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Calprest is a quantitative ELISA for detecting concentration of fecal calprest can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD, Crohn's disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.

Calprest® is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of polyclonal antibody against calprotectin. 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.

EasyCal is a single-use device for stool sample pre-analytical processing that allows the extraction of calprotectin from the specific amount of collected fecal sample required to perform Eurospital's Calprest® and Calprest®NG assays.

The device consists of a tube, containing 2.8 ml of extraction solution, a stick shaped with seven grooves for collecting the sample. The upper end is made up by two components which can be removed by opposite rotations. The screw cap (white) connected to the shaped stick traps the sample excess and can be then removed by counter-clockwise rotation. Once the extraction procedure has been completed, the sample can be transferred to an automated ELISA instrumentation, placing it directly into the sample rack. EasyCal allows an easy, reliable and reproducible way to sample from primary containers and analyze the extract directly from the device, without the need to weight the stool sample.

The provided document describes the 510(k) premarket notification for the Calprest device with the EasyCal accessory, a fecal calprotectin immunological test system. This submission primarily focuses on demonstrating that the addition of the EasyCal pre-analytical processing accessory does not negatively impact the performance of the previously cleared Calprest assay.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the requirement for the new device with EasyCal to be "comparable" and "perform equivalently" to the predicate device (Calprest with manual extraction). Specific quantitative acceptance criteria are not explicitly listed in a typical "table" format with pass/fail thresholds for each metric. Instead, the study results are presented, demonstrating agreement or reproducibility within expected analytical variations for laboratory tests.

Here's a breakdown of the reported performance demonstrating equivalence:

• Slope: 1.005 (95% CI: 0.9603 to 1.060)
• Y-intercept: -0.3639 (95% CI: -3.977 to 2.056)
• Correlation (r): 0.968
• Bias at 120 mg/kg: 0.2% (95% CI: -3.7% to 5.6%)
  Qualitative Agreement (with 120 mg/kg cutoff):
• Total Agreement: 97.0% (95% CI: 91.5 to 99.0%) (Borderline as positive) / 92.0% (95% CI: 85.0 to 95.9%) (Borderline as negative)
• Negative Agreement: 96.4% (82.3 to 99.4%) (Borderline as positive) / 94.2% (84.4 to 98.0%) (Borderline as negative)
• Positive Agreement: 97.2% (90.4 to 99.2%) (Borderline as positive) / 89.6% (77.8 to 95.5%) (Borderline as negative) |
  | Stool Sample Collection Weight | Consistency in amount of fecal material collected by EasyCal. | Mean stool sample weight collected by EasyCal: 56 mg. |
  | Reproducibility | Acceptable Coefficient of Variation (CV) and Standard Deviation (SD) across different operators, days, and within laboratory. | Within Laboratory CVs: Ranged from 5.9% to 15.9% across 7 samples with varying calprotectin concentrations. (Specific SDs reported for repeatability, between-day, within-operator, between-operator, and within-laboratory). Reproducibility was "confirmed." |
  | Sample Stability (Extracted Stool) | Maintenance of calprotectin concentration in extracted samples over time and freeze/thaw cycles. | All samples "met the acceptance criteria" for:
• Storage at 2-8°C: up to 21 days tested (recommendation states "up to 14 days").
• Storage at Room Temperature: up to 73 hours tested (recommendation states "up to 72h").
• Freeze/Thaw Cycles: up to 5 cycles tested (recommendation states "not to exceed 4 freeze-thaw cycles"). Percent recovery was calculated. |
  | EasyCal Device Stability | Maintenance of extraction buffer pH and volume, and no impact on Calprest performance over shelf life and at room temperature. | Shelf Life (Real time stability): pH values between 7.77 and 7.84, volume variation 99.4%-100.6%. All measures "met the acceptance criteria" up to 25 months. The device is stable for 24 months at 4°C and "does not affect Calprest®'s performances."
  Room Temperature Stability: All acceptance criteria were met for EasyCal stored at room temperature for 72h, confirming it "doesn't affect Calprest® performances." |

2. Sample Sizes Used for the Test Set and Data Provenance

• Method Comparison: 100 stool samples.
• Stool Sample Collection Performance: 5 different human stool samples, collected in replicates of five (total 25 collections per operator for each sample consistency implicitly).
• Reproducibility Study: 7 stool samples, tested in replicate of five, once a day, for five days (5x5x3 scheme), resulting in 75 data points per sample.
• Sample Stability and Handling: 8 stool samples.
• EasyCal Device Stability (Shelf life): Data on 3 lots of EasyCal devices. Separately, 12 samples extracted with 3 lots of devices stored at 2-8°C for up to 25 months and a freshly produced one.
• EasyCal Device Stability (Room Temperature): 6 stool samples extracted with 3 different lots of EasyCal.

Data Provenance: The document does not explicitly state the country of origin for the samples or if the data was retrospective or prospective. Given it's a 510(k) submission for an in vitro diagnostic device, it's highly likely these were laboratory studies using clinical samples collected prospectively for the purpose of validation, or samples obtained from biobanks.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This device is an in-vitro diagnostic (IVD) test for measuring fecal calprotectin concentration. The "ground truth" for such a device is typically the known concentration of an analyte or the established "true" diagnosis or condition based on comprehensive clinical assessment.

• For the analytical performance studies (method comparison, reproducibility, stability), the ground truth is implicitly the true calprotectin concentration within the samples. This is established by rigorous laboratory practices, reference methods, and quality control materials, not by human expert consensus on images or clinical cases.
• The document mentions "three independent operators" for the stool sample collection performance and "three different operators" for the reproducibility study. These are laboratory personnel performing the assays, not clinical experts establishing a medical "ground truth." Their qualifications are not specified beyond being "operators."

4. Adjudication Method for the Test Set

Not applicable in the typical sense for an IVD test validation like this one. Adjudication methods (like 2+1, 3+1) are common in studies evaluating diagnostic imaging or AI algorithms where subjective human interpretation of complex data (e.g., radiologic images) is involved in establishing ground truth. For an IVD, the assays produce quantitative results, and the comparison is statistical between methods, not between human interpretations of the raw data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These studies are specifically designed to evaluate the impact of AI on human reader performance, typically in the context of image interpretation (e.g., radiology). This submission is for an IVD kit, which measures a biomarker and does not involve human interpretation of complex images or clinical cases in the same way. The primary comparison is between two methods of sample preparation for the same quantitative assay, not between human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are essentially "standalone" in the sense that they evaluate the analytical performance of the combined "Calprest with EasyCal" system. The system provides a quantitative output (calprotectin concentration). The performance metrics (method comparison, reproducibility, stability) evaluate the accuracy, precision, and reliability of this quantitative output directly, not how it assists a human in a diagnostic task. The "human-in-the-loop" here refers to the laboratory technician performing the test, and the studies confirm the consistency of the results regardless of operator or processing method (EasyCal vs. manual).

7. The Type of Ground Truth Used

The ground truth used for these studies is analytical truth regarding fecal calprotectin concentration in stool samples. This is established by:

• Using samples with a "different levels of calprotectin evenly distributed and covering the quantification range" (method comparison).
• Performing assays according to established protocols to obtain the most accurate measurement possible for each sample.
• Using established statistical methods (e.g., Passing-Bablok regression, CLSI guidelines) for comparing the new method to the predicate method.

It is not based on:

• Expert consensus (as in radiology reads).
• Pathology (though a clinical diagnosis might correlate with calprotectin levels, the ground truth for the analytical performance is the concentration itself).
• Outcomes data (as in long-term patient follow-up).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm that requires labeled data for model training. This is a conventional IVD device, not an AI/ML diagnostic tool. The "studies" presented are analytical validation studies, demonstrating the performance of the device itself (measurement accuracy, precision, stability), not for training a predictive model.

9. How the Ground Truth for the Training Set Was Established

As there is no AI/ML "training set" in the context of this device, this question is not applicable. The device itself performs the measurement based on a biochemical reaction (ELISA), not a learned algorithm. The ground truth for the analytical validation (as described in point 7) is established through laboratory measurement and comparison to an existing validated method.

Ask a specific question about this device

CalprestNG is a quantitative ELISA for detecting concentration of fecal calprotectin. CalprestNG can in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD, 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. 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.

EasyCal is a single-use device for stool sample pre-analytical processing that allows the extraction of calprotectin from the specific amount of collected fecal sample required to perform Eurospital's Calprest® and Calprest®NG assays.

The device consists of a tube, containing 2.8 ml of extraction solution, a stick shaped with seven grooves for collecting the sample. The upper end is made up by two components which can be removed by opposite rotations. The screw cap (white) connected to the shaped stick traps the sample excess and can be then removed by counter-clockwise rotation. Once the extraction procedure has been completed, the sample can be transferred to an automated ELISA instrumentation, placing it directly into the sample rack. EasyCal allows an easy, reliable and reproducible way to sample from primary containers and analyze the extract directly from the device, without the need to weight the stool sample.

The document describes the CalprestNG device, an ELISA (enzyme-linked immunosorbent assay) for detecting fecal calprotectin, and its new pre-analytical processing accessory, EasyCal. The submission is for K191592, establishing substantial equivalence to the predicate device CalprestNG (K160447), which used manual extraction. The core of the study is to demonstrate that using EasyCal for sample extraction yields comparable results to the manual extraction method.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating the comparability of CalprestNG with EasyCal to CalprestNG with manual extraction, rather than predefined quantitative acceptance criteria with specific ranges. Instead, the "acceptance criteria" are implied by showing the comparability of the new method to the predicate method.

However, we can infer the performance metrics tested and their results, which serve as evidence of acceptance.

Table 1. Method Comparison and Performance

• Slope (95% CI): 0.9778 (0.901 to 1.003)
• Y-intercept (95% CI): 0.8495 (-0.8360 to 3.978)
• Correlation (r): 0.954
• Bias at 120 mg/kg (95% CI): -1.5% (-9.0% to 1.5%) |
  | Qualitative Agreement | High agreement (Negative, Positive, and Total Agreement) when classifying samples based on a clinical cut-off. | Referencing 120 mg/kg cut-off (borderline as positive/negative based on interpretation):
• Borderline as positive:
  • Negative Agreement (95% CI): 96.2% (81.1 to 99.3%)
  • Positive Agreement (95% CI): 100.0% (95.1 to 100%)
  • Total Agreement (95% CI): 99.0% (94.6 to 99.8%)
• Borderline as negative:
  • Negative Agreement (95% CI): 100.0% (90.1 to 100%)
  • Positive Agreement (95% CI): 95.4% (87.3 to 98.4%)
  • Total Agreement (95% CI): 97.0% (91.5 to 99.0%) |
    | Stool Sample Collection Performance| Maintain consistent and appropriate sample weight. | Mean weight collected by EasyCal: 56 mg. (This is a specific internal metric, the acceptance criteria implicitly being that this weight is consistent and adequate for the assay). |
    | Extraction Reproducibility | Low coefficient of variation (CV%) for within-run, between-day, within-operator, between-operator, and within-laboratory precision.| CV% for 8 samples across quantification range (average or example values presented): Representative CVs range from 3.8% to 6.9% for repeatability, and overall within-laboratory CVs up to 18.3%. (Specific ranges were not given as 'criteria', but the detailed table data demonstrates the measured precision). The study concludes: "Reproducibility of results obtained with Calprest® with EasyCal is confirmed." |
    | Extracted Sample Stability | Extracted samples should remain stable at specific temperatures and after freeze/thaw cycles for defined durations. | Samples met acceptance criteria for:
• 2-8 °C up to 21 days (recommendation: up to 14 days)
• Room temperature up to 73 hours (recommendation: up to 72 hours)
• Up to 5 freeze/thaw cycles (recommendation: not to exceed 4 cycles) |
  | EasyCal Device Stability (Shelf Life)| pH and volume stability over time; no adverse effect on CalprestNG performance. | pH and Volume: Between 7.77 and 7.84 (mean 7.80) for pH; 99.4% to 100.6% (mean 100.0%) for volume variation up to 25 months. All met acceptance criteria.
  CalprestNG performance: All acceptance criteria met at 25 months. Device stable for 24 months at 4 °C and does not affect CalprestNG performance. |
  | EasyCal Device Stability (Room Temp.)| Maintain performance when stored at room temperature for specified duration. | All acceptance criteria were met. Device stable for 72 hours at room temperature and doesn't affect CalprestNG performances. |

2. Sample sizes used for the test set and the data provenance

• Method Comparison (Stool extraction method comparison: EasyCal vs manual extraction procedure):

  • Sample Size: One hundred (100) stool samples.
  • Data Provenance: Not explicitly stated, but clinical studies for such devices typically involve prospective collection or use of banked samples from clinical sites. The document implies these are "patient samples" (from CLSI EP09c reference). Country of origin is not specified.
  • Retrospective/Prospective: Not explicitly stated for this particular sample set, but device validation studies often use a mix. Given the "CLSI EP09c" reference, it points to a formal comparison study, which could be prospective collection for the purpose of the study.

• Reproducibility study: Extraction Reproducibility:

  • Sample Size: Eight (8) stool samples (tested in replicate of five, once a day, for five days, by three different operators). This results in 8 samples * 5 replicates * 5 days * 3 operators = 600 total test points.
  • Data Provenance: Not specified.
  • Retrospective/Prospective: Not specified.

• Stool sample collection performance of EasyCal:

  • Sample Size: Five (5) different human stool samples. Each collected in replicates of five by three independent operators (5 samples * 5 replicates * 3 operators = 75 total weight measurements).
  • Data Provenance: Not specified.
  • Retrospective/Prospective: Not specified.

• Samples stability and handling:

  • Sample Size: Eight (8) stool samples.
  • Data Provenance: Not specified.
  • Retrospective/Prospective: Not specified.

• EasyCal device stability (Shelf life and Room Temperature):

  • Sample Size: Three lots of EasyCal devices were used for pH/volume tests. Twelve (12) samples were extracted for performance validation with aged vs. fresh devices. Eight (8) stool samples were used for room temperature storage validation.
  • Data Provenance: Not specified.
  • Retrospective/Prospective: Real-time stability studies are inherently prospective observations over time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an in vitro diagnostic (IVD) quantitative assay for fecal calprotectin. The "ground truth" for such devices is established through:

• Referenced methods: The manual extraction method of the predicate device (K160447) served as the reference or comparative "truth" for the EasyCal method. The study aimed to show equivalence to this established method.
• Known concentrations: For reproducibility and stability studies, often spiked samples or samples with predetermined concentrations are used, verified by validated analytical methods.
• Clinical correlation (indirect): The output of the assay (Calprotectin concentration) is correlated with clinical findings (IBD vs. IBS diagnosis). However, the direct clinical diagnostic "ground truth" (e.g., patient biopsy, endoscopy results) is not used within this specific analytical validation section to establish the "truth" for the quantitative assay itself. The clinical performance characteristics are stated to be "Same as approved in 510(k) submission # K160447," implying that clinical utility was established previously, and this submission focuses on analytical equivalence.

Therefore, human experts in the context of "ground truth establishment" for an image analysis or diagnostic interpretation task (like radiologists for imaging) are not directly applicable here. The "ground truth" is the precise measurement of calprotectin or the established manual extraction benchmark.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers/experts independently interpret complex data (e.g., medical images), and a consensus or adjudication process is needed to resolve discrepancies and establish a robust ground truth for classification tasks.

This study is an analytical performance study of a quantitative in vitro diagnostic (IVD) device. The "truth" is either the measured concentration by a reference method or the established manual extraction procedure. Therefore, no adjudication method involving multiple human readers/experts is pertinent or mentioned for establishing the "ground truth" of the test set in this context.

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 relevant here. This is a submission for an IVD device measuring a biomarker (fecal calprotectin), not an AI-assisted diagnostic imaging or interpretation tool for human readers. There are no "human readers" interpreting the output in a way that would be "improved with AI assistance." The technology is a laboratory assay.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is an analytical device, and its performance is inherently "standalone" in terms of its measurement capabilities. The CalprestNG ELISA, whether with manual or EasyCal extraction, provides a quantitative result for fecal calprotectin. There isn't an "algorithm" in the sense of AI or machine learning that processes images or complex data for interpretation. The "algorithm" is the biochemical assay itself, which delivers a numerical value.

The performance studies (method comparison, reproducibility) directly evaluate this standalone performance. The "human-in-the-loop" aspect relates to standard laboratory practices (performing the assay, pipetting, reading results from the instrument), but not an assistive AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the test set in this analytical validation is established by:

• Reference Method Comparison: The results obtained via the CalprestNG assay with the manual extraction procedure (K160447 predicate device) served as the primary reference method to which the new EasyCal extraction method was compared for equivalence.
• Known samples/standards: For reproducibility and stability, samples with known or well-characterized concentrations of calprotectin (likely established using a highly accurate and precise method) are typically used.
• Internal standards and controls: The assay uses calibrators (0, 2.5, 12.5, 25, 50, 150 ng/ml) to quantify calprotectin concentration, which act as internal "ground truth" for the assay's operational range.

8. The sample size for the training set

This document describes the validation of an in vitro diagnostic assay kit, not a machine learning or AI model that requires a "training set" to learn from data. Therefore, the concept of a "training set" in the AI/ML sense is not applicable here. The assay is based on established biochemical principles (ELISA) and does not "learn" from data in the way an algorithm does.

9. How the ground truth for the training set was established

As explained above, there is no "training set" in the context of AI/ML for this device. The "ground truth" for the assay's core function is inherent in its biochemical design, the use of validated reagents, and the calibration curves established with known standards. The validation studies described in the document (method comparison, reproducibility, stability) assess the performance of the final manufactured product against predefined analytical metrics and comparison to a predicate device.

Ask a specific question about this device

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.

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

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®

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.
• 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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