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BioSieve™ Fentanyl FIA Home Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

BioSieve™ Fentanyl FIA Pro Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader. It is for in vitro diagnostic use only.

The tests provide only preliminary results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method.

Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.

BioSieve™ Toxismart Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader is intended for OTC use.

BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentanyl FIA Pro Test Kit are immunoassays intended for the qualitative detection of fentanyl in human urine. These candidate test kits are the same physical devices as the predicate device cleared in K240124. Each BioSieve™ Fentanyl Test Kit consists of a test cassette and a package insert. Each test cassette is sealed with sachets of desiccant in an aluminum pouch.

BioSieve™ Toxismart Reader is a portable fluorescence instrument that is intended for use with the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentany] Pro Test Kit. The Reader scans the test cassettes included in the Test Kits and displays the results.

The provided FDA 510(k) summary (K241869) describes the BioSieve™ Fentanyl FIA Home Test Kit, BioSieve™ Fentanyl FIA Pro Test Kit, and BioSieve™ Toxismart Reader. The document focuses on demonstrating substantial equivalence to a predicate device (K240124) and includes details of a lay-user study.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, accuracy, etc., that the device must meet for clearance. Instead, the performance is demonstrated through a lay-user study, and the implied acceptance is 100% correct results for all tested samples across various concentrations relative to the cutoff.

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

• Sample Size for Test Set: 140 lay persons (participants). Each participant was provided with 1 blind-labeled sample. The total number of individual urine samples prepared for the study across all concentration levels was $20 \times 7 = 140$ samples.
• Data Provenance: The document states "Urine samples were prepared... by spiking fentanyl into drug free-pooled urine specimens." This indicates the samples were laboratory-prepared (spiked) rather than naturally occurring clinical samples. The country of origin for the data is not specified, but the submitter is VivaChek Biotech (Hangzhou) Co., Ltd. from China. The study appears to be prospective in nature, as it involved lay users actively interacting with the device and samples.

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

• Number of Experts: Not explicitly stated as a panel of experts.
• Qualifications of Experts: The ground truth for the fentanyl concentrations in the prepared urine samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate analytical method for quantifying substances, and its operation would typically be performed by trained laboratory personnel/chemists rather than medical experts like radiologists. The document does not specify the qualifications of the individuals who performed the LC/MS analysis. The reference method is considered the "ground truth."

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method involving multiple human readers or a consensus process for the results of the device tests. The lay users performed the tests, and their readings (positive/negative) were compared directly against the LC/MS confirmed concentrations of the spiked samples.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a lay-user study evaluating the device's performance when used by intended lay users, not a comparison of human readers with and without AI assistance, nor does the device itself involve AI assistance for interpretation beyond the Toxismart Reader's automated reporting.

6. Standalone (Algorithm Only) Performance

Yes, a form of standalone performance was implicitly evaluated. The "lay-user study" assessed the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Toxismart Reader system (which includes interpretation by the reader) in an "algorithm only without human-in-the-loop performance" sense, as the lay users were simply operating the device and reading its output. The reader itself performs the detection and displays the result.

7. Type of Ground Truth Used

The ground truth used was analytical confirmation by LC/MS. This is an objective quantitative method considered highly accurate for determining the precise concentration of fentanyl in the spiked urine samples.

8. Sample Size for the Training Set

The document states: "1. Analytical Performance: See analytical performance in predicate K240124. 2. Comparison Studies: See studies in predicate K240124". This implies that the training (or development/optimization) data for the device's analytical performance and the reader's algorithm were part of the predicate device's submission (K240124) and are not detailed in this 510(k) summary. Therefore, the sample size for the training set is not provided in the current document.

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

Similar to the above, the methods for establishing ground truth for any training set related to the development of the device or reader would be found in the predicate device's documentation (K240124) and are not detailed in this summary. It can be inferred that for a diagnostic device like this, ground truth would likely involve a combination of spiked samples with known concentrations and potentially confirmed clinical samples using a reference method like GC/MS or LC/MS.

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VivaChek™ Fad Blood Glucose Monitoring System is intended to quantitatively measure the glucose 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™ Fad Smart Blood Glucose Monitoring System is intended to quantitatively measure the glucose 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™ Fad Sync Blood Glucose Monitoring System is intended to quantitatively measure the glucose 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™ Fad Blood Glucose Monitoring System consists of VivaChek™ Fad Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.

VivaChek™ Fad Smart Blood Glucose Monitoring System consists of VivaChek™ Fad Smart Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.

VivaChek™ Fad Sync Blood Glucose Monitoring System consists of VivaChek™ Fad Sync Blood Glucose Meter and the VivaChek™ Fad Blood Glucose Test Strips. The glucose meter and test strips are packaged separately.

VivaChek Fad Control Solution, VivaChek Lancing Device, VivaChek Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The VivaChek Fad Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. VivaChek Lancing Device and VivaChek Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample.

VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System and VivaChek™ Fad Sync Blood Glucose Monitoring System are designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The ducose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose dehydrogenase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions meeting "FDA SMBG OTC Guidance and industry standards" for clinical performance. A specific detailed table of acceptance criteria and reported performance is not explicitly provided in the excerpt. However, based on the context of Blood Glucose Monitoring Systems, the primary acceptance criteria would relate to the accuracy of glucose readings compared to a reference method. The document states that the clinical studies data showed that the clinical performance met the FDA SMBG OTC Guidance, implying the device successfully passed these criteria. Without the specific guidance document referenced, a detailed table cannot be created from this text alone.

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

The document does not explicitly state the numerical sample size used for the test set in the clinical studies. It mentions "non-professional, inexperienced lay persons" were used for user evaluations.

• Data Provenance: The studies were conducted by Vivachek Biotech (Hangzhou) Co., Ltd, located in Zhejiang, China. The document does not explicitly state if the data was retrospective or prospective, but clinical studies (user evaluations) generally imply prospective data collection in a controlled environment.

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 blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the ground truth for blood glucose is typically a laboratory reference measurement, adjudication by experts wouldn't be directly applicable in the same way it would be for image-based diagnostics.

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 is not applicable to a Blood Glucose Monitoring System. MRMC studies are relevant for AI in diagnostic imaging where human readers interpret cases. This device is a direct measurement system.

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

The device itself is a standalone system for glucose measurement. The "study" here refers to the overall performance of the device in the hands of the intended users. The clinical studies (user evaluations) assess the device's performance when used by individuals (humans in the loop). The "algorithm only" concept doesn't apply as it's a physical meter and test strip system.

7. The Type of Ground Truth Used

While not explicitly stated for all studies, for blood glucose monitoring systems, the ground truth for accuracy studies is typically established using a laboratory reference method (e.g., YSI Glucose Analyzer) on venous blood samples. The document implies this by stating that clinical performance met FDA SMBG OTC Guidance, which mandates comparison to such reference methods.

8. The Sample Size for the Training Set

This information is not provided. For a physical device like a blood glucose meter, there isn't a "training set" in the same sense as machine learning algorithms. The device's calibration and performance characteristics are established during its design and manufacturing process, and then validated through laboratory and clinical studies.

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

Not applicable as there is no traditional "training set" for an AI algorithm here. The performance is validated against established reference methods and clinical guidelines.

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BioSieve™ Fentanyl FIA Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ ToxiSmart FIA Reader.

It is for in vitro diagnostic use only. It is intended for prescription use.

The tests provide only preliminary results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method.

Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.

BioSieve™ ToxiSmart FIA Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader can be used in a laboratory or in a point-of-care setting.

This test uses a lateral flow design with location-dependent lines and zones. BioSieve™ ToxiSmart FIA Reader scans the test strip and displays results. The sample is added to the sample well of the test card, and the sample is drawn by capillary action into and through the fluorescent labeled pad, through the nitrocellulose strip and into the adsorption pad. Within the fluorescent labeled pad, the specimen comes into contact with antibodies conjugated with fluorescent microspheres. During this interaction, if the amount of fentanyl antigen in the sample is greater than or equal to the cutoff value, the antigen in the sample and the fluorescence-labeled antibody bind to the FTY antigenantibody complex when the sample passes through a pad of fluorescence-microbead-labeled antibody conjugate. As the sample flows and reaches the FTY antigen coated by the T-line of nitrocellulose membrane, the FTY antigen coated by the T-line antigen in the sample competitively bind the FTY antibody labeled with fluorescence, then the T-line captures fluorescence signal is weaker than the cutoff fluorescence signal. When the samples do not contain fentanyl antigen or levels below the cutoff value, as the sample flow, fluorescent microsphere labeled antibody to nitrocellulose membrane T line captures fluorescent signal is stronger than the cutoff fluorescence signal. Whether or not FTY antigen was present in the sample, the rabbit IgG fluorescent microsphere conjugate not bound to the test line continued to flow with the rest of the sample and soon encountered a control line composed of goatanti-rabbit IgG. The position of C-line will accumulate fluorescence signal. The C-line control area was scanned to confirm that adequate sample flow had occurred. High resolution, narrow band SMD LED was used as light source in the Immunofluorescence Analyzer. The central wavelength of the excitation spectrum is 365nm. The central response wavelength is 610nm.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the BioSieve™ Fentanyl FIA Test Kit and BioSieve™ ToxiSmart FIA Reader.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a table format. However, the performance characteristics tested and summarized imply the criteria for acceptable performance. The study aims to demonstrate that the device performs as expected for a qualitative immunoassay for fentanyl in urine, particularly around the 1.0 ng/mL cutoff.

The reported device performance is presented in several sections:

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

• Precision Study Test Set: For each of 9 concentrations (e.g., -100% cutoff, cutoff, +100% cutoff), 6 runs per day for 10 days per device lot were performed. With 3 lots, this suggests: 9 concentrations * 6 tests/run * 10 days * 3 lots = 1620 individual tests (results reported as sums across these).
• Interference Study Test Set: Numerous interfering substances were tested with 3 batches of each device for drug-free urine and target fentanyl urine at -50% and +50% Cut-Off levels. The exact number of tests per substance is not specified, but it implies a substantial number.
• Specificity (Cross-Reactivity) Test Set: Various drug metabolites and opioid compounds were tested using three batches of device. The number of individual tests per compound is not explicitly stated.
• Effect of Urine Specific Gravity and pH Test Set: Urine samples across the specified ranges were spiked at -50% and +50% Cut-Off. Tested by three different operators per lot of device, with a total of three lots. The exact number of individual tests is not specified.
• Method Comparison Test Set: 80 unaltered clinical samples (40 negative and 40 positive based on an internal classification) were used per site across three different testing sites. This totals 240 clinical samples.
• Data Provenance: The document does not explicitly state the country of origin for the samples. It mentions "unaltered clinical samples" for the method comparison study, implying they were retrospective if they were already collected clinical samples. The precision study samples were "prepared by spiking fentanyl in negative samples," indicating these were artificially contrived samples, not naturally occurring clinical specimens, and were conducted in a controlled lab setting.

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

• For the Precision Study, "Each fentanyl concentration was confirmed by LC/MS-MS." LC/MS-MS (Liquid Chromatography/Mass Spectrometry) is a highly accurate analytical chemistry method, typically considered a gold standard for quantifying substances in biological samples. This method itself provides the "ground truth" and does not typically involve human "experts" in the sense of clinicians or radiologists reading results.
• For the Method Comparison Study, "The samples were blind labeled and compared to LC-MS/MS results." Again, LC-MS/MS is the ground truth. No human experts (e.g., radiologists) were used to establish the ground truth; it was established by an analytical instrument method.
• No information is provided about the qualifications of the operators who performed the tests on the BioSieve™ device at the three sites, nor is there mention of a panel of experts for subjective adjudication.

4. Adjudication Method for the Test Set

• None in the context of human expert adjudication. The ground truth for quantitative accuracy and comparative performance was established by LC-MS/MS, a definitive analytical method, not by human consensus or adjudication. The BioSieve™ device provides a qualitative result (positive/negative), which is then compared against the quantitative LC-MS/MS value relative to the 1.0 ng/mL cutoff.

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

• No, an MRMC study was not done. This device is a quantitative/qualitative immunoassay read by an instrument (BioSieve™ ToxiSmart FIA Reader), not interpreted by human readers in the same way an imaging AI would be. The "operators" in the method comparison study are likely technicians performing the test, not interpreting complex outputs. Therefore, a study on human reader improvement with AI assistance is not applicable.

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

• Yes, in essence. The BioSieve™ ToxiSmart FIA Reader is an automated instrument that reads the test strip and displays results. The results presented for precision, interference, specificity, and comparison studies demonstrate the standalone performance of the BioSieve™ Fentanyl FIA Test Kit and the BioSieve™ ToxiSmart FIA Reader system. The device produces a qualitative result directly from the sample, without human interpretation of the signal beyond observing the final positive/negative display.

7. Type of Ground Truth Used

• LC-MS/MS (Liquid Chromatography/Mass Spectrometry): This highly accurate analytical method was used to confirm fentanyl concentrations in precision samples and as the reference method for clinical samples in the method comparison study. It provides objective, quantitative biochemical data, which is then translated to the qualitative positive/negative ground truth based on the 1.0 ng/mL cutoff.

8. Sample Size for the Training Set

• Not specified. The document describes performance validation studies for regulatory submission (510(k)). It does not provide details about a specific "training set" for an AI algorithm because the BioSieve™ ToxiSmart FIA Reader is not described as an AI-powered device in the typical sense of a deep learning model that requires a labeled training dataset. It's a fluorescence immunoassay reader. The "development modes" refer to how the test is run (Standard vs. Quick), not algorithmic training.

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

• Not applicable. As noted above, the device is an immunoassay system and reader, not explicitly an AI/machine learning algorithm requiring a training set with established ground truth in the context of typical AI development. The document describes analytical validation, not algorithmic training.

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VivaChek™ Link Plus Blood Glucose Monitoring System is comprised of the VivaChek™ Link Plus Blood Glucose Meter and the VivaChek™ Ino Blood Glucose Test Strips.

VivaChek™ Link Plus Blood Glucose Monitoring System is intended to quantitatively measure the glucose 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 Link Plus Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed.

VivaChek Link Plus Blood Glucose Monitoring System contains 4G module, the device complies with US federal guidelines, FCC Part 15 Subpart B, FCC Part 2, FCC Part 24 Subpart E, FCC Part 27 Subpart C, and FCC 47 CFR§ 2.1093 based on the test reports.

The provided text describes the VivaChek™ Link Plus Blood Glucose Monitoring System, an in-vitro diagnostic device. Here's an analysis of the acceptance criteria and study that proves the device meets them:

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

The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested. Instead, it states that various laboratory studies were performed, and for these studies, "the test results indicated that the acceptance criteria were met."

Therefore, based on the provided text, a generic representation of this would be:

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

• Sample Size for Test Set: The document mentions "clinical study (user evaluation) was conducted with intended users." However, it does not specify the number of users or samples included in this evaluation.
• Data Provenance: The document does not explicitly state the country of origin for the data. It also directly states that the user evaluation was conducted as a "clinical study," implying it was a prospective study, though not explicitly labelled as such. The other laboratory studies listed are implicitly prospective tests performed by the manufacturer.

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 glucose monitoring system, the "ground truth" for glucose levels would typically be established using a laboratory reference method (e.g., a YSI analyzer), not by human experts interpreting results. The user evaluation focuses on the usability and ability of lay persons to obtain readings, not on expert interpretation of the device's output.

4. Adjudication method for the test set

This information is not applicable/provided in the context of this device. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers interpret images or complex data to establish a consensus ground truth, often for AI-assisted diagnostic tools. For a blood glucose meter, the reference method (e.g., YSI) provides the objective ground truth, and device readings are compared directly to this.

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 was not done. This type of study is relevant for imaging or diagnostic AI where human readers interact with AI assistance. The VivaChek™ Link Plus Blood Glucose Monitoring System is a standalone measurement device for self-testing; it does not involve human readers interpreting AI-generated insights.
• Effect size of improvement with AI vs without AI assistance is not applicable.

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

• Yes, a standalone performance evaluation was done. The entire suite of laboratory studies (e.g., precision, linearity, interference, stability, environmental, safety) represents the standalone performance evaluation of the device system (meter and test strips) without human interpretation in the loop. The "user evaluation" section primarily assesses usability rather than the intrinsic accuracy of the algorithm/device itself. The device is designed for "self-testing outside the body (in vitro diagnostic use)," operating without professional human-in-the-loop interpretation of its results for diagnosis.

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

The document does not explicitly state the specific reference method used for establishing ground truth for glucose levels. However, in the context of blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method, such as a YSI glucose analyzer, which provides highly accurate and precise glucose concentration measurements. This is an objective chemical measurement, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not provided and is generally not applicable in this context. Blood glucose monitoring systems are typically designed and calibrated based on biochemical principles and rigorous testing, rather than "training" a machine learning algorithm with a dataset in the way an AI diagnostic tool would be trained. The "training set" concept is usually associated with AI/ML development.

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

As noted above, a "training set" in the AI/ML sense is likely not applicable here. Device calibration and verification are based on established analytical chemistry methods where the "ground truth" for glucose concentrations in control solutions or reference samples would be determined using highly accurate laboratory reference instruments.

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BioSieve™ Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

BioSieve™ Multi-Drug Urine Test Panel offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

BioSieve™ Multi-Drug Urine Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

BioSieve™ Multi-Drug Urine Test Panel Rx offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

The BioSieve™ Multi-Drug Urine Test Panel and BioSieve™ Multi-Drug Urine Test Panel Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test BioSieve™ Panel and two desiccants, and a package insert. The BioSieve™ Multi-Drug Urine Test Panel is intended for over-the-counter use and the BioSieve™ Multi-Drug Urine Test Panel Rx is intended for prescription use.

Acceptance Criteria and Device Performance for BioSieve™ Multi-Drug Urine Test Panel

This document describes the acceptance criteria and the studies performed to demonstrate that the BioSieve™ Multi-Drug Urine Test Panel meets these criteria.

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the BioSieve™ Multi-Drug Urine Test Panel, as derived from the provided precision studies, is the accurate qualitative detection of drugs at various concentrations relative to the defined cutoff level. Specifically, the device is expected to:

• Consistently report Negative (no drug detected) for samples with drug concentrations at or below -25% of the cutoff level (e.g., -100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff).
• Consistently report Positive (drug detected) for samples with drug concentrations at or above +25% of the cutoff level (e.g., +25% cutoff, +50% cutoff, +75% cutoff, +100% cutoff).
• Demonstrate a balanced distribution of Positive and Negative results around the cutoff level (e.g., approximately 50% positive and 50% negative).

The reported device performance, based on the precision studies for each drug, generally aligns with these criteria. For concentrations at or below -25% of the cutoff, almost all results were negative (e.g., 50-/0+ indicating 50 negative and 0 positive). For concentrations at or above +25% of the cutoff, almost all results were positive (e.g., 0-/50+ indicating 0 negative and 50 positive). At the cutoff concentration, the results showed a mix of positive and negative, reflecting the expected performance of a qualitative assay near its detection threshold (e.g., 23-/27+, 26-/24+, etc.).

Table of Acceptance Criteria and Reported Device Performance (Example for BUP 10, PCP 25, THC 50, OXY 100)

Note: The table above provides a representative sample. The full document lists extensive data for each drug, demonstrating similar performance.

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

The primary analytical performance test (Precision Study) used a substantial sample size. For each drug, tests were performed over 25 days, with two runs per day, using three different lots of test panels. This means for each concentration level tested per drug (e.g., -100% cutoff, -50% cutoff, cutoff, +50% cutoff, +100% cutoff), there were 25 days * 2 runs * 3 lots = 150 individual tests.

The method comparison studies utilized 80 unaltered urine samples for each drug, divided into 40 negative and 40 positive. These samples were run by three different operators.

The lay-user study included a total of 280 participants.

• Configuration 1: 64 males and 76 females (140 participants)
• Configuration 2: 67 males and 73 females (140 participants)
  For each drug and each concentration level in the lay-user study, there were 20 test results. Given there are 7 concentration levels per drug, this amounts to 140 results per drug per configuration.

Data Provenance: The document does not explicitly state the country of origin for the data. However, the studies were performed by VivaChek Biotech (Hangzhou) Co., Ltd. located in Hangzhou, China, suggesting the data was collected there. The studies appear to be retrospective as they involve prepared samples or collected unaltered urine samples that were then tested.

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

The ground truth for the analytical performance and method comparison studies was established using LC/MS (Liquid Chromatography/Mass Spectrometry) or LC/MS/MS. LC/MS is a highly accurate and widely accepted gold-standard analytical method for confirming drug concentrations in urine.

The document does not specify the "number of experts" or their "qualifications" in the context of establishing LC/MS ground truth, as LC/MS is an instrumental method that provides objective quantitative results. The operation and interpretation of LC/MS data typically rely on trained laboratory personnel with expertise in analytical chemistry, but their specific "qualifications" (e.g., years of experience) are not detailed in this submission.

For the lay-user study, the ground truth was also established by spiking known concentrations of drugs into drug-free urine, confirming these concentrations via LC/MS or LC/MS/MS.

4. Adjudication Method for the Test Set

For the analytical performance (precision) studies, the raw results for each concentration level are presented (e.g., 26-/24+). This implies no specific "adjudication method" beyond the direct comparison of the device's qualitative result (positive/negative) against the quantitative LC/MS ground truth. The acceptance criteria for the cutoff concentration already imply a mixed outcome is expected.

For the method comparison study, discordant results are explicitly listed with the LC/MS result compared against the device's result by each operator. This indicates a direct comparison to the LC/MS ground truth rather than an adjudication process between device results.

For the lay-user study, the "agreement (%)" is calculated based on how often the lay user's interpretation of the device result matched the expected result based on the spiked concentration (and confirmed by LC/MS). Again, this is a direct comparison to established ground truth, not an adjudication of human interpretations.

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

No, an MRMC comparative effectiveness study was not done in the traditional sense of comparing human readers with and without AI assistance, as this device (BioSieve™ Multi-Drug Urine Test Panel) is a lateral flow immunochromatographic assay, not an AI-powered diagnostic tool for image or data interpretation.

The studies involve:

• Analytical performance: Device-to-LC/MS comparison.
• Method comparison: Three operators reading the device and comparing to LC/MS. This is a multi-reader study, but comparing the device's output to a gold standard, not assessing the improvement of human readers with AI assistance.
• Lay-user study: Multiple lay users interpreting the device results based on provided instructions. This evaluates the ease of use and interpretability for the intended over-the-counter audience, not the effectiveness of AI assistance.

Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable to this device or the studies presented.

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

Given that the BioSieve™ Multi-Drug Urine Test Panel is a physical, lateral flow immunochromatographic assay, it inherently requires a human-in-the-loop to visually interpret the test lines. It is not an "algorithm only" device. Therefore, a standalone (algorithm only) performance study was not done and is not applicable. The precision, comparison, and lay-user studies all involve human observation and interpretation of the visual reaction.

7. The Type of Ground Truth Used

The primary type of ground truth used across all analytical studies (precision, specificity, interference, method comparison, and lay-user studies) is analytical confirmation by LC/MS (Liquid Chromatography/Mass Spectrometry) or LC/MS/MS. This a quantitative chemical method considered a gold standard for drug detection and concentration measurement.

For the precision studies, various concentrations of each drug were "spiking target drug in drug-free urine samples" and "confirmed by LC/MS."
For the method comparison studies, "unaltered urine samples were blind labeled and compared to LC/MS results."
For the lay-user study, samples were "spiked with drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS or LC/MS."

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. This device is a biochemical immunoassay, not an AI/ML-based diagnostic. Therefore, there is no separate "training set" as understood in a computational context.

The studies described are for verification and validation of the device's analytical performance.

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

As there is no "training set" for an AI/ML algorithm for this device, this question is not applicable. The chemical and biological principles of the immunoassay define its detection capabilities, rather than a learned model from a training set.

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BioSieve™ Dx Marijuana Test Panel 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

BioSieve™ Dx Marijuana Test Strip 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

BioSieve™ Dx Marijuana Test Panel 50 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

BioSieve™ Dx Marijuana Test Strip 50 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

BioSieve™ Marijuana Test Panel 50 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

BioSieve™ Marijuana Test Strip 50 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

The BioSieve™ Marijuana Test Panel (Strip) and the BioSieve™ Dx Marijuana Test Panel (Strip) tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Marijuana in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the BioSieve™ Marijuana Test Panel and Test Strip devices for qualitative detection of Marijuana in human urine. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the overall device performance in a consolidated table, but rather presents performance characteristics of the device. From the precision study, it can be inferred that the device is expected to correctly identify drug-free samples and samples significantly above the cutoff, while showing a degree of variability around the cutoff. The provided precision data and the results of the comparison studies (with LC/MS) serve as the device's reported performance against implied accuracy and consistency expectations.

Inferred Acceptance Criteria / Performance Goals (based on Precision Study and Comparison Studies):

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

• Precision Study Test Set:

  • For each of the four device types (20 ng/mL Strip, 20 ng/mL Panel, 50 ng/mL Strip, 50 ng/mL Panel), 9 concentrations were tested (ranging from -100% cutoff to +100% cutoff).
  • For each concentration, tests were performed two runs per day at each site for each of 3 lots for 10 days.
  • This equates to: 9 concentrations * 2 runs/day * 3 sites * 3 lots * 10 days = 1620 tests per device type across all concentrations.
  • Data Provenance: The document does not specify the country of origin for the samples or the study sites. It implies prospective testing as samples were "prepared by spiking 11-Nor-△9-THC-9-COOH in drug-free urine samples" and confirmed by LC/MS.

• Comparison Studies Test Set (Algorithm Only/Standalone):

  • For each of the four device types (20 ng/mL Strip, 20 ng/mL Panel, 50 ng/mL Strip, 50 ng/mL Panel), 80 unaltered urine samples were used.
  • These 80 samples consisted of 40 negative and 40 positive samples, categorized further into: Drug-Free, Low Negative, Near Cutoff Negative, Near Cutoff Positive, and High Positive.
  • Data Provenance: The document does not specify the country of origin of these "unaltered urine samples." It implies these are retrospective samples as they were blind-labeled and compared to LC/MS results.

• Lay-user Study Test Set:

  • 280 lay persons participated.
  • Urine samples were prepared at 7 concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75% of 50 ng/mL cutoff).
  • Each concentration used 20 samples.
  • Each participant was given 1 blind-labeled sample. This means a total of 7 concentrations * 20 samples/concentration = 140 samples were tested across the 280 lay persons (since each person tested only one sample).
  • Data Provenance: The document does not specify the country of origin. The samples were "prepared by spiking 11-Nor-△9-THC-9-COOH into drug free-pooled urine specimens," indicating prospective preparation.

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

• Precision and Comparison Studies: The ground truth for spiked samples (-100% cutoff to +100% cutoff for precision, and the various categories for comparison studies) was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate and widely accepted analytical method. The document does not mention human experts establishing this ground truth; the instrument itself provides the "truth."
• Lay-user Study: The ground truth for the lay-user study samples was also established by LC/MS confirming the drug concentrations after spiking.

4. Adjudication Method for the Test Set

• Precision Study: The results are presented as counts of positive/negative readings. No explicit adjudication method (like 2+1) is mentioned, as is common for analytical precision studies where each test's outcome is recorded.
• Comparison Studies: The individual operators' results (positive/negative) were directly compared to the LC/MS results. Discordant results are individually listed against the LC/MS result. There is no mention of an adjudication process among the operators.
• Lay-user Study: The lay users' obtained results (positive/negative) were compared against the LC/MS confirmed drug concentration of the sample they tested. No adjudication is mentioned.

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

• No MRMC comparative effectiveness study was done, as this device is a standalone in-vitro diagnostic test kit (Strip/Panel), not an AI-assisted diagnostic tool for human readers. Therefore, there is no AI component, and no improvement effect size for human readers.

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

• Yes, standalone performance was evaluated by human observers interpreting the test results visually.
  • The "Comparison Studies" section evaluates the device's performance by having six operators visually interpret the results of the strips/panels and compare them against LC/MS ground truth. This effectively determines the device's accuracy in a standalone setting (device + human interpretation) for laboratory professional users.
  • The "Lay-user study" also evaluates the standalone performance by 280 lay persons visually interpreting the results.

7. The type of ground truth used

• The primary ground truth used for establishing drug concentrations and confirming results was LC/MS (Liquid Chromatography-Mass Spectrometry). This is considered a highly definitive analytical method for confirming drug presence and concentration.

8. The sample size for the training set

• The document does not mention a "training set" in the context of machine learning or AI. This is a traditional in-vitro diagnostic device (immunoassay) and therefore does not involve machine learning models that require training data. All samples described are used for performance validation and testing.

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

• As there is no mention of a "training set" for a machine learning model, this question is not applicable to the described device. The samples used for performance evaluation (precision, comparison, lay-user studies) had their ground truth established by LC/MS confirmation of spiked drug concentrations or by direct LC/MS reference for unaltered urine samples.

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Wisdiag Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Wisdiag Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may vield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Wisdiag Multi-Drug Urine Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of:

Wisdiag Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may vield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid, singleuse in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Wisdiag Cup and two desiccants, and a package insert. The Wisdiag Multi-Drug Urine Test Cup is intended for over-the-counter use and the Wisdiag Multi-Drug Urine Test Cup Rx is intended for prescription use.

The document describes the performance characteristics of the Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx. The device is a rapid, single-use in-vitro diagnostic test for qualitative drug detection in human urine.

Here's an analysis of the acceptance criteria and study details:

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

The document doesn't explicitly state "acceptance criteria" through a numerical threshold for accuracy metrics (e.g., "sensitivity must be >95%"). However, the precision studies and comparative studies demonstrate the device's performance against defined cut-off values. The "acceptance" can be inferred from the consistently high percentages of correct results at various concentrations relative to the cutoff, and the successful classification of samples below and above the cutoff.

Here's a table summarizing the performance based on the precision study and lay-user study for each drug at its respective cutoff concentrations. The "Reported Device Performance" here refers to the percentage of correct results for samples at the cutoff or near the cutoff values, as these are the most critical for determining accuracy. For "acceptance criteria," the expectation is generally high accuracy around the cutoff.

Table 1: Acceptance Criteria (Inferred) and Reported Device Performance

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

• Precision Studies (Analytical Performance):

  • Sample Size: For each drug and each concentration point (-100%, -75%, -50%, -25%, cutoff, +25%, +50%, +75%, +100% cutoff), 50 tests were performed per lot across 3 lots (2 runs/day for 25 days). This means 3 lots x 50 tests = 150 tests per concentration per drug. With 9 concentration points, it is 1350 tests per drug. With 15 drugs, roughly 20,250 tests in total.
  • Data Provenance: The samples were prepared by spiking target drugs into drug-free urine samples. Drug-free urine samples were used for the -100% cutoff. The document does not specify the country of origin of the "drug-free urine samples" or the location where the samples were collected. It is retrospective in the sense that samples were prepared in a lab setting rather than collected prospectively from patients.

• Comparison Studies (Standalone Performance):

  • Sample Size: For each drug, 80 unaltered urine samples (40 negative and 40 positive) were used. These were then tested by 3 operators.
  • Data Provenance: "Unaltered urine samples" were used. The document does not specify the country of origin. This appears to be retrospective as the samples were pre-collected and blinded.

• Lay-User Study:

  • Sample Size: 280 participants were recruited.
    • 140 participants (66 males, 74 females) for Configuration 1 (AMP 500, MET 500, MOP 300, COC 150, BAR 300, BZO 300, BUP 10, EDDP 300, MDMA 500, MTD 300, OXY 100, PCP 25, PPX 300, TCA 1000, THC 50).
    • 140 participants (72 males, 68 females) for Configuration 2 (AMP 1000, MET 1000, OPI 2000 (MOP 2000), COC 300, BAR 300, BZO 300, BUP 10, EDDP 300, MDMA 500, MTD 300, OXY 100, PCP 25, PPX 300, TCA 1000, THC 50).
    • Each participant tested "one blind labeled test solution, and one test device." The concentration points tested were -100%, +/-75%, +/-50%, +/-25% of the cutoff. Given there are 15 assays per cup, and 8 concentration points, and 20 tests per concentration point, this implies a total of 15 * 8 * 20 = 2400 individual assay results per configuration (which aligns roughly with 140 participants given each participant runs multiple assays/drugs).
  • Data Provenance: Samples were "prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens." It doesn't state the source of the "drug free-pooled urine specimens" or the country of origin. This is a retrospective study based on prepared samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Ground Truth Method: LC/MS or LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) was used to confirm sample concentrations and establish the ground truth for all studies (Precision, Comparison, Lay-User).
• Number/Qualifications of Experts: The document does not specify human experts for establishing ground truth. The LC/MS data is considered the analytical "gold standard" or ground truth for drug concentrations in urine.

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

• No human adjudication method is described. The ground truth in all studies is based on LC/MS results. The device results (positive/negative) are compared directly to the quantitative LC/MS measurements relative to the specified cutoff.

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

• There was no MRMC comparative effectiveness study involving human readers with/without AI assistance. The device is a lateral flow immunoassay intended for direct interpretation of visual lines, not an AI-assisted diagnostic tool.

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

• Yes, standalone performance was done.
  • Precision Studies: This directly assesses the device's ability to correctly classify samples based on LC/MS confirmed concentrations, without human interpretation variability being the primary focus. The results "-/+" notation at each concentration reflects the count of negative and positive results from the device, which are then compared to the known concentration.
  • Comparison Studies: These studies explicitly compare the "Wisdiag Multi-Drug Urine Test Cup" results (interpreted by three operators) directly against LC/MS results. While operators are involved in reading, the intent is to show the device's inherent performance when read, validating its accuracy against the gold standard. The "discordant results" further confirm areas where the device's output (even if read by a human) deviates from clinical truth (LC/MS).

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

• Analytical Ground Truth: LC/MS or LC/MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) was used as the ground truth method to confirm the concentrations of all samples. This is a highly accurate and quantitative chemical analysis method.

8. The sample size for the training set

• This device is a lateral flow immunoassay, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device's performance is determined by its inherent biochemical design (antigen-antibody reactions) and manufacturing consistency, not by learning from a dataset.

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

• As stated in point 8, there is no "training set" for this type of device.

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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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