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The INNOFLUOR® Gentamicin Assay System is an in vitro diagnostic device intended for the quantitative determination of total Gentamicin in serum for therapeutic drug monitoring by fluorescence polarization immunoassay. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.

The INNOFLUOR® Gentamicin Reagent Set is intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The reagent set is intended for use in the INNOFLUOR® Gentamicin Assay System.

The INNOFLUOR® Gentamicin Calibrator Set is intended for use in the calibration of the INNOFLUOR® Gentamicin Assay System.

The INNOFLUOR® Gentamicin Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer. The system consists of the INNOFLUOR® Gentamicin Reagent Set and the INNOFLUOR® Gentamicin Calibrator Set, which are packaged and sold separately.

This 510(k) summary describes a new version of an existing device, the INNOFLUOR® Gentamicin Assay System, referred to as "INNOFLUOR®, Modified." The submission aims to demonstrate substantial equivalence to the previously existing INNOFLUOR® Gentamicin Assay System ("INNOFLUOR®, Existing") and the Abbott Gentamicin Assay. The study described is a comparison study, not a standalone performance study in the traditional sense, as it relies on comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of specific thresholds for the regression analysis (e.g., a minimum correlation coefficient or acceptable slope/intercept range). Instead, the submission implies that showing strong correlation and close agreement to the predicate devices constitutes meeting the acceptance criteria for substantial equivalence.

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

• Sample Size: 69 patient samples
• Data Provenance: The samples were from "patients receiving gentamicin therapy," implying retrospective samples collected from a clinical setting. The country of origin is not explicitly stated in the provided text.

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

Not applicable. This study does not involve expert-established ground truth in the typical sense of diagnostic imaging or clinical interpretation. The "ground truth" for this study is effectively the results obtained from the predicate devices (Abbott Gentamicin Assay and INNOFLUOR®, Existing).

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative assay comparison study, not one requiring adjudication of diagnostic outcomes. The comparison is based on the numerical results of each assay.

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

Not applicable. This is a laboratory assay for therapeutic drug monitoring, not an AI-assisted diagnostic imaging device that involves human readers.

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

Yes, in a sense. The INNOFLUOR® Gentamicin Assay System, Modified, is the "algorithm" (the assay system) being tested in a standalone manner against two predicate devices. The study compares the quantitative output of the device itself to the quantitative output of other devices. There is no human intervention in the performance of the assay or the generation of its initial result, beyond sample preparation and loading onto the analyzer.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate devices: the Abbott Gentamicin Assay and the INNOFLUOR®, Existing Gentamicin Assay. The study aims to show that the new device's results are equivalent to these established methods.

8. The Sample Size for the Training Set

Not applicable. This device is a biochemical assay and does not appear to involve machine learning models that require a "training set" in the computational sense. The "training" for such assays typically involves method development, optimization, and validation experiments by the manufacturer, rather than a distinct "training set" of patient data for an AI model.

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

As this is not an AI/ML device, the concept of a "training set" and its ground truth in that context does not apply. The development of such an assay would involve extensive analytical validation, including studies of accuracy, precision, linearity, and interference, using reference materials and spiked samples with known gentamicin concentrations. These are internal validation processes by the manufacturer, not typically described as establishing "ground truth for a training set" in a regulatory submission like this.

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The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device intended for the quantitative determination of total Phenobarbital in serum for therapeutic drug monitoring by fluorescence polarization immunoassay. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.

The INNOFLUOR® Phenobarbital Reagent Set is intended for the quantitative determination of total phenobarbital in serum for therapeutic drug monitoring. The reagent set is intended for use in the INNOFLUOR® Phenobarbital Assay System.

The INNOFLUOR® Phenobarbital Calibrator Set is intended for use in the calibration of the INNOFLUOR® Phenobarbital Assay System.

The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device used to monitor serum levels of the therapeutic, anticonvulsant drug, phenobarbital. It is a fluorescence polarization immunoassay based on the competitive binding principle. The system consists of two products: the INNOFLUOR® Phenobarbital Reagent Set (containing Phenobarbital Antibody, Phenobarbital fluorescein TRACER, and PRE TREATMENT BUFFER) and the INNOFLUOR® Phenobarbital Calibrator Set (containing human serum with added phenobarbital at various concentrations). The system is for use on the Abbott TDx® or TDxFLx® analyzer.

The provided text is a 510(k) premarket notification for the INNOFLUOR® Phenobarbital Assay System. It describes the device, its intended use, and provides a summary of the components and principles. However, it does not contain the detailed study information or acceptance criteria and performance data that would typically be found in a clinical study report or a more comprehensive technical document.

Therefore, many of the requested items cannot be definitively answered from the provided text. I will provide information based on what is available and indicate when information is missing.

Acceptance Criteria and Device Performance Study (as much as can be inferred/extracted)

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria or present a table of device performance against such criteria. The closest information pertains to demonstrating "quantitative recovery" and "accuracy" through comparison with other methods/materials.

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

• Sample Size for Test Set: Not explicitly stated. The text refers to "recovery samples" prepared at various concentrations (0.0, 5.0, 7.5, 10.0, 15.0, 20.0, 30.0, 40.0, 60.0 and 80.0 ug/mL) and "multiple lots" of commercially available control materials and proficiency testing samples. It also mentions "patient samples." Specific numbers are absent.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective):
  • Calibrators and Recovery Samples: These are laboratory-prepared samples using human serum (phenobarbital-free normal human serum pool). The origin of this human serum is not specified, but the manufacturing entity (OXIS International, Inc.) is based in Portland, Oregon, USA.
  • Control Materials and Proficiency Testing Samples: These are described as "commercially available," implying they are external, but their specific origin is not detailed.
  • Patient Samples: Mentioned for comparison with a reference assay, but no details on their number or origin.
  • The studies appear to be laboratory-based evaluations of the assay's performance rather than clinical trials with patient cohorts, making the retrospective/prospective distinction less applicable in its typical sense.

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

• This information is not applicable and therefore not provided in the document. The "ground truth" for the calibrators and recovery samples is established by gravimetric preparation with a USP Reference Standard. For control materials and proficiency samples, the "ground truth" is implied to be values published or established by the manufacturers of those materials, often through multi-method analysis, not by individual experts or review panels in the medical imaging sense.

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

• Not applicable as the "ground truth" is established through analytical methods and reference standards, not through expert adjudication of medical cases.

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

• Not applicable. This is an in-vitro diagnostic assay for quantitative determination of a drug in serum, not an imaging device or AI-assisted diagnostic tool that involves human "readers" or "interpreters" in the clinical imaging sense.

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

• This is a standalone assay system. The performance described is that of the assay system itself using the Abbott TDx® or TDxFLx® analyzer. There isn't an "algorithm only" component separate from the reagents and analyzer interaction. Human intervention is required for sample preparation, loading, and interpreting the quantitative result displayed by the analyzer. It's not a "human-in-the-loop" application in the AI sense, but rather a standard laboratory assay where human operators execute the procedure.

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

• Analytical Ground Truth:
  • Calibrators and Recovery Samples: Gravimetric preparation by spiking known concentrations of high-purity phenobarbital analyte (United States Pharmacopoeia Reference Standard for Phenobarbital) into phenobarbital-free normal human serum.
  • Control Materials and Proficiency Testing Samples: Published values associated with commercially available materials, often established through round-robin testing or analysis by multiple reference methods.
  • Patient Samples: Comparison against a "reference assay" (Abbott Phenobarbital FPIA is mentioned as a method used for verification, implying it serves as a comparative reference).

8. The sample size for the training set:

• Not explicitly defined within the context of a "training set" for machine learning. This is a traditional immunoassay system. The development and optimization of the antibody and tracer would involve extensive laboratory work, but not in the sense of a discrete "training set" for an algorithm. The "training" for such a system involves selecting optimal reagents and optimizing assay parameters.

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

• As above, not applicable in the machine learning "training set" context. The "ground truth" for developing and optimizing the assay components (antibody selection, tracer purification, buffer formulation) relies on analytical chemistry principles, experimental validation of binding characteristics, and empirical testing to achieve desired assay performance characteristics (e.g., sensitivity, specificity, dynamic range). The "ground truth" during this development phase would be based on known concentrations of phenobarbital and the chemical and immunological properties of the reagents.

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The INNOFLUOR™ Topiramate Assay System is an in vitro diagnostic device intended for the quantitative determination of total topiramate in serum or heparinized plasma by fluorescence polarization immunoassay. Topiramate serum or heparinized plasma concentrations are measured to aid in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® (TDx or TDxFLx®) analyzer.

The INNOFLUOR™ Topiramate Reagent Set is intended for the quantitative determination of total topiramate in serum or heparinized plasma. The reagent set is intended for use in the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Calibrator Set is intended for use in the calibration of the INNOFLUOR™ Topiramate Assay System. The INNOFLUOR™ Topiramate Reagent Set and Calibrator Set are used together to generate the calibration curve on the TDx or TDxFLx® analyzer. The calibration curve must be established prior to assaying unknown samples. Prior to performing the calibration procedure, the correct analyzer operating parameters must be set by following the instructions provided in the Product Insert Supplement, which is included with every INNOFLUOR™ Topiramate Reagent Set. The INNOFLUOR™ Topiramate Control Set is intended for use in the quality control of the INNOFLUOR™ Topiramate Assay System. The Controls have been selected to best monitor the quality and stability of the calibration curve. The control results must be within established acceptable ranges before patient samples are assayed.

The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay for the quantitative determination of total topiramate in serum or heparinized plasma. Topiramate serum or heparinized plasma concentrations are measured to aid in achieving appropriate therapy. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.

Here's a summary of the acceptance criteria and study detailed in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 117 patient samples.
• Data Provenance: The text states these were "patient samples from patients receiving Topiramate therapy," implying real-world patient data. There is no information provided about the country of origin or whether it was retrospective or prospective.

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

• Not applicable/Not mentioned. The ground truth was established by Topiramate Gas Chromatography (GC), which is a laboratory method, not expert interpretation.

4. Adjudication Method for the Test Set

• Not applicable. The comparison was against a reference laboratory method (GC), not human assessment 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

• Not applicable. This is a diagnostic assay, not an AI-assisted interpretation study involving human readers.

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

• Yes, the study describes the performance of the INNOFLUOR™ Topiramate Assay System (an automated fluorescence polarization immunoassay) when compared directly to Topiramate Gas Chromatography. This is a standalone performance assessment of the device.

7. The Type of Ground Truth Used

• Reference Method/Laboratory Standard: Topiramate Gas Chromatography (GC) was used as the reference method for determining the "true" Topiramate concentrations in the patient samples.

8. The Sample Size for the Training Set

• Not explicitly mentioned. The provided document focuses on the validation of the device, not its development or training process. It's likely that a training set would have been used during the development of the immunoassay, but this information is not included in this 510(k) summary.

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

• Not mentioned. As with the training set size, details on how the ground truth was established for any potential training set are not included in this document.

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The INNOFLUOR™ Topinamate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.

The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in serum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDxf or the TDxFLX® analyzer.

Here's an analysis of the provided text regarding the INNOFLUOR™ Topiramate Control Set, focusing on the requested information.

It's important to note that this 510(k) summary is for a control set within an assay system, not a diagnostic AI device. Therefore, many of the requested categories (like "multi-reader multi-case study," "number of experts," "adjudication method," etc.) are not applicable in the context of an in-vitro diagnostic (IVD) assay comparison study. The study described focuses on analytical performance rather than diagnostic accuracy involving human interpretation.

Acceptance Criteria and Study Details for INNOFLUOR™ Topiramate Control Set

Based on the provided 510(k) summary, the device under review is the INNOFLUOR™ Topiramate Control Set, which is part of the INNOFLUOR™ Topiramate Assay System. The study described focuses on establishing the analytical performance and substantial equivalence of the overall INNOFLUOR™ Topiramate Assay System, not specifically the control set in isolation, but rather its performance in measuring topiramate.

1. Table of Acceptance Criteria and Reported Device Performance

   The document implies acceptance criteria through the reference to "substantial equivalence" and the presentation of a linear regression analysis. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient, maximum bias) are not stated, the demonstration of equivalency is the overarching criterion.

   Acceptance Criteria (Implied)	Reported Device Performance
   Substantial equivalence to current predicate devices/methods.	The technological characteristics, performance and intended use of the INNOFLUOR™ Topiramate Assay System are substantially equivalent to the INNOFLUOR™ Phenobarbital Assay System and the Abbott Phenobarbital II Assay with the exception of the specific anticonvulsant tested for by each method.
   Equivalency of results between INNOFLUOR™ Topiramate Assay System and an established method (Topiramate Gas Chromatography). Demonstrated by strong correlation and acceptable linear regression parameters.	Comparison of the patient sample results by linear regression analysis resulted in the regression equation: (INNOFLUOR™) = 0.985 x (GC) - 0.147, with a correlation coefficient of 0.9934, demonstrating equivalency of results. A correlation coefficient (r) of 0.9934 indicates a very strong linear relationship between the two methods. A slope of 0.985 is very close to 1, and an intercept of -0.147 is very close to 0, suggesting minimal systematic bias between the two methods.

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

   • Sample Size: 117 patient samples.
   • Data Provenance: The origin of the data (country) is not specified. It is prospective in the sense that samples were collected from "patients receiving topiramate therapy" and then analyzed by both methods for comparison. It is not listed as retrospective.

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

   • Not applicable. This study involves comparing the analytical measurement of a specific analyte (topiramate) by two different laboratory methods (fluorescence polarization immunoassay vs. gas chromatography). It does not involve human interpretation of images or other data where experts establish a diagnostic ground truth. The "ground truth" here is effectively the measurement obtained by the established reference method (Gas Chromatography).

4. Adjudication Method for the Test Set

   • Not applicable. See point 3.

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. This is an analytical performance study of an in-vitro diagnostic assay, not a study of an AI system for diagnostic image interpretation or similar.

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

   • Yes, analogous to standalone. The study directly compares the results of the INNOFLUOR™ Topiramate Assay System (algorithm/assay only) against Topiramate Gas Chromatography (reference method), without any human interpretive element being evaluated in the comparison. The "performance" being assessed is the analytical output of the assay system itself.

7. The Type of Ground Truth Used

   • The "ground truth" for the test set was established by Topiramate Gas Chromatography (GC). GC is a well-established and highly accurate analytical method often used as a reference standard for drug quantification.

8. The Sample Size for the Training Set

   • Not explicitly stated in terms of a "training set" for an algorithm. For an IVD assay, method development involves internal studies (calibration, linearity, precision), but these are usually not referred to as "training sets" in the same way as machine learning. The 117 patient samples are specifically for the comparison/validation study.

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

   • Not explicitly applicable in the machine learning sense. For an IVD assay, "ground truth" during development would be established through a carefully controlled laboratory setting, using gravimetrically prepared standards and reference materials, and verified by highly accurate reference methods (like GC or LC-MS/MS). The document does not detail the development process, only the validation comparison.

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The INNOFLUOR™ Topiramate Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total topiramate in senum or heparinized plaama for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxfLx® analyzer.

The INNOFLUOR™ Topiramate Assay System consists of three products that are packaged and sold separately: the INNOFLUOR™ Topiramate Reagent Set, the INNOFLUOR™ Topiramate Calibrator Set and the INNOFLUOR™ Topiramate Control Set. It is a fluorescence polarization immunoassay.

Here's an analysis of the provided 510(k) summary, aiming to extract information about acceptance criteria and the supporting study:

The provided text describes a submission for the INNOFLUOR™ Topiramate Assay System. The core of the submission revolves around demonstrating substantial equivalence to existing devices rather than defining novel acceptance criteria for a new class of device.

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

The submission demonstrates "equivalency of results" between the INNOFLUOR™ system and a reference method (Topiramate Gas Chromatography, GC) using linear regression. While specific predefined "acceptance criteria" for the regression parameters (slope, intercept, correlation coefficient) are not explicitly stated as numerical targets in the document, the reported results are presented as evidence of meeting an implicit standard for equivalence.

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

• Sample Size for Test Set: 117 patient samples.
• Data Provenance: The document states "117 patient samples from patients receiving topiramate therapy." It does not specify the country of origin, nor does it explicitly state if the data was retrospective or prospective, though the phrasing "patient samples from patients receiving topiramate therapy" often implies a retrospective collection from a patient cohort.

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)

This is not applicable to this type of device. The "ground truth" (or reference method) for the test set was established by Topiramate Gas Chromatography (GC). GC is an analytical chemistry technique, not a human expert interpretation.

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

Not applicable. This is not a study involving human interpretation where adjudication would be necessary. The comparison is between two analytical measurement techniques.

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

Not applicable. This is not an AI-based device or an MRMC study. It's a fluorescence polarization immunoassay compared to gas chromatography.

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

Yes, the study described is a standalone performance assessment of the INNOFLUOR™ Topiramate Assay System. It measures topiramate concentrations directly and compares them to values obtained from a reference method (GC), without human intervention in the interpretation of the results themselves. The "algorithm" here would be the immunoassay and analyzer's method for determining concentration.

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

The "ground truth" was established by a reference analytical method: Topiramate Gas Chromatography (GC). This is a well-established and generally accepted method for quantitative determination of substances like topiramate.

8. The sample size for the training set

Not explicitly stated. This summary focuses on the validation of the device, implying the assay system was already developed. For an immunoassay, the "training set" would typically refer to the data used to optimize assay parameters and establish calibration curves during the development phase. This information is typically not included in a 510(k) summary focused on performance comparison.

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

Not explicitly stated in this summary. Similar to point 8, the development process for establishing calibration curves and optimizing assay parameters (which would use standards with "known" concentrations as ground truth) is not detailed. This "ground truth" would also likely involve well-characterized reference materials or other analytical methods to assign target values to calibrators.

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Substantial equivalence has been demonstrated between the INNOFLUOR™ Quinidine Assay System (Modified) the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.

The technological characteristics, performance and intended use of the INNOFLUOR™ Quinidine Assay System (Modified) are substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.

Not Found

Here's a breakdown of the provided information concerning the INNOFLUOR™ Quinidine Assay System (Modified), structured according to your request.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Substantial equivalence has been demonstrated." While specific numerical acceptance thresholds for slope, intercept, and correlation coefficient are not explicitly provided in the input, the reported values are presented as evidence supporting this claim of substantial equivalence. For a medical device, these metrics being close to 1 (for slope and correlation) and 0 (for intercept) are generally considered indicative of good agreement between methods.

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

• Sample Size: 49 serum patient samples.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "patient samples."

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

This section is not applicable to this type of device and study. The "ground truth" for this performance study is established by a reference assay (the Abbott Quinidine Assay), not by human expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used when human interpretation is involved in establishing a ground truth or resolving discrepancies between reviewers. In this case, the comparison is between two analytical assays.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on reader performance. The provided study focuses on comparing the output of an automated assay system directly against a reference assay.

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

Yes, a standalone performance study was done. The INNOFLUOR™ Quinidine Assay System (Modified) is an automated assay system. Its performance was evaluated directly against a reference assay (Abbott Quinidine Assay) without human intervention in the analysis process beyond initiating the test and reading the results.

7. The Type of Ground Truth Used

The "ground truth" in this study is established by the Abbott Quinidine Assay. This is a reference standard or comparator method rather than one of the typical ground truth categories like "expert consensus" or "pathology" for diagnostic imaging. The performance of the modified INNOFLUOR™ system is being evaluated relative to this established, existing assay.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. This suggests that the INNOFLUOR™ Quinidine Assay System (Modified) is likely a re-formulation or modification of an existing assay, and its performance is being compared to established methods rather than being an AI algorithm that requires a distinct training phase in the typical sense. If there was any "training" involved, it would be in the initial development and calibration of the assay, but the document does not detail this.

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

Since no training set information is provided, how its "ground truth" was established is also not applicable/not documented in the provided summary.

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Ask a specific question about this device

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Ask a specific question about this device