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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:

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

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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The Hema-Screen TM Specific Gold is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.

hema-screen™ SPECIFIC Gold is a qualitative, sandwich dye conjugate immunoassay that employs a unique combination of monoclonal antibodies to selectively identify the globin component of human hemoglobin in fecal specimens with a high degree of analytical sensitivity. Two samples of feces, collected using the unique DEVEL-A-TAB Sampler, are dispersed in a single tube containing a known volume of buffer. The unique design of the Sampler ensures that a controlled amount of feces is added to the specimen preparation tube. Then, the feces in buffer is transferred to the test cassette detection system using the tube itself as the delivery system. In less than five minutes, unusually elevated concentrations of human hemoglobin in feces can be detected and positive results for abnormal concentrations of hemoglobin can be seen in the test cassette detection system as early as two or three minutes after application of specimen. As the feces in buffer specimen flows up through the absorbent device, the labeled antibody-dye conjugate binds to the globin of hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to anti-globin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly. In the extremely rare event of operator or test cassette failure, sufficient specimen is available in the tube to repeat the procedure with another test cassette.

The provided text describes a 510(k) submission for a medical device called "hema-screen™ SPECIFIC Gold," which is a Fecal Immunochemical Test (FIT) for detecting human blood in fecal samples. The submission asserts substantial equivalence to a previously cleared predicate device, "hema-screen™ SPECIFIC."

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify the exact number of patient fecal samples used in the "Summary of Patient Fecal Sample Testing." It only states that "Each of the three lots of hema-screen™ SPECIFIC Gold were 100% agreement with predicate..." This implies that multiple samples were tested across different manufacturing lots, but the specific count is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the document. Given that this is a comparison to a predicate device (hema-screen™ SPECIFIC), the "ground truth" for the test set appears to be the results obtained from the predicate device itself, rather than external expert assessment.

4. Adjudication method for the test set

• None specified. The study's focus was a direct comparison between the subject device and the predicate device, not on independent expert re-assessment of results.

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

• Not applicable. This device is a qualitative diagnostic kit (a Fecal Immunochemical Test), not an AI-powered image analysis system or a device that involves human readers interpreting complex data. Therefore, an MRMC study is not relevant to this type of device.

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

• Yes, in essence. The "Summary of Patient Fecal Sample Testing" describes the performance of the device itself (hema-screen™ SPECIFIC Gold) compared to the predicate. While the device is a diagnostic kit used by professionals, the performance metrics (agreement, PPA, NPA) reflect the device's inherent ability to detect human hemoglobin in fecal samples. There isn't an "algorithm" in the typical sense of AI, but the device's chemical and physical principles determine its standalone performance.

7. The type of ground truth used

• The ground truth used was comparison to a legally marketed predicate device (hema-screen™ SPECIFIC). The assumption is that the predicate device's results serve as the accurate reference point for comparison.

8. The sample size for the training set

• Not applicable. This device is a diagnostic kit, not a machine learning algorithm that requires a training set. The development of the device would involve chemical formulation and validation, not data-driven training.

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

• Not applicable. As stated above, there is no "training set" for this type of device.

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Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal(GI) bleeding. The device is suitable for use in laboratories and physician's offices as well as for over the counter use.

For in vitro diagnostic use only. For prescription use and over the counter use.

The Wondfo One Step Fecal Occult Blood Test utilizes double antibodies sandwich immunoassay for the detection of hemoglobin in test samples. The test kit consists of:

Test devices, one test in one pouch. One pouch contains a test cassette and a desiccant. The desiccant is for storage purposes only and is not used in the test procedures.
Collection tubes with 1.5mL extraction buffer solution.
Clean collection papers.
Instructions for use.

Here's a breakdown of the acceptance criteria and study information for the Wondfo One Step Fecal Occult Blood Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each performance characteristic. Instead, it presents results that were deemed "acceptable" or demonstrated "substantial equivalence" to the predicate device. Therefore, the table below reflects the reported performance which implies it met the internal acceptance benchmarks.

2. Sample Sizes and Data Provenance:

• Precision/Reproducibility:
  • Repeatability: 21 replicates for each of 7 concentrations (total 147 samples). Data provenance is "in house".
  • Reproducibility: 21 replicates for each of 7 concentrations, tested at 3 POC sites, with 3 kit lots, 3 operators, and 5 non-consecutive days each. This would be 21 * 7 * 3 * 3 * 5 = 6615 tests in total across sites for the primary experiment, with reported summarized results from a subset of this (e.g., 735 for lot-to-lot, between-run, between-device, between-site, and 2205 for combined reproducibility). Data provenance: 3 POC sites in the U.S.
• Linearity (Prozone Hook Effect): 5 aliquots for each of 7 concentrations (total 35 samples). Data provenance is "in house".
• Sample Stability: For each condition (room temp, 2-8°C, -20°C): 7 different hemoglobin concentrations, tested repeatedly over time. The exact total sample count for stability studies (especially across all time points and conditions) is not explicitly totaled but would be substantial.
• Interference: 21 aliquots of hemoglobin-negative stool spiked with 7 different Hb concentrations (total 147 samples per interfering substance tested). Tested against various vegetable extracts, vitamin C, iron, horseradish peroxidase, toilet cleaners.
• Specificity (Hb Variants): 21 aliquots for each of 7 concentrations of each Hb variant (HbA, HbS, HbC). (Thus, 21 * 7 * 3 = 441 samples).
• Cross-Reactivity: 21 aliquots of hemoglobin-negative stool spiked with 7 different Hb concentrations (total 147 samples per non-human Hb/meat extract). Tested against 8 non-human hemoglobins and 8 animal meat extracts.
• Cut-off Study: 21 aliquots of each of 7 concentrations (total 147 samples). Tested side-by-side with predicate using the same sample set. Data provenance is "in house".
• Comparison Studies (Method):
  • 407 patient samples.
  • 18 stool samples around the cut-off (purchased).
  • 100 spiked samples.
  • Total 525 samples analyzed in the comparison study tables.
  • Data provenance: Performed at three POC testing sites.
• Lay-user Study:
  • Own stool samples: 100 lay users each testing their own stool sample (100 samples).
  • Spiked samples: 20 spiked samples at each of 5 concentrations (0, 37.5, 50, 62.5, 2000 ng/mL) resulting in a total of 100 spiked samples. Each lay user tested one spiked sample.
  • Data provenance: Performed at three intended user sites.
• Test Kit Reaction Time: 21 replicates of each of 7 concentrations (total 147 samples).
• Operator Intensity Reading: 25 replicates for each of 7 concentrations (total 175 samples).
• Specimen Collection Verification: 5 positive and 5 negative clinical samples per lay user (5 * 10 = 50 samples for the primary part of the study). Stool weight measurements were taken from these.

The overall provenance of the data appears to be a mix of "in-house" (likely in China, given the manufacturer's location) and "US POC sites" for reproducibility and method comparison studies. All studies appear to be prospective for the purpose of device validation.

3. Number of Experts and Qualifications:

• Adjudication and Ground Truth for Test Sets:
  • In the precision, stability, linearity, interference, specificity, and cut-off studies, the "ground truth" was established by the known concentrations of human hemoglobin or other substances spiked into Hb-free stool samples. This is an analytical ground truth, not requiring expert review of the results in the same way clinical data would.
  • For the Method Comparison Study, the predicate device (Orient Gene Biotech One Step Rapid FOB Test) served as the comparator, with its results being the "reference standard" against which the new device was compared. This implies the predicate device's results were considered the "ground truth" for comparison.
  • For the Lay-user study: "Professional testing" results were used as the ground truth for comparison. The document does not specify the qualifications of these "professionals," but it implies they are trained laboratory or clinical staff.
  • Specimen Collection Verification: A "professional operator" was involved in weighing samples. Qualifications are not specified.

4. Adjudication Method:

• There is no mention of an adjudication method (like 2+1 or 3+1 consensus) for establishing the ground truth of the test sets. The studies rely on:
  • Analytical ground truth: Spiked samples with known concentrations.
  • Comparative ground truth: Comparison against a legally marketed predicate device or "professional testing" results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on how much human readers improve with AI vs. without AI assistance was reported. This device is a rapid diagnostic test (FOBT) for the qualitative detection of human occult blood. It is not an AI-powered image analysis device, nor does it appear to involve human "readers" interpreting complex medical images in the way an MRMC study would typically evaluate. The "operators" or "lay users" in this context are performing the test and reading a simple positive/negative result, not interpreting complex data.
• The "Operator Intensity Reading" study involved multiple readers (five) but it was to assess consistency of subjective intensity grading, not comparative effectiveness with/without AI assistance.

6. Standalone Performance:

• Yes, extensive standalone performance was done. The entire "Analytical Performance" section (Precision/Reproducibility, Linearity, Stability, Interference, Specificity, Cut-off) details the algorithm's (device's) performance characteristics independently of human-in-the-loop clinical decision making, by testing samples with known analytical parameters.
• The "Method Comparison Studies" also describe the standalone performance of the device against a predicate device.
• The "Lay-user study" also tested the standalone performance of the device when used by lay users, comparing their results to professional results.

7. Type of Ground Truth Used:

• Primarily analytical ground truth (known concentrations of human hemoglobin or other substances in spiked stool samples) for most of the analytical performance studies (precision, stability, linearity, interference, specificity, cut-off).
• Comparative ground truth using a legally marketed predicate device (Orient Gene Biotech One Step Rapid FOB Test) for the method comparison study.
• Comparison to "professional testing" results for the lay-user study.

8. Sample Size for the Training Set:

• The document does not mention or specify a training set in the context of an algorithm or AI. This device is a lateral flow immunochromatographic assay, which is a chemical and biological test, not an AI/machine learning model that typically requires a large training dataset. The development and optimization of such a test would involve internal R&D experiments to determine optimal reagent concentrations, membrane properties, etc., but these are not referred to as a "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set was Established:

• As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the submitted document.

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hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

hema-screen ER XCEL™ in its original concept as slides and tape was designed to offer the hospital, mass screening programs and clinical laboratories a convenient rapid method for handling fecal specimens in testing for occult blood. hema-screen ER XCEL™ is especially useful for mass screening programs as its enhanced readability feature facilitates the technicians' ability to make a determination.

hema-screen ER XCEL™ eliminates the mess and odors associated with the collection and transport of fecal specimens. Slides can be prepared at the patient's bedside and placed in a sealed envelope or by the patient at home and mailed to the hospital or laboratory in an inoffensive manner for development and evaluation.

hema-screen ER XCEL™ single slides are convenient for use when single stool specimens are to be tested. A single test is indicated when blood loss in the gastrointestinal tract is strongly suspected, for example, in persons with symptoms of ulcers, anemia, black stools or postoperative patients.

hema-screen ER XCEL™ Enhanced Readability Patient Packs are to be utilized so the patient can serially collect specimens at home over the course of three bowel movements. Patients should be instructed to follow the directions exactly, as the potential for false positive results exists due to improper diet, blood on the hands, hemorrhoids or if the test is used during menstrual bleeding. After all three slides are prepared, the slides may be sent back to the hospital laboratory for developing and evaluation. Preparation of three consecutive slides is recommended for screening asymptomatic patients by the American Cancer Society.

When stool specimens containing occult blood are applied hema-screen ER XCEL™ test paper, the hemoglobin portion of the occult blood comes in contact with the guaiac. When the hema-screen ER XCEL™ peroxide developing solution is added, a guaiac-peroxidase like reaction occurs. The chemical reaction becomes visible by the appearance of a blue-green color between 30 seconds and 60 seconds if occur blood is present.

This document describes the hema-screen ER XCEL™ Enhanced Readability Fecal Occult Blood Test, which is a qualitative method for detecting occult blood in stool. The application is a 510(k) premarket notification claiming substantial equivalence to the predicate device hema-screen™ ER (K102664).

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported device performance values. The substantial equivalence claim is based on the assertion that the "fundamental scientific technology of the modified device has not changed" and "There is no change in analytical sensitivity of the new device." The changes primarily involve the addition of an optional patient sampling slide with a GRID design for enhanced readability and ease of use, rather than a change in the underlying diagnostic performance.

2. Sample Size Used for the Test Set and Data Provenance:

   The document does not provide details on a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The application relies on demonstrating that the modified device's analytical sensitivity has not changed compared to the predicate device, which would imply that its performance characteristics are comparable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

   The document does not specify the number or qualifications of experts used to establish ground truth. As this is a 510(k) for a modification (addition of a GRID design for readability) to a previously cleared device, the focus is on maintaining existing performance rather than re-establishing ground truth for diagnostic accuracy with a new study.

4. Adjudication Method for the Test Set:

   No adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   No MRMC comparative effectiveness study is mentioned. The device is a qualitative test for occult blood, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study:

   The document does not describe a standalone (algorithm only) performance study as this is not an AI/algorithm-based device. The device itself is a qualitative chemical test. The "enhanced readability" feature refers to the physical design of the sampling slide.

7. Type of Ground Truth Used:

   The document implies that the ground truth for establishing the performance of the original predicate device (and by extension for demonstrating no change in the modified device) would be related to the presence or absence of occult blood, likely confirmed by established clinical methods or laboratory techniques. However, specific details on how this ground truth was used or established are not provided in this summary.

8. Sample Size for the Training Set:

   The document does not mention a training set sample size, as this is a chemical diagnostic test and not a machine learning or AI-based device that would typically involve a training set.

9. How Ground Truth for the Training Set Was Established:

   Not applicable, as no training set is described for this type of device.

Summary of Device Modification and Basis for Substantial Equivalence:

The primary change in the hema-screen ER XCEL™ device from its predicate (hema-screen™ ER) is the addition of an optional patient sampling slide with a GRID design. The manufacturer states:

• "The fundamental scientific technology of the modified device has not changed."
• "The internal guaiac paper has neither been modified nor reformulated."
• "There is no change in analytical sensitivity of the new device."
• The modified design simply features a smaller surface area (small circles) on the outer cardboard to help prevent oversampling and ease of use for the patient, which facilitates readability for technicians.

Therefore, the application argues for substantial equivalence based on the technological characteristics being identical for the core diagnostic mechanism and that the design change related to readability does not impact the scientific principle, materials, intended use, operating principle, basic design, shelf life, or enhanced developing solution. The risk analysis indicated that the modifications were satisfactory and did not raise new issues of safety or effectiveness.

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OC-Light S FIT (Fecal Immunochemical Test, also known as iFOBT, immunochemical fecal occult blood test) is a qualitative test intended for the immunochemical detection of fecal occult blood (FOB) by professional laboratories and physician office laboratories. Measurement of FOB is useful as an aid to detect blood in stool when gastrointestinal (GI) bleeding may be suspected. OC-Light S FIT is recommended for use in routine physical examinations.

OC-Light S FIT is an in vitro diagnostic device, a qualitative test designed for the immunochemical detection of human hemoglobin (hHb) in stool specimens. OC-Light S FIT consists of a test strip, and a sampling bottle containing buffer solution. OC-Light S FIT test strip consists of a nitrocellulose membrane with immobilized mouse monoclonal antibodies specific to human hemoglobin at the test region and immobilized rabbit anti-mouse antibodies at the control region, a sample pad, a conjugate pad which contains human hemoglobin specific mouse monoclonal antibodies conjugated with colloidal gold, an absorption pad, and a plastic backing. OC-Light S FIT sampling bottle is a plastic bottle for collecting fecal sample containing 2.0 mL of extraction buffer. When the sample end of the test strip is dipped in the fecal extract, the liquid fecal extract wicks through a series of absorbent materials and contacts colloidal gold conjugated with monoclonal antibodies specific to hHb. If hHb is present in the sample, it reacts with the antibodies on the colloidal gold. When the gold conjugate with hHb reaches the test region of the membrane, it binds with the immobilized antibodies also specific to hHb to form a visible reddish/pink line. The procedural control region of the membrane contains immobilized anti-mouse antibodies that capture the conjugate independent of the presence of the hHb, thereby always producing a distinct reddish/pink line. The reddish/pink line in the procedural control region demonstrates the validity of the test, and assures the operator that the device is working properly.

Here's an analysis of the acceptance criteria and study details for the OC-Light S FIT device based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold but rather presents performance data and concludes substantial equivalence based on comparisons. For this table, I'll extract the key performance metrics and the overall conclusion of substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document describes several "test sets" for different studies:

• Cut-off Study: 147 samples (7 Hb concentrations x 21 replicates). Data provenance: In-house, spiked Hb-free stool specimens.
• Reaction Time Study: 147 samples (7 Hb concentrations x 21 replicates). Data provenance: In-house, spiked Hb-free stool specimens.
• Precision/Reproducibility Study: 147 samples (7 Hb concentrations x 21 replicates) per site, across three POL sites. Total for combined reproducibility: 1764 samples. Data provenance: Spiked Hb-free stool specimens shipped to US clinical coordinator for distribution to POL sites.
• Test Kit Stability (Accelerated): 441 samples per condition (7 Hb concentrations x 21 replicates x 3 lots = 441). Data provenance: Spiked Hb-free stool specimens.
• Sample Stability: 441 samples per condition (7 Hb concentrations x 21 replicates x 3 lots = 441). Data provenance: Spiked Hb-free stool specimens.
• Test Kit Shipping Stress Test: 441 samples per condition (7 Hb concentrations x 21 replicates) for each day/temperature condition. Data provenance: Spiked Hb-free stool specimens.
• Sample Shipping Stress Test: 441 samples per condition (7 Hb concentrations x 21 replicates) for each day/temperature condition. Data provenance: Spiked Hb-free stool specimens.
• Method Comparison Study: 953 specimens. Data provenance: Presumably clinical samples collected from Physician Office Laboratory (POL) and Professional Medical Laboratory (PML) settings. The document specifies "three POL sites and three PML sites." This suggests the data is prospective, collected at these clinical sites in the US (implied by POL/PML settings).
• Prozone Effect, Hemoglobin Variants, Cross-Reactivity, Interference: Various spiked concentrations as described. These are laboratory-prepared samples rather than patient samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for most of the foundational studies (cut-off, reaction time, precision, stability, interference) was established using spiked Hb-free stool specimens with known concentrations of human hemoglobin (hHb). This means the "ground truth" was inherently known by the experimental design, not determined by experts.

For the Method Comparison Study, the ground truth for clinical samples was established by the predicate device, Polymedco OC Light FOB Test. Therefore, no independent experts were used to determine the true presence or absence of FOB for these samples; the predicate device results served as the reference.

The "Intensity Reading" study involved 5 readers at one physician office laboratory grading the intensity of the test line. Their qualifications are not specified beyond being "live participant readers at a FOL." This is a qualitative assessment of the test line based on visual interpretation, not a determination of ground truth for fecal occult blood.

4. Adjudication Method for the Test Set

Given that the ground truth for most studies was based on spiked samples with known concentrations, or the predicate device in the method comparison, there was no need for an "adjudication method" in the sense of reconciling disagreements between multiple expert readers. The results were compared directly against the known concentrations or the predicate device's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. The primary clinical study was a method comparison study between the new device and a predicate device. This study assessed the agreement between the two devices, not the improvement of human readers with or without AI assistance. The OC-Light S FIT is a qualitative test strip, not an AI-assisted diagnostic tool for interpretation by human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The OC-Light S FIT is described as an "in vitro diagnostic device, a qualitative test" and a "lateral flow chromatographic immunoassay." It produces a visible reddish/pink line for positive results. This is a standalone diagnostic device where the result (presence or absence of a line) is visually interpreted by a human, but the device itself does not involve an "algorithm" or "AI" in the modern sense. Its performance as an independent assay is what was evaluated through the various studies (cut-off, precision, stability, interference, method comparison).

7. The Type of Ground Truth Used

• For Cut-off, Reaction Time, Precision/Reproducibility, Test Kit Stability, Sample Stability, Shipping Stress Tests, Hemoglobin Variants, Cross-Reactivity, Interference, Prozone Effect: The ground truth was known concentrations of human hemoglobin (hHb) in spiked, Hb-free stool specimens. This is a laboratory-controlled, artificial ground truth.
• For the Method Comparison Study: The ground truth was established by the predicate device, Polymedco OC Light FOB Test.

8. The Sample Size for the Training Set

The document does not describe a "training set" as it would for a machine learning model. This device is a traditional immunoassay, not an AI/ML product. All described samples are for validation/testing of the device's performance characteristics.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, there is no "training set" or corresponding ground truth establishment process described for this type of device.

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The OSOM iFOB (Immunochemical Fecal Occult Blood) Test is a rapid immunoassay for the qualitative detection of fecal occult blood by laboratories or physicians' offices. It is useful for the detection of human hemoglobin in human fecal samples and is recommended for use as part of routine physical examinations or when lower gastrointestinal disorders are suspected.

The OSOM iFOB (Immunochemical Fecal Occult Blood) Test is a rapid test which can detect the presence of occult blood in human fecal samples by detecting the presence of human hemoglobin (hHb). The OSOM iFOB Test is a qualitative assay that employs immuochromatographic, lateral flow technology. A test kit contains 25 pouched Test Devices, 25 Extraction Reagent vials, 25 conjugate vial tips, and 25 sample collection packs. Tests and Reagents are also available in a 50-test kit without sample collection packs, and sample collection packs are available separately in a package of 50. Negative and positive external controls are provided separately as the OSOM iFOBT Control Kit.

The fecal sample collected using an OSOM iFOB sample collection card is placed into a prefilled vial containing Extraction Buffer. This test solution is then dispensed, through a dropper tip containing human hemoglobin antibody conjugated to latex, into the sample well of the Test Device. The sample migrates across the membrane containing a Test line coated with anti-human hemoglobin antibody and a Control line. If hemoglobin is present at or above the level of detection of the test, an antigen/antibody complex will be formed. The appearance of a visible blue Test line and a red Control line in the result window indicates the presence of human hemoglobin in the sample. A red control line must appear for the results to be valid. If a detectable level of hemoglobin is not present, only the red control line will appear. An invalid test occurs when no control line appears.

The control line serves as an internal procedural control, indicating that the test system is functioning correctly and that the operator added a sufficient volume of sample. In addition to the internal control in each Test Device, external controls are available in a separate OSOM iFOBT Control Kit. The Negative Control (buffer solution) and the Positive Control (hHb in buffer solution) are run in the iFOB Test in the same manner as an extracted fecal sample.

Here's a breakdown of the acceptance criteria and study details for the OSOM iFOB Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal, enumerated list with specific thresholds for each performance metric. However, we can infer the acceptance criteria from the study's design and the conclusions drawn about "reproducibility" and "substantial equivalence." The main inferred acceptance criteria revolve around achieving high agreement with expected results and with a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Reproducibility and Detection Limit Study:
  • Sample Size: 542 individual test results were reported (325 expected positive, 217 expected negative). This was composed of panels of 15 test samples (3 of each of 5 hemoglobin concentrations: 0, 37.5, 50, 62.5, and 2000 ng/mL hHbA). Each POL operator tested 1 panel on each of 3 lots of the device. The reference site tested the same number of samples as the three external sites. Given 3 POL sites * 3 operators/site * 1 panel/operator/lot * 3 lots = 27 panels. The reference site also tested an equivalent amount. The specific number of unique samples is not directly stated, but the total number of test repetitions is 542.
  • Data Provenance: Retrospective, using spiked fecal samples with known concentrations of human hemoglobin A. The samples are prepared specifically for the study.
• Method Comparison Study:
  • Sample Size: 125 individual test results (75 expected positive, 50 expected negative based on predicate device). This involved 25 replicates of each of the five hemoglobin concentrations (0, 37.5, 50, 62.5, and 2,000 ng/mL hHbA).
  • Data Provenance: Retrospective, using spiked fecal samples with known concentrations of human hemoglobin A. The samples are prepared specifically for the study.
• Sensitivity to Hemoglobin Variants, Hook Effect, Cross-Reactivity, and Interfering Substances:
  • Sample Size: Specific numbers of discrete samples are not explicitly provided for these studies, but they involve testing various concentrations of hHbS, hHbC, potential cross-reactants, and interfering substances with three lots of the OSOM iFOB Test.
  • Data Provenance: Retrospective, using prepared samples (spiked with specific substances) rather than naturally occurring patient samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: For the reproducibility study, expert oversight established the testing protocol. However, the ground truth for spiked samples is determined by the known concentration of human hemoglobin A added to the fecal samples, not through expert reading of results.
  • Reproducibility study: "Testing at Sekisui Diagnostics, the reference site, was performed by two experienced laboratory professionals." These professionals performed the testing, but the ground truth (expected positive/negative) was based on the known spiked hemoglobin concentrations. The "intended users" at external POL sites also performed testing, with varying levels of education and work experience.
  • Method Comparison study: The "ground truth" for the OSOM iFOB Test was effectively established by direct comparison to the predicate device (Alfa Instant-View FOB Rapid Test / QuickVue iFOB Test) which itself is cleared as substantially equivalent. The ground truth for the spiked samples themselves was the known hemoglobin concentration.
• Qualifications of Experts: For the Sekisui Diagnostics reference site, "two experienced laboratory professionals" are mentioned. For the external POL sites, it stated "3 intended users per site, with varying levels of education and work experience," implying they are general laboratory or physician office personnel, not necessarily "experts" in establishing ground truth, but rather representative end-users.

4. Adjudication Method for the Test Set

The concept of "adjudication" in the sense of multiple external experts reviewing results to establish a definitive ground truth is not applicable here.

• For the reproducibility and detection limit studies, the ground truth was analytically determined by the known concentrations of spiked human hemoglobin. Samples with 0 and 37.5 ng/mL were expected negative, and samples with 50, 62.5, and 2000 ng/mL were expected positive, based on the device's stated detection level of 50 ng/mL. Any discrepancies between the device result and this analytically derived "expected" result were simply tallied for agreement calculation.
• For the method comparison study, the "ground truth" for comparison was the result obtained by the predicate device (QuickVue iFOB Test) on the same spiked samples, with the ultimate ground truth being the known spiked concentrations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done.

This device (OSOM iFOB Test) is a lateral flow immunoassay for detecting occult blood, not an AI-powered diagnostic system that assists human readers in interpreting complex medical images or data. The "readers" mentioned in the reproducibility study (POL operators) are simply the end-users performing the physical test, not interpreting an AI output.

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

Yes, the performance studies primarily reflect the standalone performance of the device.

The OSOM iFOB Test itself is a rapid immunoassay that produces a visible result (lines on a test strip). While a human operator (the "intended user" or "laboratory professional") has to perform the steps and visually interpret the lines, the core mechanism and output are inherent to the device's chemical and immunochromatographic properties. The studies evaluate the device's ability to accurately provide this result in various conditions, independent of active "human-in-the-loop" interpretive assistance beyond basic observation. The reproducibility study explicitly tested the ability of different users to get consistent results, which is a test of the device's robustness across user variability rather than a human-machine interface evaluation.

7. The Type of Ground Truth Used

The ground truth for all performance studies was primarily analytically determined via known concentrations of spiked human hemoglobin.

• For the reproducibility, detection limit, sensitivity to variants, and hook effect studies, the ground truth was the known concentration of hemoglobin (hHbA, hHbS, hHbC) added to the fecal samples, which then dictated the expected positive or negative result based on the device's detection threshold.
• For the cross-reactivity and interfering substances studies, the ground truth was the known absence or presence of specific interfering/cross-reacting substances along with, for interference, the known presence of hHbA at a critical concentration.
• For the method comparison study, the ground truth was a combination of the known spiked hemoglobin concentrations and the results from a legally marketed predicate device (Alfa Instant-View FOB Rapid Test / QuickVue iFOB Test).

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or machine learning device.

The OSOM iFOB Test is an immunochromatographic assay, not a device that employs algorithms that require training data. The development of the test (e.g., antibody selection, membrane optimization) would have involved extensive R&D, but this is not typically referred to as a "training set" in the sense used for AI/ML.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of AI/ML, this question is not applicable. The device's underlying chemistry and biology are its "rules," not a learned algorithm.

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The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.

Not Found

The provided text does not contain information about the acceptance criteria, device performance, or any studies related to the IND One Step Fecal Occult Blood Test. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the specific performance studies, acceptance criteria, or their results.

Therefore, I cannot provide the requested information based on the input text.

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The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for Over the Counter Use.

The FOB One Step Rapid Test is a lateral flow chromatographic immunoassay based on the principle of the double antibody-sandwich technique. The membrane is pre-coated with anti-hemoglobin antibody on the test line region of the device. During testing, the specimen reacts with the particle coated with anti-hemoglobin antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-hemoglobin antibody on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the Orient Gene Biotech - One Step Rapid FOB device:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are not explicitly stated as clear, pre-defined thresholds. Instead, the study aims to demonstrate performance that is comparable to, or meets expected results. I've inferred the expected performance based on the wording.

2. Sample Size Used for the Test Set and Data Provenance

• Detection Limit: 100 hemoglobin-free stool samples were used, spiked with varying concentrations (divided into groups of 20 for each concentration level). Data provenance is not specified (e.g., country of origin), but it appears to be lab-based, likely retrospective as samples were spiked.
• Potential Interferences: Not specified, but involved aqueous fecal samples. Likely retrospective (lab-prepared).
• Potential Cross Reactors: Not specified, but involved negative and positive fecal samples spiked with animal hemoglobin. Likely retrospective (lab-prepared).
• Reproducibility (Inter-Site): 75 hemoglobin-free fecal samples (split into groups for each concentration, 15 per group, tested 5 times each lot).
• Reproducibility (Intra-Run): 50 hemoglobin-free fecal samples (split into groups, 10 per group, tested 10 times each).
• Reproducibility (Inter-Day): 50 fecal samples (split into groups, 10 per group, tested 10 replicates each day for 3 days).
• Accuracy (Technical Personnel): 100 human stool extraction samples (20 replicates at each concentration). Data provenance is not specified, but the study was conducted at "three physician office laboratories." This suggests prospective collection or preparation of samples for this specific study.
• Accuracy (Non-Technical Personnel): 150 human stool extraction samples (30 at each concentration). Data provenance is not specified, but the study was conducted in a "medical laboratory." This also suggests prospective collection or preparation for the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• For the Detection Limit, Reproducibility, Interference, and Cross-Reactivity studies, the ground truth was established by spiking known concentrations of human hemoglobin (or other substances) into hemoglobin-free fecal samples. This means the known concentration of the analyte served as the ground truth. No human experts were explicitly stated to establish this ground truth, as it was a controlled, experimental setup.
• For the Accuracy studies, the "expected results" for the spiked samples also served as a ground truth (i.e., whether the spiked concentration should result in a positive or negative test). Additionally, the predicate device was used as a comparative "ground truth" or reference standard. No specific number or qualifications of experts are given for establishing the "expected results" for spiked samples, as these are inherent to the experimental design.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for most studies was established by the known concentrations of spiked analytes. For the accuracy study, comparisons were made against "expected results" (based on spiking) and the predicate device. There was no mention of an adjudication process by multiple human observers to establish a consensus ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the traditional sense of evaluating human readers' diagnostic accuracy with and without AI assistance. This device is a rapid diagnostic test kit, not an AI imaging or diagnostic algorithm.

The "Accuracy" section does compare the new device's performance when used by both "technical personnel" and "non-technical personnel" (layusers) against the predicate device. This is a form of comparative effectiveness, but it's evaluating the device itself and its usability by different user groups, rather than the effect of AI assistance on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the device itself, being a rapid diagnostic test, operates in a standalone manner. The results are interpreted visually (presence or absence of a colored line). While human users read the result, the "performance characteristics" (detection limit, reproducibility, interference, cross-reactivity) are essentially standalone performance evaluations of the device's ability to react to specific analyte concentrations. The "Accuracy" studies then evaluate human interpretation of these standalone device results.

7. The Type of Ground Truth Used

The primary type of ground truth used was known concentrations of spiked human hemoglobin (hHb) in hemoglobin-free fecal samples. This is a form of analytically defined ground truth or experimental ground truth. For the accuracy studies, the predicate device's results also served as a comparative ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a rapid chromatographic immunoassay, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The device's components (antibodies, membrane, etc.) are manufactured based on established biochemical principles and quality control, not trained on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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hema-screen™ ER is a rapid, convenient, and non-offensive qualitative method for detecting occult blood in the stool. It is intended for professional use as an aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occult blood in the stool. This test is recommended for use in routine hospital testing, mass screening programs for colorectal cancer, and in testing of postoperative patients and newborn infants.

Not Found

The provided text is an FDA 510(k) clearance letter for the Hema Screen™ ER occult blood test. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory clearance process and does not delve into the technical validation studies of the device itself.

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