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The URiSCAN 10 ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and the determination of the ACR (albumin creatinine ratio). These measurements are useful in the evaluation of renal, urinary and metabolic disorders.

The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results.

The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and can only be read on the URiSCAN Optima urine analyzer.

The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for prescription use only, in clinical laboratory and in point-of-care settings.

The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and the determination of the ACR (albumin creatinine ratio). The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results. The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and can only be read on the URiSCAN Optima urine analyzer.

The provided document is an FDA 510(k) clearance letter for the URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer. It outlines the device's intended use and FDA's determination of substantial equivalence. However, this document does not contain the detailed study information regarding acceptance criteria and performance data requested in your prompt.

The 510(k) summary (which is typically available in a separate document for device clearances) would contain the performance data and a summary of the studies conducted to demonstrate substantial equivalence. The provided text is solely the clearance letter itself.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not in the provided text.
2. Sample sizes used for the test set and the data provenance: Not in the provided text.
3. Number of experts used to establish the ground truth and their qualifications: Not in the provided text.
4. Adjudication method: Not in the provided text.
5. MRMC comparative effectiveness study details: Not in the provided text.
6. Standalone performance details: Not in the provided text.
7. Type of ground truth used: Not in the provided text.
8. Training set sample size: Not in the provided text.
9. How ground truth for the training set was established: Not in the provided text.

The closest relevant information in the provided text is the "Indications for Use" section (Page 2), which describes what the device is intended to measure and for what purpose, but it does not include performance data or study methodology.

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The URISCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URISCAN 2ACR Urine strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN 2ACR Urine strips and to display and print the results.

The intended use of the URiSCAN 2ACR Urine strips is for the in vitro semi quantitative measurement of the following parameters;

Albumin Creatinine ACR (Albumin Creatinine Ratio)

These measurements are useful in the evaluation of renal, urinary and metabolic disorders. URiSCAN Optima urine chemistry test system is intended for prescription use only, in clinical laboratory and in point-of-care setting.

URiSCAN Optima - the semi-quantitative urine analyzer is used with the aim of helping examine patients in a professional setting through early detection of disease before they get a thorough checkup, by using chemical components contained in urine; and it is a device to measure the amounts of components in urine, including albumin, creatinine and ACR (albumin creatinine ratio). The results appear on a liquid crystal display and can be printed on the analyzer's internal printer and transferred to a host computer, if desired.

Here's a breakdown of the acceptance criteria and study information for the URiSCAN Optima Urine analyzer and URiSCAN 2ACR Urine strips, extracted from the provided text:

Acceptance Criteria and Device Performance

Note on "Acceptance Criteria": The document does not explicitly state pre-defined numeric acceptance criteria for the outcome percentages of the comparison studies (e.g., "must be >95% exact agreement"). Instead, the comparison study results are the performance claims being used to demonstrate substantial equivalence. However, for precision, there are implicit criteria for "Level 1 - Negative Control" and "Level 2 - Positive Control" for Microalbumin and Creatinine in the precision tests.

For precision, the reported performance was 100% for all sites (A, B, C) and both levels for both Microalbumin and Creatinine.

Study Information

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

   • Sample Size: 351 random urine specimens.
   • Data Provenance: Fresh urine specimens collected in a clean, dry container at three different Point-of-Care (POC) sites (157 samples at the first, 99 at the second, and 95 at the third). This indicates prospective collection at multiple sites. The country of origin is not explicitly stated, but given the manufacturer is based in Korea and the submission is to the FDA, it could be either U.S. or international data.

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

   • Does not apply. The ground truth in this comparison study was established by another device (predicate device: Clinitek Status with Clinitek Microalbumin 2 reagent strips), not human experts.

3. Adjudication method for the test set:

   • Does not apply. Ground truth was established by a predicate device, so no human adjudication was performed.

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. This was a method comparison study comparing the performance of two automated devices (URISCAN Optima vs. Clinitek Status) on urine chemistry analysis. It was not an MRMC study and did not involve human readers or AI assistance in that context.

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

   • Yes. The method comparison study directly evaluated the performance of the URiSCAN Optima Urine analyzer (an algorithm-driven device) against a predicate device. This is a standalone performance assessment of the device's ability to read and interpret the urine strips.

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

   • The ground truth was established by comparison with a legally marketed predicate device: "Clinitek Status with Clinitek Microalbumin 2 reagent strips".

7. The sample size for the training set:

   • The document does not provide details on the sample size for a "training set." This type of device (a urine chemistry analyzer) typically operates based on calibrated spectrophotometric readings of test pads rather than machine learning algorithms trained on large datasets in the way an AI-driven imaging diagnostic device would. Calibration and control samples are used, but a "training set" in the context of deep learning is not applicable here.

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

   • Does not apply in the context of a machine learning training set. For calibration and control solutions, the "ground truth" (target values) were established through an internal procedure using commercially available stock of albumin and creatinine in buffered solutions, and re-checked using a commercial calibrator set.

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The OcculTech Occult Blood Rapid Test is a card type rapid test and an immunochromatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. It is useful in determining gastrointestinal bleeding found in a number of gastrointestinal disorders (e.g. diverticulitis, colitis, polyps and colorectal cancer). This device is recommended for use in routine physical examinations, when hospital patients are first admitted, hospital monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding from any source.

The OcculTech Fecal Occult Blood Rapid Test is a colloidal gold enhanced immunoassay for the detection of hemoglobin in human stool. During the assay the specimen stool are absorbed into the sample pad and migrate upwards chromatographically on the membrane by capillary action. The specimen stool extraction containing hemoglobin forms antibody complex with monoclonal antihemoglobin IgG gold colloid conjugate in the conjugate pad. The mixure migrates to nitrocellulose membrane in the test region where other immobilized monoclonal antihemoglobin IgG is present, and then forms a colored sandwich binding (ant-hemoglobin IgG gold colloid-hemoglobin-anti hemoglobin IgG). The OcculTech Fecal Occult Blood Rapid Test is one step test based on the immunochromatography. The test results are visually determined without using any special instrument. It is a simple operation and a number of specimen can be treated in minimal time.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining new, explicit acceptance criteria tied to clinical endpoints with specific thresholds. Instead, the performance is reported as agreement with the predicate device or expected results.

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

• Sensitivity and Prozone effect: 40 stool extraction samples. The text does not specify the country of origin or whether this was retrospective or prospective data.
• Specificity (Cross-reactivity): Not explicitly stated as a number of samples, but implied to be multiple tests with various animal hemoglobin types.
• Specificity (Interference): Not explicitly stated as a number of samples, but implied to be multiple tests with various interfering substances. Each test was performed as duplicates.
• Reproducibility and Repeatability: The study involved "tests performed by the three professionals" and "results obtained from the Reference Laboratory." The number of "expected results" or cases used for comparison isn't specified, but implies a collection of results against which the performance was measured.
• Training Set: Not specified in the document.

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

• Reproducibility and Repeatability: "three professionals with diverse education backgrounds and work experiences" were involved in performing tests and achieving agreement with "expected results." Their specific qualifications (e.g., medical doctors, lab technicians) or years of experience are not detailed.
• Reference Laboratory: "the Reference Laboratory" provided "expected results," but the number and qualifications of experts within this laboratory are not given.
• Other studies (Sensitivity, Specificity): The ground truth for these studies appears to be based on the known controlled concentrations of human hemoglobin (hHb) or the absence/presence of hHb, rather than expert judgment.

4. Adjudication Method for the Test Set

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1).
• For Reproducibility and Repeatability, it states "the results obtained from the tests performed by the three professionals... agreed 98% with expected results (average)." This suggests a comparison against a predetermined or established "expected result" rather than an adjudication process among the professionals themselves.

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 was done.
• This device is a rapid diagnostic test, not an AI-powered image analysis or diagnostic tool that assists human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

• This device is a standalone rapid immunochromatography test. The results are "visually determined without using any special instrument." There is no "algorithm" in the modern sense of AI or automated interpretation. The performance reported (sensitivity, specificity, reproducibility) are for the device's standalone operation.

7. The Type of Ground Truth Used

• Sensitivity and Prozone effect: Known concentrations of human hemoglobin (hHb) spiked into a buffer.
• Specificity (Cross-reactivity): Known presence or absence of human hemoglobin and various animal hemoglobins.
• Specificity (Interference): Known presence or absence of human hemoglobin and various interfering substances.
• Reproducibility and Repeatability: "Expected results" which likely refer to the known state of control samples or a pre-established gold standard for the samples tested, possibly determined by reference methods or the predicate device.

8. The Sample Size for the Training Set

• The document does not provide information on a specific "training set" for the device. This type of diagnostic test usually undergoes development and internal validation, but a formal "training set" in the context of machine learning or AI is not applicable. The studies described are performance evaluations.

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

• As no training set is described, the method for establishing its ground truth is also not provided.

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