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510(k) Data Aggregation
(84 days)
INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
The Innovacon Flipcard™ Fecal Occult Blood Test Device is intended for rapid qualitative detection of human hemoglobin in fecal samples. Fecal occult blood tests are used as a screening tool for detecting lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer. The Flipcard™ FOBT is recommended for use by health professionals in routine physical examinations and in monitoring for GI bleeding in patients in hospitals or at physician's offices.
The Innovacon Flipcard™ Fecal Occult Blood Test Device is a rapid test intended for the qualitative detection of low levels Fecal Occult Blood. The test uses monoclonal antibodies to selectively detect human hemoglobin in fecal samples The test uses a double antibody sandwich assay to selectively detect Fecal Occult Blood at 50 ng hHb/mL buffer or 300 ug hHB/g feces. The FOB One Step Fecal Occult Blood Test does not require the patient to follow any special dietary restrictions.
Acceptance Criteria and Study for Innovacon Flipcard™ Fecal Occult Blood Test Device
This device, the Innovacon Flipcard™ Fecal Occult Blood Test Device, is a rapid qualitative test for human hemoglobin in fecal samples, intended as a screening tool for lower gastrointestinal bleeding. The study performed aims to demonstrate substantial equivalence to a predicate device, the Hemoccult® ICT Immunological Fecal Occult Blood Test.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, particularly regarding accuracy (positive, negative, and overall agreement). There are no explicitly stated numerical acceptance criteria for agreement percentages in the provided text. However, the reported performance demonstrates high agreement with the predicate device.
| Performance Metric | Acceptance Criteria (Implicit - High Agreement with Predicate) | Reported Device Performance (Innovacon Flipcard™ vs. Hemoccult® ICT) |
|---|---|---|
| Part A: Sample Collection from Study Participants | ||
| Positive Agreement | High Agreement | 100% (2/2) |
| Negative Agreement | High Agreement | 99.1% (115/116) (95.3%-100%, 95% CI) |
| Overall Agreement | High Agreement | 99.2% (117/118) (95.4%-100%, 95% CI) |
| Part B: Laboratory Study by Professionals | ||
| Positive Agreement | High Agreement | 95.8% (46/48) (85.7%-100%, 95% CI) |
| Negative Agreement | High Agreement | 98.0% (100/102) (93.1%-99.8%, 95% CI) |
| Overall Agreement | High Agreement | 97.3% (146/150) (93.3%-99.3%, 95% CI) |
2. Sample Size and Data Provenance
- Sample Size for Test Set:
- Part A (Sample Collection from Study Participants): 118 samples (2 positive, 116 negative based on agreement numbers).
- Part B (Laboratory Study by Professionals): 150 samples (48 positive, 102 negative based on agreement numbers).
- The document also states "A clinical evaluation was conducted using a total of 120 clinical specimens" but the sum of samples for Part A and Part B (118+150 = 268) is significantly higher. It's possible that the "120 clinical specimens" refers to a subset or a different overarching study, and the detailed breakdown for Part A and Part B are distinct analyses within larger datasets.
- Data Provenance: The document does not explicitly state the country of origin for the data. The study involved "clinical specimens," suggesting a prospective collection for the purpose of the evaluation, but it doesn't explicitly state "prospective" or "retrospective." Given the mention of "clinical evaluation," it implies real-world samples were used.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications. The "ground truth" for this study is the result obtained from the predicate device, Hemoccult® ICT.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. The comparison is made directly between the new device and the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the new device against a predicate device, not in the context of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone comparison was done. The study's "Accuracy" section describes the Innovacon Flipcard™ Fecal Occult Blood Test Device's performance directly against the predicate device, Hemoccult® ICT, without the explicit involvement of human readers interpreting results from both. The results for "Part A: Sample Collection from Study Participants" and "Part B: Laboratory Study by Professionals" represent the device's performance in detecting fecal occult blood.
7. Type of Ground Truth Used
The "ground truth" used in this study is the result obtained from the predicate device, Hemoccult® ICT Immunological Fecal Occult Blood Test. The study design is a comparison of the new device's performance against an already legally marketed and established device, rather than against an absolute gold standard like pathology or long-term outcomes data.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This device is a rapid diagnostic kit, rather than a machine learning algorithm that typically requires a distinct training phase. Therefore, the concept of a "training set" as understood in AI/ML is not applicable here.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the method for establishing its ground truth is not provided and is not applicable to this type of device submission.
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