagnosis, potentially involving a multidisciplinary team of gastroenterologists, endoscopists, pathologists, etc. However, the exact number and qualifications of experts for defining the IBD status of the 138 samples are not provided.
- Method Comparison: The ground truth for this comparison is the performance of the predicate device, PhiCal™ Test, which itself is a Fecal calprotectin immunological test system.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for the clinical performance test set (e.g., for resolving discrepancies in IBD diagnosis). The IBD diagnosis is treated as a given "ground truth" against which the device's performance is measured. For the method comparison, the "ground truth" is the result from the predicate device, PhiCal™ Test, thus no adjudication between readers/methods is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. This device is an in-vitro diagnostic (IVD) test, not an image-based AI device designed for human-in-the-loop assistance in analysis. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the studies presented are all standalone performance evaluations of the CALPREST® assay. As an ELISA system, it is an automated laboratory test, and its performance metrics (sensitivity, specificity, precision, linearity, etc.) are inherent to the algorithm/assay itself, without requiring human-in-the-loop adjustments or interpretations beyond standard lab procedures.
7. Type of Ground Truth Used
- Clinical Performance: The ground truth for the clinical performance study is the clinical diagnosis of Inflammatory Bowel Diseases (IBD), presumably established by standard medical diagnostic procedures (e.g., endoscopy, biopsies with pathology, clinical symptoms, and other laboratory findings) in distinguishing IBD from Irritable Bowel Syndrome (IBS).
- Method Comparison: The ground truth for the method comparison is the results obtained from the predicate device, PhiCal™ Test.
- Other Studies (reproducibility, linearity, recovery): Ground truth is typically established by reference methods, known concentrations/spikes, or ideal theoretical values.
8. Sample Size for the Training Set
The document is a 510(k) summary for an ELISA-based IVD, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of machine learning does not directly apply here. The device's calibration curves and assay parameters would be established during its development and manufacturing, using various samples (e.g., calibrators, controls, characterized clinical samples) but not typically referred to as a "training set" in the sense of AI. The provided information focuses on validation and clinical performance rather than a separate "training" phase.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, the concept of a "training set" in the AI sense is not applicable. The assay's parameters (e.g., standard curve for concentration calculation) are established using known concentrations of calprotectin standards provided with the kit. These standards would have their "ground truth" concentration established through rigorous analytical measurement and manufacturing processes.
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(25 days)
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