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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 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 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 B-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips.

The FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (8-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use).

Glucose and {}-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System includes the FORA ADVANCED GD40 Meter, analyte-specific test strips (FORA ADVANCED GD40 Blood Glucose Test Strips, FORA ADVANCED GD40 Blood Cholesterol Test Strips, and FORA ADVANCED GD40 Blood Ketone Test Strips) and control solutions (FORA Glucose Control Solutions, B-Ketone Control Solutions and Total Cholesterol Control Solutions).

The glucose/9-ketone test strips and control solutions utilized in the FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System are the same as the predicate, FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System (K161738).

The provided text describes the FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System, a device for measuring glucose, beta-hydroxybutyrate (β-ketone), and cholesterol in fresh capillary whole blood. It is a 510(k) summary, therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical study for a novel device.

Based on the provided information, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets these criteria:

Key Takeaway: The document primarily focuses on non-clinical and clinical "studies" to demonstrate performance characteristics and compare them to predicate devices, rather than a single, large-scale comparative effectiveness study with human readers (MRMC). The "acceptance criteria" are implied by the performance characteristics tested and similarity to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in a table within the provided text. Instead, the document discusses "performance criteria were met" and that the device "met design specifications and requirements." The "acceptance criteria" are implied by meeting the established ranges and performance levels comparable to the predicate devices.

However, the "performance" is reported through the summary of testing. Since this is a 510(k) submission, the primary "performance" shown is that the device is substantially equivalent to the predicate devices. The listed similarities and differences in characteristics serve as the de facto "reported device performance."

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MTM301 Blood Glucose and Ketone Monitoring System: MTM301 Blood Glucose and Ketone Monitoring System is comprised of the MTM301 Blood Glucose and Ketone Meter, the MTM301 Blood Glucose Test Strips, and the MTM301 Blood Ketone test strips.

The MTM301 Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

The MTM301 Blood Glucose and Ketone Monitoring System consists of the MTM301 Blood Glucose and Ketone Meter, MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution (Level 1, Level 2), and MTM301 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MTM301 Blood Glucose test strips, MTM301 Blood Ketone test strips, MTM301 Glucose Control Solution, and MTM301 ketone control solution are purchased separately.
The glucose test strips utilized in the MTM301 Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips previously cleared in K170267 ; The ketone test strips are the same as the KET-1 Blood Ketone test strips, previously cleared in K182593.

Here's a summary of the acceptance criteria and study information for the MTM301 Blood Glucose and Ketone Monitoring System, based on the provided FDA 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., specific accuracy percentages for glucose ranges). Instead, it states that "Results demonstrate substantial equivalence to the predicate system" for various tests. The predicate system is the Nova Max Plus Blood Glucose and β-Ketone Monitoring System (K091547).

However, the "Non-Clinical Testing" and "Clinical Testing" sections indicate the types of studies performed to demonstrate this substantial equivalence.

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

The document does not explicitly state the numerical sample size for the test set used in the accuracy studies (clinical testing) or for the individual non-clinical tests.

• Data Provenance: The submitter is Apex Biotechnology Corp. in Hsinchu, Taiwan. The document does not explicitly state the country of origin of the clinical data or whether it was retrospective or prospective, but clinical studies are generally prospective for device clearance.

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

This information is not provided in the document. For glucose and ketone monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) performed by trained laboratory personnel, rather than experts in the sense of radiologists.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This is not applicable. The MTM301 Blood Glucose and Ketone Monitoring System is a self-testing in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

Yes, the device operates as a standalone system. The clinical accuracy studies evaluate the algorithm's performance in measuring glucose and ketone in capillary whole blood. The system is intended for "self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home," indicating its standalone operational nature without professional human interpretation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used, but for blood glucose and ketone monitoring systems, the ground truth is typically established using laboratory reference methods (e.g., a YSI analyzer for glucose, or a high-performance liquid chromatography (HPLC) method for ketones) on venous blood samples, against which the capillary blood measurements from the device are compared. This constitutes a highly accurate, quantitative ground truth.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" sample size. For in vitro diagnostic devices like blood glucose meters, the development process typically involves internal calibration, optimization, and verification using various samples, but these are not usually referred to as a "training set" in the same way as machine learning models. The "clinical testing" described would be more analogous to an independent "test set" for performance evaluation.

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

As noted above, the document does not refer to a "training set" in the context of establishing ground truth for machine learning. The ground truth for development and testing would generally follow standard laboratory reference methods.

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MultiSure GK Link Blood Glucose and Ketone Monitoring System is comprised of the MultiSure GK Blood Glucose and Ketone Meter, the MultiSure GK Blood Glucose Test Strips, and the MultiSure GK Blood Ketone test strips.

The MultiSure GK Link Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood drawn from fingertips. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

The MultiSure GK Link Blood Glucose and Ketone Monitoring System consists of the MultiSure GK Link Blood Glucose and Ketone Meter, MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution (Level 1, Level 2 and Level 3), and KET-1 ketone control solution (Level 1 and Level 2). The system is for self-testing of blood glucose and blood ketone. The MultiSure GK Blood Glucose test strips, MultiSure GK Blood Ketone test strips, Contrex Plus 4 Glucose Control Solution, and KET-1 ketone control solution are purchased separately.
MultiSure GK Link Blood Glucose and Ketone Monitoring System enables automatic transmission of stored data to a data management system using upload data via USB cable (optional), or mobile device with Bluetooth when the meter and data management systems are properly configured.
The glucose test strips and glucose control solution utilized in the MultiSure GK Link Blood Glucose and Ketone Monitoring System are the same as the BGM009 glucose test strips and Contrex Plus 4 Glucose Control Solution, previously cleared in K170267; The ketone test strips and ketone control solution are the same as the KET-1 Blood Ketone test strips and KET-1 ketone control solution, previously cleared in K182593.

Here's an analysis of the provided text, extracting information related to acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides information on the accuracy studies for both glucose and ketone measurements. The acceptance criteria for these are described in the device's previous clearances (K170267 for glucose and K182593 for ketone). While the exact numerical acceptance criteria are not explicitly stated within this specific 510(k) summary for this device (K201880), it notes that the systems used are the same as previously cleared products, implying they meet the previously established criteria. The reported performance is that the "Results demonstrate substantial equivalence to the predicate system."

Given the information available, a table would look like this:

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size for the "accuracy studies for glucose and ketone" or the "evaluation of ease of use." It only mentions that these studies were "conducted with home users."
• Data Provenance: Not specified within this document. The submitter is from Hsinchu, Taiwan, but the location where the clinical studies were performed is not mentioned. It is prospective, as it involves human participants (home users) in a clinical study.

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

This document does not specify the number or qualifications of experts used to establish the ground truth for the test set. For blood glucose and ketone monitoring systems, ground truth is typically established by comparative measurements against a laboratory reference method, not necessarily by expert consensus in the way a diagnostic imaging study might.

4. Adjudication Method for the Test Set:

Not applicable or specified. For glucose and ketone measurements, adjudication methods (like 2+1, 3+1) are typically used for qualitative or imaging-based assessments where human interpretation is involved. For quantitative measurements against a reference standard, direct comparison is the method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of human readers, often comparing performance with and without AI assistance, particularly in imaging diagnostics. This device is a quantitative blood analyzer for self-testing, so this type of study is not relevant.

6. Standalone Performance (Algorithm Only Without Human-in-the-loop Performance):

Yes, a standalone performance study was done for the device itself. The "accuracy studies for glucose and ketone" assess the performance of the device (meter and test strips) in measuring blood glucose and ketone levels. While performed by "home users," the focus is on the device's ability to provide accurate readings, not on human interpretation of those readings.

7. Type of Ground Truth Used:

For the "accuracy studies for glucose and ketone," the ground truth would typically be established by a laboratory reference method. This is standard for quantitative diagnostic devices like blood glucose and ketone meters, where the device's readings are compared against a highly accurate and precise laboratory analyzer. The document states "accuracy studies," which implies comparison to a gold standard.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. This is often not explicitly detailed for diagnostic devices that rely on established electrochemical biosensor technology, as opposed to devices employing complex machine learning or AI models that require extensive "training" data. The technology itself (Glucose Oxidase for glucose, $\beta$-hydroxybutyrate dehydrogenase for ketone) is well-understood and the "training" would have been part of the initial development and calibration of the test strips and meter, not necessarily a distinct "training set" in the context of AI/ML.

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

As with point 8, the concept of a "training set" and its associated ground truth establishment isn't directly applicable in the same way for this type of device as it would be for an AI/ML diagnostic. The ground truth for the development and calibration of the technology would have been established through rigorous laboratory testing using reference methods and known concentrations of glucose and ketone.

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The KetoSens BT Blood ß-Ketone Monitoring System is intended for the quantitative measurement of 0-Ketone (betahydroxybutyrate) level in capillary whole blood drawn from the fingertip. The KetoSens BT Blood β-Ketone Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of ketoacidosis control. The system is not intended for use in the diagnosis of or screening for ketoacidosis and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.

The KetoSens Blood 0-Ketone Test Strips work with the KetoSens BT Blood 0-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the finger.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert involvement. The document primarily consists of an FDA 510(k) clearance letter for the KetoSens BT Blood $\beta$ -Ketone Monitoring System, outlining its indications for use and regulatory compliance. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information.

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VivaChek™ Blood Glucose and ß-Ketone Monitoring System is comprised of the VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Ino Blood Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips (VKS01).

The VivaChek™ Blood Glucose and ß-Ketone Monitoring System is intended to quantitatively measure the glucose concentration and/or (beta-hydroxybutyrate) concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.

VivaChek™ Blood Glucose and β-Ketone Monitoring System (Model: VGM200) is designed to quantitatively measure the glucose and/or ß-ketone concentration respectively in fresh capillary whole blood samples drawn from the fingertips.

The test principle of the ß-ketone is based on the amperometric detection of ß-hydroxybutyrate (also known as 3-hydroxybutyrate) in whole blood. β-hydroxybutyrate is converted by the enzyme ß-hydroxybutyrate dehydrogenase to acetoacetate. The magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of ß-hydroxybutyrate present in the sample.

VivaChek™ Blood Glucose and ß-Ketone Monitoring System (Model: VGM200) contains Bluetooth Low Energy (BLE), it complies with US federal quidelines, Part 15 of the FCC Rules for devices with RF capability.

Here's a breakdown of the acceptance criteria and study information for the VivaChek™ Blood Glucose and ß-Ketone Monitoring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list acceptance criteria values for most studies, but rather states that the studies "Pass" or "were acceptable." For the performance characteristics, it focuses on demonstrating equivalence to the predicate device. For the clinical study, the acceptance criteria were based on participants' ability to obtain readings and satisfaction with ease of operation and overall performance.

For the B-Ketone performance studies, generally, the acceptance criteria for a blood ketone monitoring system would align with ISO 15197 or similar guidelines, requiring a certain percentage of results to fall within defined accuracy ranges when compared to a reference method (e.g., laboratory analyzer). While not explicitly stated with numerical targets, the "Pass" conclusion for studies like Linearity, Precision, and Interfering Agents implies adherence to such generally accepted analytical performance standards.

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

The document does not explicitly state the sample sizes for the individual non-clinical (laboratory) studies. For the User Evaluation (clinical study), it refers to "participated lay persons" without specifying the exact number.

The provenance of the data is not mentioned in terms of country of origin. The studies are described as "non-clinical (laboratory) studies" and a "clinical (user evaluation) study," indicating they are likely prospective experiments conducted specifically for this submission.

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

This information is not provided in the document. For analytical devices like this, ground truth for accuracy studies (e.g., Linearity, Precision) would typically be established by a reference laboratory method using highly accurate and calibrated instruments, not necessarily by experts in the sense of human interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given the nature of a quantitative measurement device, the comparison would typically be against a reference method, rather than requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices that involve human interpretation of images or other subjective data, which is not the case for a blood ketone and glucose monitoring system.

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

Yes, the analytical and performance studies listed (e.g., Linearity, Precision, Hematocrit Effect, Interference) represent standalone (algorithm only) performance of the device without human-in-the-loop interpretation beyond operating the device. The device provides a quantitative numerical output directly. The "User Evaluation" did involve humans, but primarily to assess their ability to use the device and obtain a reading, not to interpret the reading itself.

7. The Type of Ground Truth Used

For the analytical performance studies (e.g., Linearity, Precision, Hematocrit, Interference), the ground truth would typically be established by a reference laboratory method or highly accurate comparative instrument. The document refers to "corresponding study protocols," which would detail these reference methods, but the specific methods are not described in this summary.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This device is not described as using machine learning or AI that would require a distinct training set in the conventional sense. Its performance is based on established electrochemical principles.

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

As no training set is mentioned or implied for an AI/ML context, this information is not applicable.

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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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KET-1 System: The KET-1 Blood Ketone Monitoring System is intended to quantitatively measure $\beta$ -hydroxybutyrate ( $\beta$ -ketone) in fresh capillary whole blood from fingertips. It should only be used by a single patient and it should not be shared. Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control programs. It is not to be used for diagnosis or screening of diabetes, or for neonatal use. The KET-1 Blood Ketone Monitoring System is comprised of the KET-1 Blood Ketone Meter and KET-1 Blood Ketone Test Strip.

The KET-1 Blood Ketone Monitoring System consists of the KET-1 Blood Ketone Meter, KET-1 Blood Ketone Test Strips, and KET-1 Ketone Control Solutions (Level 1 and Level 2). The system is for self-testing of blood ketone. The KET-1 Blood Ketone Test Strips and KET-1 Ketone Control Solutions are purchased separately.

This document describes the regulatory approval of the KET-1 Blood Ketone Monitoring System. The provided text is a 510(k) summary, which outlines the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

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

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

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics. Instead, it describes general categories of testing and concludes that the device demonstrates substantial equivalence. For quantitative tests like accuracy, it states that "results demonstrate substantial equivalence to the predicate system" without providing specific numbers or ranges for the acceptance criteria.

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

• Sample Size for Test Set: The document mentions an "accuracy study" conducted with "home users using finger capillary whole blood." However, it does not specify the sample size (number of participants or samples) used for this accuracy study or any other mentioned tests (e.g., precision, repeatability, linearity).
• Data Provenance: The device manufacturer is Apex Biotechnology Corp. located in Hsinchu, Taiwan. The location of the clinical study (accuracy study) is not explicitly stated, but it is reasonable to infer it would be in Taiwan or a region where the manufacturer operates or has a testing facility. The data provenance is retrospective in the sense that the studies were completed before the 510(k) submission for regulatory review. However, the accuracy study itself was likely conducted prospectively (data collected specifically for the study) from the home users.

3. 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 document. For a blood ketone monitoring system, ground truth would typically be established by a reference laboratory method (e.g., gas chromatography-mass spectrometry or a highly accurate clinical chemistry analyzer) rather than expert human interpretation of images. The document does not specify details of the ground truth method or the personnel involved.

4. Adjudication method for the test set

This information is not applicable in the context of a blood ketone monitoring system, as it measures a quantitative analyte. Adjudication methods (e.g., 2+1, 3+1) are typically used for qualitative or diagnostic imaging studies where human experts interpret results and disagreements need to be resolved. For a quantitative measurement, the "ground truth" (reference method result) is directly compared to the device's measurement.

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

An MRMC study is not applicable to this device. This type of study is relevant for AI-powered diagnostic imaging devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The KET-1 Blood Ketone Monitoring System is a quantitative point-of-care device that measures a chemical analyte and does not involve human interpretation of complex images or AI assistance for human readers.

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

The KET-1 Blood Ketone Monitoring System is a standalone device in the sense that it provides a direct quantitative measurement of β-ketone. Its "performance" is its accuracy and precision in measuring blood ketone levels compared to a reference method, rather than a diagnostic algorithm that processes complex data for human review. The documented testing (accuracy, precision, linearity) essentially assesses the standalone performance of the device.

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

The document implies that the ground truth for the accuracy study was established by a reference method, as is standard for quantitative diagnostic devices. While not explicitly stated, clinical chemistry analyzers or other highly accurate laboratory methods would be used to obtain the "true" β-ketone values against which the KET-1 system's results are compared. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

The document does not provide any information about a training set. This is likely because the KET-1 Blood Ketone Monitoring System is a pre-calibrated electrochemical device, not an AI/machine learning model that typically requires a large training dataset. The "training" of such a device usually refers to the internal calibration and manufacturing processes, not the statistical training of a data-driven model.

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

As there is no mention of a training set in the context of an AI/ML model, the establishment of ground truth for a training set is not applicable or described. The device's calibration and internal algorithms would be developed and validated through rigorous engineering and internal testing, using precisely known, manufactured control solutions and spiked samples, rather than a labeled training dataset in the AI sense.

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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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