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The Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit-Qualitative is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Healgen® Immunofluorescence analyzer OG-H180. This in vitro diagnostic device is for prescription use only.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to a Fentanyl test result, particularly when a preliminary positive result is obtained.

The Healgen® Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to detect test results from in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or point-of-care setting.

The AccuFluor Fentanyl FIA Test Kit-Qualitative is a rapid fluorescence immunoassay based on the principle of competitive binding, which uses fluorescent microspheres-labeled antibody as the indicator marker to qualitatively detect fentanyl in human urine. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Fentanyl, if present in the urine specimen below 1.0 ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. The antibody coated fluorescence particles will then be captured by immobilized Fentanyl conjugate, and the signal will be detected in the test line (T) region to show a negative result. The signal will not be detected in the test line (T) region if the Fentanyl level exceeds 1.0 ng/mL because all the binding sites for the anti-Fentanyl antibodies will be saturated and the result will show as positive. To serve as a procedural control, a signal will be detected at the control line (C) region indicating the proper volume of specimen has been added and membrane wicking has occurred. The test is interpreted by the Healgen® Immunofluorescence analyzer OG-H180 and the result will be interpreted by the analyzer.

The provided FDA 510(k) clearance letter pertains to the Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative and the Healgen® Immunofluorescence Analyzer (OG-H180). This document outlines the general regulatory approval and provides some performance characteristics, but it is not a comprehensive study report detailing all aspects of the acceptance criteria and the full study that proves the device meets those criteria.

Specifically, the document does not explicitly state "acceptance criteria" as a defined set of metrics and thresholds prior to presenting performance data. Instead, it presents results from various analytical performance studies which are implicitly used to demonstrate equivalence to a predicate device. Similarly, it does not describe "human expert ground truth establishment," "adjudication methods," or "MRMC comparative effectiveness studies" because these are typically relevant for AI/ML-based diagnostic devices utilizing image interpretation or complex decision support, which is not the primary function described for this immunoassay and analyzer.

This device is an in vitro diagnostic (IVD) test for qualitative detection of fentanyl in urine, which relies on a chemical reaction read by an analyzer. Therefore, the "study" described is a series of analytical performance tests, rather than a clinical study with human readers and ground truth established by medical experts in the way that would be done for an AI radiology device, for example.

Despite these limitations in the provided text for certain categories, I will extract and infer information where possible based on the provided document and common IVD device clearance practices.

Acceptance Criteria and Device Performance for Healgen® AccuFluor Fentanyl FIA Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not explicitly list pre-defined "acceptance criteria" with specific numerical thresholds for all metrics. However, based on the provided performance data, here's an interpretation of the implied criteria and the reported performance. The "acceptance criteria" inferred here are based on what constitutes successful demonstration of performance for an IVD device of this type, often aiming for high accuracy, precision, and lack of interference, especially around the cutoff concentration.

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

• Analytical Precision: 60 replicates per concentration (6 replicates/day for 10 days) per lot, across 9 concentration levels, for 3 device lots. Total: 60 * 9 * 3 = 1620 individual tests.
• Interference: Samples with various interfering substances were tested, each at both drug-free and ±50% Cut-Off spiked fentanyl concentrations, using three batches of device. (Exact number of tests not specified, but implies a comprehensive set).
• Specificity: Various drug metabolites and other compounds tested, each using three batches of device. (Exact number of tests not specified).
• Effect of Urine Specific Gravity and pH: Samples across the specified ranges were tested at -50% and +50% Cut-Off levels by three different operators using three device lots. (Exact number of tests not specified).
• Method Comparison (Clinical Samples): 80 unaltered clinical samples (40 negative, 40 positive). These samples were run at three different testing sites.
• Data Provenance: The document does not explicitly state the country of origin for the clinical samples. It does state they were "unaltered clinical samples," implying they were retrospective real-world samples collected from patients. It does not indicate if they were prospective.

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

• Not Applicable in the traditional sense for this device. For this IVD device, the primary ground truth for its performance studies (precision, specificity, method comparison) is established by analytical gold standards, specifically:
  • LC/MS-MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) for confirming fentanyl concentrations in precision studies and as the comparator method in the method comparison study.
  • This is a highly accurate and precise laboratory method for quantifying drug concentrations, and its results are considered the "ground truth" for chemical concentration data.
• There were "three different operators" for the specific gravity/pH study, but these are not "experts" in the sense of medical professionals establishing a clinical diagnosis ground truth. They are laboratory personnel performing the test.

4. Adjudication Method for the Test Set

• Not Applicable in the traditional sense. Given that the ground truth is established by LC-MS/MS, there is no human "adjudication" process like consensus reading by multiple radiologists for image interpretation. The LC-MS/MS results serve as the definitive reference.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on complex interpretation tasks) is not applicable to a qualitative immunoassay and analyzer like the Healgen AccuFluor Fentanyl FIA Test Kit, which determines the presence or absence of a substance based on a fluorescent signal. The device performance is assessed on its analytical accuracy against a gold standard method.

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

• Yes, the performance presented is primarily standalone. The Healgen® Immunofluorescence Analyzer (OG-H180) automatically interprets the fluorescent signal from the test kit. The performance data (precision, specificity, interference, method comparison) directly reflects the analytical capability of the device and test kit combination, without any human interpretation or intervention in the final "positive" or "negative" determination. A human loads the sample and the device performs the analysis and provides the result.

7. The Type of Ground Truth Used

• Analytical Gold Standard (LC-MS/MS): This is the primary method used to establish the true concentration of fentanyl in samples for precision studies and as the comparative reference for clinical samples.
• Spiked Samples: For analytical performance studies (precision, interference, specificity), known concentrations of fentanyl or interfering substances were added to negative urine samples, establishing a controlled ground truth.

8. The Sample Size for the Training Set

• Not explicitly stated in the document, and likely not applicable in the typical AI/ML sense. This device is an immunoassay, not an AI/ML diagnostic algorithm that undergoes a "training" phase with a large dataset. Immunoassays are based on biochemical principles and do not "learn" from data in the same way. Performance is optimized during development and validated analytically.

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

• Not Applicable / Not Described. As it's not an AI/ML device relying on a training set, the concept of establishing ground truth for training does not apply here. The analytical performance is characterized through rigorous testing under controlled conditions and comparison to established reference methods (like LC-MS/MS).

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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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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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The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Superbio Immunofluorescence Analyzer EASY-11. This in vitro diagnostic device is for prescription use only.

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.

This test uses a lateral flow design with location-dependent lines and zones. The Immunofluorescence Analyzer EASY-11 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 detection limit, the antigen in the sample and the fluorescence-labeled antibody bind to the FTY antigen-antibody 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 and the antigen in the sample competitively bind the FTY antibody labeled with fluorescence, then the T-line captures no fluorescence signal. When the samples do not contain fentanyl antigen or levels below the detection limit, as the sample flow, fluorescent microsphere labeled antibody to nitrocellulose membrane T line captures fluorescent 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 sheep antirabbit 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.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text.

Acceptance Criteria and Device Performance for Superbio Fentanyl Urine Detection Kit

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, the performance characteristics are reported as results of various analytical studies.

Table 1: Analytical Performance of the Superbio Fentanyl Urine Detection Kit

• 7/7 low negative samples correctly identified.
• 17/17 very low negative samples correctly identified.
• 13/16 near-cutoff negative samples correctly identified.
• 21/24 near-cutoff positive samples correctly identified.
• 16/16 high positive samples correctly identified.
  Site 2 & 3: Very similar results with minimal variations in near-cutoff performance. Total 80 samples per site. |

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

• Test Set Sample Size:
  • Precision Study: For each of 9 concentration levels, 6 runs per day for 10 days per device lot were performed. With 3 lots, this implies 9 concentrations * 6 runs * 10 days * 3 lots = 1620 individual tests (though not explicitly stated as unique samples for each test). Samples were prepared by spiking fentanyl in negative samples.
  • Interference Study: Not explicitly stated, but "three batches of each device" were used, and samples were drug-free urine and target drug fentanyl urine spiked at specific concentrations.
  • Specificity (Cross-Reactivity) Study: "Three batches of device" were used with various fentanyl analogs and other opioid compounds.
  • Effect of Urine Specific Gravity and Urine pH: "Three lots of device" were used.
  • Method Comparison Study: 80 unaltered clinical samples were used per site across three different testing sites, totaling 240 clinical samples.
• Data Provenance: The document does not explicitly state the country of origin for the clinical samples used in the method comparison study. The samples were described as "unaltered clinical samples." It does not specify if these were retrospective or prospective, but the context of "clinical samples" for method comparison suggests they were collected for diagnostic purposes, which could be either.

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

• Ground Truth for Test Set: The ground truth for the clinical samples in the method comparison study was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate and commonly accepted confirmatory method for drug testing, often considered the gold standard.
• Number and Qualifications of Experts: The document does not mention the use of human experts to establish the ground truth for the test set. LC/MS results are objective chemical measurements, not subjective expert interpretations.

4. Adjudication method for the test set

• Not applicable as the ground truth was established by LC/MS, which is an objective analytical method, not human interpretation requiring adjudication.

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 or reported. This device is an in vitro diagnostic (IVD) kit that is read by an automated immunofluorescence analyzer (Superbio Immunofluorescence Analyzer EASY-11), not by human readers interpreting images. Therefore, the concept of human readers improving with AI assistance is not relevant in this context.

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

• Yes, the performance studies described are essentially standalone algorithm performance (though the "algorithm" is embedded in the immunoassay and analyzer's interpretation). The Superbio Fentanyl Urine Detection Kit, combined with the Superbio Immunofluorescence Analyzer EASY-11, functions as a system that provides a qualitative result (positive/negative) based on the fluorescent signal. The method comparison study directly compares the device's output to the LC/MS ground truth, representing its standalone performance. The operator's role is to run the test, not interpret the result.

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

• LC/MS (Liquid Chromatography/Mass Spectrometry) was used as the ground truth for the clinical samples in the method comparison study. For the analytical studies (precision, interference, specificity), ground truth was established by preparing samples with known concentrations (e.g., spiking fentanyl into negative urine) and confirming these concentrations with LC/MS where applicable.

8. The sample size for the training set

• The document does not describe a training set or machine learning model in the conventional sense. The Superbio Fentanyl Urine Detection Kit and Superbio Immunofluorescence Analyzer EASY-11 operate based on established immunochemical principles and fixed analytical protocols, not a trainable artificial intelligence algorithm. Therefore, there is no "training set" to report.

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

• Not applicable, as there is no training set for this type of IVD device.

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The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:

This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.

Quidel Triage® MeterPro:

The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.

Quidel Triage® TOX Drug Screen, 94600:

The Quidel Triage® TOX Drug Screen, 94600 is a single use test device and is used in conjunction with the Quidel Triage® MeterPro. The device contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.

Quidel Triage® MeterPro:

The Quidel Triage MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage MeterPro can be used in a laboratory or in a point-of-care setting.

The Quidel Triage MeterPro uses a laser as a light source. Light from the laser hits a test device that has been inserted in the meter. This causes the fluorescent dye in the test device to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.

The provided document describes the Quidel Triage® TOX Drug Screen, 94600 and the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine. The acceptance criteria and the study results are detailed in the "Performance Characteristics" section (1.13) and "Comparison studies" section (1.13.2.a).

Here's a breakdown of the requested information:

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

The acceptance criteria for each analyte are based on the percentage of positive and negative results at concentrations around the cutoff, as shown in the "Precision/Reproducibility" data in section 1.13.1.a and "Assay cut-off" in section 1.13.1.f. The primary performance metric from the method comparison study (1.13.2.a) is the agreement between the Quidel Triage TOX Drug Screen, 94600 and GC/MS or LC-MS/MS values, particularly for specimens near the threshold and outside the threshold.

Below is a summary table, combining data from the precision/reproducibility testing (1.13.1.a) and the method comparison study (1.13.2.a). For the precision/reproducibility, a high percentage of correct results (e.g., all negative below -75% of cutoff, all positive above +50% of cutoff) would be considered acceptance. For method comparison, "agreement" is implicitly the acceptance criteria, with discordant results requiring explanation.

• 126 ng/mL (-75%): 720/720 Neg (100%)
• 760 ng/mL (+50%): 720/720 Pos (100%)
• 522 ng/mL (Cutoff): 50 Neg/669 Pos (89.5% Pos) | Out of 220 samples:
• Negative (150% of threshold): 2 Neg/98 Pos (98% Pos)
  (Discordant results acknowledged and explained related to isomeric cross-reactivity.) |
  | mAMP (500 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 250 ng/mL (-50%): 720/720 Neg (100%)
• 742 ng/mL (+50%): 720/720 Pos (100%)
• 529 ng/mL (Cutoff): 281 Neg/431 Pos (60.0% Pos) | Out of 218 samples:
• Negative (150% of threshold): 7 Neg/91 Pos (92.9% Pos)
  (Discordant results acknowledged, with some attributed to isomeric differences in cross-reactivity.) |
  | BAR (200 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 53 ng/mL (-75%): 736/736 Neg (100%)
• 306 ng/mL (+50%): 719/719 Pos (100%)
• 192 ng/mL (Cutoff): 111 Neg/605 Pos (84.5% Pos) | Out of 218 samples:
• Negative (150% of threshold): 0 Neg/97 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | BZO (200 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 58 ng/mL (-75%): 704/704 Neg (100%)
• 306 ng/mL (+50%): 720/720 Pos (100%)
• 219 ng/mL (Cutoff): 318 Neg/402 Pos (55.9% Pos) | Out of 221 samples:
• Negative (150% of threshold): 0 Neg/99 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | COC (150 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 76 ng/mL (-50%): 719/719 Neg (100%)
• 218 ng/mL (+50%): 736/736 Pos (100%)
• 157 ng/mL (Cutoff): 26 Neg/694 Pos (96.4% Pos) | Out of 220 samples:
• Negative (150% of threshold): 0 Neg/99 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | EDDP (100 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 29 ng/mL (-75%): 720/720 Neg (100%)
• 143 ng/mL (+50%): 716/716 Pos (100%)
• 111 ng/mL (Cutoff): 126 Neg/594 Pos (82.5% Pos) | Out of 220 samples:
• Negative (150% of threshold): 0 Neg/98 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | OPI (300 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 165 ng/mL (-50%): 722/722 Neg (100%)
• 480 ng/mL (+50%): 720/720 Pos (100%)
• 344 ng/mL (Cutoff): 197 Neg/507 Pos (72.0% Pos) | Out of 220 samples:
• Negative (150% of threshold): 1 Neg/98 Pos (99.0% Pos)
  (Some discordant results explained by secondary reference testing.) |
  | THC (50 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 12 ng/mL (-75%): 716/716 Neg (100%)
• 78 ng/mL (+50%): 4 Neg/700 Pos (99.4% Pos)
• 54 ng/mL (Cutoff): 163 Neg/559 Pos (77.4% Pos) | Out of 221 samples:
• Negative (150% of threshold): 0 Neg/99 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | TCA (1000 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 498 ng/mL (-50%): 719/719 Neg (100%)
• 1577 ng/mL (+50%): 1 Neg/719 Pos (99.9% Pos)
• 996 ng/mL (Cutoff): 218 Neg/518 Pos (70.4% Pos) | Out of 220 samples:
• Negative (150% of threshold): 1 Neg/95 Pos (99% Pos)
  (Some discordant results explained by data entry errors or pH interference.) |

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

• Precision/Reproducibility Test Set:
  • For each of the 9 analytes, 720-736 samples were tested for each concentration point (0 to +100% of cutoff, plus negative control). This means for each analyte, n=720-736 replicates were performed at each concentration.
  • Data provenance: Not explicitly stated, but the submission is for the FDA in the US. The study involved "three (3) study sites" which implies data collection within a controlled, prospective study setting, most likely in the US, given the FDA submission. The samples were "blinded and randomized" prior to testing.
• Method Comparison Test Set:
  • The total number of samples for each analyte in the method comparison study with GC/MS or LC-MS/MS varies slightly per analyte but is around 220 samples (e.g., for AMP, 99+11+2+98+0+0+8 = 218 specimens + 2 discordant cases).
  • Data provenance: The samples were described as "unaltered urine specimens," implying they were clinical samples. The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the use of "patient specimens" strongly suggests prospective collection for the purpose of the study.

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

• For the Precision/Reproducibility study, the ground truth was established by the prepared concentrations of the analytes (e.g., negative control, 25%, 50%, 75%, cutoff, 125%, 150%, 175%, and 200% of cutoff). This does not involve human experts establishing ground truth for individual samples, but rather analytical controls.
• For the Method Comparison study, the ground truth was established by a "reference method," specifically GC/MS or LC-MS/MS values. These are analytical methods considered the gold standard for drug confirmation and quantification. This does not involve human experts establishing ground truth for each case, but rather the laboratory performing these reference methods. No specific number or qualifications of experts operating these reference instruments are mentioned, as the results of these instruments are considered the objective ground truth.

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

• For the Precision/Reproducibility study, no adjudication method is explicitly described as the results are based on measured values against known concentrations.
• For the Method Comparison study, particularly for discordant results between the device and the reference method, an adjudication process did occur. In some cases, explanations are provided for the discordance (e.g., isomeric cross-reactivity for AMP and mAMP, the presence of multiple metabolites for BZO and OPI, pH interference for TCA, or data entry errors). For OPI, one discordant case (Specimen ID 572644) was sent to a "second reference testing laboratory" for reconfirmation, which then aligned with the device's negative result. This indicates a form of secondary confirmation/adjudication by an additional reference lab for specific discordant cases, rather than a typical 2+1 or 3+1 expert consensus model for image/clinical interpretation.

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

• This document describes an in vitro diagnostic (IVD) device that performs qualitative drug screening using a fluorescence immunoassay and a meter (Quidel Triage® MeterPro). It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or clinical data. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable to this device.

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

• The Quidel Triage® TOX Drug Screen, 94600 with the Quidel Triage® MeterPro functions as a standalone device in terms of producing a "POS" or "NEG" result for each drug assay. The meter reads the test device and provides a direct qualitative result. While the meter requires a human operator to insert the device and, if desired, print or transmit results, the interpretation of the fluorescence signal into a positive or negative drug screen result is entirely performed by the instrument's programming, which is equivalent to an "algorithm only" performance. The performance data presented in the precision/reproducibility and method comparison studies directly reflect this standalone performance.

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

• For the analytical performance studies (precision/reproducibility, analytical specificity, cutoff characterization), the ground truth was established by known prepared concentrations of drugs/metabolites or spiking experiments.
• For the method comparison study, the ground truth was established by Gas Chromatography / Mass Spectroscopy (GC/MS) or Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) values. These are analytical "gold standard" methods.

8. The sample size for the training set

• The document describes a 510(k) submission for a new IVD device and presents validation studies. It does not explicitly mention a "training set" in the context of machine learning or AI models. The studies are designed to demonstrate the analytical performance and substantial equivalence of the device to existing predicate devices. Therefore, a specific training set sample size is not applicable/not provided in this type of submission. The performance data is from a test/validation set.

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

• As a "training set" is not explicitly referenced in the context of AI/machine learning development, the method of establishing its ground truth is not applicable/not provided. The ground truth for the validation studies (test sets) was established via known concentrations of analytes and reference methods (GC/MS, LC-MS/MS) as detailed above.

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The Sofia Strep A+ FIA detects Group A Streptococcal antigens from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by either bacterial culture or an FDA-cleared molecular assay because negative results do not prection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.

The Sofia Strep A+ FIA may be used with Sofia or Sofia 2.

The Sofia Strep A+ FIA involves the extraction of the antigenic components of the Group A Streptococcus (GAS) bacteria. The patient's Swab sample is placed in the Reagent Tube containing the Reagent Solution, during which time the bacterial antigens are extracted, making them more accessible to the specific antibodies. An aliquot of the extracted sample is dispensed into the Test Cassette sample well. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If Group A Streptococcal antigens are present, they will be bound by antibodies coupled to fluorescent microparticles that migrate through the test strip. The fluorescent microparticles containing bound antigen will be captured by antibodies at a defined location on the test strip where they are detected by Sofia or Sofia 2. If antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia or Sofia 2.

Depending upon the user's choice, the Test Cassette is either placed inside of Sofia or Sofia 2 for automatically timed development (WALK AWAY Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (READ NOW Mode).

Sofia or Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Test results will be displayed (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.

Sofia 2 is a microprocessor-controlled device about the size of a desk top telephone and weighs less than 3 pounds. Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results.

The Sofiea Strep A+ FIA is a device intended to detect Group A Streptococcal antigens from throat swabs of patients with signs and symptoms of pharyngitis. All negative test results must be confirmed by either bacterial culture or an FDA-cleared molecular assay.

As this is a 510(k) submission, the device does not have explicit acceptance criteria mentioned, but rather demonstrates substantial equivalence to a predicate device. The performance data section of the document describes several studies undertaken to document the performance characteristics of the Sofia 2 and the Sofia Strep A+ assay, as well as to compare performance between Sofia and Sofia 2.

Here's the information about the studies presented:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each test set in these studies, nor does it specify the country of origin of the data or whether the studies were retrospective or prospective. It refers to "a panel of clinical samples" for the Method Comparison study and "a panel of test samples" for the Reproducibility study.

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

This information is not provided in the document. The nature of the device (antigen detection) likely implies a microbiological gold standard (e.g., bacterial culture), rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

A MRMC comparative effectiveness study involving human readers and AI assistance is not mentioned. The studies focus on the performance of the device itself and its equivalence to a predicate device.

6. Standalone Performance Study:

Yes, standalone performance studies were done. All the studies listed in the "Performance Data" section (LoD, Precision, Assay development time, Method Comparison, Reproducibility) assess the performance of the Sofia Strep A+ FIA on Sofia 2 (and its comparison to Sofia) as a standalone algorithm/device without explicit human-in-the-loop performance measurement.

7. Type of Ground Truth Used:

The document mentions that negative test results "should be confirmed by either bacterial culture or an FDA-cleared molecular assay." This implies that bacterial culture or an FDA-cleared molecular assay would serve as the ground truth for determining the presence or absence of Group A Streptococcal infection in the clinical sample studies.

8. Sample Size for the Training Set:

The document does not provide information about a specific training set or its sample size. This is common for this type of in vitro diagnostic device, where performance is evaluated against known concentrations or clinical samples with confirmed status, rather than training a machine learning model in the conventional sense.

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

As there is no mention of a traditional training set for a machine learning model, the method for establishing ground truth for a training set is not applicable or described in this document. The "ground truth" for the performance evaluation studies would be established using validated methods like bacterial culture or FDA-cleared molecular assays, as mentioned in the indications for use.

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The CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction.

The Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the rapid diagnosis of heart disease, for example, acute myocardial infarction.

For in vitro diagnostic use. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

The AQT90 FLEX is a cartridge-based immunoassay analyzer, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.

This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups – no liquids other than the sample itself together with the assay buffer are required.

The provided document is a 510(k) premarket notification from Radiometer Medical ApS for their AQT90 FLEX CKMB Test Kit, AQT90 FLEX Myo Test Kit, and the AQT90 FLEX analyzer. The submission is to seek clearance for modifications to the existing AQT90 FLEX system devices.

The document does not describe a study involving an AI model or a human-in-the-loop performance study. Instead, it describes analytical performance studies of in-vitro diagnostic assays (Myoglobin and CKMB) on a laboratory analyzer. Therefore, many of the requested elements pertaining to AI models, human experts, ground truth adjudication, MRMC studies, and training datasets are not applicable to this document.

However, I can extract information related to the acceptance criteria (implicitly, the performance metrics evaluated) and the studies conducted to prove the device meets these criteria in the context of an in-vitro diagnostic device.

Here's a breakdown of the available information:

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

For an in-vitro diagnostic device, acceptance criteria are typically related to analytical performance characteristics such as linearity, limits of detection/quantitation, method comparison (agreement with a predicate), and precision. The reported device performance is the outcome of the studies conducted for these characteristics.

AQT90 FLEX Myo Test Kit

AQT90 FLEX CKMB Test Kit

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

• Linearity (Myo & CKMB): 11 sample levels for linearity series, measured with 10 replicates each. This is an in vitro analytical study, not patient data.
• LoB/LoD/LoQ (Myo & CKMB):
  • LoB: Four blank samples measured with 5 replicates on 3 days, using 2 test kit lots and 2 analyzers. Total 60 measurements per test kit lot.
  • LoD/LoQ: 10 samples per matrix (lithium heparin whole blood and plasma).
• Method Comparison (Myo & CKMB):
  • Myo: n=103 lithium heparin plasma samples.
  • CKMB: n=107 lithium heparin plasma samples.
• Matrix Comparison (Myo & CKMB):
  • Myo: n=125 for most comparisons (e.g., Liph/Pl vs Liph/WB), some n=127. Paired lithium heparin and EDTA specimens.
  • CKMB: n=106 for Liph/Pl vs Liph/WB, others n=104, 103, 101. Paired lithium heparin and EDTA specimens.
• Precision (Myo & CKMB):
  • Whole Blood: 3 lithium heparin whole blood samples, measured 5 times five replicates (total 25 measurements per sample level).
  • Plasma: 3 lithium heparin plasma pools, measured across 20 test days, twice a day with 2 replicates (total 80 measurements per sample level).

Data Provenance: The studies were conducted "at one internal test site" for method comparison and "at three hospital laboratory sites" for matrix comparison. This indicates domestic (likely Denmark, where the manufacturer is located) or potentially international clinical laboratory settings. The data are prospective in the sense that they were generated specifically for these validation studies using prepared samples (diluted native specimens, spiked specimens, blank samples). They are not patient-outcome data or retrospective chart reviews.

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

• Not Applicable. For an in-vitro diagnostic device measuring analytes (myoglobin, CK-MB), the "ground truth" isn't established by human experts in the same way as, for example, image interpretation. The ground truth for these studies is the reference measurement from the original (predicate) device or the known concentration of prepared analytical samples.

4. Adjudication Method for the Test Set:

• Not Applicable. No human interpretation or adjudication is involved in determining the concentration of analytes in a blood sample by an immunoassay method.

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

• No. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation. This document describes the analytical performance of an in-vitro diagnostic device that quantitatively measures biochemical markers. There are no human readers or AI assistance involved in this context.

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

• Yes, in the context of an IVD. The performance data presented (linearity, LoD/LoQ, method comparison, precision) are all "standalone" in the sense that they demonstrate the analytical performance of the AQT90 FLEX system (analyzer and test kits) independent of human interpretation or intervention beyond proper sample handling and instrument operation. This isn't an "algorithm only" in the AI sense, but rather the performance of analytical machines.

7. The Type of Ground Truth Used:

• Reference Measurement/Known Concentration:
  • For Linearity, LoB/LoD/LoQ, and Precision: The ground truth is established by preparing samples with known or precisely characterized concentrations of the analytes (e.g., diluted native specimens, spiked specimens, blank samples).
  • For Method Comparison: The ground truth is the measurement obtained from the predicate device (the previously cleared version of the AQT90 FLEX system devices). The goal is to show agreement between the modified device and the predicate.

8. The Sample Size for the Training Set:

• Not Applicable. This document describes the validation of an in-vitro diagnostic device, not an AI model. Therefore, there's no "training set" in the machine learning sense. The device performs a chemical reaction and optical measurement based on established immunoassay principles, not a learned algorithm trained on data.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant.

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The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared RSV molecular assay.

The Sofia RSV FIA may be used with the Sofia or Sofia 2.

The Sofia RSV FIA test employs immunofluorescence technology that is used with Sofia for the rapid detection of RSV antigens. The Sofia RSV FIA test involves the disruption of RSV viral antigens. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the Cassette sample well. From the sample well, the specimen migrates through a test strip containing various unique chemical environments. If RSV viral antigens are present, they will be trapped in a specific location.

Note: Depending upon the user's choice, the cassette is either placed inside of Sofia or Sofia 2 for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (Read Now Mode).

Sofia or Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Test results will be displayed (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.

Sofia 2 is a microprocessor-controlled device about the size of a desk top telephone and weighs less than 3 pounds. Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results.

The document describes the Sofia RSV FIA device and its performance, but it does not contain a detailed table of acceptance criteria and reported device performance with specific metrics like sensitivity and specificity, nor does it detail the specific clinical study design, sample sizes, and ground truth establishment methods for a clinical evaluation.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "Numerous studies were undertaken to document the performance characteristics of Sofia 2 and the Sofia RSV assay, as well as to compare the performance between Sofia and Sofia 2." The conclusion is that "These studies demonstrated equivalent performance of the Sofia RSV FIA on the Sofia and Sofia 2 analyzer."
While specific numerical acceptance criteria (e.g., "sensitivity must be >90%") are not explicitly stated within this document, the studies listed (Limit of Detection, Precision, Assay Development Time, Early Read, Method Comparison, Reproducibility) confirm the equivalence of the Sofia RSV FIA on Sofia 2 to the predicate device (Sofia RSV FIA on Sofia). This implies that the acceptance criteria for performance are met if the performance on Sofia 2 is comparable to the already cleared Sofia device.

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

The document mentions "a panel of clinical samples" for the Method Comparison study and "a panel of test samples at various RSV concentrations" for the Reproducibility study. However, the specific sample sizes for these test sets are NOT provided. The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated in this document.

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 an in vitro diagnostic device like Sofia RSV FIA, the "ground truth" for clinical samples is typically established by a reference method, such as viral culture or an FDA-cleared molecular assay for RSV, as mentioned in the "Indications for Use" for confirming negative results. Expertise would be in performing and interpreting these reference methods.

4. Adjudication Method for the Test Set

This information is not provided in the document, as it likely pertains to expert review of ambiguous cases, which is not described.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not described in this document. This device is an in vitro diagnostic (IVD) test, which is a standalone algorithm-based test. The "readers" would be the Sofia/Sofia 2 instruments themselves, not human interpreters of AI output.

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

Yes, the studies described are standalone performance evaluations of the Sofia RSV FIA device (algorithm only), specifically when performed on the Sofia 2 analyzer, and comparing its performance to the Sofia analyzer. The device automatically scans the test strip and processes results using "method-specific algorithms." Humans load the cassette and read the displayed result.

7. The Type of Ground Truth Used

The "Indications for Use" section states: "A negative result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared RSV molecular assay." This indicates that the ground truth for clinical samples, especially for confirmation, would be established by these reference methods. For laboratory studies like LoD and Reproducibility, the ground truth would be based on known concentrations of RSV.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. For an IVD device like this, the "algorithm" is likely developed and refined during the product development phase (which would involve internal testing and optimization data, akin to a training set), but specific details on that are not provided in this regulatory submission summary for substantial equivalence. The studies described are performance validation studies.

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

Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided. If an algorithm was trained, the ground truth would typically be established through highly accurate reference methods (like viral culture or PCR) on a diverse set of samples.

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The FREND™ PSA Plus as performed on the FREND™ system, is a quantitative in vitro diagnostic test which measures total Prostate Specific Antigen (PSA) in human serum and plasma. The NanoEnTek FREND™ PSA Plus is designed for in vitro DIAGNOSTIC USE ONL Y for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, heparinized plasma, and EDTA plasma using the FREND™ System. This device is indicated for the serial measurement of total PSA in serum, heparinized plasma and EDTA plasma to be used as an aid in the management of patients with prostate cancer.

The FREND™ PSA Plus is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in managing patients with prostate cancer.

The information provided from this test may supplement decision-making and should only be used in conjunction with routine monitoring by a physician and the use of other diagnostic procedures. Because of the variability in the effects of various medications used in the treatment of prostate cancer, clinicians should use professional judgment in the interpretation of PSA results as an indicator of disease status.

The FREND™ PSA Plus is a rapid fluorescence immunoassay that measures prostate specific antigen (PSA) in human serum and in lithium heparin and EDTA plasma using the FREND™ system. The FREND™ PSA Plus is intended for use as an aid for prostate cancer management. The FREND™ PSA Plus Test is a single use fluorescence immunoassay designed to quantify the concentration of total PSA in serum and lithium heparin and EDTA plasma samples. The specimen is added by the operator to the sample inlet with a transfer pipet, allowing the appropriate volume of sample (30 µL) to be delivered into the FREND™ PSA Plus Test Cartridge. The Cartridge is then placed into the FREND™ System, which is programmed to begin analysis once the sample has reacted with the reagents. The reaction and analysis time is approximately 6 minutes. The PSA quantification is based on the amount of fluorescence detected by the FREND™ System at the FREND™ PSA Plus Test Cartridge window. A higher level of fluorescence is indicative of a higher PSA concentration. In other words, the magnitude of the fluorescent signal is directly proportional to the amount of total PSA in the sample.

The FREND™ System is a bench top fluorescence reader containing a touchscreen user interface. The System has a slot that accepts the FREND™ PSA Plus Test Cartridge (which contains the reagents and sample), and is programmed to analyze the Test when the sample has fully reacted with the on-board in cartridge reagents. Results of the test are displayed on the screen and can be printed on an optional printer through the RS232C interface.

Here's a summary of the acceptance criteria and study findings for the FREND™ PSA Plus on the FREND™ system, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

| Performance Metric | Acceptance Criteria (Stated or Implied) | Total (Total CV%) | |
| Site-to-Site Value) | 3.50% | 1.57% | 1.67% | 3.47% | 1.61% | 2.06% | |
| Inter-cartridge | 18.45% | 6.81% | 7.94% | 20.03% | 6.17% | 7.49% | |
| Total (Total CV%) | 20.87% | 7.74% | 10.79% | 21.22% | 7.69% | 9.81% | |

Note: The document explicitly states "acceptance criteria" for some tests (e.g., dilution linearity, spiked recovery, interference) but for others (e.g., imprecision, method comparison), it describes the results and concludes they are "acceptable" or "compared well," implying that the performance met internal thresholds comparable to predicate devices.

2. Sample Sizes and Data Provenance

• Clinical Samples: 1219 evaluable clinical serum samples.
  • Provenance: Prospectively collected stored samples were utilized for the clinical study. No specific country of origin is explicitly stated, but NanoEnTek is a Korean company with a CRO (DOCRO, Inc.) in the US, and testing was done at both NanoEnTek facilities and CLIA licensed facilities in the US.
• Precision (Analytical):
  • Intra-assay/inter-assay/complex imprecision: Three clinical samples (0.186, 2.757, 16.625 ng/mL) assayed in duplicates twice a day for 20 days using a single lot cartridge (total 80 measurements per sample).
  • Multi-Site, Multi-Lot Imprecision: Four replicates each of Material A, B, C and two replicates of QC 1, 2, 3 were evaluated in two runs performed for five days at each of three geographically diverse sites. This yielded a total of 40 results on each material per site, and 120 total replicates for each material across all sites.
• Dilution Linearity & Recovery: A serum pool with elevated PSA (34 ng/mL) was diluted to seven levels, plus neat and zero samples. Each level was tested in 6 replicates.
• Spiked Recovery: A serum pool from females (tPSA

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AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction.

AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer.

AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.

The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.

This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.

Here's an analysis of the provided text regarding the AQT90 FLEX Myo Test, Myo CAL cartridge, and LQC Multi-CHECK, detailing the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes the AQT90 FLEX Myo Test being compared to a predicate device, the ARCHITECT STAT Myoglobin. The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate device, particularly in terms of analytical performance.

A key performance metric presented is the correlation between the new device and the predicate device for Myoglobin measurements.

Table of Acceptance Criteria and Reported Device Performance

Study Details

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

   • Whole Blood Samples: 157 samples
   • Plasma Samples: 165 samples
   • Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using existing samples to compare performance against a predicate device.

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

   • Not Applicable. This study is a comparative method study for an in vitro diagnostic device, comparing its quantitative measurements against a previously cleared predicate device. "Ground truth" in this context is the quantitative measurement provided by the predicate device, not expert interpretation of images or clinical outcomes.

3. Adjudication method for the test set:

   • Not Applicable. As mentioned above, this is a quantitative comparison, not a study requiring adjudication of expert interpretations.

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

   • Not Applicable. This document describes an in vitro diagnostic device for quantitative measurement of myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.

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

   • Yes. The study presents the performance of the AQT90 FLEX Myo assay (the algorithm/device only) in measuring myoglobin concentrations and comparing these measurements directly to those obtained from the predicate device. There is no human-in-the-loop component in the measurement process itself.

6. The type of ground truth used:

   • The "ground truth" for comparison was the measurements obtained from the predicate device: ARCHITECT STAT Myoglobin assay. This is considered a "reference standard" or "comparator method" for demonstrating substantial equivalence.

7. The sample size for the training set:

   • Not explicitly stated in the provided text. The document describes a "comparison" study. For quantitative IVD devices, a "training set" in the machine learning sense is not typically discussed in 510(k) summaries as the device calibration and analytical method development process usually involves proprietary internal development and validation, separate from the clinical performance comparison against a predicate.

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

   • Not explicitly stated. As noted above, typical IVD development involves extensive analytical validation. The "ground truth" for establishing the device's accuracy and precision during its development (analogous to a training phase) would involve reference materials, spiked samples, and potentially calibrators whose concentrations are established using highly accurate reference methods or certified reference materials. The provided document focuses on the comparison to the predicate device for regulatory submission.

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