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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 Healgen Series Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH and Ascorbic Acid in urine. The test systems consist of the Healgen Series Reagent Strips (Healgen 10 and Healgen 11) and the Healgen 500 or Healgen 800 Urine Analyzers. The Healgen 10 and 11 strips can be read visually and instrumentally with the Healgen 500 and 800 Analyzers. The Healgen 4 reagent strip can be read visually only. The Healgen Series Urine Reagent Strips and Urine Analyzers are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

Healgen Series Reagent strips for Urinalysis and urine analyzers are in vitro diagnostic test devices that use reagents for qualitative and semiquantitative urinalysis.

The device is composed of several color pads aligned on a strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.

Healgen Series Reagent Strip provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.

Here's an analysis of the provided text regarding the acceptance criteria and study data for the Healgen Series Reagent Strips and Analyzers for Urinalysis:

Overview:
The submission (K111999) describes the Healgen Series Reagent Strips and Analyzers, in-vitro diagnostic devices for qualitative and semi-quantitative urinalysis of various analytes. The primary goal of the submission appears to be demonstrating substantial equivalence to a predicate device (URISTK H Series Reagent Strips for Urinalysis and Dirui H-50, H-100, or H-500 Urine Analyzer). The information provided largely focuses on the analytical performance of the device rather than a clinical outcome study.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes analytical performance characteristics but does not explicitly state acceptance criteria for a "device meets acceptance criteria" study in the typical sense of a clinical trial with predefined end-points for sensitivity/specificity. Instead, it demonstrates the analytical capabilities and equivalence to a predicate device.

The tables below summarize the reported analytical performance related to:

• Analytical Limits (Cutoff): These are the thresholds at which a positive or negative result is typically determined.
• Reportable Ranges: These define the concentration ranges within which the device can provide meaningful qualitative or semi-quantitative results.
• Analytical Specificity (Interference Study): This identifies substances and their concentrations that do not affect the test results.

Table 1: Analytical Limits (Cutoffs)

Table 2: Reportable Ranges

Table 3: Analytical Specificity - Non-Interfering Concentrations of Substances

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

• Sample Size for Precision (repeatability/reproducibility):
  • Within-run: 20 replicates for each of 3 urine control levels, using strips from 3 lots.
  • Within-day: 3 urine control levels analyzed in duplicate, once a day, for 10 days, using strips from 3 lots.
  • Analytical Specificity: 5 test strips from each of 3 lots for each interference test.
• Sample Size for Clinical Comparison Studies: Not explicitly stated with a specific number of clinical specimens. The text only mentions "clinical comparison studies were conducted in 3 sites using the Healgen 11 Reagent Strip for Urinalysis and the predicate devices."
• Data Provenance: Not explicitly stated (e.g., country of origin). The document implies the studies were conducted to support a submission to the US FDA, but does not specify the geographic location of the clinical sites or specimen collection. The study appears to be prospective for the analytical performance evaluations (precision, specificity) as these were performed as part of the validation. The "clinical comparison studies" also imply prospective data collection for comparison purposes.

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

• Experts: The precision study involved "6 technicians" across 3 clinical sites. No specific qualifications (e.g., years of experience, specific certifications) are provided for these technicians, nor are they explicitly stated as "experts establishing ground truth."
• Ground Truth Qualification: For the precision and analytical specificity studies, the ground truth was established by using urine controls (Bio-Rad Level 1 and Level 2) and a 3rd control with analyte concentrations around cutoff, which was created by pooling Bio-Rad controls and spiking with pure analytes. For the clinical comparison study, the "ground truth" was implicitly the result obtained by the predicate device, as the study aimed to show comparability. There is no mention of external expert consensus or a gold standard method separate from the predicate for establishing ground truth for the clinical specimens.

4. Adjudication Method for the Test Set

• No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The analytical studies used technical replication (e.g., 20 replicates, duplicates over 10 days). For the clinical comparison, the comparison was made against the predicate device, suggesting the predicate's results served as the reference for comparability.

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

• No, an MRMC comparative effectiveness study was not explicitly described in the provided text in the typical sense of measuring human reader improvement with AI assistance.
• The document mentions "visual reading" alongside "instrumental reading" for the Healgen strips and states that "comparable testing data could be obtained by intended users when using the Healgen 11 Reagent Strip for Urinalysis and the legally marketed URISTK H Series Reagent Strips for Urinalysis from Dirui." This indicates a comparison between visual and instrumental readings, and between the new device and the predicate. However, it does not detail a study specifically designed to assess human reader improvement with AI (in this case, the analyzer acting as an 'AI' for reading strips) versus without it.
• The effect size of how much human readers improve with AI vs without AI assistance is not provided or discussed. The focus is on the performance comparability of the device (both visual and instrumental readings) to a predicate device.

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

• Yes, a form of standalone performance was implicitly studied for the instrumental reading. The Healgen 500 and 800 Urine Analyzers use "reflectance photometry to quantitate analyte values" and provide "instrumental reading." Precision, analytical limits, and reportable ranges are characteristics of the instrument's performance (the "algorithm") when reading the strips. The "analytical specificity" study also evaluates the instrument's performance in the presence of interfering substances. While not strictly an "AI algorithm" in the modern interpretative sense, the analyzers are automated systems that perform the reading without human interpretation beyond initiating the test and reading the display.

7. The Type of Ground Truth Used

• For analytical performance (precision, reportable ranges, analytical specificity): The ground truth was based on controlled lab-prepared samples using Bio-Rad urinalysis controls and custom-spiked controls with known analyte concentrations.
• For clinical comparison studies: The ground truth was the results obtained from the predicate device (URISTK H Series Reagent Strips for Urinalysis and Dirui H-50, H-100, or H-500 Urine Analyzer).

8. The Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" for an AI or machine learning model. This is consistent with the nature of reflectance photometry-based devices, which typically rely on calibrated physics-based models rather than data-driven machine learning for their primary function of quantifying color changes. The development of the reagents and the instrumental reading parameters would be based on chemical principles and extensive analytical validation rather than a distinct machine learning training set.

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

• As a distinct "training set" for AI/ML is not described, the concept of establishing ground truth for it is not applicable in the context of this submission. The device's operational parameters and measurement accuracy are established through the analytical performance studies rather than a machine learning training process.

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The Mission® U500 Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Billirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection Nitrite. The instrument is intended for prescription, for in vitro diagnostic use only. Mission Urinalysis Reagent Strips are available in different test configurations and the measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.

The Mission® U500 Urine Analyzer is a semi-automated reflectance photometer in conjunction with Mission Urinalysis Reagent Strips (originally cleared under K061559) that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. The analyzer throughput is 500 tests per hour and the measuring cycle is 7 seconds per test. The analyzer stores up to 2,000 patient records and prints the results in Conventional, SI, or Arbitrary units using an integrated internal or external printer.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Mission® U500 Urine Analyzer:

Acceptance Criteria and Device Performance for Mission® U500 Urine Analyzer

The provided document describes the Mission® U500 Urine Analyzer and its substantial equivalence to a predicate device (ACON U120 Urine Analyzer). While explicit "acceptance criteria" are not presented as a standalone table with numerical targets, the document implicitly defines acceptance based on demonstrating substantial equivalence to the predicate device through analytical and clinical performance.

The "reported device performance" is primarily articulated through the comparison to the predicate device and the conclusion that the new device is "substantially equivalent."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "Clinical study data are presented for the percent positive agreement, percent negative agreement, and percent agreement on and between color blocks," which implies a set of clinical samples were used.
• Data Provenance: The studies were conducted "in-house and in a clinical setting." The document does not specify the country of origin for the clinical data. It also doesn't explicitly state whether the data was retrospective or prospective, though "clinical performance testing" typically implies prospective collection for such comparison studies.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • For this type of device (urine chemistry analyzer reading reagent strips), the "ground truth" would typically refer to a consensus reading by trained, certified clinical laboratory personnel or medical professionals, or possibly reference methods of laboratory analysis, rather than "experts" in the sense of radiologists.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with or without AI assistance. This device is an automated analyzer, not an AI-assisted diagnostic tool for human readers. The clinical study compares the device's performance to a predicate device's performance.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance: Yes, the entire study effectively serves as a standalone performance evaluation of the "algorithm" (the automated reflectance photometer) as it compares the new device's readings to those of a predicate automated device. The device itself is the algorithm, interpreting the color changes on reagent strips. The "Analytical Performance Testing" and "Clinical Performance Testing" sections describe this.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical comparison was based on comparison to the predicate device (ACON U120 Urine Analyzer). The document states: "Clinical performance of the Mission® U500 Urine Analyzer was evaluated in a method comparison study between the Mission® U500 Urine Analyzer and ACON U120 Urine Analyzer predicate device." For the analytical performance, it would involve known concentrations/values of analytes in controlled samples.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable in the context of this device. This device is a reflectance photometer, which relies on a fixed optical and chemical-reaction principle, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its calibration is "Automatic," implying an internal, fixed calibration procedure rather than a learning algorithm.

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

• Ground Truth for Training Set: Not applicable for the reasons stated above (not an AI/ML algorithm requiring a training set). The calibration of such a device would be established using certified reference materials or standardized solutions with known analyte concentrations.

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The Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for prescription, in vitro diagnostic use only. The instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acidbase balance and bacteriuria. The instruments use the accompanying check strip for daily calibration.

Untest 10G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH in urine. The Uritest 10G urine reagent strips are for use with the Uritest-50 urine analyzer and are for prescription, 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.

Untest 11G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid in urine. The Untest 11G urine reagent strips are for use with Untest-500B urine analyzer and are for prescription, 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 Uritest-50 and Uritest-500B Urine Analyzers are reflectance spectorphotometers that instrumentally measure the reflectance of a reacted Uritest 10G or Uritest 11G urine reagent strip for urinalysis. The Uritest-50 and Uritest-500B Urine Analyzers display and print urinalysis results and can be connected to a laboratory computer for data management.

The provided text is a 510(k) summary for the Uritest-50 and Uritest-500B Urine Analyzers and accompanying reagent strips. It states that "Studies were conducted in-house and in clinical settings to demonstrate that the performance of the Uritest-50 and Uritest-500B Urine Analyzers and Uritest 10G or Uritest 11G urine reagent strips are equivalent to the predicate devices." and thus "demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use."

However, this document does not include any specific acceptance criteria or detailed results from the performance studies. It generally claims equivalence to predicate devices but does not provide data or methodology to support this claim in the given text.

Therefore, for most of your requested information, I cannot provide an answer based only on the provided text.

Here's what I can provide and what is missing:

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

• Acceptance Criteria: Not specified in the provided text.
• Reported Device Performance: Not detailed in the provided text. The document only makes a general statement about equivalence to predicate devices.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: "in-house and in clinical settings." The country of origin is not explicitly stated for the clinical settings, but the submitter is in China. Whether it was retrospective or prospective is not mentioned.

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)

• Not specified or mentioned in the provided text. The nature of the ground truth (e.g., comparison to predicate devices, or a specific reference method) is implied to be relative to predicate devices, but the process of establishing ground truth for the test set based on expert input is not described.

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

• Not specified or mentioned in the provided text.

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

• This device is a urine analyzer and reagent strips, which performs semi-quantitative detection automatically. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or results with and without AI assistance. Therefore, an MRMC study in the context of human reader improvement with AI is not applicable to this type of device based on its description.

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

• The device, as described, is a standalone instrument (Uritest-50 and Uritest-500B Urine Analyzers) that performs semi-quantitative detection on reagent strips. The user manually dips the strip and places it in the analyzer, which then measures and displays results. This effectively performs as an "algorithm only" device in terms of its measurement and result generation.

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

• The document implies that the ground truth for comparison was the performance of predicate devices (Bayer Clinitek 500 Urine Chemistry Analyzer, Bayer Multistix 10-SG Reagent Strips for Urinalysis, Dirui URISTK H-11 Reagent Strips and Dirui H-500 Urine Analyzer). The specific type of ground truth data (e.g., what independent reference method these predicate devices themselves were compared against) is not detailed.

8. The sample size for the training set

• Not specified in the provided text.

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

• Not specified in the provided text, and given the nature of the device (semi-quantitative chemical analysis), a "training set" in the context of supervised machine learning might not be directly applicable in the same way it would be for an AI-based image analysis device. However, system calibration and validation would involve known samples. This detail is not provided.

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Urine strips are for "in vitro" diagnostic use and are intended for prescription use near-patient (point of care) and centralized laboratory locations.

Urine Strip includes test pads for qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine.

Urine test strips results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

The test is to be read visually.

Wiener lab. Urine Strip are plastic strips to which glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leucocytes and ascorbic acid reagents pads are affixed. The reagent pads react with the urine and provide a visible color reaction. The product is packaged in a plastic bottle. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The instructions for use must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Laboratory instrumentation is not required.

The provided text is a 510(k) Summary for the "Wiener lab. Urine Strip" device. It outlines the device's intended use and claims substantial equivalence to the predicate device, Bayer Multistix® 10SG. However, it does not contain a study that explicitly details acceptance criteria and proves the device meets those criteria with specific performance metrics such as sensitivity, specificity, or accuracy.

The document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The diagnostic purposes of the device.
• Equivalencies and Differences to Predicate Device: A comparison of methodologies and sensitivities for each parameter with the predicate device.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's the information that can be extracted or inferred from the provided text, along with what is missing:

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

The document lists "Sensitivity" for several parameters, comparing the Wiener lab. Urine Strip to the predicate device. While this indicates detection limits, it doesn't explicitly state "acceptance criteria" against which these sensitivities are being measured, nor does it present full performance metrics (like accuracy, specificity, etc.) typically found in a clinical study report.

Missing:

• Explicitly defined acceptance criteria values for each performance metric. The document mentions "substantial equivalency" but does not define quantitative thresholds for this equivalency in terms of performance.
• Full device performance report (e.g., accuracy, sensitivity, specificity, PPV, NPV) against a defined ground truth for various concentrations for all analytes. The provided sensitivities are detection limits, not comprehensive performance metrics.

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

Missing: This information is not provided in the 510(k) summary. The document does not describe a specific clinical study with a test set. It primarily compares the methodologies and stated sensitivities/detection limits to a predicate device.

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)

Missing: This information is not provided. There is no mention of an expert panel or ground truth establishment process for a test set.

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

Missing: Not applicable, as no external test set or adjudication process is described in this document.

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

Missing: Not applicable. The device is a chemical reagent strip read visually against color blocks, not an AI-assisted diagnostic tool.

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

Missing: Not applicable. The device is a chemical reagent strip, not an algorithm. Its performance is inherent in its chemical reactions and visual color change. The instructions state "Results are obtained by direct comparison of the test strip with the chemical-reaction and optical features of the reagent strip itself and comparison with color blocks. It is not an algorithm-only device."

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

Missing: The document does not describe a specific "ground truth" reference method for a clinical study. The comparison is based on the stated methodologies and sensitivities of the new device and the predicate device, implying that the performance claims are based on internal validation using established analytical methods rather than a head-to-head clinical trial with patient outcomes.

8. The sample size for the training set

Missing: The document does not describe a "training set" as this is not an algorithm-based device that undergoes machine learning training.

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

Missing: Not applicable, as this is not an algorithm-based device.

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URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for ascorbic acid, pH, specific gravity, ketones (acetoacetic acid), blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Dirui H Series Reagent Strips are for single use in professional near-patient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening in the following areas:

• Kidney function
• Urinary tract infections
• Carbohydrate metabolism (e.g. diabetes mellitus)
• Liver function
• Acid-base balance
• Urine concentration

Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

URISTIK H Series Reagent Strips For Urinalysis provide qualitative and semiquantitative tests for ascorbic acid, pH, specific gravity, ketones, blood, protein, nitrite, leukocytes, glucose, bilirubin and urobilinogen in urine. URISTIK H Series Reagent Strips For Urinalysis are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Dirui H-50, H-100, or H-500 Urine Analyzer. The results are available within one minute. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.

The provided text describes the regulatory filing for the URISTIK H Series Reagent Strips but lacks specific quantitative acceptance criteria or detailed study results with exact performance metrics. However, it does provide a summary of the studies conducted and the conclusions reached regarding performance.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) are not explicitly stated in the provided document. Similarly, detailed quantitative performance data (like exact percentages of agreement or accuracy values) are not reported.

The document broadly states:

• "The studies demonstrated that professional users in centralized and point-of-care (POC) hospital, clinic, and doctor's office settings can obtain valid urinalysis test results."
• "Dirui studies showed that the URISTIK H Series Reagent Strips For Urinalysis provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC settings."

Therefore, a table with specific acceptance criteria and reported performance cannot be fully constructed from the given text.

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

• Sample Size: Not specified. The document only mentions "clinical laboratory settings."
• Data Provenance: The studies were conducted in "clinical laboratory settings by professional users." The product's manufacturer is Changchun Dirui Industrial Co., Ltd. (China), but the specific locations (e.g., countries) where these clinical studies were performed are not detailed. It is not explicitly stated whether the data was retrospective or prospective, but clinical laboratory studies often imply prospective collection.

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

• Number of Experts: Not specified.
• Qualifications: "Professional users" performed the tests and comparisons. Implicitly, these would be laboratory professionals or clinicians, but specific qualifications (e.g., "clinical pathologist with 5 years of experience") are not provided.

4. Adjudication Method for the Test Set

• The document states that "The results were compared to results obtained from Bayer MULTISTIX 10 SG Reagent Strips and from laboratory test methods." This implies a comparison against established methods. However, the specific adjudication method (e.g., whether multiple experts reviewed discrepant results, or if there was a predefined algorithm for determining a 'true' result) is not described.

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

• It is not explicitly stated that an MRMC comparative effectiveness study was done regarding human readers improving with or without AI assistance. The device is a reagent strip for urinalysis, which is typically read visually or by a dedicated analyzer; it's not an AI-assisted diagnostic imaging device for human interpretation. The study focused on the performance of the strips when read visually by professional users versus instrumentally, and in comparison to predicate devices and laboratory methods.

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

• Yes, performance was assessed both visually (implying human-in-the-loop) and "instrumentally using Dirui H Series Urine Analyzers." The instrumental reading can be considered a form of standalone performance for the combined strip-analyzer system, independent of visual human interpretation. However, the exact performance metrics for the instrumental reading versus visual reading are not provided.

7. Type of Ground Truth Used

• The ground truth was established by "laboratory test methods." These "laboratory test methods" are implied to be established, more definitive reference methods for the urinalysis parameters being assessed (e.g., chemical assays for glucose, microscopic examination for blood cells).

8. Sample Size for the Training Set

• The document does not mention a training set or its sample size. This is typical for reagent strip validation, which often focuses on clinical performance rather than machine-learning model training.

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

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

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The TECO Diagnostics URS-1B (Blood Test) is intended for "Professional Use." The test is used, by professional people, for a qualitative determination of blood in human urine. Urinary blood measurements are used in the diagnosis and treatment of hematuria and glomerulonephritis.

Not Found

The provided text is a 510(k) summary from the FDA for a medical device called URS-1B (Blood Test) by Teco Diagnostics. It states that the device is substantially equivalent to a predicate device for the qualitative determination of blood in human urine for professional use.

However, the provided document does not contain the detailed information required to answer your request about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies. This document is primarily an FDA clearance letter, confirming substantial equivalence to a predicate device, and includes the indications for use. It does not elaborate on the specific performance studies that led to this clearance.

Therefore, most of the information requested cannot be extracted from the given text.

Here is what can be inferred or stated based on the provided text, with the understanding that much of the request cannot be fulfilled:

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

• Cannot be provided. The document does not specify quantified acceptance criteria or detailed performance metrics from a study (e.g., sensitivity, specificity, accuracy). It only states that the device is "substantially equivalent" to a legally marketed predicate device.

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

• Cannot be provided. This information is not present in the FDA clearance letter.

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):

• Cannot be provided. This document does not detail how ground truth was established for any studies, nor does it mention experts or their qualifications.

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

• Cannot be provided. This information is not present in the FDA clearance letter.

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:

• Cannot be provided. This device is a "Blood Test" (likely an in-vitro diagnostic strip or similar), not an AI-assisted imaging device. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.

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

• Cannot be provided directly. While the device itself would have a standalone performance, the specific study details (if one was done in this context) are not described in this document. Given it's a qualitative test for "Professional Use," it implies the professional interprets the result, so a true "algorithm only without human-in-the-loop" study in the AI sense is unlikely.

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

• Cannot be provided. The document does not specify the method for establishing ground truth for any studies. For a qualitative blood test for hematuria, ground truth would typically be established by a more definitive laboratory method or clinical diagnosis, but this is not detailed here.

8. The sample size for the training set:

• Cannot be provided. This document is silent on any training sets or their sizes.

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

• Cannot be provided. This document is silent on any training sets or their ground truth establishment.

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