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AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples.

A trained operator can set criteria for flagging speciment analyte image decisions should be reviewed and reclassified as necessary by a trained technologist.

The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.

The AI-4510 System (AUTION EYE AI-4510) is a fully automated urine particle analyzer for in vitro diagnostic use that uses flow cell digital imaging technology in a clinical laboratory setting. Based on images captured in the flow method, the instrument automatically classifies the images of various formed elements. The AI-4510 System can quantitatively measure RBC, WBC, and SQEC; semi-quantitatively measure BACT, and CRYS; and qualitatively measure WBCC, NSE, HYAL, NHC, YST, MUCS and SPRM in urine samples. In addition, the AI-4510 System allows trained operators to manually review and reclassify all the element images collected by the system.

This document describes the validation of the AUTION EYE AI-4510 Urine Particle Analysis System. The device is intended for the quantitative, semi-quantitative, and qualitative measurement of various elements in urine samples. The validation primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (iQ200 Urine Analyzer).

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

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a single table for all performance measures. Instead, it states that "all results meeting the predefined acceptance criteria" for precision studies, and that "Quantitative, Semiquantitative and Qualitative parameters met the acceptance criteria" for the method comparison study. The reported performance is presented in various tables throughout the "Summary of Performance Data" section (5.6).

Here's an aggregated table derived from the provided performance data:

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

• Precision Studies:
  • Repeatability Study: Clinical urine samples were used.
    • Quantitative elements: Not explicitly stated, but "clinical urine samples in the evaluation of repeatability for all twelve (12) elements from low to high concentrations."
    • Semi-quantitative and Qualitative elements: n=10 replicates per test level (e.g., Level 1, 2, 3 etc.).
  • Within-Laboratory Precision Study: ARKRAY control materials prepared using clinical samples.
  • Reproducibility Study: Commercially available control materials and ARKRAY control materials prepared using clinical samples were used.
• Linearity Testing: Not specified for sample size beyond "one instrument."
• Limit of Detection: Not specified for sample size.
• Carryover Testing: High-level and low-level samples, aliquoted into 5 tubes each, measured in sequences (e.g., H1 L1 H2 L2 H3 L3 H4 L4 H5 L5, repeated 5 times).
• Interference Testing: Not specified for sample size beyond the substances tested.
• Sample Stability: Positive and negative samples for all 12 elements.
• Method Comparison:
  • Population for Reference Range results: n=247
  • Quantitative Elements (RBC, WBC, SQEC): n=377 (RBC), n=845 (WBC), n=382 (SQEC) for comparison between AI-4510 (M) and iQ200 (M).
  • Semi-quantitative & Qualitative Elements: n=1474 (CRYS, BACT, WBCC, MUCS, SPRM), n=765 (NSE, NHC, HYAL, YST).
  • Data Provenance: Clinical samples. The method comparison study was conducted at "three (3) CLIA-Moderate complexity laboratories." The document states samples were "collected fresh within two (2) hours or refrigerated up to six (6) hours post collection," implying a prospective collection directly for these studies. The country of origin is not explicitly stated, but the submission is for FDA clearance in the US, and the company and testing sites (CLIA labs) suggest operations relevant to the US market.

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

The ground truth for the method comparison study (especially for semi-quantitative and qualitative elements) appears to be established by comparison to the predicate device iQ200 (Manual) and Manual Microscopy.

• For the method comparison, it refers to "CLIA-trained operators" performing testing and "A trained operator can set criteria for flagging speciment analyte image decisions should be reviewed and reclassified as necessary by a trained technologist." This indicates that trained technologists or CLIA-trained operators (which implies suitable qualifications for laboratory testing) established the "ground truth" or reference values, either by manual microscopy or using the predicate device's manual review function.
• The document does not specify the exact number of individual experts or their specific qualifications (e.g., specific years of experience, board certification as pathologists or medical technologists). It only refers to "CLIA-trained operators" and "trained technologists."

4. Adjudication method for the test set

• The document states: "All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist." This implies a form of human override or adjudication post-AI classification.
• For the "Method Comparison" tables (14, 15, 16), most comparisons are listed as "AI-4510 (Manual) vs. iQ200 (Manual)" or "AI-4510 (Manual) vs. Manual Microscopy." The "(M)" denotes "manually reviewed and reclassified results." This indicates that the results from both the investigational device and the predicate device/manual microscopy were subjected to manual review/adjudication by trained human operators to establish the final classification used for comparison.
• The specific method of adjudication (e.g., 2+1, 3+1 consensus) among multiple readers for establishing the ground truth is not specified. The comparison is against already "manual" classifications from the predicate or direct manual microscopy, suggesting that the human reading itself serves as the reference, likely by one or more trained technologists.

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

• This document describes performance characteristics of the device itself, often compared to a predicate device or manual microscopy.
• It does not describe an MRMC comparative effectiveness study where the performance of human readers with AI assistance is directly compared to human readers without AI assistance to quantify improvement or effect size. The AI-4510 System is an automated analyzer with a manual review component, not an AI assistance tool for human interpretation of images outside of the system.

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

• The document mentions "The software processes the recorded images, automatically identifying and classifying the formed elements based on the sorting algorithm." (Section 5.5)
• However, the indications for use explicitly state: "A trained operator can set criteria for flagging specimens. All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist."
• Furthermore, the "Method Comparison" tables are predominantly listed as "AI-4510 (Manual) vs. iQ200 (Manual)" or "AI-4510 (Manual) vs. Manual Microscopy," where "(M)" denotes "manually reviewed and reclassified results."
• This strongly suggests that the reported performance data for clinical claims (method comparison) represents the combined human-in-the-loop performance after technologist review and reclassification, particularly for the semi-quantitative and qualitative elements.
• While the device has an "automatic classification" function (also mentioned in section 5.4 under "Automatic Classification"), the reported clinical performance data does not appear to be purely standalone (algorithm-only) without human intervention.
• Table 11 (Interference Effect on Auto-classified Results) hints at some testing of the auto-classified performance in specific scenarios (interference), but the bulk of the clinical validation on the main intended use appears to involve human review.

7. The type of ground truth used

The ground truth used for the method comparison study was established through:

• Comparison to the iQ200 System (Manual): This means the results obtained from the predicate device after its own manual review and reclassification process.
• Manual Microscopy: This is considered the traditional gold standard for urine particle analysis, established by trained technologists.

Therefore, the ground truth is a combination of expert consensus (implied via "trained technologist" review) and comparison to a legally marketed predicate device (also with human review), with manual microscopy serving as a reference.

8. The sample size for the training set

The document provided does not contain any information about the training set for the AI-4510 System's algorithm. This K submission focuses on device performance studies for validation and comparison to a predicate, not on the developmental aspects of the AI model.

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

As no information about the training set is provided, how its ground truth was established is also not available in this document.

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

c. Comparison with Predicate Devices

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

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

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

• Linearity/Assay Reportable Range:

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

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

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

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

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

• Comparison Studies with Predicate Devices (Clinical Samples):

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

The ground truth used in the studies includes:

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

8. The Sample Size for the Training Set

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

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

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

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

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

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

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The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device's kit includes a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.

The provided text describes the Minuteful-kidney test (K222921) and its substantial equivalence to a predicate device (K210069). However, it specifically states that "The rest of the analytical performance studies are still relevant for the modified version of the Minuteful - kidney test, and their summary is available in the predicate device documentation (K210069)." This means the detailed acceptance criteria and the comprehensive study demonstrating the device meets those criteria are not present in this document but are referenced as being in the predicate device's documentation.

Therefore, I can report on the studies performed for K222921 to assert its substantial equivalence, but I cannot provide a table of acceptance criteria and reported device performance from this document for the overall device functionality as those details are in K210069. Nor can I provide information regarding sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for K222921's overall performance since those are tied to the K210069 submission.

The studies described in K222921 (the current device) are focused on demonstrating that changes made to the device in K222921 do not negatively impact performance, thus maintaining substantial equivalence to its predicate.

Here's an analysis based solely on the provided text for K222921, noting the limitations:

Acceptance Criteria and Device Performance (Limited to K222921 changes):

Since the comprehensive performance data is referenced in K210069, the "acceptance criteria" discussed here are implicitly related to demonstrating that the modifications in K222921 (e.g., multilingual support, software enhancements) do not degrade the performance previously established for K210069. The studies conducted for K222921 focused on the robustness of the Image Validation Transfer System (IVTS) and the analytical limits of detection.

Study Details (for K222921 specific enhancements):

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

   • Limit of Detection (LoD): The document does not specify the sample size for the LoD study for K222921. It mentions the study was designed and executed according to CLSI document EP17-A2.
   • Illumination, Physical, Shadow, Blurriness, Misplaced Urine Stick, Dirty Color-Board Studies: The document refers to "Tested smartphones" and "different conditions," but specific numerical sample sizes (e.g., number of images, tests, or smartphones) are not provided. The data provenance is implied to be laboratory-controlled since these are experimental conditions, but no explicit country of origin or retrospective/prospective nature is stated for these new studies. The overall device is intended for home use, so these validations mimic adverse home conditions.

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

   • This information is not provided in the K222921 document. These types of analytical studies typically rely on reference methods or scientifically established standards rather than expert consensus. For the clinical performance, the document refers to the predicate device K210069, where such details would likely be found if applicable.

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

   • Not applicable/Not provided for these specific analytical studies. The assessment of whether performance was "not impacted" would likely come from statistical analysis against pre-defined thresholds.

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

   • No MRMC or comparative effectiveness study involving human readers with and without AI assistance is mentioned in the K222921 submission. This device is an in-vitro diagnostic home-use test system where the smartphone app performs the measurement, rather than assisting a human in interpreting diagnostic images. Thus, the concept of "human readers improve with AI" in a traditional MRMC sense does not directly apply to this device's function.

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

   • The core of the described studies (LoD, Illumination, Physical, Shadow, Blurriness, Misplaced Urine Stick, Dirty Color-Board) are indeed standalone performance tests of the device's algorithmic capability to accurately read the test strip under various challenging conditions encountered in a home setting. The device is described as having "image recognition algorithms" and performing "image analysis activities."

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

   • For the analytical studies described (LoD, Illumination, etc.), the ground truth would be based on controlled experimental conditions and potentially quantitative reference measurements (e.g., known concentrations for LoD, controlled lighting conditions). The document does not specify the exact methods for establishing this ground truth but implies scientific rigor (e.g., "in accordance with guidance provided by the Clinical and Laboratory Standards Institute (CLSI) document EP17-A2"). For the clinical performance aspects, the document refers to K210069.

7. The sample size for the training set:

   • Not provided in the K222921 document. Training set details would typically be part of the initial K210069 submission for the machine learning algorithms.

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

   • Not provided in the K222921 document. This information would be found in the K210069 submission, likely involving laboratory-controlled tests with known analyte concentrations and reference methods for accurate measurement.

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. Type of Ground Truth Used

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

8. Sample Size for the Training Set

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

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

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

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The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.

Here's a breakdown of the acceptance criteria and study information for the Healthy.io Minuteful - kidney test (K210069), based on the provided document:

Acceptance Criteria and Device Performance for Minuteful - kidney test (K210069)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies acceptance criteria by reporting performance results against the predicate device that demonstrate substantial equivalence.

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

• Sample Size: More than 450 subjects were recruited for the clinical trials.
• Data Provenance: The document does not explicitly state the country of origin. The study was a prospective clinical trial, as subjects were "recruited" and tasks were "completed" within the context of the study.

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

The ground truth was established by comparing the Minuteful - kidney test results to those obtained from a professional user performing the test on the URISCAN Optima Urine Analyzer (predicate device).

• Number of Experts: Not explicitly stated as a count of individual professionals, but referred to as "a professional user." It's implied that this
  professional operated the predicate device.
• Qualifications: "Professional user" suggests trained laboratory or healthcare personnel familiar with operating the URISCAN Optima Urine Analyzer and interpreting its results. Specific credentials (e.g., medical technologist, clinical laboratory scientist, years of experience) are not provided.

4. Adjudication Method for the Test Set

The adjudication method involved a 2-part comparison:

1. A lay user (subject in the clinical trial) performed the test using the Minuteful - kidney test app.
2. A professional user (operating the predicate device, URISCAN Optima Urine Analyzer) then performed the test on the same urine sample.

The professional user was blinded to the results of the lay user until after they had completed their test. This can be considered a form of adjudication where the predicate device's result, as read by a professional, serves as the comparison benchmark. There was no explicit multi-expert consensus or 2+1/3+1 method described for establishing a single "ground truth" independent of the comparison devices; rather, the predicate device's output was the reference.

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

No, an MRMC comparative effectiveness study was not explicitly done in the sense of comparing multiple human readers with and without AI assistance on the same cases. The study compared a lay user with the AI-powered device to a professional user with a predicate device. It was a method comparison study to show substantial equivalence, not a study evaluating human reader improvement with AI assistance.

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

The clinical performance study involved a lay user interacting with the smartphone application and performing the test steps guided by the app. While the app uses "image recognition algorithms" and "machine learning algorithmic components," it is not a purely standalone algorithm-only performance assessment in the sense of a laboratory-based algorithm evaluation without human interaction for image capture and strip preparation. However, the analytical performance testing (Precision, Interference, Limit of Detection, Linearity, Stability) would represent the closest to "standalone" algorithm performance testing, as these evaluate the device's technical capabilities in a controlled environment. The linearity study, showing 100% exact match for every level of albumin, creatinine, and ACR, is a strong indicator of the core algorithm's accuracy at different concentrations.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device (URISCAN Optima Urine Analyzer) operated by a professional user. This is a form of reference standard comparison where the predicate device's output serves as the truth.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set used for the device's algorithms.

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

The document does not provide information on how the ground truth was established for the training set of the device's algorithms. It only describes the ground truth for the clinical performance (test set) comparison.

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iQ200 System: The iQ200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ200 analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantative or qualitative counts of all formed sediments present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

iChemVELOCITY Automated Urine Chemistry System: 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 Chemietry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 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 nitrite, 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 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 iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostics use only.

The iQ200 System auto-identifies and processes specimens in 10-position racks by mixing. sampling, and analyzing automatically. The iQ200 Series Automated Urine Microscopy system presents a specimen sandwiched between enveloping layers of lamina to a microscope coupled to a CCD (charge coupling device) video camera. This lamination positions the specimen exactly within the depth of focus and field of view of the objective lens of the microscope. The iQ200 System provides automatic sample handling for automated intelligent microscopy and automatic analyte classification for improved data reporting, presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Individual particle images are isolated within each frame. The Auto-Particle Recognition (APR) software, uses size, shape, contrast and texture features to classify each image into one of 12 categories: RBCs, WBCs, WBC Clumps, Hyaline Casts, Unclassified Casts, Squamous Epithelial Cells, Non-squamous Epithelial Cells, Bacteria, Yeast, Crystals, Mucus and Sperm. Additionally, 27 predefined sub-classifications are available for identifying specific types of casts, crystals, non-squamous epithelial, dysmorphic, and others. Particle concentration is calculated using the number of particles images and the volume analyzed. User-defined release criteria are checked and results are sent to an operator review screen or directly uploaded to the LIS based on these criteria. Specimen results can be edited, imported, and exported.

The iQ Body Fluids Module is a software program that runs on the iQ Series Systems and automates body fluid sample handling, capturing particle images in a manner similar to that of the urinalysis application. The iQ200 Series System uses a CCD camera to capture images from each sample.

The iChemVELOCITY is an automated urine chemistry system performing measurements of defined physical and chemical constituents in urine. The system utilizes iChemVELOCITY urine chemistry test strips which are read in the Strip Reader Module (SRM) by measuring light reflectance. The device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVELOCITY Urine 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. 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.

The primary function of the iQ200 and iChemVELOCITY analyzers is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing, data storage, and external communications. The analyzers run embedded code on micro controllers and the workstation software runs Microsoft Windows 7 or Windows XP Operating System (OS). The workstation can be connected to: A printer for creating reports; A Laboratory Information System (LIS) for receiving test orders and releasing results.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Beckman Coulter iQ200 System and iChemVELOCITY Automated Urine Chemistry System.

Important Note: The provided document is a 510(k) Summary for a "Special 510(k)" submission. This type of submission is used when there are design modifications to a legally marketed device, and the modifications do not significantly alter the device's intended use or fundamental scientific technology. Therefore, the document focuses on demonstrating that the changes do not negatively impact the substantial equivalence to the original predicate device, rather than providing a full de novo performance study.

The primary change described is a software update (APUI software version 7.2) to address a duplicate specimen flagging issue and cybersecurity vulnerabilities.

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy for classification of urine sediment elements or chemistry analytes) for the iQ200 System or iChemVELOCITY Automated Urine Chemistry System, nor does it report new device performance metrics directly tied to the software update.

Instead, the submission states that: "These software design changes do not impact the intended use or performance claims of the iQ200 Automated Urine Microscopy and iChemVELOCITY Automated Urine Chemistry analyzers."

The "acceptance criteria" in this context are related to demonstrating that the software changes do not adversely affect the previously established performance of the predicate device.

The "reported device performance" from the original predicate device (K022774 for iQ200 and K101852 & K171083 for iChemVELOCITY) is implicitly upheld by the assertion that the new software does not change performance.

However, specific to the new software features (duplicate specimen flagging and cybersecurity), the following can be inferred as "acceptance criteria" and "reported performance":

• Flag specimens with duplicate IDs and same Medical Record Number.
• Flag specimens with duplicate IDs and different Medical Record Number.
• Allow user-configurable time window (12-72 hours) for duplicate detection.
• Hold results for operator review if a duplicate is flagged. | Duplicate Specimen Detection:
• Software generates "DUPLICATE SPECIMEN ID (SAME MEDICAL RECORD NUMBER)" flag if condition met.
• Software generates "DUPLICATE SPECIMEN ID (DIFFERENT MEDICAL RECORD NUMBER)" flag if condition met.
• APUI software uses a user-configurable time window from 12 to 72 hours (default 12 hours).
• Specimen result is held until operator review. |
  | Cybersecurity Vulnerability Mitigation (Windows XP):
• Address Bluekeep vulnerability.
• Address WannaCry vulnerability. | Cybersecurity Update (Windows XP):
• Vulnerability Assessment scan successfully performed.
• Penetration test successfully done; XP OS patched for most common Bluekeep and WannaCry viruses.
• Source code review successfully done, vulnerabilities triaged. |
  | Cybersecurity Vulnerability Mitigation (Windows 7):
• Not susceptible to Bluekeep.
• Not susceptible to WannaCry. | Cybersecurity Update (Windows 7):
• Does not have Bluekeep vulnerability (Remote Desktop Protocol ports closed).
• Not susceptible to WannaCry (firewall enabled, communication ports closed to external connections). |
  | Maintenance of Intended Use and Performance Claims:
• Software changes do not alter intended use.
• Software changes do not impact existing performance claims. | Maintenance of Intended Use and Performance Claims:
• "No change" to intended use for all listed predicate devices.
• "These software design changes do not impact the intended use or performance claims..." |

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

The document does not specify a "test set" in the traditional sense for evaluating the primary diagnostic performance of the device, as this is a software update to an already cleared device.

For the duplicate specimen detection feature, the document describes the functionality of the software (how it flags duplicates) but does not provide details of a specific test set (number of samples, etc.) used to validate this functionality. The validation would likely involve software testing to confirm correct flagging under various conditions (same ID/same MRN, same ID/different MRN, within/outside time window). Data provenance for such internal software testing is not provided.

For the cybersecurity updates, "Vulnerability Assessment scan" and "penetration test" were mentioned, but no sample size (e.g., number of systems tested) or data provenance (country of origin, retrospective/prospective) is specified. These are typically internal verification activities rather than clinical studies.

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

Not applicable in this context. This submission focuses on a software update to an already cleared device, and the changes are not related to the classification or diagnosis of specific analytes that would require expert ground truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission does not detail a clinical test set that required expert adjudication for ground truth.

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

No MRMC comparative effectiveness study was done. The device (iQ200 System) is an automated cell counter and the iChemVELOCITY is an automated urine chemistry system. The software update is on the Analytical Processing User Interface (APUI) and cybersecurity, not on a feature that directly assists human readers in interpretation where an "AI vs. human" comparison would be relevant. The iQ200 does produce particle images and allows human review and override, but the modifications described here do not pertain to that specific human-in-the-loop performance measurement.

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

While the iQ200 System has "Auto-Particle Recognition (APR) software" that classifies images into categories, the document for this specific 510(k) does not detail standalone performance testing for the current software version's classification algorithm. The original clearance for the predicate device would have established this. This submission mainly addresses the APUI (user interface) functionality and cybersecurity.

7. The Type of Ground Truth Used

For the software functionalities specifically mentioned (duplicate specimen flagging, cybersecurity), the ground truth would be based on:

• For Duplicate Specimen Flagging: The actual specimen IDs, Medical Record Numbers, and timestamps in a simulated or real system environment, and whether the software correctly identifies and flags duplicates based on its configured rules.
• For Cybersecurity: Known vulnerabilities (e.g., Bluekeep, WannaCry technical specifications) and standard cybersecurity testing methodologies to verify patch effectiveness.

For the underlying diagnostic performance of the iQ200 (urine sediment analysis) and iChemVELOCITY (urine chemistry), the ground truth for their original clearances would have been clinical reference methods, expert microscopy, and laboratory-confirmed results (pathology, etc.), but this is not detailed in this particular submission for the software update.

8. The Sample Size for the Training Set

Not applicable. This document describes a software update to an existing device, not the development of a new AI algorithm that would require a training set in the machine learning sense. The "Auto-Particle Recognition (APR) software" in the iQ200 system would have had a training set for its initial development and clearance, but details of that are not provided here, as this submission is for a modification.

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

Not applicable, as no new training set is described for this software update. For the original APR software (if it involves machine learning), ground truth would typically have been established by expert consensus or reference laboratory methods for classifying urine sediment particles.

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The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The ACR | LAB Urine Analysis Test System is intended for in-vitro diagnostic use by a healthcare professional in a point of care setting. These results may be used in conjunction with clinical evaluation as an aid in the diagnosis for kidney function.

The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The device is provided as a kit that is comprised of a canister of 100 FDA-cleared urine test strips (ACON Laboratories Inc. Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) K150330), 10 Color-Boards, and a User Manual. The ACR | LAB Urine Analysis Test System also consists of a smartphone application for use on iPhone 7 device (iOS 12), and an image recognition algorithm running on the Backend. The software component of the ACR | LAB consists of both an application (App) and a Backend server (Backend). The App instructs the professional user how to accurately perform the test. The App conducts a series of boundary condition analyses, and if the scan is approved, sends the information to the Backend for complete analysis and results classification. Once analyzed, the results are securely transmitted to a patient Electronic Medical Record for review by a healthcare professional. The patients do not have access to the results at any point during the testing process.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria are based on the agreement between the ACR | LAB Urine Analysis Test System and the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). The study aimed for high percentages of exact match and ±1 color block match.

| Metric (Agreement with Predicate Device) | Acceptance Criteria (Implicit from "high levels of accuracy") | Reported Device Performance (ACR | LAB) |
| :--------------------------------------- | :----------------------------------------------------------- | :-------------------------------------- |
| Albumin | High Exact Match % | 89% Exact Match |
| Albumin | High ±1 Color Block Match % | 100% ±1 Color Block Match |
| Creatinine | High Exact Match % | 84% Exact Match |
| Creatinine | High ±1 Color Block Match % | 100% ±1 Color Block Match |
| Albumin-Creatinine Ratio | High Exact Match % | 93% Exact Match |
| Albumin-Creatinine Ratio | High ±1 Color Block Match % | 100% ±1 Color Block Match |

Note: The document explicitly states that the primary acceptance criteria for the method comparison study were the percent of exact match and ±1 color block match. While specific numerical targets for "high levels of accuracy" are not given as explicit "acceptance criteria," the reported performance exceeding predicate device agreement in these metrics is implicit evidence of meeting those criteria.

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

• Sample Size:
  • Native Urine Samples: 375 subjects
  • Contrived Samples: 60 samples
  • Total Samples for Clinical Performance: 435 samples (375 native + 60 contrived)
• Data Provenance: The study evaluated native urine samples from 375 subjects as well as 60 contrived samples at three U.S. clinical sites. This indicates the data is prospective (newly collected for the study) and from the United States.

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

The document refers to the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer) as the "ground truth" or reference for comparison.

• Number of "Experts" (for ground truth): The ground truth was established by readings from the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). Two separate lab technicians measured each urine sample, one using the iPhone 7 device (ACR | LAB) and the second using the predicate device (U120 Ultra).
• Qualifications of "Experts": The document states "Two separate lab technicians were responsible for measuring each urine sample." Their specific qualifications (e.g., years of experience, certifications) are not explicitly mentioned, but they are identified as "lab technicians."

4. Adjudication Method for the Test Set

The adjudication method appears to be none in the traditional sense of multiple human experts reviewing and deciding. Instead, the study directly compared the results of the ACR | LAB device against the results obtained from the predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). Each sample was tested once by the ACR | LAB and once by the predicate device, and the agreement between these two measurements was assessed.

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

• Was an MRMC study done? No, a traditional MRMC comparative effectiveness study was not done. This study is focused on the performance of a clinical diagnostic device, where consistency with a reference device is key, rather than an AI-assisted interpretation by multiple human readers.
• Effect size of human readers improve with AI vs without AI assistance: This information is not applicable/not provided, as the study design was a direct comparison of the new device to a predicate device, not an assessment of human reader performance with and without AI assistance. The ACR | LAB system itself includes the smartphone app and image recognition algorithm as central components of its operation, so human interaction is inherent, but not a separate "with vs. without AI assistance" arm for human readers.

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

The device description indicates that the "ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips." It also mentions that "The App instructs the professional user how to accurately perform the test. The App conducts a series of boundary condition analyses, and if the scan is approved, sends the information to the Backend for complete analysis and results classification."

This suggests that the device does not operate purely standalone (algorithm-only without human-in-the-loop). A healthcare professional is involved in:
* Performing the physical test (dipping the strip).
* Operating the smartphone application.
* Placing the strip on the Color-Board for scanning.

The algorithm on the Backend performs the complete analysis and classification, but this is initiated and guided by the human user through the app. Therefore, it's a human-in-the-loop system, and no standalone algorithm-only performance is documented separately.

7. The Type of Ground Truth Used

The ground truth for the clinical performance study was established by comparison to a legally marketed predicate device (ACON Laboratories' Mission U120 Ultra Urine Analyzer). The aim was to demonstrate substantial equivalence, meaning the new device's results should align closely with those of the established predicate.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for the image recognition algorithm. It focuses on the validation studies.

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

The document does not explicitly describe how the ground truth for the training set was established. It broadly mentions the software validation and hazard analysis but doesn't detail the data labeling process for the algorithm's training. It is common for such systems to be trained on a large dataset of images with corresponding known (e.g., laboratory-confirmed) values for albumin and creatinine, but this specific information is not provided here.

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

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

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

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

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

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

The cobas u 601 analyzer consists of several major components:

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

The functions of the cobas u 601 urine analyzer include:

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

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

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

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

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

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

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

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

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

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

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

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

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

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:

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

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

3. Number of Experts and Qualifications for Ground Truth

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The 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 Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infections (UTI). It is intended for over-the-counter home use only.

The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The Scanostics UTI Check Application measures the colour developed in two reaction zones (leukocytes and nitrite pads) on the UTI test strip following application of a urine sample. The developed colors are then compared to calibration colours located on the Scanostics backing material and the result for each pad is determined based on the minimum colour distance between the developed colours and calibration colours.

The URS-2L UTI Test Strip comprises of two reagent pads areas, which are absorbent material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive.

The backing card comprises of thirty-two (32) calibration colour blocks and three (3) black and white alignment squares printed onto a rigid card stock and die cut to provide a groove for the strip (preventing strip misalignment). The use of the backing card is primarily to compensate for different lighting environments as it allows the calibration colours and the test strip to be subjected to the same conditions as the reagent pads for comparison - this would not be possible if the calibration colours were stored within the application itself.

The representative platform for the test system is the iPhone 6 with iOS 9. The application has been proven to be compatible on the iPhone 6S (iOS 9) and iPod touch (8th gen with iOS 8 and iOS 9). The application's core technology is based on four (4) patents held by Teco Diagnostics (US 8655009, 8877140, 8911679 and 8506901).

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Scanostics UTI Check Application Test System.

Please note: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the findings rather than presenting the full study report. Therefore, some information like specific statistical metrics for acceptance criteria and the exact number of participants in all study phases might not be explicitly detailed.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., sensitivity > X%, specificity > Y%). Instead, it indicates that the device should perform "comparably" to the predicate device in the hands of lay users and "satisfactorily" in non-clinical studies. The ultimate acceptance criterion implicitly relies on the demonstration of substantial equivalence to the legally marketed predicate device, Clinistrip (URS-10).

Study Details

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

   • Test Set Sample Size: Not explicitly stated for specific metrics like sensitivity/specificity studies. The "lay user studies were performed at three sites," suggesting a multicenter approach, but the number of participants or urine samples is not provided in detail.
   • Data Provenance: The document does not specify the country of origin of the data. It seems to be a prospective study, as it describes "lay user studies were performed," implying new data collection rather than retrospective analysis.

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

   • The document implies a comparison against "a trained HCP using the Clinistrip (URS-10)" as a reference for the lay user study. However, it does not specify the number of HCPs, their qualifications, or how a definitive "ground truth" was established for each sample (e.g., if a definitive culture result was also used). Given the nature of a 510(k) submission focusing on substantial equivalence, the "ground truth" for the test set often stems from the established predicate device's performance.

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

   • Not described in the provided text.

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 in the traditional sense was not performed. This device is an AI-powered reader for a diagnostic strip, intended for over-the-counter home use only by lay users. The comparison was between the lay user with the Scanostics app and a "trained HCP using the Clinistrip (URS-10)" (the predicate device). The focus is on enabling accurate interpretation by lay users, not improving expert reader performance.
   • Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in the context of this study design as presented.

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

   • The "Scanostics UTI Check Application test system" inherently involves the app (algorithm) reading the test strip. The "lay user studies" describe the performance when the human (lay user) operates the system. However, the non-clinical studies ("method comparison, precision, detection limit, interference, specificity, shelf life and stress studies as well as several flex studies") would largely assess the standalone performance of the algorithm's ability to read the strips under various controlled conditions, separate from a human's interpretation error. The document states these studies found the device performers "satisfactorily," implying the algorithm itself functions as intended.

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

   • The primary ground truth for comparison in the lay user study appears to be the results obtained by a "trained HCP using the Clinistrip (URS-10)" (the predicate device). For the non-clinical studies, the "ground truth" would likely be established through controlled laboratory testing with known concentrations for precision, detection limit, specificity, etc., but this is not explicitly detailed. It does not mention pathology or outcomes data as direct ground truth for this device's performance.

7. The sample size for the training set:

   • The document does not provide information about the sample size used for the training set of the Scanostics UTI Check Application's algorithm.

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

   • This information is not provided in the 510(k) summary. Training set ground truth would typically be established through expertly-read images of a large number of test strips, potentially correlated with laboratory-confirmed analyte concentrations, but these details are absent.

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