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The UC-1800 Automatic Urine Analyzer is automated instrument which is intended for professional, in vitro diagnostic use only.

Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, setone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

UC-1800 Automatic Urine Analyzer is characterized by fully automated and simple operation. All you need to do is to set test strips and samples, press the START key, and the rest of operations are fully automated with UC-1800, which can measure samples continuously. For each measurement, the instrument automatically performs a series of operation: sample transmitting, sample aspirating, sample dropping, rinsing strip feeding and color identifying, etc. The instrument is used in conjunction with a serial of URIT urine test strips for measuring 15 parameters. Measure results are printed through either built-in printer or external printer.

Urine Reagent Strips is used to determine the components to be measured in urine by dry chemistry method together with urine analyzer. Various components to be tested in the urine can result in changes to the colors of corresponding reagent blocks on the Urine Reagent Strips. The depth of reaction color is proportional to the corresponding component to be tested in the urine. Qualitative and semi-quantitative detection can be conducted to the contents of the corresponding detected components. As a reagent for the determination of multiple components in human urine and the most basic test item for clinical urine routine test), it is suitable for the screening test or auxiliary diagnosis for clinical diagnosis, without the specificity for diseases or indications, and urine dry chemistry test is a screening test and cannot be used as a single diagnostic method.

The provided document describes the URIT UC-1800 Automatic Urine Analyzer and its associated reagent strips (URIT 11FA and 12FA Urine Reagent Strips). The information below summarizes the acceptance criteria and the studies performed to demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents the performance in terms of "Exact agreement" and "± 1 color block" agreement with expected values or between the proposed device and predicate devices. For most analytes, the criteria seem to be high exact agreement and 100% agreement within ±1 color block. Specific thresholds for acceptance were not explicitly stated as global criteria but are implied by the "Qualified" conclusions for individual tests. The comparison to predicates also uses agreement rates.

Below is a summary of the reported device performance from the "Precision / Reproducibility" section (Tables 8, 9, 10, 11) for repeatability and "Comparison Studies" section (Tables a.1, a.2, a.3) for agreement with predicate devices. Given the extensive number of analytes and concentration levels, key representative results are presented.

a. Repeatability (Within-Run Precision)
Reported as "Exact agreement" and "± 1 color block". All tests for all expected values show 100% agreement for "± 1 color block". Exact agreement varies slightly, but most are 100% or very close.

b. Reproducibility (Between-Run Precision)
Reported as "Exact agreement" and "± 1 color block". All tests for all expected values show 100% agreement for "± 1 color block". Exact agreement varies slightly, but most are 100% or very close.

c. Comparison with Predicate Devices

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

• Repeatability (within-run) & Reproducibility (between-run):

  • Sample Size:
    • Repeatability: 60 measurements per concentration level per analyte (20 replicates x 3 instruments).
    • Reproducibility: 120 measurements per concentration level per analyte (20 days x 2 runs/day x 1 time/run in 3 sites, with 1 instrument/site, 3 operators).
  • Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "negative urines and spiked urines of known concentrations." This suggests controlled laboratory-prepared samples rather than direct patient samples.

• Linearity/Assay Reportable Range:

  • Sample Size: 63 measurements per concentration level per analyte (reference solutions tested 21 times on 3 UC-1800 machines with 3 lots of reagent strips).
  • Data Provenance: Laboratory-prepared reference solutions, not clinical samples.

• Analytical Sensitivity: No sample sizes mentioned, values are stated directly.

• Critical Value: No sample sizes mentioned, values are stated directly.

• Analytical Specificity (Interference, pH, Color, Specific Gravity):

  • Sample Size: For interference studies, samples were tested 5 times on 2 UC-1800 machines with 2 batch numbers of 11FA and 12FA reagent strips. This totals 20 measurements per condition (5 tests x 2 machines x 2 strips).
  • Data Provenance: Laboratory-prepared urine samples (negative samples prepared and spiked with interfering substances or adjusted for pH/color/SG).

• Comparison Studies with Predicate Devices (Clinical Samples):

  • Uritest-500B (K082811): 1000 clinical urine samples.
  • Mission® U120 Ultra Urine Analyzer (K142391): 979 clinical urine samples.
  • AUTION MAX AX-4030 Urinalysis System (K093098):
    • Color: 1365 clinical urine samples.
    • Turbidity: 1000 clinical urine samples.
  • Data Provenance: The document explicitly states "clinical urine samples were collected." The country of origin is not specified but given the submitter's address (China), it is highly likely that these clinical samples were collected in China and were retrospective as the study compares against existing predicate devices.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image interpretation or clinical diagnosis. For chemical analyzers, the "ground truth" (or reference standard) is typically established by:

• Known concentrations: For repeatability, reproducibility, linearity, and analytical sensitivity, samples are prepared with known concentrations of the analytes.
• Reference methods: For the analytical specificity and comparison studies, the predicate devices themselves or established reference methods (e.g., 2,6-Dichlorophenolindophenol Titration Method for Ascorbic Acid, Lange method for Ketone, etc. as specified in Table 35 "Traceability") serve as the reference for comparison.

Therefore, the concept of "number of experts" and their "qualifications" for ground truth establishment, as typically applied in AI/ML performance evaluation (e.g., for image interpretation), is not directly applicable here. The ground truth is analytical and based on laboratory standards and established measurement techniques.

4. Adjudication Method for the Test Set

Not applicable in the context of this analytical device. As explained above, the "ground truth" refers to known concentrations or results from predicate/reference methods. There isn't a subjective interpretation by multiple experts that would require an adjudication method like 2+1 or 3+1.

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 an automated urine analyzer, not an AI/ML-driven diagnostic aid for human readers. It performs measurements to provide semi-quantitative results for various urine analytes. Therefore, there is no human-in-the-loop performance or comparison of human reader improvement with or without AI assistance.

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

Yes, the studies presented are all standalone performance evaluations of the device (UC-1800 Automatic Urine Analyzer with URIT 11FA/12FA Urine Reagent Strips) without human intervention in the measurement process. The device operates automatically to detect and report analyte levels. The comparison studies demonstrate its performance against existing predicate (standalone) analyzers.

7. The Type of Ground Truth Used

The ground truth used in the studies includes:

• Known Concentrations: For analytical performance studies such as precision (repeatability and reproducibility), linearity, analytical sensitivity, and analytical specificity (interference testing), samples were prepared with known, precisely measured concentrations of the target analytes or interfering substances.
• Predicate Device Measurements: For method comparison studies, the results obtained from the established predicate devices (Uritest-500B Urine Analyzer, Mission® U120 Ultra Urine Analyzer, and AUTION MAX AX-4030 Urinalysis System) served as the reference standard for comparison. These predicate devices also operate based on defined analytical principles.
• Reference Methods: Table 35 details the "Reference Method" used for traceability for each analyte (e.g., 2,6-Dichlorophenolindophenol Titration Method for Ascorbic Acid, Glucose Oxidase Method for Glucose, Acidometer measurement for pH, etc.). This indicates fundamental analytical standards are the basis for the stated detection ranges and performance.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. The UC-1800 Automatic Urine Analyzer uses reflectance photometry and other physical principles (refractometer for specific gravity, light-scattering for turbidity, light-transmission for color) to generate results, not an AI algorithm that learns from a dataset in the conventional sense. The "training" of such a system typically involves calibrating optical sensors and algorithms to known standards, which is part of the engineering design and quality control processes.

If interpretation of "training set" refers to the data used for the initial development and calibration of the device's measurement algorithms:

• No specific sample size for a "training set" for an AI model is reported because the device does not employ machine learning that requires a distinct "training set" and "test set" in the typical AI/ML development lifecycle.
• The system is calibrated using URIT urine control materials and calibration test strips (Table 9, "Calibration").

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

As noted above, the device does not use an AI/ML model with a "training set" in the common understanding. The system's operational parameters and calibration are established using:

• Reference materials and calibrators: The device is calibrated using "URIT urine control materials and calibration test strips" (Table 9, "Calibration"). These control materials and calibration strips would have their values established using highly accurate reference methods or certified reference materials, ensuring traceability to scientific standards (as indicated in Table 35 "Traceability").
• Chemical principles: The underlying "ground truth" for the device's internal algorithms (i.e., how they convert optical signals to analyte concentrations) is based on established chemical reactions and physical measurement principles (e.g., reflectance photometry, refractometry, light scattering, dye-binding, enzymatic reactions). The "ground truth" for developing and fine-tuning these algorithms would be derived from rigorous scientific validation against these known chemical and physical properties.

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The AUTION MAX AX-4060 Urinalysis System (AUTION MAX) is comprised of the AUTION MAX AX-4060 automated urine analyzer and AUTION Sticks 9EB multi-parameter test strips.

The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.

AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, and leukocytes with the AUTION MAX AX-4060 urine analyzer. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders.

Special conditions for use statements: Prescription use only. AUTION Sticks 9EB test strips are not to be read visually.

The AUTION MAX AX-4060 Urinalysis System is a fully automated urine analyzer that provides a semi-quantitative or qualitative measurement for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity, turbidity, and color tone. The AUTION MAX AX-4060 Urinalysis System consists of AUTION MAX AX-4060 urine analyzer and AUTION Sticks 9EB test strips.

The AUTION Sticks 9EB test strips consist of a plastic strip containing 9 dry chemistry reagent pads impregnated with chemical substances for the determination of the above analytes in urine. These substances if present in urine leads to a chemical reaction that results in a color change, which is measured by the AUTION MAX AX-4060 urine analyzer based on spectrophotometry. In addition, three additional parameters, specific gravity, turbidity, and color tone are directly measured based on reflectance refractometry, transmitted and scattered light measurements.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

Device: AUTION MAX AX-4060 Urinalysis System
Predicate Device: AUTION MAX AX-4030 Fully Automated Urinalysis System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the document. Instead, the study aims to demonstrate substantial equivalence to the predicate device. Therefore, the "acceptance criteria" are implicitly understood as matching or performing comparably to the predicate device's established performance, particularly in terms of agreement percentage. The reported device performance is presented as the agreement between the proposed device (AUTION MAX AX-4060) and the predicate device (AUTION MAX AX-4030).

Key Performance Metric: Percentage of Exact Match and Percentage within +/- 1 Color Block Match compared to the predicate device.

(Note: The +/- 1 CB Match indicates results falling within one color block difference from the predicate, which is often considered acceptable for semi-quantitative tests.)

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

• Sample Size for Test Set (Method Comparison): A total of 1374 samples were used. This included:
  • 1333 natural patient samples
  • 41 spiked samples
• Data Provenance: The study was conducted at two (2) clinical laboratories. The document does not specify the country of origin, but given the FDA submission, it's likely conducted in or in accordance with standards for the U.S. and/or Japan (where the manufacturer is located). It is a prospective comparison study.

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

This study does not involve human experts establishing a "ground truth" for each sample in the typical sense of diagnostic imaging or pathology. Instead, the "ground truth" for the method comparison study is the result obtained from the legally marketed predicate device (AUTION MAX AX-4030 Automated Urinalysis System). The study demonstrates the correlation and agreement of the new device's readings with the predicate device's readings. No information is provided about experts interpreting results aside from the automated systems.

4. Adjudication Method for the Test Set

Since the "ground truth" is established by the predicate device's results and the comparison is between two automated systems, there was no human adjudication process (e.g., 2+1, 3+1 consensus) described for the test set.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study evaluates the performance of an automated urinalysis system against a predicate automated system, not the improvement of human readers with AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes. The primary study detailed, especially the Method Comparison (Section 14), assesses the standalone performance of the AUTION MAX AX-4060 Urinalysis System. It compares the results generated by the new automated system directly against those generated by the predicate automated system, without human intervention in the result interpretation or decision-making process during the comparison phase. The device itself is an automated system intended to be used by trained operators in clinical laboratories, but the performance data presented is for the automated analyzer's output.

7. Type of Ground Truth Used

The ground truth for the method comparison study was the results obtained from the legally marketed predicate device (AUTION MAX AX-4030 Automated Urinalysis System). For the initial precision study (Tables 3-5), the "Expected Result" for quality controls served as the reference.

8. Sample Size for the Training Set

The document is a 510(k) summary for a medical device (urinalysis system), not a typically "AI-driven" software device that undergoes explicit training. The device determines analytes based on chemical reactions and spectrophotometry (reflectance refractometry, transmitted and scattered light measurements). Therefore, there is no explicit "training set" in the context of machine learning algorithms usually discussed. The system is likely calibrated and validated during its development, but this is a different process than training an AI model.

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

As noted above, there is no explicit "training set" in the machine learning sense for this device. The chemical principles and measurement methods are well-established for urinalysis. Any calibration or internal development would have relied on known concentrations and reference methods for each analyte to ensure accurate colorimetric or other measurements. The basis of the technology relates to established chemical reactions on the test pads (e.g., Glucose oxidase reaction for glucose, Protein-error reaction for protein, etc.).

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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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The cobas u 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack.

The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi- quantitative determination of urine analytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.

The cobas u pack is a cassette loaded with cobas u 601 test strips for the in vitro qualitative or semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes in urine with the cobas u 601 urine analyzer. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders.

The cobas u 601 Urinalysis Test System consists of the following components:

• . cobas u 601 urine analyzer
• . cobas u pack

The cobas u 601 urine analyzer is a fully automated urine analysis system. It is optimized for high throughput workloads in the professional environment. The cobas u 601 urine analyzer performs a maximum theoretical throughput of up to 240 samples per hour.

The cobas u 601 analyzer consists of several major components:

• Rack transport system
• Liquid handling system
• Test strip cassette compartment
• Automated test strip processing area
• Photometer which is a 4 wavelength reflectance measuring unit based on a Complementary Metal Oxide Semiconductor chip used in digital cameras (CMOS sensor)
• Physical Measurement Cell (PMC): flow cell connected to an optical detector ●
• Touch Screen
• Inbuilt Computer

The functions of the cobas u 601 urine analyzer include:

• Sample loading and transport ●
• . Sample identification
• Robotic pipetting of samples onto test pads on test strips
• Robotic aspiration of samples into the PMC
• . Controlled incubation
• . Photometric measurement of test strips
• Optical determination in the PMC
• Automatic disposal of used test strips ●
• . Result readout
• Result memory
• Optional formats for data output including electronic result communication

The operating system will be a Microsoft Windows for embedded devices. The system will use a Postgres/SQL database.

The cobas u 601 urine analyzer is designed to be inter-connected mechanically and electronically with another urine sediment analyzer (cobas u 701) in order to create a urine work area (cobas® 6500).

The cobas u pack is a cassette containing 400 tests strips. The cobas u 601 analyzer will use the cobas u pack to dispense single test strips for each sample.

Each test strip has ten individual test pads that are used to test for different substances or characteristics. The test strips are analyzed automatically through the analyzer. One test strip is used per sample. When a strip is dispensed for use by the cobas u 601, an aliquot of the urine sample is pipetted onto each of the test pads. The resulting color changes are measured photometrically.

The test strip in the cobas u pack cassette ("cassette test strip") is a multi-parameter urine analysis test strip, with test pads for blood (Erythrocytes), Leukocytes, Nitrite, Proteins, Glucose, Ketones, Bilirubin, Urobilinogen, Color and pH.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device: cobas u 601 urinalysis test system
Predicate Devices: cobas u 411 (for pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes), Urisys 2400 (for specific gravity, color, and clarity).

Based on the provided 510(k) Summary, the term "acceptance criteria" is not explicitly defined as a single, overarching set of numerical thresholds for all performance metrics. Instead, the document describes the studies performed and their results, implying that demonstrating acceptable performance within clinical ranges and in comparison to predicate devices constitutes meeting the "acceptance criteria" for substantial equivalence.

For each study, the "acceptance criteria" are implied by the reported results meeting the necessary performance for a diagnostic device, particularly demonstrating "exact agreement" or "agreement ± 1 block" within clinically relevant ranges and comparable to the predicate devices.

The information is extracted from the "NON-CLINICAL PERFORMANCE EVALUATION" and "CLINICAL PERFORMANCE DATA" sections.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Since explicit numerical acceptance criteria for each test in a pass/fail format are not directly stated as "acceptance criteria," the table below presents the implied acceptance criteria (what the study aimed to demonstrate as acceptable performance) and the reported device performance as found in the document. The primary method for showing acceptance is often "exact agreement" or "agreement ± 1 block" with the predicate device/reference.

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:

  • Analytical Sensitivity: Multiple samples tested for each analyte, each sample measured 20 times on each of 3 instruments using 3 reagent test strip lots. (e.g., 20 measurements x 3 instruments x 3 lots = 180 total per sample condition per analyte if all combinations were tested). Specific number of "samples" (unique spiked concentrations) not explicitly stated for each analyte.
  • Drug and Endogenous Interferences: Urine pools (negative/normal and first positive range) tested at 2 concentrations of interferents. Multiple replicates measured. Number of replicates not specified for each condition.
  • Color Interference: Final test solutions (for each parameter) tested in a 10-fold determination. (e.g., 10 measurements per condition).
  • Stability:
    • Real-time: Defined set of samples (native urine, artificial urine, low/high spiked urine) measured with n=10 determinations at each time point (0, 3, 13, 16 months).
    • On-board: 400 tests over 15 days from a single cassette (using native and artificial urine samples).
  • Precision (Repeatability): Controls measured in 2 runs, 21 determinations each, producing n=42 results per control.
  • Precision (Intermediate Precision): Controls measured in 21 days with 2 runs per day and duplicate measurements per control, producing n=84 results per control.
  • Method Comparison (cobas u 411): "fresh samples" used to cover claimed ranges. Specific total number of samples for comparison is not explicitly stated.
  • Method Comparison (Urisys 2400):
    • Color: 478 total samples.
    • Clarity: 1364 total samples.
  • Sample Carryover: Not specified, but involved testing low/negative and high concentration samples.

• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for an in vitro diagnostic device, these are typically prospective laboratory studies conducted by the manufacturer, often at their R&D facilities or contracted clinical sites.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish ground truth for the test sets.
• It also does not specify the qualifications of these experts.
• For urinalysis strips, ground truth is typically established by reference methods such as quantitative chemical assays or microscopic examination, rather than relying solely on human expert consensus on visual interpretation of the strips themselves. The comparison is made against a "reference system" which implies an objective and validated method.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method (e.g., 2+1, 3+1) for the test sets. For objective chemical measurements like those performed by this device, human adjudication of "ground truth" is typically less relevant than the use of quantitative reference methods.

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

• A MRMC comparative effectiveness study was not conducted. This device is an automated urinalysis system, and its performance is evaluated against established analytical methods and predicate devices, not by comparing human reader performance with and without AI assistance. The "AI" component is implicit in the automated analysis of reflectance, which is a core function of the machine's software, but it's not presented as an AI-assistive tool for human readers.

6. Standalone (Algorithm Only) Performance

• Yes, the performance data presented (e.g., Analytical Sensitivity, Accuracy/Method Comparison studies) represents the standalone performance of the cobas u 601 urinalysis test system. It is an automated device designed to perform urinalysis without human interpretation of the test strip results; the human role is in operating the system and interpreting the numerical/qualitative results provided by the machine.

7. Type of Ground Truth Used

• The ground truth used for these studies generally aligns with:
  • Reference System/Predicate Device Comparison: For the method comparison studies, the cobas u 411 and Urisys 2400 systems served as "reference systems" against which the new device's qualitative and semi-quantitative results were compared.
  • Spiked Samples/Defined Concentrations: For sensitivity, interference, stability, and precision studies, the ground truth was established by preparing urine samples with precisely known concentrations of analytes or interfering substances ("spiking the negative urine pool with the appropriate agent," "known concentrations").
  • Control Materials: For precision studies, standardized control materials with known values were used.

8. The Sample Size for the Training Set

• The document does not provide information regarding the sample size for a "training set." This type of device, based on reflectance photometry and chemical reactions, typically relies on predetermined algorithms derived from extensive analytical characterization of the strip chemistry and optical properties, rather than "training" an AI model in the conventional machine learning sense using a large, distinct "training set" of patient data. The development process would involve calibration and algorithm refinement using controlled samples, but not necessarily a "training set" as defined in AI/ML contexts with expert-labeled ground truth for each case.

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

• Since there's no explicit mention of a "training set" in the context of an AI/ML model for this device, the question of how ground truth was established for it is not applicable in the provided document. The "training" in this context would refer to the calibration and algorithm development process, which relies on the principles of analytical chemistry and physics inherent to reflectance photometry to accurately read the color changes on the test strips. This would involve precise chemical and optical characterization using known standards and samples.

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The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose. Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite,

The DIP | U.S. Urine Analysis Test System is intended for prescription home-use only, with results provided directly to the physician. The results can be used to guide patient management and care, and aid in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function and endocrine disorders. Physician interpretation of the results should be made in conjunction with the patient's other clinical information to determine if further confirmatory tests or consultations are necessary. Patients do not have access to the results at any point in the process.

The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose, Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite.

The DIP | U.S. Urine Analysis Test System is intended for prescription home-use only, with results provided directly to the physician. The results can be used to guide patient management and care, and aid in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function and endocrine disorders. Physician interpretation of the results should be made in conjunction with the patient's other clinical information to determine if further confirmatory tests or consultations are necessary. Patients do not have access to the results at any point in the process.

The device is provided as a kit that comprises a urine receptacle, an FDA-cleared urine test strip (ACON Mission Urinalysis Reagent Strips, 510K number K061559), a Color-Board, and a User Manual. The DIP | U.S. Urine Analysis Test System also consists of a smartphone application for use with a LG Nexus 5 device (running operating system Lollipop 5.0), and an image recognition algorithm running on the back-end.

The software component of the DIP | U.S. Urine Analysis Test System consists of both an application and a back-end server. The App instructs the patient how to accurately administer the test and conducts a number of algorithm processes. Once analyzed, the DIP | U.S. Urine Analysis Test System's software securely transmits the clinical results directly to the patient's Electronic Medical Records for review by the physician. As stated above, the patients do not have access to the results at any point during the testing process.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the Healthy.io DIP | U.S. Urine Analysis Test System.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the "percent exact match" and "±1 color block match" compared to the predicate device (ACON Mission U500 Urinalysis System). The exact numerical acceptance thresholds are not explicitly stated as strict percentages for all analytes, but the narrative implies "high-levels of accuracy" and specific target ranges are mentioned for certain analytes.

Additional Performance Metrics (from Analytical Performance Testing):

• Repeatability: 99.3% exact match
• Reproducibility: 98.5% exact match
• Linearity: At least 89.4% exact match and 100% ±1 color block accuracy.
• Illumination Study: 99.5% exact match
• Boundary Study: 99.5% exact match

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

Two method comparison studies were conducted for the test set:

• Study 1:

  • Sample Size: 429 subjects, 500 total samples (including spiked samples). Only 284 results from LG Nexus 5 smartphones were used for performance data.
  • Data Provenance: Two U.S. clinical sites. The studies involved lay-users in a simulated home-use environment. This indicates prospective data collection for the purpose of this validation.

• Study 2:

  • Sample Size: 250 subjects, 289 total samples (including spiked samples).
  • Data Provenance: One U.S.-based clinic. Similar to Study 1, this appears to be prospective data collection in a simulated home-use setting.

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

The ground truth for the comparison studies was established by "a laboratory professional using the predicate (ACON Mission U500 Urinalysis System)" measuring aliquots of the same samples. The specific number of laboratory professionals or their detailed qualifications (e.g., years of experience, specific certifications) are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The text describes comparing the DIP system's results to those from a laboratory professional using the predicate device. It does not mention any formal adjudication method (e.g., 2+1, 3+1 consensus) for discrepancies between the device and the predicate. The predicate device's readings appear to be treated as the reference standard (ground truth).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This was not a MRMC comparative effectiveness study in the typical sense of evaluating human reader improvement with AI assistance. The study evaluates the performance of the device itself as used by a lay-user, compared to a predicate device operated by a laboratory professional. There is no mention of human readers interpreting images with and without AI assistance to measure improvement.

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

The performance data presented, particularly the "Method Comparison Study," represents the device's performance with a human-in-the-loop (lay-user) interacting with the smartphone application and Color-Board. The device itself (including its image recognition algorithm on the back-end) performs the analysis of the test strip after the user interacts with it. The usability results (e.g., 99% success rate for lay users completing the test) address the human-in-the-loop aspect.

However, the "Analytical Performance Testing" (Precision, Interference, Limit of Detection, Linearity, Illumination, Boundary Studies) implicitly evaluates the algorithm's performance under controlled conditions with pre-determined reagent values or spiked samples, which can be seen as a form of standalone evaluation of the core analytical capability. For example, the Illumination Study and Boundary Study evaluate the device's (and thus the algorithm's) ability to measure accurately under varying external conditions. In these studies, the device measured against "predetermined reagent values," which serves as the ground truth for evaluating the algorithm's accuracy under those specific conditions.

7. The Type of Ground Truth Used

The primary ground truth used for the method comparison studies (clinical validation) was the readings obtained from the predicate device (ACON Mission U500 Urinalysis System) by a laboratory professional.

For the analytical performance studies (Precision, Interference, Limit of Detection, Linearity, Illumination, Boundary), the ground truth was based on validated spiked urine solutions at known concentrations or predetermined reagent values.

8. The Sample Size for the Training Set

The provided text does not explicitly state the sample size used for the training set for the image recognition algorithm. It focuses on the validation studies.

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

The text does not describe how the ground truth for the training set was established. It only mentions that the device includes an "image recognition algorithm running on the back-end." It is standard practice for such algorithms to be trained on large datasets with established ground truth, but the details of this process are not provided in this specific document.

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This device is intended for the in vitro measurement of the following in urine: Leukocyte, Nitrite, Urobilinogen, Protein, pH, Blood, Specific gravity, Ketone, Bilirubin, Glucose. These strips are intended for prescription, in vitro diagnostic use only and they are visually read.

DUS 2GP reagent strips provide qualitative and semiquantitative measurements for protein, and glucose in urine specimens. Test results may provide information regarding the status of carbohydrate metabolism and kidney function.

DUS 5 reagent strips provide qualitative and semiquantitative measurements for leukocytes, nitrite, blood , protein, and glucose in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies and urinary tract infections.

DUS 10 reagent strips provide qualitative and semiquantitative measurements for specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood in urine speciments are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

The DUS Series are urine test strips with different reagent pads for the determination of specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood affixed onto plastic strips. of which leukocyte, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketone, bilirubin and glucose reagent pads are affixed onto the plastic strips. The reagent pads react with analytes in the urine giving a visible color. Results are confirmed by comparison of the test strip with the color chart on the container. For each color result for each analyte, a semiquantitative value is available on the box label (e.g. bilirubin results include negative, 1, 2, and 4 mg/dL) and the associated qualitative result (e.g. bilirubin results include negative. +. ++, +++).

Here's an analysis of the provided document, outlining the acceptance criteria and study details for the DUS Reagent Strips:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the "Exact Agreement" or "Agreement within +/- one block (%)" in the method comparison study. However, the study results, which consistently show high percentages (generally in the high 90s and 100%) for both metrics across all analytes, implicitly represent the device meeting an expected high level of agreement with the predicate device.

For the linearity/assay reportable range, the acceptance criteria are implied by the reported "% Exact match." A high percentage (generally 97.7% to 100%) indicates acceptance.

For the detection limit study, the acceptance criteria are stated as "Sensitivity was defined as the cutoff for which ≥95% of the contrived pooled measurements were trace or the first positive result."

The interference study implicitly accepts the device if interference is either not observed at clinically relevant concentrations or if observed interferences are adequately addressed in the labeling.

Here's a table summarizing the reported device performance, where the values themselves act as the demonstration that the implied or stated acceptance criteria (high agreement, 95% detection, or non-interference/labeling for interference) were met.

Table of Reported Device Performance

Study Details

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

   • Method Comparison Study: Total of 867 samples.
     • Provenance: Fresh urine samples obtained at three medical facilities. The country of origin is not explicitly stated but implied to be South Korea, given the submitter's address. The data is prospective as samples were "processed within 4 hours."
   • Precision/Reproducibility: Two levels of commercially available urine-based control solutions.
     • Sample Size: 90 replicates for within-run (10 tests from 3 lots at 3 sites) and 90 replicates for within-day (1 test a day from 3 lots, at 3 sites for 10 days) for each level.
     • Provenance: Commercially available control solutions.
   • Linearity/Assay Reportable Range:
     • Sample Size: 90 replicates per concentration level (10 replicates with each of 3 lots of test strips).
     • Provenance: Samples created by spiking known concentrations of standard materials or by serial dilution of a high concentration urine sample with negative urine.
   • Detection Limit:
     • Sample Size: 90 replicates for each concentration (each sample concentration analyzed 30 times using 3 reagent strip lots).
     • Provenance: Negative urine spiked with standard materials.
   • Analytical Specificity:
     • Sample Size: 3 replicates using 3 lots of DUS 10 test strips for each concentration level of interfering substance.
     • Provenance: Urine sample pools prepared at 3 analyte concentrations (negative, low, high positive) spiked with potential interfering substances.

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

   • Precision, Linearity, Detection Limit, Analytical Specificity: Ground truth was established by the known concentrations of control solutions or spiked samples. Testing was performed by 3 medical technicians as reported in the linearity study and precision study, but their specific qualifications (e.g., years of experience) are not stated beyond being "medical technicians."
   • Method Comparison Study: The ground truth for the method comparison study was established by comparing the DUS 10 test strips results against a predicate device (Multistix 10SG). The testing was performed by three medical technicians at each of the clinical sites. Similar to above, their specific qualifications are not detailed beyond "medical technicians."

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

   • The document does not describe an explicit adjudication method (like 2+1 or 3+1) involving multiple human readers or experts resolving discrepancies for the test set in the traditional sense of image-based AI studies.
   • The method comparison study compares the new device's readings to the predicate device's readings, and the percentage agreement is calculated. The process for resolving discrepancies between the new device and the predicate device is not detailed, nor is there a mention of an expert panel reviewing cases.
   • For other studies (precision, linearity, detection limit), the ground truth is analytically determined by control concentrations.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study as typically understood for AI-assisted diagnostic tools (i.e., human readers with and without AI assistance) was not explicitly performed or described in this document.
   • The studies focus on the performance characteristics of the device itself (the reagent strips) and its comparison to a predicate device, which is also a reagent strip for visual reading. The device's use is "visually read" by operators, but the study design is not one of AI assistance to human readers.

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

   • This device is a reagent strip that is visually read. It is not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the context of an AI device. The performance data presented (precision, linearity, detection limits, analytical specificity, method comparison) are essentially standalone performance characteristics of the physical reagent strip, with human visual interpretation being the intended mode of operation for reading the results. The method comparison specifically assesses this human-read performance against a predicate device.

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

   • Method Comparison Study: The ground truth for comparative analysis was the results obtained from the predicate device (Multistix 10SG).
   • Precision, Linearity, Detection Limit, Analytical Specificity: The ground truth was analytically determined concentrations derived from commercial control solutions or spiked urine samples with known analyte levels.

7. The sample size for the training set:

   • This document is for a traditional in-vitro diagnostic (IVD) reagent strip that is visually read, not an AI/ML device. Therefore, there is no "training set" in the context of machine learning model development. The assays are based on chemical reactions, and the performance is inherent to the chemical formulation and strip manufacturing.

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

   • As there is no AI/ML component or "training set" in the context of an algorithm, this question is not applicable. The chemical reactions on the strips are designed to react to specific analytes, and their performance is validated through the studies described.

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The DUS R-50S System provides a qualitative measurements for specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin, blood, microalbumin and creatinine in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function. The system is intended for prescription, in vitro diagnostic use only.

The DUS R-50S (Urine Chemistry system) is a portable analyzer. It is designed to read only DUS Series for urinalysis. This analyzer reports semi-quantitatively assays for 12 urine analytes [Leukocyte, Nitrite, Urobilinogen, Protein, pH, Blood, Specific gravity, Ketone, Bilirubin, Glucose, Microalbumin, Creatinine]. Reagent strip results are automatically displayed on the screen. The DUS R-50S is intended for in vitro diagnostic use only

The DUS R-50S (Urine Chemistry system) device is intended for qualitative and semi-quantitative measurements of various analytes in urine specimens to aid in diagnosing metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the requirement for "very high concordance of between 90-100%" with the predicate device and the "majority of analysis display 90-100 % concordance over all blocks." The detailed "Exact agreement (%)" and "Within one block (%)" values for each analyte serve as the reported device performance against these implicit acceptance criteria.

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

The method comparison study was conducted with a total of 867 samples. The data provenance is described as being collected at three clinical sites. The document does not specify the country of origin of the data, but the submitter information lists DFI Co., Ltd. in Korea. The study appears to be retrospective, as it compares the new device results against a legally marketed predicate device using collected samples.

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

The document does not explicitly mention the use of experts to establish ground truth for the test set. Instead, the performance is evaluated by "method comparison" against a predicate device (Siemens Clinitek Status + urine chemistry instrument). The predicate device's results are considered the reference for comparison.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method involving human experts for the test set. The comparison is directly between the new device and the predicate device.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as per the provided information. The study focuses on comparing the new device's analytical performance against a predicate device, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done in the form of a method comparison study where the DUS R-50S (DUS R-50S instrument, DUS10 and DUS2AC reagent strips) was compared to the predicate device (Siemens Clinitek Status + urine chemistry instrument using Multistix 10SG and CLINITEK Microalbumin 2 test strips). This evaluates the algorithm and device's performance directly.

7. Type of Ground Truth Used

The "ground truth" for the test set was the results obtained from the predicate device, specifically the Siemens Clinitek Status + urine chemistry instrument using Multistix 10SG and CLINITEK Microalbumin 2 test strips.

8. Sample Size for the Training Set

The document does not explicitly specify a separate sample size for a "training set." The performance evaluation focuses on the method comparison study using 867 samples. For a 510(k) submission for an in vitro diagnostic device, the manufacturer typically performs internal validation and verification studies during development, but the detailed breakdown of training data vs. test data for algorithm development is not typically part of the regulatory submission summary provided.

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

Since a "training set" is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided. If an algorithm was developed using machine learning, the ground truth for training would generally be established by laboratory reference methods or expert interpretation of the results from traditional methods, similar to how the predicate device results are used for the test set.

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

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

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

Acceptance Criteria and Reported Device Performance

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

The tables below compile the key performance metrics provided:

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

Study Details:

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

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

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study involving AI assistance is mentioned. This device is a rapid immunochemical assay, not an AI-powered diagnostic imaging tool. Human interpretation is involved in reading the lines on the cassette.
• A "method comparison with predicate device" study was performed, which compared the new device's readings to those of a predicate device. This is a comparison between devices, not between human readers with and without AI assistance.
• A "consumer study" was performed, which likely involved lay users or professional users following instructions, but it was to assess the device's performance, not the improvement of human readers with AI.

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

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

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

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

8. The sample size for the training set

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

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

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

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The InSure® ONE™ is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. The InSure® ONE™ test is used to aid in the detection of lower gastrointestinal bleeding.

The InSure® ONE™ – One Day Fecal Immunochemical Test qualitatively detects human hemoglobin from blood in fecal samples. The fecal sample is generally collected by the test subject at home. Toilet bowl water samples are taken using long handled brushes to collect a small volume of water from around the defecated stool. The toilet water test sample once collected is placed on an InSure ONE Test Card. The InSure ONE Test Card then serves as a means to transport the dried samples to the laboratory. The InSure ONE test detects human hemoglobin in toilet bowl water. The test is developed in the laboratory or medical professional office with appropriate quality control. The FOBT Controls (K101831) are recommended for use as external controls.

Components of InSure® ONE™ - One Day Fecal Immunochemical Test:

• a. The InSure® ONE™ Collection Kit* contains:
  • InSure® ONE™ Instructions for Use-Patient ●
  • InSure® ONE™ Test Card ●
  • Brush Kit containing 2x brushes and a waste bag ●
  • Business reply form and envelope ●
• b. The InSure® ONE™ or InSure® FIT Developer Kit* (for development and interpretation of the test) contains:
  • InSure® ONE™ Instructions for Use-Professional Laboratory .
  • InSure® ONETM Test Strips: The Test Strips contain mouse monoclonal anti-. human hemoglobin test line antibodies and a conjugate-specific polyclonal (donkey anti-goat) antibody control line, and a conjugate of anti-human hemoglobin polyclonal (goat) antibodies bound to colored (colloidal gold) particles.
  • . InSure® ONE™ Run Buffer: Contains borate salts, ethanol, bovine serum albumin, and sodium azide as preservative.
• c. The InSure® ONE™ or InSure® FIT FOBT Controls contains:
  • · Instructions for Use
  • · Positive Control
  • · Negative Control

*The above kits and components are supplied in a variety of packaging configurations and sold in combination or separately to meet customer requirements.

Here's the breakdown of the acceptance criteria and study information for the InSure® ONE™ – One Day Fecal Immunochemical Test based on the provided text:

Acceptance Criteria and Device Performance

• At 50 ug Hb/g stool: Positive Percent Agreement (PPA) of 97.5% (87.1% to 99.6% CI).
• At 40 ug Hb/g stool: PPA of 92.5% (80.1% to 97.4% CI). Officially, the cut-off was determined to be 50 ug hemoglobin/g stool. |
  | Method Comparison (Clinical Performance): Acceptable overall agreement with InSure® FIT™ (predicate device) in clinical positive predictive value (PPV) and clinical negative predictive value (NPV). No statistically significant differences in test results between the new InSure ONE sampling method (two aliquots from one bowel movement) and the predicate InSure FIT method (one aliquot from two separate bowel movements). | The study demonstrated that there were no statistically significant differences in the test results obtained from two fecal water sample aliquots taken from one bowel movement (new sampling method InSure ONE), when compared to one fecal water sample aliquot taken from two separate bowel movements (predicate sampling method InSure FIT). The InSure ONE test is substantially equivalent to the predicate device. |

Study Details

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

• Analytical Sensitivity (Assay Cut-off Study):
  • Sample Size: 40 samples per hemoglobin concentration level, across 9 different concentrations, totaling 360 prepared samples.
  • Data Provenance: The text describes the preparation of spiked stool samples and the simulation of toilet water. This suggests a retrospective, laboratory-based study rather than collection from actual patients.
• Method Comparison (Clinical Study):
  • Sample Size: 859 patients.
  • Data Provenance: Patients were recruited from three intended use sites, and the study was performed at one intended use site in Australia. This was a prospective clinical study.

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

• Analytical Sensitivity (Assay Cut-off Study): No external experts are mentioned for establishing ground truth. The ground truth was based on the known, spiked hemoglobin concentrations.
• Method Comparison (Clinical Study): The text states, "Tissue samples collected at colonoscopy were histopathologically examined for the type of lesion (i.e., cancer, advanced adenoma, etc.)." This implies that pathologists established the ground truth based on histopathological examination. The number and specific qualifications (e.g., years of experience) of these pathologists are not specified in the provided text.

4. Adjudication method for the test set:

• Analytical Sensitivity (Assay Cut-off Study): Not applicable, as the ground truth was based on predefined concentrations. The determination of whether a test was positive or negative was likely by trained laboratory personnel following a specific protocol.
• Method Comparison (Clinical Study): The text does not explicitly mention an adjudication method for the histopathological examination of tissue samples. It is standard practice in pathology for samples to be reviewed by at least one pathologist, and potentially a second for complex cases or discrepancies, but this is not detailed in the provided information.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This device is a Fecal Immunochemical Test (FIT), which is a diagnostic assay, not an AI-assisted diagnostic imaging or analysis tool that typically involves human readers interpreting results with or without AI assistance. The study compares the performance of two different sampling methods for the FIT itself.

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

• Yes, a standalone performance was done for both studies.
  • Analytical Sensitivity (Assay Cut-off Study): This study directly assessed the device's ability to detect hemoglobin at various concentrations, which is the standalone performance of the test kit itself.
  • Method Comparison (Clinical Study): This study evaluated the performance of the InSure ONE test (device and sampling method) in detecting occult blood, independent of a human interpreting complex outputs to derive a diagnosis. The "human-in-the-loop" aspect here is the patient collecting the sample and laboratory staff developing it, but the intrinsic performance of the test strip itself is being evaluated.

7. The type of ground truth used:

• Analytical Sensitivity (Assay Cut-off Study): Predefined concentrations of hemoglobin in spiked stool samples.
• Method Comparison (Clinical Study): Pathology results from histopathological examination of tissue samples collected during colonoscopy (e.g., cancer, advanced adenoma).

8. The sample size for the training set:

• The provided text does not mention a training set as this is a diagnostic test kit (FIT), not a machine learning or AI algorithm that typically requires a large training dataset to learn patterns. The studies described are performance and method comparison studies for the physical test device.

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

• As no training set is mentioned for this type of device, this information is not applicable.

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