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The Instant-view-plus™ Immunochemical Fecal Occult Blood Test is a qualitative immunoassay for detection of Fecal Occult Blood. It is intended for professional and over the counter use.

This device is a Driven Flow™ chromatographic immunoassay consisting of a test strip housed in a plastic cassette.

Here's a breakdown of the acceptance criteria and study information for the Instant-view-plus™ Immunochemical Fecal Occult Blood Test, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance demonstrated in the various studies, particularly the precision/reproducibility and method comparison studies. The goal is to show substantial equivalence to predicate devices, meaning the device performs as well as or better than already approved devices.

The tables below compile the key performance metrics provided:

• Positive Percent Agreement: 100% (492/492) (99.3%, 100%)
• Negative Percent Agreement: 99% (404/408) (97.5%, 99.7%) |
  | | | Reproducibility (Lot Variability):
• Lot 1: Pos. 100%, Neg. 98.6%
• Lot 2: Pos. 100%, Neg. 97%
• Lot 3: Pos. 100%, Neg. 96.4% |
  | | | Reproducibility (Day Variability):
• Day 1: Pos. 100%, Neg. 95.1%
• Day 2: Pos. 100%, Neg. 89%
• Day 3: Pos. 100%, Neg. 98.6%
• Day 4: Pos. 100%, Neg. 95.4%
• Day 5: Pos. 100%, Neg. 96.8% |
  | | | Reproducibility (Site Variability):
• Site 1: Pos. 100%, Neg. 97.1%
• Site 2: Pos. 100%, Neg. 97.4%
• Site 3: Pos. 100%, Neg. 96.7% |
  | Assay Cut-off | Clearly defined sensitivity/specificity around cut-off | 50 ng/ml (human hemoglobin in fecal sample mixed with detection buffer).
  At 50 ng/ml: Positive % = 55%, Negative % = 45%
  At 60 ng/ml: Positive % = 100%, Negative % = 0% |
  | Method Comparison (vs. Predicate) | Acceptable Overall, Positive, and Negative Percent Agreement | Combined Sites:
• Overall Percent Agreement: 97.7% (95.2%, 99.1%)
• Positive Percent Agreement: 96.0% (90.2%, 98.9%)
• Negative Percent Agreement: 98.5% (95.6%, 99.7%) |
  | Prozone Effect | No significant prozone effect | No prozone effect observed up to 500,000 ng/mL |
  | Analytical Specificity (Hb variants) | Equivalent recognition of Hb variants | Equivalently recognizes HbA, HbS, and HbC |
  | Cross-Reactivity (Animal Hb) | No significant cross-reactivity | No significant cross-reactivity with tested animal hemoglobins (beef, chicken, fish, horse, goat, rabbit, pig, horseradish peroxidase, sheep) |
  | Interfering Substances (Vegetables) | No significant interference | No significant interference from tested vegetable extracts (broccoli, cantaloupe, cauliflower, parsnip, red radish, turnip) |
  | Interfering Supplements (Iron, Ascorbate) | No significant interference | No significant interference from iron and sodium L-ascorbate |
  | Interference from Toilet Water | No significant interference | No significant interference from samples collected in toilet water |
  | Stability (Accelerated/Real Time) | Defined shelf-life | stable for 24 months at 8-23°C |

Study Details:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Precision/Reproducibility (Repeatability): 6 concentrations (0, 25, 50, 55, 500 ng/ml). 50 replicates per concentration (total of 300 tests per lot). Data provenance is in-house by trained laboratory professionals. This implies retrospective testing of prepared samples.
• Precision/Reproducibility (Reproducibility): 9 concentrations (0, 25, 50, 60, 60 [repeated], 500 ng/ml). 14 replicates for each sample and concentration level. Performed across three intended use sites over a minimum of 5 days. This suggests a prospective data collection design using controlled, spiked samples.
• Prozone Effect Study: 7 concentrations (1,000 to 500,000 ng/ml). 20 aliquots of each concentration. Data provenance is in-house. This is retrospective testing of prepared samples.
• Assay Cut-off Study: 7 concentrations (0, 25, 48, 50, 60, 72, 500 ng/ml). 20 aliquots of each concentration. Data provenance is in-house. This is retrospective testing of prepared samples.
• Method Comparison with Predicate Device: 299 patient samples. Performed at three POC testing sites. Data provenance is not explicitly stated beyond "patient samples" and "POC testing sites," but it implies real-world clinical samples, likely prospective or retrospective from those sites.
• Consumer Study: Concentrations were 0, 25, 50, 60, and 500 ng/ml. "Number of Samples" is consistently "20" (represented as "રત" in the table, clearly a transcription error for 20). Data provenance is in-house using spiked samples. This is retrospective testing of prepared samples.

No specific country of origin for the data is mentioned, but the manufacturer is based in Poway, California, USA, making it highly probable the studies were conducted domestically.

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)

• For the precision/reproducibility, prozone, assay cut-off, analytical specificity, cross-reactivity, and interference studies, the ground truth was established by preparing fecal samples spiked with known concentrations of human hemoglobin or other controlled substances. Therefore, no human experts were needed to establish the ground truth; it was experimentally determined.
• For the method comparison study, the "predicate test Instant-view™ Fecal Occult Blood Rapid Test" results served as the reference standard (comparative ground truth). The predicate device itself would have undergone its own validation based on established ground truth (e.g., clinical diagnosis or pathology). For this specific study, the experts are the operators at the three POC testing sites, but their qualifications are not specified beyond "two operators at each site."
• For the consumer study, similarly, no human experts established a true "ground truth." The comparison was between the new device and the predicate device on spiked samples.

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

• No explicit adjudication method (like 2+1, 3+1 consensus) is described in the provided text for any of the studies involving human interpretation.
• For studies involving spiked samples, the "truth" is the known concentration of hemoglobin or other substances, eliminating the need for adjudication.
• For the method comparison study, the readings of the Instant-view-plus™ were compared directly to the results of the predicate device, not against an expert-adjudicated ground truth.

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 involving AI assistance is mentioned. This device is a rapid immunochemical assay, not an AI-powered diagnostic imaging tool. Human interpretation is involved in reading the lines on the cassette.
• A "method comparison with predicate device" study was performed, which compared the new device's readings to those of a predicate device. This is a comparison between devices, not between human readers with and without AI assistance.
• A "consumer study" was performed, which likely involved lay users or professional users following instructions, but it was to assess the device's performance, not the improvement of human readers with AI.

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

• This device is a standalone test kit that provides a visual readout (presence/absence of lines). Its performance is the algorithm's performance, as the "algorithm" is the biochemical reaction and visual indication. There isn't a separate "human-in-the-loop" vs. "standalone algorithm" distinction in the context of this immunochemical test. The studies evaluate the device's performance directly.

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

• For the precision/reproducibility, prozone, assay cut-off, analytical specificity, cross-reactivity, interfering substances, and stability studies: The ground truth was experimentally determined by preparing Hb-free fecal samples spiked with known, precise concentrations of human hemoglobin, hemoglobin variants, animal hemoglobins, vegetable extracts, or other interfering substances.
• For the method comparison study: The ground truth was the result from the predicate device (Instant-view™ Fecal Occult Blood Rapid Test).
• For the consumer study: The ground truth was again the known concentration of hemoglobin in the spiked samples, used to compare the new device to the predicate.

8. The sample size for the training set

• The provided text describes studies for validation and verification of the device's performance, not the training of an algorithm. Therefore, there is no specific training set identified in the context of machine learning. The "training" for this type of device would involve development and optimization of the immunoassay components, likely using iterative testing, but this is not a formally reported "training set" in the sense of AI.

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

• As there's no identified "training set" for an algorithm in the provided text, this question is not applicable. The device's "ground truth" during its development would have been established through controlled laboratory experiments, optimizing reagent formulations and design to achieve desired sensitivity and specificity.

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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

• 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.

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