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

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

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

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

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

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

Acceptance Criteria and Device Performance

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

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

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

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

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

Table of Reported Device Performance

Study Details

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

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

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

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

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

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

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

   • No, a multi-reader, multi-case (MRMC) comparative effectiveness study as typically understood for AI-assisted diagnostic tools (i.e., human readers with and without AI assistance) was not explicitly performed or described in this document.
   • The studies focus on the performance characteristics of the device itself (the reagent strips) and its comparison to a predicate device, which is also a reagent strip for visual reading. The device's use is "visually read" by operators, but the study design is not one of AI assistance to human readers.

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

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

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

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

7. The sample size for the training set:

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone Performance Study

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

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

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The 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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