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Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories.

Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.

For in vitro diagnostic use. For Prescription use.

Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.

The principle of measurement is an automated sandwich dye conjugate immunoassay that employs a combination of monoclonal antibodies to selectively identify and provide qualitative determination of human hemoglobin in feces. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hemoglobin in the specimen, forming an antibody-antigen complex. This complex binds to anti-hemoglobin 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 positive test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly.

The throughput of the instrument is 100 samples are collected in the sample collection tube "Sample Collection tube". The sample tube and test cartridge are assembled and placed on the sample tray. The instrument positions the plunger station to initiate the test cartridge testing by plunging the sample collection buffer tube into the chamber of the cartridge and thereby piercing its aluminum seal. The test fecal sample buffer is released into the test cartridge and fecal sample buffer will migrate on the enclosed test strip affixed on the test cartridge. Results are read after the tray makes one full rotation, which takes 5 minutes. Immediately after sample reading, the result (positive, negative or invalid) is displayed on the touchscreen and printed on paper whose dispensing slot is situated at the top of the Accu-Reader™ A100.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Hemosure Accu-Reader A100 device:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state a single, overarching acceptance criterion as a numerical threshold (e.g., "accuracy > 95%"). Instead, it demonstrates acceptable performance across various studies (precision, cross-reactivity, interference, stability, clinical performance) by consistently achieving high levels of "agreement" and confirming expected results. The primary measure used to show effectiveness, particularly in the clinical method comparison, is the "Overall Percent Agreement (OPA)," "Positive Percent Agreement (PPA)," and "Negative Percent Agreement (NPA)" with a predicate device.

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

• Clinical Performance Study:

  • Sample Size: A total of 377 clinical fecal samples were used.
  • Data Provenance: The samples were collected from individuals who had previously been screened by colonoscopy. The study was conducted at three different sites, indicating a likely prospective or retrospective multi-center clinical study setup, although the document does not definitively state "prospective" or "retrospective." The samples are human fecal samples. The country of origin is not explicitly stated.

• Other Studies (Precision, Cross-Reactivity, Interference, Stability, Analytic Sensitivity):

  • The test set for each of these studies used 21 replicates for each concentration (spanning various hemoglobin levels, including negative controls, around the cut-off, and high positive).
  • Data Provenance: These studies generally involved contrived or spiked samples (e.g., human hemoglobin, animal hemoglobin, interfering substances spiked into fecal samples). The provenance of the base fecal samples or the location of these analytical studies is not explicitly stated, but they are laboratory-based analytical studies rather than clinical field studies.

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

• For the Clinical Performance Study, the ground truth appears to be based on a legally marketed predicate device (OC-Auto Micro FOB Test) and "individuals who had previously been screened by colonoscopy." The document does not specify the number or qualifications of experts (e.g., radiologists, gastroenterologists, pathologists) who established the ground truth from the colonoscopy results. It's implied that the findings from the colonoscopy were used to determine the true positive/negative status for fecal occult blood, which was then compared to the device and predicate.

• For the Analytical Studies (Precision, Cross-Reactivity, Interference, Stability, Analytic Sensitivity), the "ground truth" for the test samples was established by preparing samples with known concentrations of human hemoglobin (or other substances). This is a controlled laboratory setting, so "experts" in the sense of clinical reviewers for ground truth are not applicable here. The known concentrations themselves served as the ground truth.

4. Adjudication Method for the Test Set:

• The document does not describe an explicit adjudication method for the clinical study test set in terms of human expert review. The comparison is made against a "predicate device" and implied "colonoscopy" results.
• For the analytical studies, the "ground truth" was established by the known concentrations of spiked analytes, so adjudication was not necessary.

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

• No, a standard MRMC comparative effectiveness study, where human readers interpret cases with and without AI assistance to measure improvement, was not conducted.
• This device, the Hemosure Accu-Reader A100, is an automated immunochemical fecal occult blood test system. It is designed for qualitative detection of fecal occult blood in human feces by clinical laboratories, with results read by a camera-based reader and displayed as "positive, negative or invalid." It is an in vitro diagnostic device, not an image interpretation AI system that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to this type of device.

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

• Yes, this was a standalone performance study. The Hemosure Accu-Reader A100 is an automated system. Its "performance characteristics" (precision, analytical sensitivity, cross-reactivity, interference, stability, and clinical comparison to a predicate) reflect the algorithm's performance in analyzing the test cartridge without human intervention in the result interpretation. The reader (machine) identifies and provides qualitative determination of human hemoglobin.

7. The Type of Ground Truth Used:

• For the Clinical Performance Study: The ground truth was based on the performance of a predicate device (OC-Auto Micro FOB Test) and, implicitly, outcomes data from colonoscopy screenings.
• For Analytical Studies (Precision, Prozone, Analytic Sensitivity, Cross-Reactivity, Interfering Substances, Specimen and Shipping Stability, Accelerated and Real-Time Kit Stability): The ground truth was known concentrations of spiked human hemoglobin (or other substances like animal hemoglobin or interfering agents) in fecal samples. These are essentially controlled experimental conditions.

8. The Sample Size for the Training Set:

• The document does not provide information on a training set size. As an in vitro diagnostic device, this typically refers to a specific assay method and an automated reader. While the reader uses digital imaging to analyze lines, it's not described as a deep learning or traditional machine learning system requiring a large "training set" in the common sense for AI algorithms. The system's "training" would be more akin to calibration and optimization of its optical analysis and interpretation logic, rather than iterative learning from a large labeled dataset. The various analytical studies validate its performance but are not explicitly referred to as a "training set."

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

• Since a "training set" in the context of an AI algorithm is not explicitly mentioned or implied for this device, the method for establishing its ground truth is not applicable/not provided. The device relies on a pre-defined sandwich dye conjugate immunoassay principle and a calibrated optical system.

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"OC-Auto Sensor io iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitatitye detection of fecal occult blood in feces by professional laboratories. The automated test is used for the measurement of fecal occult blood and is useful as an aid to detect blood in stool when lower gastrointestinal bleeding may be suspected.

OC-Auto Sensor io iFOB Test is intended for the automated in vitro qualitative detection of fecal occult blood in feces by professional laboratories. The test system is comprised of test reagents (latex, diluent buffer, wash concentrate, calibrator, negative and positive controls), sample collection bottles and analyzer.

The principle of measurement employed for the reagent system is latex agglutination. A latex agglutination reaction is the clumping of antibody-sensitized polystyrene latex particles through an antigen-antibody reaction. A light beam is passed through the reaction liquid to measure changes in the intensity of the transmitted light beam (latex turbidimetry), and changes in the intensity of the scattered light beam (latex nephelometry). With OC-Auto Sensor io iFOB Test analyzer, latex turbidimetry is used to measure the amount of an antigen or an antibody by measuring changes in scattered light rays in latex agglutination.

The throughput of the instrument is 88 samples per hour. The samples are collected in the sample collection bottles that are sent home with the patient. The sample collection bottles are then returned to the laboratory. The inverted sample collection bottles are racked and placed onto the instrument platform. The sample collection bottle is punctured and a sample is pipet into the cuvette followed by the latex reagent and mixed. Measurements are taken between the mixing cycles. After a series of washes the blank is read and the final results calculated and printed.

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

Acceptance Criteria and Device Performance

The acceptance criteria for the OC-Auto Sensor io iFOB Test are largely demonstrated through its equivalence to the predicate device and robust validation of its performance characteristics. The specific acceptance criteria themselves are not explicitly listed in a table format with quantitative targets for each category. However, the performance characteristics studies confirm that the device meets implied acceptance levels by showing high agreement with expected values and the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

• Negative Samples (0, 50, 80 ng/mL): 100.0% Negative Percentage Agreement (99.5% ~ 100.0% CI for individual sites, 99.9% ~ 100.0% CI for all clinical sites combined).
• Positive Samples (120, 450, 700 ng/mL): Very high Positive Percentage Agreement.
  • 120 ng/mL: 99.8% - 100.0% PPA (99.1% ~ 99.9% CI to 99.5% ~ 100.0% CI for individual sites, 99.7% ~ 100.0% CI for all clinical sites combined).
  • 450 ng/mL: 100.0% PPA (99.5% ~ 100.0% CI for individual sites, 99.9% ~ 100.0% CI for all clinical sites combined).
  • 700 ng/mL: 100.0% PPA (99.5% ~ 100.0% CI for individual sites, 99.9% ~ 100.0% CI for all clinical sites combined).
• The negative/positive threshold (100 ng/mL) showed variable distribution of positive/negative results, which is expected at the cutoff. Overall Percentage Agreement for this range was 100.0% (99.9% ~ 100.0% CI).
• All test results satisfied the acceptance criteria (stated in the text). |
  | Linearity | Measured values should align with theoretical values across the reported detection range. | Measured values were treated as regression values and compared against theoretical values (intended hemoglobin concentration from dilution). The test results satisfied the criteria. (Specific quantitative results not provided, but deemed acceptable). |
  | Prozone Effect | No susceptibility to prozone effect within the specified concentration range. | Device is not susceptible to prozone effect up to 1953 ng/mL. |
  | Limit of Detection (LoD) | Ability to detect hemoglobin at a specific low concentration. | 20 ng/mL was determined as the limit of detection. |
  | Hemoglobin Variants | Equivalence in sensitivity to common hemoglobin variants (S, C, F). | Device is equally sensitive to hemoglobin S, C, and F. |
  | Cross Reactivity | No false positives or interference from animal hemoglobin, vegetable extracts, or meat extracts. | Animal Hemoglobin: No cross reactivity with bovine, equine, porcine, goat, sheep, rabbit, turkey, and fish hemoglobin.
  Vegetable Extracts: No cross reactivity with broccoli, cauliflower, cantaloupe, horseradish, red radish, parsnip, and turnip extracts.
  Animal Meat Extracts: No interference with beef, pork, chicken, lamb, and fish extracts. |
  | Interference | No interference from common toilet cleaners, drugs, and dietary supplements. | Toilet Cleaners: No interference with Nuriper, Lysol Bleach, and Blue Enzyme.
  Drugs and Dietary Supplements: No interference with Iron, Vitamin C, laxative, glycerol concentration for enema, and peroxidase. |
  | Stability (Reagents) | Reagents maintain performance over their labeled shelf life. | Stable for 12 months at 2-8°C (Latex Reagent and Buffer). |
  | Stability (Calibrator) | Calibrator maintains performance over its labeled shelf life. | Stable for 12 months at 2-8°C. |
  | Stability (Controls) | Controls maintain performance over their labeled shelf life. | Stable for 12 months at 2-8°C (Positive and Negative Controls). |
  | Stability (Sampling Bottle) | Sampling bottle maintains integrity and sample stability over its labeled shelf life and under simulated extreme shipping conditions. | Stable for 18 months at 2-30°C.
  Inoculated Native Sample Stability: Samples stable for 15 days at room temperature, and 30 days when refrigerated.
  Inoculated Sample Shipping Test: Samples stable for 15 days during shipment under simulated extreme heat conditions. |
  | Reagent Open Bottle Stability | Reagents maintain performance after opening for a specified period on-board the analyzer. | Stable for 7 days after opening and kept on-board. |
  | Humidity Effect | No adverse effect of humidity on reagent stability. | No effect of humidity (25%, 50%, 80% at 23°C) on reagents (latex, buffer, calibrator, controls). |
  | Method Comparison | Substantial equivalence to the predicate device in terms of diagnostic performance (PPA, NPA, OPA). | Overall percent agreement (OPA) was 100 % (95 % CI 99.1 - 100 %), with positive percent agreement (PPA) 100 % (95 % CI 96.9 - 100 %), and negative percent agreement (NPA) 100 % (95 % CI 98.8 - 100 %). For CRC patients' samples, PPA was 100% (95% CI 79.6% - 100%) and NPA was 100% (95% CI 56.6% - 100%), with OPA 100% (95% CI 83.9% - 100%). The study demonstrated that the analytical performance of the device is substantially equivalent to the predicate. |
  | Cybersecurity | Immune to cyberattacks via network, secure USB/RS-232C terminals. | No network connecting function. USB memory and RS-232C terminals are for data output only and have no read functions. |
  | Electromagnetic Compatibility (EMC) | Meets relevant EMC standards. | Passed tests at Power Frequency Magnetic Field 30 A/m and Electrostatic Discharge ±2 kV, ±4 kV, ±8 kV contact; ±2 kV, ±8 kV, ±15 kV air. |

Study Information:

1. Sample sizes used for the test set and the data provenance:

• Precision/Reproducibility:
  • For each of the seven known concentrations (0, 50, 80, 100, 120, 450, 700 ng/mL): 21 replicates were measured.
  • This was performed daily (morning and afternoon) over 20 days.
  • Total individual measurements per concentration per site = 21 (replicates) * 2 (times/day) * 20 (days) = 840 measurements.
  • Total measurements across 3 clinical sites for each concentration = 2520 measurements.
  • Data Provenance: Not explicitly stated, but performed "in-house and in three intended use sites." The "intended use sites" typically imply clinical laboratories, likely in Japan (country of origin of manufacturer) or the US (for regulatory submission). The study is prospective in nature as samples were intentionally prepared and tested.
• Linearity, Prozone Effect, Limit of Detection, Hemoglobin Variants, Cross Reactivity, Interference:
  • For each specific condition/concentration tested: 21 replicates were measured.
  • Data Provenance: In-house studies. Prospective.
• Stability Studies (Reagents, Calibrator, Controls, Open Bottle):
  • For each time point and condition: 21 replicates of stool samples spiked with the seven known hemoglobin concentrations were measured.
  • Data Provenance: In-house studies. Prospective.
• Inoculated Native Sample Stability:
  • Not explicitly stated, but samples were prepared with 6 hemoglobin concentrations similar to the 7 known concentrations (excluding 0, presumably, or similar). Replicates are implied.
  • Data Provenance: In-house studies. Prospective.
• Inoculated Sample Shipping Test:
  • Samples prepared in the same way as the native sample stability study (implying similar replicates/conditions).
  • Data Provenance: In-house simulated study. Prospective.
• Method Comparison:
  • Total samples: 425 samples.
  • This included 20 CRC patients samples.
  • Data Provenance: Performed at "one professional medical laboratory in the U.S. and two international professional medical laboratories." This indicates prospective collection of samples used for the comparison study, though the samples themselves might have been collected retrospectively from patients or prepared for the study.

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

• For the Precision/Reproducibility, Linearity, Prozone Effect, Limit of Detection, Hemoglobin Variants, Cross Reactivity, Interference, Stability studies, and Inoculated Native Sample Stability/Shipping tests, the ground truth was established by preparation of controlled samples with known concentrations of hemoglobin or interfering substances. No human expert consensus was required for these analytical performance studies.
• For the Method Comparison study, the ground truth was the predicate device's result. The predicate device (OC-Sensor DIANA iFOB Tes, K092330) itself would have been validated against a clinical ground truth (e.g., colonoscopy, pathology) in its own clearance process, but for this specific study, the predicate served as the reference standard. Thus, no new experts were used to establish ground truth in this comparative effectiveness study.

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

• No explicit adjudication method (like 2+1, 3+1) is mentioned. This is typical for in vitro diagnostic (IVD) devices where results are quantitative or qualitative (positive/negative) based on pre-defined cutoffs, rather than subjective interpretations by multiple readers.
• For the precision studies, the "expected value" (negative/positive) served as the reference for agreement. For the method comparison, the predicate device result served as the reference.

4. 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 was done.
• This device is an automated in vitro diagnostic (IVD) test system. It performs qualitative detection of fecal occult blood using immunoassay, meaning the results are determined by the analyzer itself, not through human interpretation of images or complex data that AI would assist with. The "AI" would be the automated algorithm within the device for analysis, and its performance is evaluated as a standalone system.

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

• Yes, the entire set of performance studies (Precision, Linearity, Prozone Effect, LoD, Stability, Cross-reactivity, Interference) represents a standalone performance evaluation. The device (OC-Auto Sensor io iFOB Test system, including the analyzer and reagents) performs the analysis and provides results automatically without human interpretation in the decision-making loop for individual sample outcomes. The method comparison also evaluates the standalone performance against a predicate standalone device.

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

• For most analytical performance studies (Precision, LoD, etc.): The ground truth was controlled samples with known, spiked concentrations of human hemoglobin or interfering substances.
• For the method comparison study: The ground truth was the results obtained from the predicate device (OC-Sensor DIANA iFOB Tes). While the predicate's original clearance would have relied on clinical correlation (potentially pathology or outcomes data), for this specific 510(k) submission, the predicate itself served as the reference.

7. The sample size for the training set:

• The document describes performance studies and comparisons, but does not explicitly mention a "training set" or "validation set" in the context of machine learning. This is because the device is an immunoassay system, not an AI/ML-based diagnostic software. Its underlying principles are based on known chemical reactions and optical density measurements, which are "trained" through calibration curves rather than an algorithm trained on large datasets.
• The "calibration curve" is established using 5 points: 0, 50, 200, 500, 1000 ng Hb/mL.

8. How the ground truth for the training set was established:

• As above, there isn't a traditional "training set" as understood in AI/ML. The device is calibrated.
• The ground truth for calibration is established using purified hemoglobin in buffer at precisely known concentrations (0, 50, 200, 500, 1000 ng Hb/mL). The 1000 ng/mL calibrator is derived from human blood and tested to be negative for HBS antigens, HIV, and HCV antibodies.

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AFIAS iFOB in conjunction with AFIAS 50 is a fluorescence immunoassay system for qualitative detection of fecal occult blood (FOB) in human fecal samples. AFIAS iFOB is an in vitro diagnostic test used by professional clinical laboratories and clinical reference laboratories for routine physical examination when gastrointestinal bleeding may be suspected. Intended users/operators for AFIAS iFOB is professional medical personnel.

AFIAS iFOB in conjunction with AFIAS-50 is a fluorescence immunoassay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.
Components of AFIAS iFOB: AFIAS iFOB consist of a test cartridge, ID chip, sample collection tube contain the extraction buffer, package insert, applicator sticks, collection slide, mailing envelope, sample collection tissues, instruction for use and patient instructions.
The AFIAS iFOB test cartridge contains a test strip; with a nitrocellulose membrane of which, mouse monoclonal anti hemoglobin labeled with fluorescence and anti rabbit IgG labeled fluorescence have been immobilized at the glaze line, mouse monoclonal anti hemoglobin at the test line and rabbit IgG at the control line. Each test cartridge is individually sealed in an aluminum foil pouch containing a desiccant. Twenty-five sealed test cartridges are packed in a box which also contains an ID chip and 25 mailing envelopes which contain a collection slide, applicator sticks and sample collection tissues.
The ID chip contains a memory device that contains encoded calibration data/information for the batch (lot-to-lot) variation. With the ID chip inserted in the designated port, AFIAS-50 reads and utilizes the calibration data regarding the batch/lot under consideration and applies appropriate correction to the conversion formula while computing the test result.
The AFIAS iFOB extraction buffer tube with extraction buffer is sealed with plastic caps. The upper side is capped with a plastic cap without a sampling stick. The bottom side is capped with a plastic cap with a sampling stick. The extraction buffer contains bovine serum albumin (BSA) as a stabilizer, tween 20 as a surfactant and sodium azide in phosphate buffered saline (PBS) as a preservative. Each extraction buffer tube contains 1 mL extraction buffer. Twenty-five pre-filled extraction buffer tubes are packed in a test cartridge box.
Components of AFIAS-50: Power cable, Barcode reader, Thermal printer paper, Collection tube rack holder, Sample tips, Test cartridge magazine, Waste bin, System check cartridge set.

The provided text describes the performance characteristics of the AFIAS iFOB device, including precision, prozone effect, specificity, cross-reactivity, interference, stability studies, assay cut-off, and method comparison with a predicate device.

Here's the information extracted and organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in a separate section with specific numerical thresholds for each performance characteristic. Instead, it presents study results and then generally states whether the results "passed acceptance criteria" or demonstrated "acceptable overall percent agreement." For the purpose of this response, I will interpret the reported performance as meeting implicit acceptance criteria due to phrases like "passed acceptance criteria" or "acceptable overall percent agreement."

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

• Precision/Reproducibility:
  • Sample Size: Seven fecal hemoglobin concentrations (4 µg Hb/g stool to 80 µg Hb/g stool or equivalent ng/mL). Fourteen replicates were performed for each sample and concentration level per study (repeatability, lot-to-lot, between-run, between-device, between-site, combined). Totaling 98 samples for repeatability and 294 for each reproducibility component, and 1274 for combined reproducibility results shown in the table.
  • Data Provenance: Not explicitly stated, but implies laboratory-controlled spiked fecal samples. Conducted at "one intended use site" for repeatability, and "three intended use sites" for reproducibility. Locations of these sites (e.g., country of origin) are not specified. The study design (spiked samples) suggests a controlled laboratory setting rather than direct patient samples.
• Prozone (Hook Effect):
  • Sample Size: Twelve hemoglobin concentrations (700 ng/mL to 2000 ng/mL). Twenty aliquots of each sample mixed with extraction buffer.
  • Data Provenance: Spiked stool specimens with human blood (controlled laboratory setting).
• Specificity & Cross-Reactivity:
  • Sample Size: Not explicitly stated for each test, but involved testing with specific animal hemoglobin concentrations and a 'Hemoglobin S' human variant.
  • Data Provenance: Spiked test samples (controlled laboratory setting).
• Interference:
  • Sample Size: Not explicitly stated for each test, but involved testing with specific biomolecule concentrations.
  • Data Provenance: Spiked test samples (controlled laboratory setting).
• Stability Studies (Test Kit, Stool Sample on Slide, Stool Sample in Buffer Tube, Stool Sample in Cups):
  • Sample Size: Nine hemoglobin concentrations (25 ng/mL to 500 ng/mL) for test kit, slide, and buffer tube stability. Twenty-one aliquots of each concentration for slide and buffer tube stability. Six hemoglobin concentrations (50 ng/mL to 150 ng/mL), with 384 specimen cups (64 cups x 6 concentrations x 4 storage temperatures) for stool sample in cups stability.
  • Data Provenance: Spiked Hb-free stool samples with human blood (controlled laboratory setting).
• Stability of i-CHROMA iFOB Controls:
  • Sample Size: Ten aliquots of each control level. Three lots of i-CHROMA iFOB Controls (negative and positive).
  • Data Provenance: Not entirely clear if these are spiked or internal controls themselves, implying a controlled laboratory evaluation.
• Humidity Effect Stability Study:
  • Sample Size: Seven hemoglobin concentrations (50 ng/mL to 1,000 ng/mL). 50 AFIAS iFOB test cartridges.
  • Data Provenance: Spiked Hb-free stool samples with human blood (controlled laboratory setting).
• Assay Cut-off:
  • Sample Size: Seven fecal hemoglobin concentrations (50 ng/mL to 150 ng/mL). Forty aliquots of each concentration.
  • Data Provenance: Spiked stool samples with human blood (controlled laboratory setting).
• Method Comparison:
  • Sample Size: 522 patient samples (165 positive, 357 negative).
  • Data Provenance: Patient samples. Conducted at "one professional medical laboratory in the U.S. and two international professional medical laboratories." The document does not specify if these were retrospective or prospective, but the phrasing "patient samples" and "method comparison" often implies prospective or a mix.
• Specimen Collection Verification:
  • Sample Size: Eight hemoglobin concentrations (25 ng/mL to 1,000 ng/mL). Twenty aliquots of each concentration.
  • Data Provenance: Spiked Hb-free fecal samples with human blood (controlled laboratory setting).

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

• For Precision, Prozone, Specificity, Cross-Reactivity, Interference, Stability, Humidity Effect, Assay Cut-off, and Specimen Collection Verification studies: The "ground truth" was established by creating spiked fecal samples with known hemoglobin concentrations. This means the "expert" here is the precise control over the spiking process and analytical methods to determine the exact hemoglobin levels. Human experts were not involved in establishing this ground truth, rather the experimental design.
• For Method Comparison: The ground truth for the 522 patient samples was established by the predicate device, i-CHROMA iFOB test (K132167). This study compared the new device's results to the predicate device's results. No explicit mention of human experts defining the "true" positive or negative status of these patient samples beyond the predicate device's output.

4. Adjudication Method for the Test Set

• For Precision, Prozone, Specificity, Cross-Reactivity, Interference, Stability, Humidity Effect, Assay Cut-off, and Specimen Collection Verification studies: No adjudication method was mentioned as the ground truth was based on known, spiked concentrations or direct comparison to the predicate's established output for comparison.
• For Method Comparison: No specific adjudication method (like 2+1 or 3+1) is mentioned. The comparison was directly between the AFIAS iFOB and the predicate i-CHROMA iFOB device.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) fluorescence immunoassay system for qualitative detection of fecal occult blood (FOB), which automatically produces a result (positive or negative) without human interpretation of images or complex data where an "AI assistant" would typically improve a human reader's performance. The studies performed were analytical performance studies and a method comparison with a predicate device.

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

• Yes, the performance studies described are essentially standalone. The AFIAS iFOB system (device with its instrument AFIAS-50) is an automated system. The performance characteristics (precision, stability, cut-off, method comparison) evaluate the device's ability to accurately detect FOB based on its internal algorithms and fluorescence detection, without human interpretation of the final result. The professional medical personnel are "users/operators," not "interpreters" who then make a diagnostic decision on top of what the device outputs.

7. The Type of Ground Truth Used

• For most performance studies (Precision, Prozone, Specificity, Cross-Reactivity, Interference, Stability, Humidity Effect, Assay Cut-off, Specimen Collection Verification): The ground truth was spiked samples with known, carefully defined concentrations of human hemoglobin or other target analytes/interferents. This is a form of analytical ground truth.
• For Method Comparison: The ground truth for the patient samples was established by the predicate device (i-CHROMA iFOB test). This means the new device was compared against a previously cleared and accepted device's results.

8. The Sample Size for the Training Set

The document does not mention a "training set" or machine learning in the context of device development. This type of IVD device (fluorescence immunoassay) typically relies on pre-programmed calibration data and antigen-antibody reactions, not on machine learning algorithms that require explicit training sets. The "ID chip" contains encoded calibration data, which serves a similar function to calibration in traditional assays rather than training in machine learning.

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

As no "training set" is mentioned or implied for machine learning, this question is not applicable. The device's operation is based on established immunochemistry principles and factory-calibrated parameters transmitted via an "ID chip" for each lot.

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i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immuno-chromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.

i-CHROMA iFOB is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected.

i-CHROMA iFOB in conjunction with i-CHROMA Reader is a fluorescence immunochromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.

The provided text describes the i-CHROMA iFOB with i-CHROMA Reader device, a fluorescence immunochromatographic assay system for qualitative detection of fecal occult blood (FOB) in human fecal samples.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided text does not explicitly state "acceptance criteria" as a separate section with numerical targets. Instead, performance testing results are presented as summaries. The performance is compared to a predicate device (OC Auto Micro FOB Test). The acceptance of the device is implied by its demonstrated performance in these studies, showing high agreement and accuracy with the predicate device and being "equally sensitive" to certain hemoglobin types.

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

• Analytical Method Comparison Study: "Analytical method comparison study at three US sites performed on spiked human fecal samples..." The sample size is not explicitly stated for this study, only that it was conducted at three US sites. The data provenance is US sites and involves spiked human fecal samples.
• Clinical Testing Study: "Clinical testing study at two Korean and one US site involving prospective testing of clinical human fecal samples..." The sample size is not explicitly stated for this study. The data provenance is two Korean and one US site and involves prospective testing of clinical human fecal samples.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. It primarily relies on comparison with a predicate device.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

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

This device is an automated occult blood analyzer (i-CHROMA Reader) that provides qualitative (positive/negative) results. It is not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and was not conducted. The device acts as the "reader" itself.

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

Yes, the performance studies described are for the device as a standalone system: "i-CHROMA iFOB with i-CHROMA Reader". The "i-CHROMA Reader" automatically scans the test cartridge and displays the result. There is no human-in-the-loop performance described for this qualitative test, as the device itself determines and displays the positive/negative outcome.

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

The ground truth for the performance studies appears to be established by comparison with a predicate device (OC Auto Micro FOB Test). In the analytical method comparison, spiked human fecal samples were used, where the "ground truth" would be the known concentration of hemoglobin in the spiked samples. For the clinical testing study, the comparison was against the predicate method.

8. The sample size for the training set

The document does not mention a separate training set or its sample size. This device is not described as involving machine learning that would typically require a distinct training set. The device operates based on pre-programmed calibration and an analytical cut-off.

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

Since a dedicated "training set" for a machine learning model is not mentioned, the concept of establishing ground truth for such a set is not applicable in this context. The device relies on a pre-programmed calibration, and the ID chip contains encoded calibration data for batch-to-batch variation. The establishment of this calibration data (which serves a similar purpose to informing the device's measurement accuracy) is not detailed beyond being "pre-programmed."

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"OC-Sensor DIANA iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders (GI), e.g. colitis, polyps, and colorectal cancer. The OC-Sensor DIANA iFOB test is recommended for use in: 1. Routine physical examinations 2. Monitoring bleeding in patients 3. Screening for colorectal cancer or gastrointestinal bleeding

Not Found

The provided text is related to an FDA 510(k) clearance letter for the "OC-Sensor DIANA iFOB Test." It describes the intended use and regulatory classification of the device. However, it does not contain information about acceptance criteria, device performance, study details (like sample sizes, data provenance, expert qualifications, adjudication methods), or any comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text.

The document mainly focuses on:

• Device Name: OC-Sensor DIANA iFOB Test
• Regulatory Information: 510(k) number K092330, Regulation Number 21 CFR 864.6550, Regulation Name Occult Blood Test, Regulatory Class Class II, Product Code OOX.
• Indications for Use: Qualitative detection of fecal occult blood in feces by professional laboratories for determining gastrointestinal bleeding (e.g., colitis, polyps, colorectal cancer), routine physical examinations, monitoring bleeding, and screening for colorectal cancer or GI bleeding.

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The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., colitis, polyps, and colorectal cancer.

The OC Auto Micro FOB Test is recommended for use in

• 1. Routine physical examinations
• 2. Monitoring for bleeding in patients
• 3. Screening for colorectal cancer or gastrointestinal bleeding

The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories.

This document is a 510(k) clearance letter for "The Polymedco OC Auto Micro 80 FOB Test." It describes the intended use of the device but does not contain information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document confirms the device's substantial equivalence to a predicate device and states its indications for use, but it does not detail the technical performance data that would typically be included in a study report.

Ask a specific question about this device