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510(k) Data Aggregation
(93 days)
HEMOCCULT ICT
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. Fecal occult blood tests are useful screening aids for detecting primarily lower gastrointentinal (g.i.) disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. Hemoccult ICT is recommended for use by health professionals as part of routine physical examinations or when lower g.i. disorders are suspected.
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. It incorporates multiple components including separate sample collection card(s), applicator sticks, test devices, buffer, patient instructions, physician instructions and product instructions for use.
While the provided text describes the Hemoccult ICT device and its intended use, it does not explicitly state acceptance criteria in a quantifiable manner or present a clinical study that "proves the device meets the acceptance criteria" in the way one might expect for a new device seeking regulatory approval based on robust statistical outcomes.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Hemoccult ICT, formerly FlexSure OBT, K961062). The "Summary of Performance Data" section provides some overall performance characteristics observed during evaluations, but these are presented as descriptive observations rather than predefined criteria or the results of a specific clinical trial designed to prove meeting those criteria.
Therefore, many of the requested points cannot be directly extracted from the provided text. I will answer based on the information that is available.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in a tabulated format with specific thresholds that the device must meet. Instead, it describes general performance observations and states that the data "supports a finding of substantial equivalence."
Reported Device Performance (from "Summary of Performance Data"):
| Performance Aspect | Reported Performance / Observation |
|---|---|
| Positivity Rate (Screening Population) | Approximately 2% in a screening population of average risk, asymptomatic individuals aged 50 or older. This was a general expectation from immunochemical fecal occult blood tests. |
| Positivity Rate (Multi-day, Young Volunteers) | Approximately 2% in a group of 88 young, presumed normal volunteers, ages 17-33, who did not follow a restricted diet. (Multi-day fecal collections, all returned collections of the three dispensed slides regardless of number of days). |
| Positivity Rate & Estimated Positive Predictive Value (Multi-day, Average Risk) | Multi-day screening positivity rate: 1.8% |
| Estimated positive predictive value for colorectal neoplasia: 15.6% | |
| (In a group of 1734 average risk individuals, ages 41-97, who followed a restricted diet). | |
| Clinical Sensitivity for Colorectal Cancer (High-Risk Patients) | 90% (for multi-day screening in high-risk patients). |
| Clinical Sensitivity for Large Adenomas (High-Risk Patients) | 28% (for multi-day screening in high-risk patients). |
| Sensitivity for Non-neoplastic Colorectal Lesions | Low (in high-risk patients study). |
Note: The document states that "Equivalence is demonstrated through intended use, material composition, formulation, and clinical performance data analysis." The specific "acceptance criteria" for demonstrating this equivalence for each of these performance metrics are not detailed, but the reported performance figures are what was observed.
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "clinical performance data analysis" as a basis for demonstrating equivalence and mentions specific groups from which performance data was derived. These can be considered the test sets for calculating the reported performance metrics.
- Sample Sizes:
- Group 1: 88 young, presumed normal volunteers, ages 17-33.
- Group 2: 1734 average risk individuals, ages 41-97.
- Group 3: "high risk patients" - specific number not provided, but studied for sensitivity to colorectal cancer and large adenomas. This study is referenced in the predicate device for "Clinical Performance Source Data."
- Data Provenance: The document explicitly states "Clinical Performance Source Data: Same as Predicate HOICT." This implies the data was collected for the original predicate device (Hemoccult ICT, formerly FlexSure OBT, K961062). There is no mention of the country of origin. The data appears to be retrospective relative to the current 510(k) submission, as it originates from the predicate device's evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical performance data. Given the nature of a fecal occult blood test, the ground truth would typically be established through more definitive diagnostic procedures (e.g., colonoscopy with biopsy for pathology).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not described in the document. The device is a "visually read, qualitative immunochemical chromatographic method," implying human interpretation. However, the study focuses on the device's performance in detecting hemoglobin, not on comparing human readers' performance with and without AI assistance. This is a diagnostic test, not an AI-assisted diagnostic tool.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is described as "visually read," meaning human interpretation is an integral part of its normal operation. Therefore, a standalone study without human-in-the-loop performance would not be applicable, as it's not an automated algorithm in that sense. The results (presence/absence of color change) are interpreted by a human user.
7. The Type of Ground Truth Used
The nature of the reported performance metrics (e.g., "positive predictive value for colorectal neoplasia," "clinical sensitivity for colorectal cancer" and "large adenomas") strongly suggests that the ground truth was established through pathology or definitive diagnostic outcomes (e.g., colonoscopy with biopsy confirming polyps, adenomas, or cancer) for individuals who tested positive or were part of the relevant patient groups.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or machine learning model. This is a traditional diagnostic kit, not an AI/ML device. The clinical performance data mentioned would serve as evaluation data for the device itself.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an algorithm, this question is not applicable based on the provided text.
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