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510(k) Data Aggregation
(294 days)
I-CHROMA IFOB WITH I-CHROMA READER
i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immuno-chromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
i-CHROMA iFOB is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected.
i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immunochromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
The provided text describes the i-CHROMA iFOB with i-CHROMA Reader device, a fluorescence immunochromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
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 provided text does not explicitly state "acceptance criteria" as a separate section with numerical targets. Instead, performance testing results are presented as summaries. The performance is compared to a predicate device (OC Auto Micro FOB Test). The acceptance of the device is implied by its demonstrated performance in these studies, showing high agreement and accuracy with the predicate device and being "equally sensitive" to certain hemoglobin types.
| Acceptance Criteria (Implied from performance summary) | Reported Device Performance (i-CHROMA iFOB) |
|---|---|
| No hook effect | Showed no prozone/hook effect up to analyte concentration 2000 ng/mL. |
| Sensitivity to Hemoglobin S | Equally sensitive to 'Hemoglobin S' as the abnormal hemoglobin associated with sickle cell anemia. |
| No significant cross-reactivity with animal hemoglobin | Showed no significant cross-reactivity with any of the eight animal hemoglobin (bovine, chicken, fish, horse/equine, goat, pig/swine, rabbit, and sheep origin). |
| No significant interference from endogenous substances | No significant interference from any of the four endogenous substances (Ascorbic acid, Bilirubin, Albumin and Myoglobin). |
| High repeatability and reproducibility | Showed high degree of repeatability as well as between-run, lot-to-lot, instrument-to-instrument and site-site reproducibility. |
| High overall percent agreement with predicate device (analytical method comparison) | Analytical method comparison study at three US sites showed high degree of overall percent agreement as well as positive percent agreement and negative percent agreement between test results obtained with i-CHROMA iFOB and the predicate method OC Auto Micro FOB. |
| High positive and negative percent agreements with predicate device (clinical testing) | More than 96% positive and negative percent agreements in test results when compared with the predicate method OC Auto Micro FOB. |
| High accuracy with weak positive and weak negative samples | 95-99.66% accuracy in test results with weak positive and weak negative samples. |
2. Sample size used for the test set and the data provenance
- Analytical Method Comparison Study: "Analytical method comparison study at three US sites performed on spiked human fecal samples..." The sample size is not explicitly stated for this study, only that it was conducted at three US sites. The data provenance is US sites and involves spiked human fecal samples.
- Clinical Testing Study: "Clinical testing study at two Korean and one US site involving prospective testing of clinical human fecal samples..." The sample size is not explicitly stated for this study. The data provenance is two Korean and one US site and involves prospective testing of clinical human fecal samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts used or their qualifications for establishing the ground truth. It primarily relies on comparison with a predicate device.
4. Adjudication method for the test set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.
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
This device is an automated occult blood analyzer (i-CHROMA Reader) that provides qualitative (positive/negative) results. It is not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and was not conducted. The device acts as the "reader" itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance studies described are for the device as a standalone system: "i-CHROMA iFOB with i-CHROMA Reader". The "i-CHROMA Reader" automatically scans the test cartridge and displays the result. There is no human-in-the-loop performance described for this qualitative test, as the device itself determines and displays the positive/negative outcome.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance studies appears to be established by comparison with a predicate device (OC Auto Micro FOB Test). In the analytical method comparison, spiked human fecal samples were used, where the "ground truth" would be the known concentration of hemoglobin in the spiked samples. For the clinical testing study, the comparison was against the predicate method.
8. The sample size for the training set
The document does not mention a separate training set or its sample size. This device is not described as involving machine learning that would typically require a distinct training set. The device operates based on pre-programmed calibration and an analytical cut-off.
9. How the ground truth for the training set was established
Since a dedicated "training set" for a machine learning model is not mentioned, the concept of establishing ground truth for such a set is not applicable in this context. The device relies on a pre-programmed calibration, and the ID chip contains encoded calibration data for batch-to-batch variation. The establishment of this calibration data (which serves a similar purpose to informing the device's measurement accuracy) is not detailed beyond being "pre-programmed."
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