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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 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 DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose. Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite,

The DIP | U.S. Urine Analysis Test System is intended for prescription home-use only, with results provided directly to the physician. The results can be used to guide patient management and care, and aid in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function and endocrine disorders. Physician interpretation of the results should be made in conjunction with the patient's other clinical information to determine if further confirmatory tests or consultations are necessary. Patients do not have access to the results at any point in the process.

The DIP | U.S. Urine Analysis Test System consists of a smartphone application, a proprietary Color-Board, and Urinalysis Reagent Strips. It is intended for the semi-quantitative detection of the following analytes in urine: Glucose, Specific Gravity, Blood, pH and Protein, as well as the qualitative detection of Nitrite.

The DIP | U.S. Urine Analysis Test System is intended for prescription home-use only, with results provided directly to the physician. The results can be used to guide patient management and care, and aid in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function and endocrine disorders. Physician interpretation of the results should be made in conjunction with the patient's other clinical information to determine if further confirmatory tests or consultations are necessary. Patients do not have access to the results at any point in the process.

The device is provided as a kit that comprises a urine receptacle, an FDA-cleared urine test strip (ACON Mission Urinalysis Reagent Strips, 510K number K061559), a Color-Board, and a User Manual. The DIP | U.S. Urine Analysis Test System also consists of a smartphone application for use with a LG Nexus 5 device (running operating system Lollipop 5.0), and an image recognition algorithm running on the back-end.

The software component of the DIP | U.S. Urine Analysis Test System consists of both an application and a back-end server. The App instructs the patient how to accurately administer the test and conducts a number of algorithm processes. Once analyzed, the DIP | U.S. Urine Analysis Test System's software securely transmits the clinical results directly to the patient's Electronic Medical Records for review by the physician. As stated above, the patients do not have access to the results at any point during the testing process.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the Healthy.io DIP | U.S. Urine Analysis Test System.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the "percent exact match" and "±1 color block match" compared to the predicate device (ACON Mission U500 Urinalysis System). The exact numerical acceptance thresholds are not explicitly stated as strict percentages for all analytes, but the narrative implies "high-levels of accuracy" and specific target ranges are mentioned for certain analytes.

Additional Performance Metrics (from Analytical Performance Testing):

• Repeatability: 99.3% exact match
• Reproducibility: 98.5% exact match
• Linearity: At least 89.4% exact match and 100% ±1 color block accuracy.
• Illumination Study: 99.5% exact match
• Boundary Study: 99.5% exact match

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

Two method comparison studies were conducted for the test set:

• Study 1:

  • Sample Size: 429 subjects, 500 total samples (including spiked samples). Only 284 results from LG Nexus 5 smartphones were used for performance data.
  • Data Provenance: Two U.S. clinical sites. The studies involved lay-users in a simulated home-use environment. This indicates prospective data collection for the purpose of this validation.

• Study 2:

  • Sample Size: 250 subjects, 289 total samples (including spiked samples).
  • Data Provenance: One U.S.-based clinic. Similar to Study 1, this appears to be prospective data collection in a simulated home-use setting.

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

The ground truth for the comparison studies was established by "a laboratory professional using the predicate (ACON Mission U500 Urinalysis System)" measuring aliquots of the same samples. The specific number of laboratory professionals or their detailed qualifications (e.g., years of experience, specific certifications) are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The text describes comparing the DIP system's results to those from a laboratory professional using the predicate device. It does not mention any formal adjudication method (e.g., 2+1, 3+1 consensus) for discrepancies between the device and the predicate. The predicate device's readings appear to be treated as the reference standard (ground truth).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This was not a MRMC comparative effectiveness study in the typical sense of evaluating human reader improvement with AI assistance. The study evaluates the performance of the device itself as used by a lay-user, compared to a predicate device operated by a laboratory professional. There is no mention of human readers interpreting images with and without AI assistance to measure improvement.

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

The performance data presented, particularly the "Method Comparison Study," represents the device's performance with a human-in-the-loop (lay-user) interacting with the smartphone application and Color-Board. The device itself (including its image recognition algorithm on the back-end) performs the analysis of the test strip after the user interacts with it. The usability results (e.g., 99% success rate for lay users completing the test) address the human-in-the-loop aspect.

However, the "Analytical Performance Testing" (Precision, Interference, Limit of Detection, Linearity, Illumination, Boundary Studies) implicitly evaluates the algorithm's performance under controlled conditions with pre-determined reagent values or spiked samples, which can be seen as a form of standalone evaluation of the core analytical capability. For example, the Illumination Study and Boundary Study evaluate the device's (and thus the algorithm's) ability to measure accurately under varying external conditions. In these studies, the device measured against "predetermined reagent values," which serves as the ground truth for evaluating the algorithm's accuracy under those specific conditions.

7. The Type of Ground Truth Used

The primary ground truth used for the method comparison studies (clinical validation) was the readings obtained from the predicate device (ACON Mission U500 Urinalysis System) by a laboratory professional.

For the analytical performance studies (Precision, Interference, Limit of Detection, Linearity, Illumination, Boundary), the ground truth was based on validated spiked urine solutions at known concentrations or predetermined reagent values.

8. The Sample Size for the Training Set

The provided text does not explicitly state 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 text does not describe how the ground truth for the training set was established. It only mentions that the device includes an "image recognition algorithm running on the back-end." It is standard practice for such algorithms to be trained on large datasets with established ground truth, but the details of this process are not provided in this specific document.

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The inui In-Home Urine Analysis Test System consists of the inui In-Home Urine Analysis Device and the inui Urine Analysis Mobile Application. The inui In-Home Urine Analysis Test System is intended for detecting the following parameters in urine: Protein, Glucose, Leukocytes, Nitrites, and Ketones. The test results provide information regarding the status of Urinary Tract Infections (UT), proteinuria, glucosuria, and ketonuria. These results can be used as an aid for monitoring kidney functions and metabolic disorders (e.g. diabetes mellitus), and can be used in the screening for Urinary Tract Infections (UTI).

The inui In-Home Urine Analysis Device is intended for use as a prescription home use device.

The inui In-Home Urine Analysis Test System consists of inui In-Home Urine Analysis Device and the inui Urine Analysis Mobile Application. It is an in vitro diagnostic device comprised of a disposable test paddle, a urine collection cup, a gray background sheet, and a mobile application ("inui App"). The plastic "paddle" contains multiple chemistry test pads (CTPs) and 1 quick response (QR) barcode. CTPs contain pre-dried chemicals that react to specific substances in a urine sample. A color reaction occurs on the CTP based on the amount of substance in the urine sample. The color reaction is captured as an image using the mobile device camera and should only be read using the inui App. The results are reported as specified by the measurement range for each test. The QR Code is used for quality control purposes to track lot number, expiration date, and paddle use.

The inui In-Home Urine Analysis System reports semi-quantitative or qualitative results for each test parameters.

Here's a breakdown of the acceptance criteria and the study details for the inui In-Home Urine Analysis Test System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

General Acceptance Criteria from Analytical Performance:

• Precision and Reproducibility: Proportion of agreement for each level and analyte tested to be above 95% to the expected values.
• Limit of Detection (LOD) and Linearity: Established for each level and analyte.
• Specificity and Interference Testing: Identification of interfering substances and their minimum concentration levels causing false positives/negatives. The device should produce an error message for substances introducing colors outside the analyte's normal range.

Clinical Performance Acceptance Criteria:

• Clinical Accuracy (Method Comparison): Lay-user clinical test results should be comparable to those of professional users using the predicate device. Specific agreement percentages are implicitly set by the reported data in Table 5.
• Usability: Lay users should be able to follow procedural steps to obtain successful test results with a specified performance percentage.
• Lay-user Reproducibility: Lay-users should obtain the same results after repeated testing with a high reproducibility percentage.

1. Table of Acceptance Criteria and the Reported Device Performance

• Protein: Albumin (>3000 mg/dL), Bilirubin (>10 mg/dL), Hemoglobin (>100 mg/dL), Chlorhexidine (>40 mg/dL), Riboflavin (>5 mg/dL), Hypochlorite (>375 mg/dL), Specific Gravity (>1.025).
• Leukocyte: Human Leukocyte Esterase (>0.025 U/mL), Hemoglobin (>150 mg/dL), Albumin HSA (>3000 mg/dL), Bilirubin (>10 mg/dL), Sodium Chloride (>324 mg/dL), Hypochlorite (>375 mg/dL), Chlorhexidine (>60 mg/dL), Microbial Peroxidase (>0.65%), Riboflavin (>5 mg/dL), Sodium Acetate (>600 mg/dL), Sodium Bicarbonate (>630 mg/dL), Specific Gravity (>1.020), Urobilinogen (>4 mg/dL).
• Nitrite: Sodium Nitrite (>5 mg/dL), Human Hemoglobin (>100 mg/dL), Hypochlorite (>375 mg/dL), Human Leukocyte (>0.0375 U/mL), Urobilinogen (>4 mg/dl), Sodium Bicarbonate (>945mg/dl), Sodium Acetate (>900 mg/dL), Hypochlorite (>375 mg/dL), Sodium Nitrite (>7.5 mg/dL).
• Ketone: Lithium Acetoacetate (>40 mg/dL), Hypochlorite (>375 mg/dL), Sodium Nitrite (>7.5 mg/dL).
• Glucose: D-(+)-Glucose (>500 mg/dL), Hypochlorite (>375 mg/dL), Bilirubin (invalid results at all conc), Lithium Acetoacetate (>80 mg/dL), Sodium Chloride (>486 mg/dL). (Pages 8-9) |
  | Clinical Performance | | |
  | Method Comparison (Lay User vs. Predicate) | Lay user results comparable to professional users with predicate device; high agreement percentages. An explicit threshold for each analyte/level is implied by the successful submission. | Achieved; "clinical test results that are comparable to those of a professional users".
  Protein: Negative (83% exact, 100% within 1 block), Trace (75% exact, 100% within 1 block), Moderate (90% exact, 100% within 1 block), Large (100% exact, 100% within 1 block).
  Glucose: Negative (100% exact, 100% within 1 block), Low (74% exact, 100% within 1 block), Moderate to Large (100% exact, 100% within 1 block).
  Leukocyte: Negative (100% exact), Positive (97% exact).
  Nitrite: Negative (96% exact), Positive (100% exact).
  Ketone: Negative/Trace (99% exact, 100% within 1 block), Small (67% exact, 100% within 1 block), Moderate to Large (100% exact, 100% within 1 block). (Table 5, Page 10) |
  | Usability | Lay users can follow all procedural steps to obtain a successful test result, with a high overall performance percentage. | Achieved: Overall performance of 88.9% (1st paddle), 86.7% (2nd paddle), and 91.1% (3rd paddle). (Page 10) |
  | Lay-user Reproducibility | High reproducibility (e.g., 100%) for lay-user repeated testing. | Achieved: "reproducibility of the inui Device in the hands of the lay user was 100%." (Page 10) |

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

• Test Set Sample Size:
  • Clinical Accuracy (Method Comparison): Two studies were conducted using 190 and 91 lay users, respectively.
  • Usability Study: 45 lay users.
  • Lay-User Reproducibility Study: 10 lay users.
• Data Provenance: The document does not explicitly state the country of origin. It indicates that the clinical evaluation followed an "Investigational Review Board approved clinical protocol," suggesting prospective data collection.

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

• The ground truth for the clinical accuracy study was established by comparing lay-user results from the inui device to results obtained from the predicate device, Siemens Multistix® 10SG, "by professional users."
• The document does not specify the exact number of professional users or their specific qualifications (e.g., "radiologist with 10 years of experience"). It just refers to them as "professional users."

4. Adjudication Method for the Test Set

• The document describes a direct comparison method where lay-user results from the inui device are compared against results from the predicate device read by professional users.
• It does not mention an explicit adjudication method like "2+1" or "3+1" to resolve discrepancies between multiple professional readers or to establish a consensus ground truth beyond the professional reading of the predicate device. The professional reading of the predicate device serves as the reference.

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, an MRMC comparative effectiveness study involving AI assistance for human readers was not explicitly described.
• The study focuses on the standalone performance of the inui system (which incorporates an app for image capture and analysis) when used by lay-users, against a predicate device read by professional users.
• The system itself is the "AI assistance" in the sense that the mobile app performs the color analysis traditionally done visually. The comparison is between the inui system's performance by lay users and the predicate device's performance by professional users, not human readers with vs. without AI assistance.

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

• Yes, in spirit, the core of the inui device's performance is essentially standalone algorithm performance within the context of a "lay-user-in-the-loop" setting.
• The "inui App" performs the electronic color analysis via the mobile phone camera. The "lay user reproducibility study" and the "clinical accuracy study" demonstrate the device's (including the algorithm's) performance when operated by lay users. The comparison in the clinical accuracy study is effectively between the inui device's algorithm output (managed by lay users) and a predicate device's visual interpretation by professionals.

7. The Type of Ground Truth Used

• The ground truth for the clinical accuracy (method comparison) study was established by comparison to a legally marketed predicate device (Siemens Multistix® 10SG device) assessed by professional users. This is a form of "reference method" ground truth.
• For the analytical performance studies (Precision, LOD, Specificity), the ground truth was based on expected values and established protocols in accordance with CLSI guidelines.

8. The Sample Size for the Training Set

• The document is a 510(k) summary, which focuses on validation data. It does not provide information on the sample size for the training set used to develop the inui device's mobile application algorithm.

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

• The document does not provide details on how the ground truth for the training set was established, as it pertains to the development process of the device which is typically not included in a 510(k) summary.

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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 iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilingen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.

iChemVELOCITY strips are intended for use only with the iChem Velocity analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.

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

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, in addition the iChemVELOCITY measures color and clarity using light transmittance through Color/Clarity Module (CCM) and specific gravity using refractive index through Specific Gravity Module (SGM).

The subject of this submission is a design change to the Color/Clarity Module (CCM) of the Color/Clarity/Specific Gravity Module (CGM) subassembly of the iChemVELOCITY. The CCM measures the color and clarity of a urine sample using transmitted and scattered light, incident on a color sensor. An algorithm then converts the output of the different channels of the sensor into semi-quantitative colors. The CCM is being changed to replace end-of-life components (color sensor and scatter light source) and update the color detection algorithm.

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

Device: iChem®VELOCITY™ Automated Urine Chemistry System with redesigned Color/Clarity Module (CCM)

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

The document doesn't explicitly state "acceptance criteria" with numerical targets for the redesigned CCM. Instead, it aims to demonstrate substantial equivalence to the predicate device (iChemVELOCITY with the original CCM). Therefore, the reported performance is compared to the predicate's expected performance, with the implicit criterion being that the redesigned CCM performs at least as well as, or is in agreement with, the predicate.

Here's an interpretation of the performance data in the context of implied acceptance:

Detailed Performance Tables from the Document:

Method Comparison Results Summary (Page 8):

Precision Results Summary (Page 9):

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

• Sample Size: The "Precision Results Summary" table on page 9 indicates that for each color and clarity level category, 240 samples were tested.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that "Performance testing of the iChemVELOCITY with the redesigned CCM was conducted."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. The "Method Comparison" results compare the "Redesigned CCM" to a "Comparator." Given the context of a design change to an existing device, the "Comparator" likely refers to the predicate iChemVELOCITY device with the original CCM. The ground truth, in this case, would be the results generated by the predicate device, not necessarily external human experts.

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

The document does not mention any adjudication method, as the comparison is primarily machine-to-machine (redesigned CCM vs. predicate CCM).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated urine chemistry system, and the study focuses on the performance of the redesigned CCM against its predicate, not on human reader performance or AI assistance.

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

Yes, a standalone performance study was done. The entire study focuses on the performance of the automated iChemVELOCITY system with the redesigned CCM. There is no mention of human-in-the-loop performance evaluation for the color and clarity measurements. The device is intended "for clinical laboratory and in vitro diagnostic use only" and "is not intended for visual reading."

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

The primary ground truth for the performance study is the predicate device's performance. The study aims to show that the redesigned CCM produces results equivalent to the iChemVELOCITY with the original CCM, which was previously cleared.

8. The sample size for the training set

The document does not specify a separate training set size. The study describes a design change to existing hardware/software components, including an updated algorithm. It's possible that the "new firmware has been written and installed on the CCM's microprocessor... to update the CCM algorithm" implies some form of development/training, but the specifics and size are not provided in this regulatory summary.

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

Since no specific training set and its size are explicitly mentioned, the method for establishing its ground truth is also not described. If algorithm development involved training, the ground truth would likely have been established using reference methods during the design phase of the original or updated algorithm, but this is not detailed in the provided text. The document focuses on the verification that the redesigned component performs equivalently to the existing, cleared device.

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The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurements for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone in urine specimens. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:

• · AUTION ELEVEN model AE-4022 Urine Analyzer (device component)
• · AUTION Sticks 10EA Test Strips (reagent component)

The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurement for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The AUTION ELEVEN Semi-Automated Urinalysis System consists of AUTION ELEVEN model AE-4022 urine analyzer and AUTION Sticks 10EA test strips.

The AUTION sticks 10EA consist of a plastic strip containing 10 pads impregnated with chemicals specific for the determination of a particular analyte. The chemical reaction with the urine results in a color change which is measured by the AUTION ELEVEN AE-4022 device, resulting in a display and print out indicating analyte concentration. The AUTION ELEVEN technology provides fast results that can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

The semi-automated nature of the device requires the user to dip an AUTION Stick 10EA test strip into a patient urine specimen and place it on the instrument. The instrument processes the test strip, allowing 60 seconds for the chemical reactions to occur on the test strip reagent pads. After 60 seconds, the device measures the amount of reflectance generated from each reagent pad and converts the reflectance measurements to qualitative and semi-quantitative results for physician use.

Here's a breakdown of the acceptance criteria and study information for the AUTION ELEVEN Semi-Automated Urinalysis System, extracted from the provided text:

Acceptance Criteria and Device Performance

Precision Results

Note: The document states that "results from bench testing met pre-determined acceptance criteria and support a determination of substantial equivalence." However, the specific numerical acceptance criteria for "Exact match %" and "+/- 1 Color Block %" were not explicitly listed in the tables provided for precision. The reported device performance values are the results obtained from the study.

Method Comparison Results (Accuracy)

Note: Similar to precision, the document states "The overall conclusion from the clinical evaluation is that the results are acceptable and support a determination of substantial equivalence," implying the reported accuracy rates met their internal acceptance criteria. However, the specific numerical acceptance thresholds were not provided in these tables.

Detection Limits/Sensitivity Results

The acceptance criteria here are that the "Actual Concentration" for a given semi-quantitative rank should result in the device reporting that rank (or a higher rank) at a certain "Percent in Rank." These are implicitly the acceptance criteria for sensitivity. The table shows the "Actual Concentration" and the "Percent in Rank" achieved. For instance, for Glucose, the acceptance criterion for the 4+ rank might be that at 750 mg/dL, it should be in the 4+ rank at least 50% of the time (reported 87%).

Interfering Substances

The acceptance criteria are implicitly that the identified interferents cause a specific shift in color blocks as described (e.g., False negative (-2 to -3 color block change) for Glucose with Ascorbic acid). The study identifies what interference occurs and its magnitude, implying these findings were deemed acceptable within the context of device labeling.

Study Details

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

   • Precision Study:
     • Sample Size: Not a direct patient sample size. Three (3) levels of quality controls were used for each analyte.
     • Data Provenance: Not specified, but likely controlled laboratory conditions given the use of commercial controls and specified dilutions/spiking.
   • Method Comparison Study (Accuracy):
     • Sample Size: 8395 tests of individual analytes. The number of unique patient samples is not explicitly stated, but the note mentions "Each site collected urine patient samples from their clinical laboratory or obtained them from nearby hospitals."
     • Data Provenance: Clinical patient samples, collected and refrigerated within 2 hours of collection for up to 24 hours prior to testing. Country of origin is not specified, but the clinical sites suggest real-world data collection. The study is prospective in the sense that samples were collected for the purpose of this study.

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

   • Precision Study: Not applicable. Ground truth was established by the known concentrations of the quality control materials.
   • Method Comparison Study: Ground truth was established by comparison against "2 commercially available urinalysis predicates, 1 semi-automated urine analyzer was used for specific gravity comparison and one fully-automated urine analyzer was used to compare all the rest of the analytes." No human experts were explicitly mentioned for ground truth establishment for this comparison. The predicate devices served as the reference standard.

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

   • Not applicable for either the precision or method comparison studies as ground truth was established either by known control concentrations or by predicate device performance, not by human expert consensus requiring adjudication.

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 was not conducted. This device is an automated and semi-automated urinalysis system, and the studies focused on its analytical performance against predicate devices and known controls, not on human reader performance or AI assistance.

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

   • Yes, the performance characteristics studies (Precision, Method Comparison, Detection Limits, Interfering Substances) represent standalone (algorithm only) performance of the AUTION ELEVEN Semi-Automated Urinalysis System. While a human dips the strip, the measurement and interpretation of the color change are performed by the automated device's optical unit and algorithms. The system then provides qualitative and semi-quantitative results automatically.

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

   • Precision Study: Known concentrations of quality control materials.
   • Method Comparison Study: Comparison against established predicate urinalysis devices for each analyte.

7. The sample size for the training set:

   • No information about a "training set" is provided in the document. This type of device (urinalysis analyzer) is typically developed and validated using analytical samples (spiked, diluted, known concentrations) and clinical samples, rather than a machine learning "training set" in the conventional sense. The "Performance Characteristics" section details the validation of the device's measurement accuracy and precision.

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

   • Not applicable, as no training set was explicitly mentioned or described for this type of device validation.

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The Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

The Uritek TC-201 Urine Analyzer (TC-201) is a portable easy to use instrument which reads Teco Diagnostics' Urine Reagent (URS-10) Strips for testing in the clinical laboratory. The analyzer can determine the intensity of different colors on the reagent strip test area. It does this by irradiating the test area with light and detecting the reflectance of different wavelengths using photodiode. Results are calculated by a reflection rate which is a percentage of the total reflectance of the testing wavelength and are printed automatically. The Uritek TC-201 Urine Analyzer reports semi-quantitative assays for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. The analyzer features a display, internal printer, a serial computer interface and an electrical outlet. Communication between the operator and the analyzer is made through the display using the user interface touch screen on the front surface of the instrument. Reagent strip results are automatically displayed on the screen in one minute. A printed hardcopy can also be created either from the results screen or recalled from memory. The Urine Reagent Strips (URS-10) for Urinalysis are firm plastic strips to which ten different reagent pads are affixed. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. The Teco Urine Reagent (URS-10) Strips provide tests for the semi-quantitative determination of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine.

Here's a breakdown of the acceptance criteria and the study results for the Uritek TC-201 Urine Chemistry Test System, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criterion for most analytes in the precision studies (both in-house and Point-of-Care) was 100% agreement within ±1 color block. For the comparative studies, the acceptance criteria were also based on agreement within and outside of specified color blocks. For Specific Gravity, the acceptance criteria was +/- 0.005.

Here's a summary table combining the reported performance from various studies:

Note: "L1", "L2", "L3" refer to Level I (High), Level II (Low), and Level III (Negative/Trace) control solutions, respectively. "N" indicates the number of tests performed.

Additional Information:

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

• Precision Studies (In-house):
  • Within-Run: 180 strips per control level (20 strips x 3 strip lots x 1 day x 3operators/analyzers).
  • Run-to-Run: 120 strips per control level (3 strips x 2 runs x 10 days x 2 operators/analyzers/strip lots).
  • Data Provenance: In-house studies using commercially available urine control solutions. The country of origin of the data is not explicitly stated but implied to be from the manufacturer's facility.
• Precision Studies (Point-of-Care):
  • Sample Size: 40 tests per sample (duplicates per run, two runs per day for 10 days). Combined across 3 POC sites, the total for each control level (L1, L2, L3) was 120 (40 tests x 3 sites).
  • Data Provenance: Prospective, from three Point-of-Care (POC) sites: Clinica Medica Del Sagrado Corazon (Anaheim, CA), Clinica Medica San Miquel (Santa Ana, CA), and Artritis & Osteoporosis Center (Edinburg, TX). This data is from the USA.
• Method Comparison Study:
  • Sample Size: A total of 509 urine specimens. This comprised:
    • At least 115 unaltered patient samples per site from 3 POC sites (total > 345).
    • Additional contrived samples (10% of total samples).
    • 91 clinical samples from POC Site I and Site II.
    • A separate study at Site I with 26 patient urine samples prescreened at pH ≥ 8.0.
  • Data Provenance: Prospective, from three Point-of-Care (POC) sites in the USA. Samples were a mix of unaltered patient samples and contrived samples.

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

• Precision Studies: Ground truth was established by the expected ranges of commercially available urine control solutions (HYCOR Biomedical), which have known target analyte concentrations confirmed by their package inserts and certificates of analysis. No external human experts are explicitly mentioned for these studies beyond the internal operators.
• Method Comparison Study: The ground truth for the method comparison study was established by the predicate device, the Siemens Clinitek Status+ Urine Analyzer (using Clinitek Multistix 10 SG Strips). This is a comparison between two devices, not a comparison against a clinical expert consensus or pathology.
• Linearity/Assay Reportable Range: For pH, a pH meter was used to confirm results. For specific gravity, a clinical, handheld refractometer was used. These serve as the "ground truth" or reference methods for these specific parameters. Three operators performed these measurements.

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

• Adjudication Method: Not explicitly described in the provided text for most studies. The precision studies rely on the expected values of control solutions. The method comparison study compares the Uritek TC-201 directly against the predicate device; discrepancies are noted but a formal multi-expert adjudication process is not detailed. For the precision studies, results were considered "within the expected results +/- one color block"; however, the process for resolving disagreements or establishing a definitive ground truth in cases of initial disagreement is not specified beyond relying on the control solution's stated values.

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 a clinical chemistry test system for urine analysis, which is an automated instrument reading reagent strips. It is not an AI-assisted diagnostic imaging or human-in-the-loop system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• The Uritek TC-201 Urine Analyzer is described as an automated, bench top instrument that "reads Teco Diagnostics' Urine Reagent (URS-10) Strips". It operates by "irradiating the test area with light and detecting the reflectance of different wavelengths using photodiode" and "Results are calculated by a reflection rate... and are printed automatically." This indicates that the device operates in a standalone (algorithm only) manner for interpreting the reagent strips. Human involvement is primarily in sample preparation and loading, and interpreting the printed results.

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

• Precision Studies: Ground truth was established by the expected ranges of commercially available urine control solutions with confirmed analyte concentrations.
• Linearity/Assay Reportable Range Study: For pH, a pH meter was the ground truth. For Specific Gravity, a clinical, handheld refractometer was the ground truth.
• Method Comparison Study: The ground truth was the predicate device's measurements (Siemens Clinitek Status+ Urine Analyzer).

8. The sample size for the training set:

• The document describes performance testing for a diagnostic device, not the development or training of a machine learning model. Therefore, a "training set" in the context of AI/ML is not applicable here. The studies described are for verification and validation of the device's analytical performance against established standards and a predicate device.

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

• As mentioned above, there is no "training set" in the context of AI/ML for this device. The ground truth for the various performance studies (precision, linearity, method comparison) was established using commercially available control solutions with known values, reference instruments (pH meter, refractometer), and comparison to a legally marketed predicate device.

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The TC-Thunderbolt Automated Urine Analyzer System is an in vitto diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with TC-Thunderbolt Automated Urine Analyzer System, they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for Point of Care Use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

The proposed device is an automated urine chemistry analyzer system intended for use only with TC-Thunderbolt URS-10 strips for the measurement of ten urine chemistry analytes from the chemistry strip. The system consists of the TC-Thunderbolt Automated Urine Analyzer and the TC-Thunderbolt URS-10 strips.

This document describes the performance of the TC-Thunderbolt Automated Urine Analyzer System, an in vitro diagnostic device for semi-quantitative analysis of urine chemistry. The studies presented focus on the analytical performance of the device and its associated test strips (TC-Thunderbolt URS-10 strips) rather than human-in-the-loop performance with an AI. Therefore, sections related to human reader improvement with AI assistance (MRMC studies) and expert consensus in the typical sense for AI model ground truth are not directly applicable to this type of device submission.

Here's a breakdown of the requested information based on the provided text, focusing on the device's analytical performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the results of the precision and method comparison studies, generally aiming for high agreement with either the expected control values or a predicate device. The tables below summarize the reported device performance for selected analytes from the precision (within-run and run-to-run) and method comparison studies.

Precision Study Acceptance Criteria & Performance (Within-Run & Run-to-Run for Urine Controls):

The acceptance criteria for precision studies are generally for high exact match agreement and 100% agreement within +/- one color block.

Method Comparison Study Acceptance Criteria & Performance (vs. Predicate Device):

The acceptance criteria for method comparison studies are generally for high overall agreement, with a specific note for SG.

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

Precision Study (Test Set):
For Within Run precision: 60 strips per control level (20 replicates x 1 day x 3 operators/strip lots) were tested. There were 3 control levels (I, II, III).
For Run to Run precision: 60 strips per control level (2 replicates x 2 runs x 5 days x 3 operators/strip lots) were tested. There were 3 control levels (I, II, III).
Data Provenance: Not explicitly stated for all samples, but the "Method Comparison Study Summary" states: "This comparison study testing was performed at Teco Diagnostics, Anaheim CA in United States." It also mentions "The urine samples for analysis in these method comparison studies were provided by external clinical sites." This implies a prospective data collection for the method comparison, and likely also for the precision studies, as real-time control solutions were used.

Method Comparison Study (Test Set):
A total of 487 urine samples were used for the method comparison study.
Data Provenance: The study was performed at Teco Diagnostics, Anaheim, CA, United States. Samples were collected from external clinical sites. These could be considered a mix of retrospective and prospective, as some samples might have been collected specifically for the study (prospective), and others could have been existing samples (retrospective), but the description implies a prospective approach to sample collection and testing for the study. Spiked samples were also prepared.

Sensitivity/Cutoff Point Determination Study & Linearity Study (Test Set):
For Sensitivity: 21 data points for each level (7 strips x 3 operators/strip lots). This study used spiked urine samples.
For Linearity: 21 measurements for every sample tested (7 strips x 3 operators/strip lots). This study used negative urine and spiked negative urine.
Data Provenance: Performed at Teco Diagnostics, Anaheim, CA, United States. Samples were negative urine, with many spiked to achieve various concentrations.

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

For this type of in vitro diagnostic device, "ground truth" is typically established by:

• Reference materials/control solutions: For precision studies, commercially available urine control solutions with confirmed target analyte concentrations were used.
• Comparative method (Predicate Device or Reference Method): For method comparison, the predicate device (Uritek-720+ Urine Analyzer) served as the comparative method against which the new device's performance was evaluated.
• Known concentrations: For sensitivity and linearity studies, samples were prepared by spiking known concentrations of analytes into negative urine. For pH, a pH meter confirmed results, and for Specific Gravity, a clinical, handheld refractometer confirmed values.

Therefore, the ground truth is established by analytical reference methods and known chemical concentrations, rather than human expert reads of images. There is no mention of human experts establishing ground truth in the context of image interpretation or reading. The studies mentioned involve operators performing tests, but their role is to execute the protocol and collect data, not to adjudicate ground truth. The number of operators (3) is mentioned for precision and sensitivity/linearity studies, indicating consistency checks across different users of the device.

4. Adjudication Method for the Test Set

Adjudication as typically understood in the context of human reader disagreement for AI models is not directly applicable here. The "ground truth" for these analytical tests is based on the known concentrations of controls, the results from a predicate device, or measurements by reference instruments (pH meter, refractometer). Discrepancies in device readings are analyzed as agreement percentages (exact match and +/- color block) against these pre-established analytical references, rather than being arbitrated by human experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This submission is for an automated in vitro diagnostic device (urine analyzer) that produces semi-quantitative results by measuring chemical reactions on test strips. It is not an AI-assisted diagnostic imaging device that involves human readers interpreting images. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

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

Yes, the studies are essentially standalone performance evaluations of the automated device (TC-Thunderbolt Automated Urine Analyzer System). While operators conduct the tests, the output is generated by the instrument's sensing and processing of the chemical reactions on the strips. The tables presented show the performance of the device itself (e.g., % agreement with controls or predicate device), representing its standalone analytical capability.

7. The Type of Ground Truth Used

The types of ground truth used are:

• Defined Control Solutions/Reference Materials: For precision studies, commercially available urine control solutions with certified analyte concentrations were used.
• Predicate Device Gold Standard: For method comparison, the Uritek-720+ Urine Analyzer (the predicate device) served as the reference against which the new device was compared.
• Known Chemical Concentrations: For sensitivity/cutoff point determination and linearity studies, samples were prepared by spiking urine with precise, known concentrations of analytes.
• Reference Instruments: For pH, a pH meter was used as the ground truth. For specific gravity, a clinical, handheld refractometer was used as the ground truth.

8. The Sample Size for the Training Set

This document only describes analytical performance studies for a medical device submitted for 510(k) clearance, which demonstrates substantial equivalence to a predicate device. It does not provide information about a "training set" in the context of machine learning. The device's operation is based on established chemical principles and optical measurement, not on a machine learning model that requires a "training set."

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

Since there is no mention of a machine learning model or a "training set" in the context of AI development, this question is not applicable. The device relies on chemical reactions and optical measurement, for which the underlying scientific principles and performance are validated through the analytical studies described.

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