(223 days)
The InSure® ONE™ is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. The InSure® ONE™ test is used to aid in the detection of lower gastrointestinal bleeding.
The InSure® ONE™ – One Day Fecal Immunochemical Test qualitatively detects human hemoglobin from blood in fecal samples. The fecal sample is generally collected by the test subject at home. Toilet bowl water samples are taken using long handled brushes to collect a small volume of water from around the defecated stool. The toilet water test sample once collected is placed on an InSure ONE Test Card. The InSure ONE Test Card then serves as a means to transport the dried samples to the laboratory. The InSure ONE test detects human hemoglobin in toilet bowl water. The test is developed in the laboratory or medical professional office with appropriate quality control. The FOBT Controls (K101831) are recommended for use as external controls.
Components of InSure® ONE™ - One Day Fecal Immunochemical Test:
- a. The InSure® ONE™ Collection Kit* contains:
- InSure® ONE™ Instructions for Use-Patient ●
- InSure® ONE™ Test Card ●
- Brush Kit containing 2x brushes and a waste bag ●
- Business reply form and envelope ●
- b. The InSure® ONE™ or InSure® FIT Developer Kit* (for development and interpretation of the test) contains:
- InSure® ONE™ Instructions for Use-Professional Laboratory .
- InSure® ONETM Test Strips: The Test Strips contain mouse monoclonal anti-. human hemoglobin test line antibodies and a conjugate-specific polyclonal (donkey anti-goat) antibody control line, and a conjugate of anti-human hemoglobin polyclonal (goat) antibodies bound to colored (colloidal gold) particles.
- . InSure® ONE™ Run Buffer: Contains borate salts, ethanol, bovine serum albumin, and sodium azide as preservative.
- c. The InSure® ONE™ or InSure® FIT FOBT Controls contains:
- · Instructions for Use
- · Positive Control
- · Negative Control
*The above kits and components are supplied in a variety of packaging configurations and sold in combination or separately to meet customer requirements.
Here's the breakdown of the acceptance criteria and study information for the InSure® ONE™ – One Day Fecal Immunochemical Test based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytical Sensitivity: Reliably detects 50 ug hemoglobin/gram stool for up to 14 days after sample collection. | Assay Cut-off Study: |
- At 50 ug Hb/g stool: Positive Percent Agreement (PPA) of 97.5% (87.1% to 99.6% CI).
- At 40 ug Hb/g stool: PPA of 92.5% (80.1% to 97.4% CI). Officially, the cut-off was determined to be 50 ug hemoglobin/g stool. |
| Method Comparison (Clinical Performance): Acceptable overall agreement with InSure® FIT™ (predicate device) in clinical positive predictive value (PPV) and clinical negative predictive value (NPV). No statistically significant differences in test results between the new InSure ONE sampling method (two aliquots from one bowel movement) and the predicate InSure FIT method (one aliquot from two separate bowel movements). | The study demonstrated that there were no statistically significant differences in the test results obtained from two fecal water sample aliquots taken from one bowel movement (new sampling method InSure ONE), when compared to one fecal water sample aliquot taken from two separate bowel movements (predicate sampling method InSure FIT). The InSure ONE test is substantially equivalent to the predicate device. |
Study Details
2. Sample size used for the test set and the data provenance:
- Analytical Sensitivity (Assay Cut-off Study):
- Sample Size: 40 samples per hemoglobin concentration level, across 9 different concentrations, totaling 360 prepared samples.
- Data Provenance: The text describes the preparation of spiked stool samples and the simulation of toilet water. This suggests a retrospective, laboratory-based study rather than collection from actual patients.
- Method Comparison (Clinical Study):
- Sample Size: 859 patients.
- Data Provenance: Patients were recruited from three intended use sites, and the study was performed at one intended use site in Australia. This was a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Analytical Sensitivity (Assay Cut-off Study): No external experts are mentioned for establishing ground truth. The ground truth was based on the known, spiked hemoglobin concentrations.
- Method Comparison (Clinical Study): The text states, "Tissue samples collected at colonoscopy were histopathologically examined for the type of lesion (i.e., cancer, advanced adenoma, etc.)." This implies that pathologists established the ground truth based on histopathological examination. The number and specific qualifications (e.g., years of experience) of these pathologists are not specified in the provided text.
4. Adjudication method for the test set:
- Analytical Sensitivity (Assay Cut-off Study): Not applicable, as the ground truth was based on predefined concentrations. The determination of whether a test was positive or negative was likely by trained laboratory personnel following a specific protocol.
- Method Comparison (Clinical Study): The text does not explicitly mention an adjudication method for the histopathological examination of tissue samples. It is standard practice in pathology for samples to be reviewed by at least one pathologist, and potentially a second for complex cases or discrepancies, but this is not detailed in the provided information.
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, an MRMC comparative effectiveness study was not done. This device is a Fecal Immunochemical Test (FIT), which is a diagnostic assay, not an AI-assisted diagnostic imaging or analysis tool that typically involves human readers interpreting results with or without AI assistance. The study compares the performance of two different sampling methods for the FIT itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance was done for both studies.
- Analytical Sensitivity (Assay Cut-off Study): This study directly assessed the device's ability to detect hemoglobin at various concentrations, which is the standalone performance of the test kit itself.
- Method Comparison (Clinical Study): This study evaluated the performance of the InSure ONE test (device and sampling method) in detecting occult blood, independent of a human interpreting complex outputs to derive a diagnosis. The "human-in-the-loop" aspect here is the patient collecting the sample and laboratory staff developing it, but the intrinsic performance of the test strip itself is being evaluated.
7. The type of ground truth used:
- Analytical Sensitivity (Assay Cut-off Study): Predefined concentrations of hemoglobin in spiked stool samples.
- Method Comparison (Clinical Study): Pathology results from histopathological examination of tissue samples collected during colonoscopy (e.g., cancer, advanced adenoma).
8. The sample size for the training set:
- The provided text does not mention a training set as this is a diagnostic test kit (FIT), not a machine learning or AI algorithm that typically requires a large training dataset to learn patterns. The studies described are performance and method comparison studies for the physical test device.
9. How the ground truth for the training set was established:
- As no training set is mentioned for this type of device, this information is not applicable.
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.