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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 Mission® U120 Ultra 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, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite.

The instrument is intended for point-of-care, in vitro diagnostic use only. 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. It is intended for professional use only.

The Mission® Liquid Urine Controls Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.

The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Without a urine analyzer, users must visually compare the reagent areas of the strip to a color chart using the naked eye. Mission® U120 Ultra Urine Analyzer also features data management and report generation capabilities.

Acceptance Criteria and Device Performance Study for Mission® U120 Ultra Urine Analyzer

This report summarizes the acceptance criteria and the study proving the device meets these criteria for the Mission® U120 Ultra Urine Analyzer, as derived from the provided 510(k) summary (K142543).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mission® U120 Ultra Urine Analyzer were established through comparison with a predicate device (ACON U120 Urine Analyzer, K070929) and through various performance studies, including sensitivity, precision, interference, and environmental stability. The primary acceptance criteria for clinical performance were based on the agreement levels with the predicate device.

Note: The exact acceptance criteria were not explicitly stated as numerical thresholds for each analyte in the provided document beyond the general statement of "demonstrated that the intended user can follow the product instruction and obtain comparable instrument read results when using the Mission®U120 Ultra Urine Analyzer and a predicate Analyzer." The reported performance statistics (exact and within one level agreement) implicitly serve as the achieved acceptance. For Sensitivity, the achievement of specific low and high end ranges, as listed in the document, constitutes the acceptance. For Precision, 100% within +/- one block agreement was explicitly stated.

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

The primary clinical test set involved approximately 468 patient urine specimens for each analyte (sample sizes varied slightly for some analytes, e.g., 451 for Nitrite, 450 for Bilirubin, etc.). This number includes both patient-collected specimens and "few contrived urine specimens" to ensure coverage of the measuring range.

The data provenance is prospective, as it involved "patient urine specimens randomly collected from patients at each of 3 clinical sites" and "Additional study was carried out at 2 sites in US," indicating a planned data collection process for the study. The country of origin for the clinical data is the United States (2 sites in US mentioned).

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

The ground truth for the clinical test set was established by comparing the results from the Mission® U120 Ultra Urine Analyzer with those from a predicate device, the ACON U120 Urine Analyzer (K070929), rather than human experts.

The testing was performed by 9 intended users in total across 3 clinical sites (3 users at each site). Their qualifications are described as "intended users," implying they are professionals who would typically operate such devices in a point-of-care setting, but specific expert qualifications (e.g., radiologist with 10 years of experience) are not provided.

4. Adjudication Method for the Test Set

The adjudication method used seems to be a direct comparison between the results obtained from the candidate device (Mission® U120 Ultra Urine Analyzer) and the predicate device (ACON U120 Urine Analyzer). The agreement percentages (exact and within one level) are reported, indicating that the predicate device's readings served as the reference for comparison. There is no mention of an independent adjudication panel or a consensus method among multiple experts for the test set's ground truth beyond the comparison to the predicate.

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

An MRMC comparative effectiveness study, in the traditional sense of evaluating human reader performance with and without AI assistance, was not performed. The study compared the new automated analyzer (Mission® U120 Ultra Urine Analyzer) against a predicate automated analyzer (ACON U120 Urine Analyzer), with "intended users" operating the devices. The study objective was to evaluate the performance of the new analyzer compared to the predicate and to observe operational issues. It did not focus on the effect size of how much human readers improve with AI vs. without AI assistance, as the "AI" (automated analyzer) is the primary testing modality being evaluated for its standalone performance relative to a predicate.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

Yes, a standalone study was performed. The core of the clinical study involved comparing the "Mission® U120 Ultra Urine Analyzer" reading "Mission® Urinalysis Reagent Strips" against the "ACON U120 Urine Analyzer" reading "Mission® Urinalysis Reagent Strips." This evaluates the algorithm-driven output of the Mission® U120 Ultra Urine Analyzer as a standalone device against a legally marketed predicate device. The precision, sensitivity, interference, and environmental studies also evaluate the device's performance in a standalone capacity under various conditions.

7. The Type of Ground Truth Used

For the clinical study, the reference standard (ground truth) was the performance of the legally marketed predicate device, the ACON U120 Urine Analyzer (K070929), when reading the same Mission® Urinalysis Reagent Strips. The study directly compared the results from the new device against those of the predicate. Some "contrived urine specimens" were also used, implying that these had pre-defined or known concentrations of analytes, which would also serve as a form of ground truth.

For the precision study, the "target concentration of the analyte in each control solution was confirmed with Siemens reagent strips read by Clinitek Status urine analyzer and Mission® Urinalysis Reagent Strip read by ACON U120 urine analyzer," indicating a combination of predicate devices and validated controls as ground truth.

For the sensitivity study, the "low and high end range of sensitivity" for the reagent strips were determined, which likely relied on precisely prepared samples with known analyte concentrations as the ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state a separate "training set" sample size for the Mission® U120 Ultra Urine Analyzer, as it is primarily a reflectance photometer analyzing color changes rather than a complex machine learning model that typically requires a distinct training phase. The device's operation is based on pre-programmed algorithms for color interpretation.

The clinical study and other performance studies described serve as validation of the device's accuracy and functionality. If any internal calibration or parameter tuning occurred, the data used for that is not detailed in this section.

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

As mentioned above, the document does not describe a distinct training set for a machine learning algorithm. The device is an optical reader with established "tests principles" based on reflectance photometry and CMOS image sensing. The "ground truth" for its development and programming would implicitly derive from the chemical reactions on the reagent strips and the expected colorimetric responses at different analyte concentrations. These foundational principles are well-established in urinalysis technology. The sensitivity study, for instance, establishes the "low and high end range of sensitivity" for the device, which reflects its ability to correctly interpret known concentrations.

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The CLINITEK Novus® Automated Urine Chemistry Analyzer is a fully automated urinalysis instrument. The CLINITEK Novus analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus Cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus 10 Urinalysis Cassette is intended for the seniquantitative measurement of the following parameters in urine: bilirubin, blood (occult), glucose, ketone (acetoacetic acid), leukocytes, nitrite (qualitative), pH, protein, color, and urobilinogen.

These measurements are used to assist diagnosis in the following areas:

• · Carbohydrate metabolism (such as diabetes mellitus)
• · Kidney function
• · Liver function
• · Metabolic disorders
• · Urinary tract infection

For in vitro diagnostic use.

The CLINITEK Novus® Calibration Kit is intended to be used with the CLINITEK Novus Urinalysis Cassette to calibrate the CLINITEK Novus Automated Urine Chemistry analyzer. This product is for professional in vitro diagnostic use.

The CLINITEK Novus® system is a fully automated urine chemistry analyzer that is designed for use with the CLINITEK Novus® 10 Urinalysis Cassette. The analyzer automates the process of urine strip testing by dispensing urine samples onto a test pad, and then by reading the color and intensity of light reflected from the reacted test pads, converts the results into clinically meaningful units.

Test results from the test pads are qualitative and semi-quantitative; specific gravity is measured by a refractometer assembly.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve X% agreement"). However, it does present the results of comparison studies against a predicate device and states that "The results for overall percent agreement and within one level agreement met acceptance criteria." This implies that acceptable thresholds were achieved. Based on the presented data, we can infer the achieved performance. For specific analytes, the values vary, but they consistently show high exact match and very high agreement within +/- 1 block.

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

• Sample Size:
  • For the method comparison study (comparing CLINITEK Novus to the predicate CLINITEK Atlas), up to 2773 specimens were tested across 3 sites for most analytes.
  • For Urobilinogen, an additional fourth site was involved due to a high number of contrived samples in the initial three sites. This fourth site tested 261 samples (187 negative, and then 48, 10, 12, 4 for various positive levels).
• Data Provenance: The document does not explicitly state the country of origin. The study was conducted "across 3 sites" (and later a fourth), implying a multi-center study within the scope of the device manufacturer's operations/clinical trials. It is a prospective comparison study as it compared the new device (CLINITEK Novus) against an existing predicate device (CLINITEK Atlas) using actual patient specimens.

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

The context of this device being an automated urine chemistry analyzer comparing its readings to a predicate automated urine chemistry analyzer suggests that the "ground truth" for the test set was established by the results from the predicate device (CLINITEK Atlas), not human experts. Therefore, the concept of a number of experts and their qualifications for establishing ground truth is not directly applicable in this context. The predicate device's established performance serves as the reference.

4. Adjudication Method for the Test Set

Since the comparison is primarily between two automated devices, and the "ground truth" is derived from the predicate device's readings, a typical adjudication method involving human readers (like 2+1 or 3+1 consensus) is not applicable. The data presented is a direct comparison of the readings obtained from the CLINITEK Novus analyzer against the readings obtained from the CLINITEK Atlas analyzer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers and AI assistance was not performed. This device is an automated in vitro diagnostic (IVD) analyzer, not an AI-powered image analysis tool meant to assist human readers. Its primary function is to automatically measure chemical parameters in urine.

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

Yes, the performance reported is a standalone performance of the CLINITEK Novus Automated Urine Chemistry Analyzer. It assesses the device's ability to accurately measure urine parameters independently, by comparing its results directly to those of a predicate automated device. There is no human-in-the-loop component in the reported performance evaluation.

7. The Type of Ground Truth Used

The primary "ground truth" used for the method comparison study was the results obtained from the predicate device, the CLINITEK Atlas Automated Urine Chemistry Analyzer. For the detection limit study, "ground truth" was established by spiking negative pooled human urine with known quantities of analytes.

8. The Sample Size for the Training Set

The document describes studies comparing the new device to a predicate device and analytical performance characteristics. It does not explicitly mention a "training set" or a machine learning/AI model training process for this IVD device. The description focuses on demonstrating substantial equivalence to a predicate device through analytical and method comparison studies. If the device uses algorithms derived from prior data, that information is not detailed in this summary.

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

Since a "training set" is not explicitly mentioned in the context of machine learning/AI for this device, the method for establishing its ground truth is not applicable/not provided in this document. The device's operation appears to be based on established reflectance photometry and refractive index principles for chemical analysis, rather than a learned model from a training set.

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The AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet™ S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Uriflet™ S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only.

The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.

The AUTION HYBRID AU-4050 is a fully automated urine analysis system. The AU-4050 contains a test strip chemistry urine analyzer also called the chemistry module (CHM) and a flow cytometry urine particle analyzer also called the flow cytometry module (FCM) together in a single integrated device. The CHM module analyzes the following parameters in urine: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The FCM module measures the following parameters in urine utilizing flow cytometry technology: Red Blood Cells. White Blood Cells. Epithelial Cells, Casts, and Bacteria. The FCM module flags for the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells. Yeast Like Cells and Mucus.

The provided document is a 510(k) summary for the ARKRAY AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System, Uriflet™ S 9HA Urine Test Strips, and AUTION Control Solution. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a novel device might.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in this 510(k) summary. The document emphasizes comparison to predicate devices and states that "Clinical and bench testing was used to verify the performance characteristics of this device. This testing showed acceptable device performance that is substantially equivalent to the performance of the predicate devices."

However, I can extract the available information and also highlight what is not present in the document.

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

The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics in a table format for the new device against predefined thresholds. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (AUTION MAX AX-4030 Urinalysis System (K093098), SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (K080887), and Sysmex UF-II Control (K070910)).

The "performance" demonstration is primarily through comparison of technological characteristics, intended use, operating principles, and design features to the predicate devices. The assumption is that since the predicate devices are already cleared, demonstrating equivalence implies acceptable performance.

Here's a summary of the comparisons provided, which implicitly serve as performance benchmarks by virtue of their equivalence:

Note: Changes in operational characteristics like "Processing Speed," "Sample Volume," "Display," "Built-in Printer," "Dimensions," and "Weight" are noted but are not considered performance criteria in the context of substantial equivalence for accuracy or clinical efficacy. The critical aspect for this type of submission is that these changes do not raise new questions of safety or effectiveness.

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

The document states: "Clinical and bench testing was used to verify the performance characteristics of this device." However, it does not provide details on:

• The specific sample sizes used for any test sets.
• The provenance of the data (e.g., country of origin, retrospective or prospective nature of the studies).

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)

This information is not provided in the 510(k) summary. For in-vitro diagnostic devices like this, expert review for ground truth might involve clinical pathologists or laboratory professionals, but the document does not elaborate.

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

This information is not provided in the 510(k) summary.

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

The device is an automated urine analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not performed or referenced. The device performs the analysis automatically.

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

Yes, the device is inherently a standalone (algorithm only) device as it is a fully automated integrated urine analyzer system performing in vitro measurements. Its performance would be evaluated based on the accuracy and precision of its automated measurements against a reference method or predicate device, independent of direct real-time human interpretation assistance during the analysis. The "comparison to predicate devices" and "clinical and bench testing" mentioned constitute this standalone performance evaluation relative to known performance.

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

The document does not explicitly state the specific type of ground truth used. For IVD devices, "clinical and bench testing" typically refers to studies where:

• Bench testing might involve spiked samples, controls, or samples with known concentrations/particle counts verified by confirmatory lab methods.
• Clinical testing would involve patient samples, likely compared against a reference method (e.g., manual microscopy for urine sediment, or established clinical chemistry methods for parameters like glucose, protein) which would effectively serve as the ground truth. Since the application is for "in vitro diagnostic use in screening patient populations," the ground truth would likely be established by clinical laboratory standards and reference methods.

8. The sample size for the training set

This information is not provided in the 510(k) summary. The document describes a traditional automated analyzer, not a machine learning/AI device that typically employs distinct "training" datasets in the computational sense. Performance verification for this device involved "clinical and bench testing."

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

As the document does not describe a "training set" in the context of machine learning, this information is not applicable/provided. For traditional IVD analyzers, ground truth for sample data used in method comparison or verification studies (analogous to validation) would be established by reference laboratory methods, sometimes using spiked samples or certified reference materials for precision and accuracy assessments.

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The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers are semi-automated analyzers intended to be used with CYBOW 11 and CYBOW 10 Reagent Strips as a test system to semi-quanititatively or qualitatively measure the specified analytes in urine as follows: glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry test systems are intended for prescription and in vitro diagnostic use only.

CYBOW Reader 300, 720 are reflectance photometer. The strip is illuminated by white light, and there flected light from the strip is detected by a color Image Sensor. The RGB signals are digitized, and this digitized image is evaluated by the processor. The intelligent image analyzer SW locates the strip and the pads, and based on these color data the parameter values are determined. The results with the date and time of the measurement as well as the sequence number and the ID are stored and printed out by the internal printer.

The provided document is a 510(k) summary for the DFI Co., Ltd's CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers. It describes the device, its intended use, and indicates substantial equivalence to a predicate device based on non-clinical studies.

However, the summary does not explicitly state specific acceptance criteria (e.g., performance thresholds like sensitivity, specificity, accuracy targets) for the device. Instead, it broadly states that non-clinical studies for analytical performance (precision, linearity, reportable range, detection limit, analytical specificity/limitation) and comparison studies were conducted. The conclusion is that the device is "safe and effective and substantially equivalent" to the predicate, implying that its performance met unstated internal criteria for equivalence.

Additionally, the document does not provide the detailed results of the device performance for direct comparison against any acceptance criteria. It only mentions that a "Comparison study Method comparison with predicate device, clinical study" was performed according to NCCLS EP9A guidelines.

Given these limitations, I will extract and infer information from the provided text to fulfill the request as best as possible.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria are not explicitly stated in the provided 510(k) summary. The document only mentions that analytical performance and comparison studies were conducted to demonstrate substantial equivalence to the predicate device.

Inferred Acceptance Criteria (based on the context of a 510(k) submission for substantial equivalence):

• Analytical Performance: Performance (precision, reproducibility, linearity, assay reportable range, detection limit, analytical specificity/limitation) should be comparable to or not worse than the predicate device.
• Method Comparison: Agreement with the predicate device should be within acceptable clinical and analytical limits, as defined by standard guidelines like NCCLS EP9A.

Reported Device Performance:
The document states that a "Non-Clinical study was conducted on the CYBOW Reader 300 and CYBOW Reader 720" including "Analytical performance" and a "Comparison study Method comparison with predicate device, clinical study."
The conclusion is that the device is "safe and effective and substantially equivalent" to the predicate, implying that the performance met unstated criteria. No specific numerical performance results (e.g., correlation coefficients, bias, accuracy rates) are provided in this summary.

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

• Sample Size for Test Set:

  • Site A (Samsung Hospital): 255 samples
  • Site B (Authoritative local university hospital at national Univ. of Pusan): 280 samples
  • Site C (Authoritative local university hospital at national Univ. of Dong Ai): 332 samples
  • Total Samples (across three sites): 867 samples (assuming these are distinct samples rather than samples per parameter, which is typical for method comparison studies)

• Data Provenance:

  • Country of Origin: Based on the names of the hospitals (Samsung Hospital, National Univ. of Pusan, National Univ. of Dong Ai) and the submitter's address (Kimhae-city, Gyung-nam, Korea; Seoul, Korea), the data originated from South Korea.
  • Retrospective or Prospective: The document implies prospective collection for the purpose of the study. It states, "Three independent laboratory evaluations of the New Device and Predicative Device were conducted... for 20 days." And also, "Three operators, reflective of the intended users of the devices, performed the testing at each site." This strongly suggests the samples were run during this 20-day study period, rather than being historical retrospective data.

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

The document does not mention the use of experts or a specific ground truth establishment process for the test set in the way one might see for imaging or diagnostic interpretation devices.

For a urine chemistry analyzer comparing to a predicate, the "ground truth" for the test set is typically established by the measurement results from the predicate device itself, or a recognized reference method if one exists and is specified (which is not the case here).

Therefore:

• Number of Experts: Not applicable in the context of this type of comparison study, as the ground truth is the predicate device's measurement.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. This is expected for a method comparison study of a quantitative/semi-quantitative analyte measurement device. The comparison method typically involves statistical analysis (e.g., regression, bias plots) between the new device's readings and the predicate device's readings, rather than a human adjudication process for ground truth.

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

• Was an MRMC study done? No. The study described is a method comparison study between an automated device and a predicate device, focusing on analytical performance and agreement on patient samples. While "Three operators, reflective of the intended users of the devices, performed the testing at each site," this is to assess reproducibility and routine use, not a multi-reader (human interpretation) comparative effectiveness study of diagnostic accuracy.
• Effect Size of Human Readers Improvement with AI vs. Without AI: Not applicable, as this was not an AI-assisted human interpretation study.

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

• Yes, a standalone study was done. The CYBOW Reader 300 and CYBOW Reader 720 are described as "reflectance photometer" devices with "intelligent image analyzer SW" that "locates the strip and the pads, and based on these color data the parameter values are determined." The non-clinical studies, including analytical performance and method comparison, evaluate the performance of these devices in a standalone manner (the algorithm/system itself, without human interpretation of the final result). The human operators are involved in running the device and handling samples, but the "performance" directly refers to the device's measured output.

7. The Type of Ground Truth Used

For the comparison study, the ground truth was the measurement results from the predicate device (Clinitek 200+, 500). The evaluation explicitly states it followed "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (2002) NCCLS, EP9A," which is a standard for comparing a new method to an existing method (the predicate) using patient samples.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. For reflectance photometers with "intelligent image analyzer SW," a training set would typically be used during the development phase to optimize the algorithms for color interpretation. However, this 510(k) summary focuses on the validation of the final product.

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

The document does not provide information on how the ground truth for the training set was established. This information is generally part of the device's internal development process and is not typically detailed in a 510(k) summary, which focuses on the validation of the finished device.

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The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL ™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.

These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.

The iChem®VELOCITY™ CalChek Kit is a set of assayed and unassayed in vitro diagnostic controls for monitoring performance of the iChem VELOCITY urine chemistry analyzer.

The controls include assayed liquid controls for the monitoring of the specific gravity measurement module, and unassayed liquid color and clarity controls for the monitoring of color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements.

These measurements monitored by these controls are part of an automated urine chemistry analyzer used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.

The proposed device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVelocity Chemistry Strips for the measurement of ten urine chemistry analytes from the chemistry strip plus the measurement of specific gravity using an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods, respectively.

Here's an analysis of the provided text to extract the acceptance criteria and study data for the iChem VELOCITY Automated Urine Chemistry System:

The provided 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (iChem 100 Urine Chemistry Analyzer and iChem 10SG strips) for regulatory clearance. It describes the device, its intended use, and compares its design, materials, safety, and electromagnetic compatibility with the predicate.

Crucially, the 510(k) summary does not include detailed acceptance criteria or a dedicated study section proving the device meets specific performance criteria beyond asserting "substantial equivalence." This is a common practice in 510(k) applications, where extensive performance data (like clinical trial results with predefined acceptance criteria) might not be explicitly summarized in the public document if the device is deemed substantially equivalent based on similarity to an already cleared device and analytical performance tests.

However, we can infer some "acceptance criteria" from the comparison section and general principles of diagnostic device performance. The study described is an analytical performance comparison to the predicate device, not a human reader study or a standalone clinical effectiveness study in the typical sense.

Here's an attempt to answer your questions based on the available information:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Claim)

Since explicit acceptance criteria for performance are not listed, we can infer that the device's performance was deemed acceptable if it was substantially equivalent to the predicate device, the iChem 100 Analyzer and 10SG strips, for all analytes and measurements. The "Reported Device Performance" below refers to the general claim of equivalence, as specific numerical performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) are not provided in this summary.

Study Information (Based on 510(k) Summary)

Given the nature of a 510(k) for substantial equivalence, the "study" described is primarily an analytical performance comparison against a predicate device, rather than a full clinical trial.

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

   • Sample Size: Not explicitly stated within this 510(k) summary. For a device like this, the "test set" would typically refer to a range of urine samples (both normal and abnormal, prepared or clinical) used for analytical validation across the measurement range of each analyte.
   • Data Provenance: Not explicitly stated. For a device manufactured by an US-based company (Iris Diagnostics, Chatsworth, CA), it is highly likely that the testing and data generation occurred in the United States, usually at the manufacturer's facility or an associated clinical/analytical laboratory. The summary does not specify if the data was retrospective or prospective, but analytical performance studies often involve prospective collection or preparation of samples.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. For this type of analytical device (measuring chemical properties of urine), the "ground truth" for the test set would typically be established by established reference methods or highly accurate laboratory analyzers, not necessarily by "experts" in the human interpretation sense (like radiologists). If visual assessments were part of a comparison (e.g., for color/clarity in early development stages), then trained laboratory personnel would likely be involved.

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

   • Adjudication method: Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where there's subjectivity and potential for disagreement among readers. For an automated chemistry analyzer, the comparison would be against a quantitative or semi-quantitative reference method, or the predicate device's output.

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:

   • MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an automated urine chemistry system, not an AI-assisted diagnostic tool that aids human readers in interpreting complex data. Its function is to perform the measurements directly.

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

   • Standalone Performance: Yes, the fundamental "performance" of this device is inherently standalone. It is an automated system ("algorithm only" in a broader sense of automation) that performs measurements without direct human real-time intervention for each test. The summary explicitly states: "iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading." This clearly indicates it functions as a standalone system without human-in-the-loop for reading the strips themselves.

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

   • Ground Truth Type: While not explicitly detailed, for an analytical chemistry system, the ground truth would typically be established by reference laboratory methods (e.g., established gold standard chemical assays, refractometry for specific gravity) or by agreement with the predicate device's measurements on a diverse set of samples. The objective is to demonstrate that the new device measures the analytes accurately and consistently.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable/not specified in this summary. This document describes a medical device seeking 510(k) clearance, which would typically rely on pre-defined chemical reactions and optical detection methods, rather than machine learning algorithms requiring explicit "training sets" in the modern AI sense. While some internal calibration or parameter optimization (which could be loosely termed "training") would have occurred during development, it's not a "training set" in the context of deep learning or statistical model training that would be detailed in this type of regulatory submission in 2011.

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

   • Ground Truth for Training Set: Not applicable, as no explicit training set in the AI sense is described. For calibration or development, ground truth would have been established through controlled experiments using known concentrations of analytes and reference methods.

In summary, the provided document is a 510(k) summary demonstrating "substantial equivalence," not a detailed clinical study report. It highlights the device's technical comparability and regulatory compliance (safety, EMC) with a previously cleared device. Detailed performance metrics with specific acceptance criteria and the methodologies for establishing ground truth for test and training sets (especially in the context of AI/ML) are typically more extensively covered in PMA submissions or in supporting documentation that is not part of this public summary.

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ARJ Medical URITEST 50 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARI Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration.

ARI Medical URITEST 50 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

ARJ Medical Uritest 500 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARJ Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration.

ARJ Medical URITEST 500 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

ARJ Medical Uritest 50 and Uritest 500 urine analyzer is a kind of semi-automatic photoelectronic colorimeter that can be used together with the Uritest 10 Urine Reagent Strips manufactured by ARJ Medical, Inc. Adopting the advanced "super-high luminosity cold light source reflection determination" technology, the "high luminosity cold light source" has two main advantages. (1) the usable life of a cold light is longer than the normal light source (2) the temperature of the normal light source will increase during testing, affecting the test result vs the temperature of the cold light source is constant not potentially affecting the result. It can finish the tests on 10 kinds of biochemical components in urine within 30 seconds, and it also can revise the affects toward the test result which is caused by ambient temperature, ambient light, acid-base scale and abnormally colored sample. The Uritest 50 and Uritest 500 urine analyzers are in vitro-diagnostic devices (IVDD).

Here's an analysis of the acceptance criteria and study details for the URITEST 50 and URITEST 500 Urine Analyzers, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages). Instead, the criterion for device performance is implicitly defined as providing "test results consistent with laboratory methods and performance comparable to that of the Bayer Clinitek 50 Urine Analyzer and the Bayer Clinitek 500."

Therefore, the table below reflects this comparative performance and the conclusion drawn from the study.

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

• Total Sample Size (Test Set): 901 urine samples
  • 520 natural negative samples
  • 381 positive natural urine samples
• Distribution by Site:
  • No.1 Clinical Hospital of Jilin University: 135 Negative, 110 Positive (245 total)
  • China-Japan Friendship Hospital of Jilin University: 180 Negative, 140 Positive (320 total)
  • The People's Hospital of Jilin Province: 205 Negative, 131 Positive (336 total)
• Data Provenance: The data was collected from three hospital laboratory settings in China (as indicated by the names of the hospitals: "No.1 Clinical Hospital of Jilin University," "China-Japan Friendship Hospital of Jilin University," and "The People's Hospital of Jilin Province"). The samples were "natural samples" and "unaltered," indicating they were prospective or retrospectively collected real-world biological samples. Given the study took place in hospital settings, it implies a clinical context.

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

The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. The ground truth was established by comparing the URITEST 50/500 results to those obtained from the Bayer Clinitek 50 and Clinitek 500 Urine Analyzers, which served as the reference method.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense involving expert consensus for conflicting readings. The comparison was solely against the results from the predicate devices (Bayer Clinitek 50 and 500).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described in the provided text. The study involved instrumental readings of urinalysis strips by the URITEST devices and comparison to predicate devices, rather than an assessment of human reader performance with or without AI assistance. The study "demonstrated that professional users... can obtain valid urinalysis test results," but this refers to the usability and outcome when using the device, not an evaluation of human readers' diagnostic accuracy with AI.

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

Yes, the study primarily functions as a standalone performance evaluation of the URITEST 50 and URITEST 500 instruments. It assesses the instruments' ability to read urinalysis strips and provide results, comparing these instrumental readings to those of predicate devices. While professional users are involved in operating the device and handling samples, the performance being measured is that of the analyzer itself, operating autonomously to interpret the strips.

7. The Type of Ground Truth Used

The ground truth for the test set was established by comparison to a legally marketed predicate device's results. Specifically, the results from the URITEST 50 and URITEST 500 were compared to those obtained from the Bayer Clinitek 50 and Clinitek 500 Urine Analyzers. This effectively uses the predicate devices' established performance as the "ground truth" or reference standard for equivalence.

8. The Sample Size for the Training Set

The document does not provide any information regarding a distinct training set sample size or how the device itself was trained. This implies that the device is a rule-based or spectrophotometric analyzer, not an AI/machine learning model in the modern sense that requires a separate training phase with labeled data. Its "training" would be through its design, calibration, and engineering specifications.

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

As no training set is described for an AI/machine learning model, the concept of establishing ground truth for a training set does not apply in the context presented by this document for these devices. The device's operational parameters would have been set during its development and manufacturing, likely based on chemical reaction principles and calibration against known standards.

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The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer which is designed to read the Chemstrip 10 UA (Combur' Test M) test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u411 are intended for prescription, in vitro diagnostic use only.

The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer which is designed to read Chemstrip 10 UA (Combur10 Test M) test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u411 are intended for prescription, in vitro diagnostic use only. The functions of the cobas u 411 analyzer includes: o Sample identification (with optional barcode scanner) o Controlled incubation period o Photometric measurements o Result memory o Optional formats for data output

The provided text is a 510(k) Summary for the cobas u 411 Urinalysis Test System. While it describes the device's intended use, its components, and compares it to a predicate device, it does not contain information about acceptance criteria, specific study designs, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance data.

The document states that the cobas u 411 urinalysis test system is "substantially equivalent to other devices legally marketed in the United States" and claims equivalence to the Chemstrip Urine Analyzer (K921087 and K931602). This implies that the device likely met performance criteria comparable to the predicate device, but the details of those criteria and the specific study proving their achievement are not included in this summary.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, and expert involvement as the information is not present in the provided text.

The text focuses on classifying the device, describing its technology, and comparing its features to an existing, legally marketed device to establish substantial equivalence. It does not delve into the detailed clinical or analytical performance study results that typically include acceptance criteria and their verification.

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The AUTION MAX AX-4030 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The AUTION MAX is intended for use only with AUTION Sticks 9EB multi-parameter test strips.

The AX-4030 device is composed of one main unit. A power cord provides the necessary electricity to run both the device and all of its components. The device is powered by the power cord which, itself, provides 100-200/200-240VAC with a frequency of 50-60Hz. The front of the main unit includes the LCD display screen and operator panel (top-center). In addition, there are several other features located along the bottom of the device including loading and u unloading sides for urine samples. One of the best features that the AX-4030 includes is a builtin printer that is located on top of the device.

Here's a summary of the acceptance criteria and study information for the AUTION MAX AX-4030 Urinalysis System, extracted from the provided text.

The provided document is a 510(k) summary for the AUTION MAX AX-4030 Urinalysis System. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results and acceptance criteria in the same way a typical medical device study report might. Therefore, some of the requested information (like specific acceptance criteria values, detailed study designs, and expert qualifications/adjudication) is not explicitly present in this regulatory filing.

However, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria for each analyte are not explicitly detailed in this 510(k) summary. The document states "Non-clinical verification and validation testing was conducted on the AX-4030 device and the results of such testing appear in Section 18 of this submission." This indicates that detailed performance data exists, but it is not included in the publicly available summary provided.

For a device like this, acceptance criteria would typically be defined for parameters such as:

• Accuracy/Correlation: Comparison of results to a reference method or predicate device results (e.g., % agreement, correlation coefficient).
• Precision/Reproducibility: Repeatability and intermediate precision (e.g., coefficient of variation within acceptable limits).
• Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration at which an analyte can be reliably detected/quantified.
• Interference: Performance in the presence of common interferents in urine.
• Carryover: Ensuring no significant contamination between samples.

Since these specific values are not in the provided text, a table cannot be fully constructed. The summary states that the results of non-clinical testing "appear in Section 18," indicating that the device met whatever acceptance criteria were established for those tests to support its substantial equivalence claim.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided 510(k) summary. The document mentions "Non-clinical verification and validation testing," but does not detail the sample sizes used for this testing.
• Data Provenance: Not specified in terms of country of origin for the test data, nor whether it was retrospective or prospective. It is implied to be internal verification and validation conducted by ARKRAY, Inc., likely involving various urine samples.

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

Not applicable/provided. For an automated urinalysis system measuring defined analytes, "ground truth" is typically established by reference methods or validated laboratory techniques, not by human expert interpretation in the same way an imaging study would.

4. Adjudication Method for the Test Set

Not applicable/provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary mode of operation for this automated system.

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

No. An MRMC study is not relevant for an automated urinalysis system like the AX-4030, which performs objective measurements of chemical analytes. This type of study is typically used for imaging diagnostics where human readers interpret images, often with and without AI assistance, to assess diagnostic performance.

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

Yes, implicitly. The "Non-clinical verification and validation testing" described in the document as appearing in "Section 18" would constitute standalone performance testing of the device (its algorithms and hardware) without human intervention in the analysis process itself. The device is described as an "automated urine analyzer."

7. The Type of Ground Truth Used

The ground truth for an automated urinalysis system is typically established by:

• Reference Laboratory Methods: Gold standard chemical assays for each analyte (e.g., enzymatic methods for glucose, turbidimetric methods for protein).
• Gravimetric methods for specific gravity, etc.
• Microscopic examination for correlation with certain parameters (e.g., blood, leukocytes, though the AX-4030 measures these chemically).
• Predicate Device Comparison: Often, a key component of a 510(k) submission is demonstrating performance equivalent to a legally marketed predicate device.

The specific ground truth methods are not detailed in this summary but would be found in Section 18 of the original submission.

8. The Sample Size for the Training Set

Not specified. The 510(k) summary does not provide details about a training set, as this document focuses on the performance validation rather than the development of the algorithm itself. For a device that measures analytes using test strips, the "training" would primarily relate to calibration and ensuring the spectrophotometric readings accurately correlate with analyte concentrations, rather than machine learning training in the contemporary sense.

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

Not specified. As mentioned above, the concept of a "training set" with established ground truth is less directly applicable in the sense of a machine learning model for image interpretation. For a chemical analyzer, ground truth for calibration and initial validation would involve using precisely prepared calibrators, controls, and known concentration samples analyzed by reference methods.

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The ACON™ U120 Urine Analyzer is intended for use in conjunction with the ACON Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The ACON Urinalysis Reagent Strips are available in different combinations of the aforementioned analytes. The instrument is intended for professional, in vitro diagnostic use only. 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 U120 Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Without a urine analyzer, operators must visually compare the reagent areas of the strip to a color chart using the naked eye. Obviously, visual determination for urinalysis is a time consuming task and is prone to inaccuracy due to human misinterpretation and variable light sources. To minimize the variability associated with visual testing, the ACON U120 Urine Analyzer is specifically designed for improved accuracy and efficiency of urinalysis featuring data management and report generation capabilities.

The provided text describes the ACON™ U120 Urine Analyzer and its substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular numerical performance targets. The document focuses on demonstrating substantial equivalence to a predicate device (Bayer Clinitek Status Urine Chemistry Analyzer) through various tests, rather than establishing and meeting predefined performance metrics.

Therefore, many of the requested sections (Table of acceptance criteria and reported device performance, sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, training ground truth establishment) cannot be extracted from the given text.

Here's an analysis based on the information available:

Acceptance Criteria and Study Overview for ACON™ U120 Urine Analyzer

The provided document describes the ACON™ U120 Urine Analyzer and its comparison to a predicate device, the Bayer Clinitek Status Urine Chemistry Analyzer (K031947). The primary goal of the studies mentioned was to demonstrate "substantial equivalence" to the predicate device, rather than meeting a specific set of numerical acceptance criteria publicly disclosed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document.
The submission focuses on demonstrating substantial equivalence without detailing specific numerical performance acceptance criteria for each analyte. The "Discussion of Non-Clinical Tests Performed" and "Discussion of Clinical Tests Performed" sections indicate that various studies were conducted to show the device's performance is comparable to the predicate.

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

The document states: "Studies were conducted in-house and in clinical setting..." and "Clinical studies were conducted using the ACON U120 Urine Analyzer." However, specific sample sizes for clinical or test sets are not provided. The provenance of the data (country of origin, retrospective/prospective) is also not specified.

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

Not explicitly provided. The document mentions "inexperienced intended users" in the context of obtaining comparable testing results, but does not detail how ground truth for the test set was established or the number/qualifications of any experts involved.

4. Adjudication Method for the Test Set

Not described in the document.

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

No MRMC comparative effectiveness study is mentioned. The study compared the ACON U120 Urine Analyzer against the predicate device, with a focus on whether "inexperienced intended users were able to obtain comparable testing results." This suggests a device-to-device comparison rather than an AI-assisted human vs. human-alone study.

6. Standalone Performance Study

The clinical study described compares the ACON U120 Urine Analyzer directly with the Bayer Clinitek Status Urine Chemistry Analyzer. This implies a standalone performance comparison of the device against the predicate. The document states: "Study results indicate that the inexperienced intended users were able to obtain comparable testing results when using the ACON U120 Urine Analyzer and a legally marketed Bayer Clinitek Status Urine Chemistry Analyzer (K031947)."

7. Type of Ground Truth Used

The document implies that the predicate device's results (Bayer Clinitek Status Urine Chemistry Analyzer) served as the de facto "ground truth" or reference for establishing substantial equivalence. The goal was to show "comparable testing results." No mention of pathology, expert consensus (beyond the predicate), or outcomes data as "ground truth" is made.

8. Sample Size for the Training Set

Not applicable/Not provided. This device is a reflectance photometer, which measures the intensity and color of light reflecting from reagent areas on urinalysis strips. It is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning.

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

Not applicable/Not provided as this is not an AI/ML algorithm that uses a training set.

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