The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT iSystem with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

The ARCHITECT iGentamicin Reagent Kit contains:

• Microparticles: 1 bottle (7.11 mL per 100 test cartridge). Anti-gentamicin (mouse, monoclonal) coated microparticles in TRIS buffer with protein (bovine) stabilizer. Minimum concentration: 0.13% solids. Preservatives: ProClin 950 and sodium azide.

• Conjugate: 1 bottle (11.75 mL per 100 test cartridge). Gentamicin acridinium-labeled conjugate in MES buffer. Minimum concentration: 3 nM. Preservative: ProClin 300.

N/A

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VITROS® Automation Solutions is intended to automate pre-analytical sample processing in the clinical laboratory. VITROS® Automation Solutions allows the consolidation of software, automation modules and clinical analyzers, such as VITROS® Systems into a unified workstation to perform a variety of assays such as total T4, carbamazepine and gentamicin.

Carbamazepine measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. Gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. Total thyroxine (T4) measurements are used to aid in the differential diagnosis of thyroid disease.

VITROS® Automation Solutions is a configurable, scalable laboratory automation system (LAS) designed to streamline pre and post analytical processes in the clinical laboratory. VITROS® Automation Solutions is comprised of personal computer (PC) Kit(s) (including software and hardware), sample conveyors with turns, parallel and perpendicular bypasses, storage module, single-tube entry, rack entry and exit, centrifuge, de-capper modules and clinical analyzers.

In the basic configuration, patient sample tubes are loaded onto the automation track to be centrifuged, de-capped, and sorted for further processing on clinical analyzers such as the VITROS® Systems. Additional modules may be added to enable aliquot capability, sample capping, and refrigerated storage.

Parallel and perpendicular bypasses are extensions of the automation track that link with an analyzer's existing laboratory automation system (LAS) interface. These bypasses support on-track metering at the analyzer based on point-in-space pipetting technology and robotic interface module (RIM). With point in space pipetting, the automation performs the sample bar code read function, presents the sample identification to the connected analyzer, and then signals for direct sampling of the open tube by the connected analyzer at an aspiration point on the automation track. With robotic interface modules, the sample tube is transferred to the analyzer and the analyzer will read the bar code to identify the sample, aspirate sample from the tube and perform the test(s) requested and then return the tube to the LAS.

VITROS® Automation Solutions allows the establishment of a connection with clinical analyzers such as VITROS® Systems to enable sample routing based on reagent and calibration status. The clinical analyzers, such as VITROS® Systems, will perform all functions with respect to result generation, including sample metering, assay processing and reporting for the assays.

The VITROS® Systems are fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid.

The VITROS® Systems operate in conjunction with VITROS® Immunodiagnostic and Chemistry Products, reagents, calibrators and controls designed for use with the systems in the MicroSlide, MicroTip or MicroWell format. Representative assays (carbamazepine, gentamicin and total thyroxine) are used to demonstrate acceptable performance.

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

Disclaimer: The provided document is a 510(k) summary for a laboratory automation system. It focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria in the same way a clinical trial for a diagnostic algorithm might. Therefore, some of the requested information (like effect size for MRMC studies, details of expert qualifications, or sample size for training sets) is not directly present as it's not typically required for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the VITROS® Automation Solutions as a standalone device with specific performance metrics (e.g., sensitivity, specificity). Instead, it aims to demonstrate substantial equivalence by showing that assay performance characteristics remain consistent whether samples are introduced manually or via the automation system. The acceptance criterion is implied to be that the automated method should produce results comparable to the manual method.

Conclusion from document: "The test results showed no clinically significant difference in assay performance between the two sample processing methods. This data demonstrates substantial equivalence between VITROS® Automation Solutions and the stand-alone analyzer, VITROS® Systems."

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

• Sample Size for Test Set:
  • CRBM: 70 samples
  • GENT: 55 samples
  • Total T4: 57 samples
• Data Provenance: The study used "patient samples." The country of origin is not specified, but the applicant (Ortho-Clinical Diagnostics, Inc.) is based in Rochester, New York, USA. The study design is retrospective in the sense that existing patient samples were used for comparative testing. It is not explicitly stated if these were left-over clinical samples or prospectively collected for the study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information (number and qualifications of experts) is not relevant or provided for this submission. The "ground truth" here is the result obtained from manual processing on the VITROS® System itself, which is a standardized and validated analytical method, not expert interpretation.

4. Adjudication Method

Not applicable. This study compares analytical results from an automated process versus a manual process using the same analyzer. There's no human interpretation or adjudication involved in establishing the "correct" value, as it's a quantitative measurement compared against another quantitative measurement.

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

No, an MRMC study was not done. This device is a laboratory automation system, not an AI or imaging diagnostic tool that involves human readers. The study focuses on the analytical performance of the automated sample processing system compared to manual processing.

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

Yes, in a sense, the performance shown for the automated system is "standalone" to the degree that it measures the impact of the automation on the analyzer's performance, independent of human intervention beyond loading samples onto the system. The automation itself does not produce a "reading" that a human would then confirm or interpret; rather, it handles the pre-analytical processing to feed into existing, validated analyzers. The data presented demonstrates the performance of tests conducted via the automation solution, which then provides results without further human modification.

7. Type of Ground Truth Used

The ground truth was established by:

• Comparison to manual processing results: The "ground truth" or reference method was the results obtained from samples manually introduced to the standalone VITROS® System (referred to as "off track" in the document). This is a validated and established method on a legally marketed device.

8. Sample Size for the Training Set

This information is not applicable and not provided. This submission is for a laboratory automation system, not a machine learning model that requires a training set. The system's functionality is based on mechanical and software-driven processes, not adaptive learning.

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

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

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The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

The ARCHITECT iGentamicin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma.

The ARCHITECT iGentamicin assay is a one-step immunoassay for the quantitative determination of gentamicin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. In the ARCHITECT iGentamicin assay, sample, anti-gentamicin coated paramagnetic microparticles, and gentamicin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-gentamicin coated microparticles bind to the gentamicin present in the sample and to the acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of gentamicin in the sample and the RLUs detected by the ARCHITECT i System optics.

The provided text describes a 510(k) submission for the ARCHITECT iGentamicin assay and its calibrators. It outlines the intended use, device description, and a summary of analytical performance studies conducted to demonstrate substantial equivalence to a legally marketed predicate device (AxSYM Gentamicin). However, it does not contain specific acceptance criteria values or detailed results of the studies in a manner that would allow for the construction of the requested table and comprehensive answers to all questions.

Here's an attempt to answer based on the available information, with significant limitations due to the missing data:

Acceptance Criteria and Device Performance

The document states that the ARCHITECT iGentamicin assay is "substantially equivalent to the AxSYM Gentamicin assay in terms of analytical performance data in this 510(k) submission." This implies that the acceptance criteria for each validation study would have been defined to demonstrate this equivalence, likely by showing that the performance of the new device is within predefined statistical limits compared to the predicate. However, the specific numerical acceptance criteria and the reported device performance values are not detailed in the provided text.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the given text. The text only lists the types of studies performed (e.g., Precision, Linearity, Method Comparison).

Study Details Based on Available Information:

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

   • Cannot be fully constructed as the specific numerical acceptance criteria and reported performance values are not provided in the input text. The text only lists the types of studies performed without their results or target specifications.

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

   • Not specified in the provided text. The document lists "Method Comparison (Correlation)" as one of the studies, which would typically involve a test set of patient samples. However, details on sample size, origin, or retrospective/prospective nature are absent.

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):

   • Not applicable/Not specified. This device is an in vitro diagnostic (IVD) assay for quantitative determination of gentamicin. Ground truth for such assays is typically established through a reference method or validated analytical techniques, not by expert consensus (e.g., radiologists interpreting images). The text does not mention expert involvement in establishing ground truth for the analytical performance studies.

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

   • Not applicable/Not specified. Adjudication methods are typically used in clinical studies where subjective interpretation (e.g., image reading) is involved. For an IVD assay's analytical performance, the "ground truth" (or reference values) for samples are typically determined by highly accurate and precise analytical methods, not through an adjudication process involving multiple human experts.

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 submission is for an in vitro diagnostic (IVD) reagent kit and calibrator, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study or assessment of human reader improvement with AI is not relevant to this submission.

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

   • Yes, implicitly. The ARCHITECT iGentamicin assay, as an automated chemiluminescent microparticle immunoassay (CMIA), operates as a standalone analytical system to produce quantitative results. Its "performance" refers to the accuracy, precision, linearity, and other analytical characteristics of the assay itself, independent of human interpretation or assistance beyond operating the instrument and processing samples. The "Summary of Analytical Performance" directly addresses its standalone performance.

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

   • For the "Method Comparison (Correlation)" study, the "ground truth" would be the results obtained from the legally marketed predicate device, AxSYM Gentamicin assay, or a recognized reference method. The study would aim to demonstrate correlation and agreement between the new device's results and this established reference. For other analytical studies (Precision, Linearity), the "ground truth" is derived from known concentrations of analytes in control materials or reference standards.

8. The sample size for the training set:

   • Not specified. As an IVD assay based on established chemical and immunological principles, it's unlikely that the "training set" in the sense of machine learning applies directly here. If "training" refers to method development and optimization, the sample sizes used for such internal studies are not detailed in this summary.

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

   • Not applicable in the context of machine learning training. If "training set" refers to samples used during assay development and optimization, the "ground truth" for these samples would typically be established using highly accurate and precise analytical methods, often a reference method or gravimetrically prepared standards with known concentrations. The specific details are not provided in this regulatory summary.

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The DGTX method is an in vitro diagnostic test for the quantitative measurement of digitoxin in serum and plasma on the Dimension Vista™ System. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

The DIG method is an in vitro diagnostic test for the quantitative measurement of digoxin in serum and plasma on the Dimension Vista™ System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

The GENT method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The NAPA method is an in vitro diagnostic test for the quantitative measurement of N-acetylprocainamide in serum and plasma on the Dimension Vista™ System. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.

The PTN method is an in vitro diagnostic test for the quantitative measurement of phenytoin, (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma on the Dimension Vista™ System. Phenytoin measurements may be used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline in human serum and plasma on the Dimension Vista™ System.

Dade Behring Dimension VistaTM Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension VistaTM system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

The provided text describes a 510(k) submission for several Dimension Vista™ Flex® reagent cartridges intended for diagnostic testing. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a packaging modification that allows these reagents to be used on the Dimension Vista™ integrated system. The reagents themselves and their fundamental scientific technology are stated to be the same as the predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical "acceptance criteria" or provide a table of "reported device performance" in the typical sense of a clinical study (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the demonstration of performance relies on comparative testing to show substantial equivalence to the predicate devices. The implicit acceptance criterion is that the performance of the new Dimension Vista™ Flex® reagent cartridges must be substantially equivalent to that of the predicate Dimension® Flex® reagent cartridges.

The text states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." and "Comparative testing also demonstrates substantially equivalent performance."

Since the document is a summary and not the full study protocol, specific performance metrics and their comparison values are not detailed. However, the nature of these in-vitro diagnostic tests typically involves:

• Precision/Reproducibility: Measuring the consistency of results when the same sample is tested multiple times.
• Accuracy/Method Comparison: Comparing the results obtained by the new device against a reference method (in this case, the predicate device results) using patient samples. This often involves statistical methods like regression analysis (e.g., Deming regression) to assess agreement.
• Linearity/Measuring Range: Confirming that the device accurately measures analytes across its claimed analytical range.
• Interference Studies: Assessing the impact of common interfering substances (e.g., hemoglobin, bilirubin, lipids) on the test results.

The key takeaway is that the "acceptance criteria" here are defined by the established performance characteristics of the predicate devices, and the new devices are deemed acceptable if their performance is statistially similar.

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

The document states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." However, it does not specify the sample size used for the comparative testing (test set) or the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

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

This information is not applicable in the context of this 510(k) submission. For in-vitro diagnostic (IVD) devices measuring specific analytes, the "ground truth" is typically the quantitative concentration of the analyte as determined by a reference method or the predicate device itself, not by expert consensus on qualitative interpretation. No human experts are described as establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the submission concerns quantitative measurements of chemical analytes, there is no need for an adjudication method as would be relevant for subjective medical image interpretation or clinical decision-making.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

This information is not applicable. The device is an in-vitro diagnostic reagent cartridge for laboratory analysis, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

The entire "device" described here (the reagent cartridges used on an automated analyzer) operates in a standalone (algorithm/system only) manner in terms of its measurement process. The Dimension Vista™ system is described as a "floor model, fully automated, microprocessor-controlled, integrated instrument system." The reagents enable this automated system to perform the quantitative measurements without direct human intervention in the measurement execution. Human involvement is in sample preparation, loading, and interpretation of the numerical results delivered by the automated system.

7. The Type of Ground Truth Used:

The ground truth for the performed comparative testing would have been the quantitative concentration of the specific analyte (Digitoxin, Digoxin, Gentamicin, N-acetylprocainamide, Phenytoin, Theophylline) as measured by the predicate device. Since the reagents themselves are stated to be the same as the predicate and only the packaging is modified for a new instrument system, the primary ground truth is established by the well-characterized performance of the predicate device on its intended system for each analyte.

8. The Sample Size for the Training Set:

This document does not mention a "training set" in the context of an algorithm or machine learning model. This is expected as the device is a reagent cartridge for a chemical assay, not a machine learning-based diagnostic. Therefore, information about the training set size is not applicable.

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

As there is no "training set" in the machine learning sense, this information is not applicable. The "training" of such a system involves the development and optimization of the chemical assay reagents and the instrument's detection capabilities during the initial development phases of the predicate devices and the Dimension Vista™ analyzer itself.

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The Multigent® Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System. The results obtained are used in the diagnosis and treatment of Gentamicin overdose and in monitoring levels of Gentamicin to ensure appropriate therapy.

The Multigente Gentamicin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti-gentamicin monoclonal antibody and R2: gentamicin-coated microparticles. A six-level set of Multigent" Gentamicin Calibrators (A through F) is used to calibrate the assay.

This document describes the acceptance criteria and the studies performed to demonstrate the performance of the Multigent® Gentamicin assay.

1. Table of Acceptance Criteria and Reported Device Performance:

Note regarding Rheumatoid Factor interference: The reported % Recovery (132.34%) for Rheumatoid Factor at 582 IU exceeds the stated acceptance criteria of 100 ± 10%. This indicates potential interference from high levels of Rheumatoid Factor, which should be noted in the device labeling.

2. Sample Size and Data Provenance:

• Accuracy: 5 samples (0.25, 1.00, 2.25, 4.50, 8.00 µg/mL) each run in triplicate (total of 15 measurements in the table shown). Data provenance not specified (retrospective/prospective, country of origin).
• Linearity: 4 serially diluted samples (6.88, 5.16, 3.44, 1.72 MG/ML) each run in triplicate (total of 12 measurements in the table shown). Data provenance not specified.
• Precision: 3 control levels (low, mid, high) tested, with N=80 for each (number of replicates over time). Data provenance not specified.
• Sensitivity: Calibrator A (0 µg/mL) run for a total of 20 replicates. Data provenance not specified.
• Interferences (Endogenous Substances):
  • Bilirubin: 3 replicates for "N=3" (interpreted as the number of independent samples or measurement replicates, as the "N" column is inconsistent).
  • Hemoglobin: 2 replicates for "N=2".
  • Triglyceride, Total Protein: "N" is listed as a non-numeric character (presumably an error in transcription, but the text mentions "run in triplicate" for triglyceride and total protein).
  • Rheumatoid Factor: "N" is listed as a non-numeric character (text mentions "run in triplicate").
  • Data provenance not specified.
• Interferences (HAMA): Duplicate HAMA samples (Type-1 and Type-2) and duplicate control samples. Data provenance not specified.
• Interferences (Common Co-Administered Drugs): Test samples and control samples assayed in duplicate for each drug. Data provenance not specified.
• Anticoagulants: Blood drawn from at least ten healthy donors for each of the 9 tube types. Samples were spiked with Gentamicin and run in duplicate. Data provenance not specified.
• Method Comparison: 55 serum and plasma samples, ranging from 0.78 to 9.02 µg/mL Gentamicin. Data provenance not specified.

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

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a drug concentration. The "ground truth" for chemical concentration assays is typically established by reference methods, primary standards, or gravimetric/volumetric preparation of known concentrations. There is no mention of human "experts" establishing ground truth in the traditional sense of clinical opinion (e.g., radiologists, pathologists). The ground truth for performance studies like accuracy and linearity is based on the theoretical concentrations of prepared samples or reference materials. For method comparison, the predicate device (Abbott TDx®/TDxFLx® Gentamicin assay) serves as the reference method.

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

Not applicable. Adjudication methods are typically used in studies involving subjective assessment (e.g., image interpretation) where multiple readers provide independent evaluations that might conflict. For quantitative chemical assays, the result is a numerical value, and "adjudication" is not a standard practice. Statistical methods are used to compare results to expected values or reference methods.

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, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.

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

The performance studies described (Precision, Accuracy, Linearity, Sensitivity, etc.) represent the standalone performance of the Multigent® Gentamicin assay system. The device itself generates a quantitative result without direct human interpretation of a visual output. The human-in-the-loop would be the laboratory personnel operating the Architect C8000 System and interpreting the numerical result in a clinical context.

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

The ground truth for this device's performance relies on:

• Theoretical Concentrations: For accuracy, linearity, and sensitivity studies, known concentrations of Gentamicin in control matrices serve as the ground truth. These are typically prepared using gravimetric or volumetric methods with highly pure reference standards.
• Reference Method: For the method comparison study, the Abbott TDx®/TDxFLx® Gentamicin assay served as the reference (or comparative) method, with its results considered the "ground truth" for evaluating the new device's correlation.

8. The sample size for the training set:

Not applicable. This device is a chemical immunoassay, not a machine learning or artificial intelligence system that requires a "training set" in the computational sense. The assay works based on established biochemical principles and reagents rather than being "trained" on data.

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

Not applicable, as there is no training set for this type of in vitro diagnostic device.

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1. For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
2. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).
3. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and GENT on VITROS Chemistry Systems.

The VITROS Chemistry Products GENT Reagent. VITROS Chemistry Products Calibrator Kit 13, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS GENT assay. VITROS Chemistry Products GENT Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure gentamicin. VITROS Chemistry Products Calibrator Kit 13 and TDM Performance Verifiers are packaged and sold separately. VITROS Chemistry Products Calibrator Kit 13 is a liquid ready to use calibrator set for gentamicin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters. VITROS Chemistry Products TDM Performance Verifier I, II and III are liquid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).

This document describes the VITROS Chemistry Products GENT Reagent, VITROS Chemistry Products Calibrator Kit 13, and VITROS Chemistry Products TDM Performance Verifiers I, II, and III used to quantitatively measure gentamicin (GENT) concentrations.

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent to the predicate device (SYVA® Emit® 2000 Gentamicin Plus Assay) based on the correlation and analytical performance studies. The primary acceptance criterion for the GENT assay is its strong correlation with the predicate device.

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

• The document states that "patient samples" were used for the equivalence study. However, the exact sample size of the test set is not specified.
• The data provenance (e.g., country of origin, retrospective or prospective) is not specified in the provided text.

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 in-vitro diagnostic devices like this, the "ground truth" is typically established by comparative analysis with an established, legally marketed predicate device, or by reference methods, rather than expert consensus on patient images or clinical assessments.

4. Adjudication Method for the Test Set

• This information is not applicable as the evaluation involves comparing quantitative measurements from the new device against a predicate device, rather than expert adjudication of qualitative judgments.

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

• A MRMC comparative effectiveness study was not performed as this device is an in-vitro diagnostic assay, not an imaging device that would typically involve human readers interpreting results. The comparison is between the new assay and a predicate assay.

6. Standalone (Algorithm Only) Performance Study

• This description refers to the device's performance as a standalone assay. The study cited (correlation with predicate device, precision, expected values, linearity, and specificity studies) falls under this category of standalone analytical performance. The device is designed to operate autonomously with the VITROS 5,1 FS Chemistry System.

7. Type of Ground Truth Used

• The ground truth for the equivalence study was established by the measurements obtained from the predicate device (SYVA® Emit® 2000 Gentamicin Plus Assay) using the same "patient samples." Additionally, the product's instructions for use refer to studies on precision, expected values, linearity, and specificity, which would use established analytical methods or reference materials to determine ground truth.

8. Sample Size for the Training Set

• This document describes a 510(k) submission for an in-vitro diagnostic assay, not an AI/ML-driven device that typically requires a distinct "training set." Therefore, information regarding a specific training set size is not applicable and not provided. The development process for such assays involves internal studies (e.g., reagent optimization, calibration curve development) that are not typically referred to as "training sets" in the context of these submissions.

9. How Ground Truth for the Training Set Was Established

• As noted in point 8, the concept of a "training set" with ground truth in the AI/ML sense is not applicable to this type of device and submission. The analytical performance (e.g., linearity, precision) is established through rigorous laboratory experiments using reference materials and spiked samples with known concentrations, or comparison to established methods.

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The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Gentamicin reagent kits.

The Roche ONLINE Gentamicin Assay is an in vitro diagnostic reagent system designed for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. The device is used to diagnose and treat gentamicin overdose and monitor drug levels for appropriate therapy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a formal table with pass/fail thresholds. Instead, it presents performance characteristics (precision and method comparison) of the new device and compares them to a legally marketed predicate device (COBAS INTEGRA Gentamicin Assay). The statement "All of the evaluation studies gave acceptable results compared to the predicate device" implies that the new device's performance characteristics were deemed equivalent to those of the predicate.

Below is a table summarizing the reported device performance, with the implicit acceptance criteria being performance comparable to the predicate device.

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

• Sample Size for Test Set:
  • For the method comparison study comparing the Roche/Hitachi 917 to the COBAS INTEGRA 700 (new device vs. predicate), the sample size was N = 112.
  • For the comparison of the predicate device (COBAS INTEBRA Gentamicin) to COBAS FARA II Gentamicin assay, the sample size was N = 145. This appears to be a historical comparison for the predicate, not directly reflecting the current test set for the new device.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It is implied to be data collected specifically for this 510(k) submission, likely prospective, given the nature of performance evaluation studies for new devices.

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

This type of information is not applicable to this device. The Roche ONLINE Gentamicin Assay is an in vitro diagnostic device that quantifies a drug concentration in biological samples. The "ground truth" for its performance is established by comparison to a reference method or a legally marketed predicate device, and through analytical performance characteristics like precision, not by expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable to this device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers interpret data, and discrepancies need to be resolved. This device performs a quantitative chemical analysis, not 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 is not applicable to this device. MRMC studies are relevant for AI-powered diagnostic tools that assist human readers in tasks like image interpretation. The Roche ONLINE Gentamicin Assay is a laboratory assay for drug concentration measurement and does not involve human readers for interpretation in this context, nor does it use AI.

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

Yes, a standalone performance study was conducted. The entire evaluation, including method comparison and precision, assesses the performance of the device (reagent system on an automated analyzer) without human intervention in the analytical process itself. The numbers reported (e.g., correlation coefficient, CV%) directly reflect the algorithm/assay's performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was established by:

• Comparison to a Legally Marketed Predicate Device: The Roche ONLINE Gentamicin Assay was compared to the COBAS INTEGRA Gentamicin Assay, which serves as a recognized standard in the market. The predicate's results are considered the comparative "truth" or reference.
• Analytical Performance Metrics: Intrinsic analytical performance characteristics such as precision (within-run and total CV%) are fundamental to establishing the reliability and "truthfulness" of the measurements.

8. The Sample Size for the Training Set

This is not applicable to this device in the context of an AI/machine learning training set. The Roche ONLINE Gentamicin Assay is a chemical assay, not an AI or machine learning algorithm that requires a "training set." Its calibration involves calibrator materials with known concentrations, but this is a standard chemical assay procedure, not an AI training process.

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

This is not applicable for the same reasons as point 8. The "ground truth" for calibration in a chemical assay is established through the gravimetric preparation of calibrators with certified concentrations or by comparison to definitive reference methods.

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The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. When a sample containing gentamicin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By monitoring the change in scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or absorbance is inversely proportional to the concentration of gentamicin in the sample.

Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and are for use by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. When a sample containing gentamicin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By monitoring the change in scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or absorbance is inversely proportional to the concentration of gentamicin in the sample.

The provided text is related to a 510(k) premarket notification for a Gentamicin Test Kit. It includes the FDA's letter of substantial equivalence and the indications for use. However, it does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as this information is not present in the provided document.

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For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of gentamicin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.

IMMULITE® 2000 Gentamicin is a solid-phase chemiluminescent enzyme immunoassay for use with the IMMULITE® 2000 Automated Analyzer.

Acceptance Criteria and Study for IMMULITE® 2000 Gentamicin

The IMMULITE® 2000 Gentamicin device's performance was evaluated by comparing it to a predicate device, the Abbott AxSYM® Gentamicin. The acceptance criteria essentially revolved around demonstrating substantial equivalence in measuring gentamicin concentrations in human specimens.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state pre-defined quantitative acceptance criteria. The "Acceptance Criteria (Implied by Comparison)" are inferred from the typical standards for demonstrating substantial equivalence against a predicate device in method comparison studies.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 89 patient samples.
• Data Provenance: Not explicitly stated, but based on the nature of the device (in vitro diagnostic for monitoring drug levels in human specimens), it is prospective, collected from patients. The country of origin is not specified, but the manufacturer is based in the USA.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for the test set was established by the predicate device (Abbott AxSYM® Gentamicin), not through expert consensus.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: None. The comparison was directly between the IMMULITE® 2000 and the predicate device's measurements for each sample.

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

• MRMC Study: No. This is an in vitro diagnostic device for quantitative measurement, not an imaging or diagnostic interpretation device that typically involves human readers.

6. Standalone Performance Study

• Standalone Performance Study: Yes, in the sense that the IMMULITE® 2000 Gentamicin's measurements were observed independently. However, its performance was evaluated and understood in the context of comparison to the predicate device. The results (linear regression, correlation coefficient, means) represent the standalone performance relative to a reference.

7. Type of Ground Truth Used

• Type of Ground Truth: Measurements from a legally marketed and accepted predicate device (Abbott AxSYM® Gentamicin).

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not explicitly mention a separate "training set" in the context of an AI/machine learning model. The IMMULITE® 2000 Gentamicin is a chemiluminescent immunoassay, a chemical assay, not an AI-powered algorithm that requires a training set in the typical sense. Its calibration would rely on reference standards rather than a "training set" of patient data.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, this is a chemical immunoassay, not an AI algorithm. Calibration and quality control for such assays typically involve known concentrations of gentamicin standards, which serve as the reference for accurate measurement.

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The Emit® 2000 N-Acetylprocainamide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of N-Acetylprocainamide in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of N-Acetylprocainamide overdose or in monitoring levels of N-Acetylprocainamide to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

The provided text is a 510(k) summary for the Emit® 2000 N-Acetylprocainamide Assay, a diagnostic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, novel device might. The core of this submission is that the modified device is similar to an already approved predicate device, with minor packaging differences.

Therefore, the typical structure for reporting acceptance criteria and a study proving their achievement is not directly applicable in this context. The document emphasizes that the "modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." This implies that the performance characteristics (e.g., accuracy, precision, linearity) are expected to be the same as the predicate device, and the demonstration of substantial equivalence serves as the "proof."

However, I can extract information related to what would be considered "performance" in such a context, even if the detailed study results aren't explicitly provided in this summary.

Here's an attempt to answer your questions based on the provided text, acknowledging its limitations:

Acceptance Criteria and Study for Emit® 2000 N-Acetylprocainamide Assay

Based on the provided 510(k) summary (K011620), the primary "acceptance criteria" for the modified Emit® 2000 N-Acetylprocainamide Assay relate to its substantial equivalence to an existing predicate device. The underlying assumption is that the predicate device's performance already meets established clinical and analytical requirements. The study here essentially demonstrates that the minor changes (packaging, bottle size, barcode) do not negatively impact the assay's performance characteristics.

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

Since this is a 510(k) for a modified device emphasizing substantial equivalence due to minor packaging changes, explicit quantitative acceptance criteria for primary diagnostic metrics (e.g., sensitivity, specificity, accuracy) are not detailed in this summary for the modified device. Instead, the "performance" demonstrated is that the re-packaged device maintains the "same assay performance characteristics" as the predicate device.

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

The 510(k) summary does not provide specific details about the sample size, type (e.g., patient samples vs. spiked controls), or provenance of a test set used to explicitly re-evaluate performance characteristics for this modified device. The declaration of "same assay performance characteristics" suggests that validation was performed, but the specifics are not included in this high-level summary. Given the nature of a chemical assay, it would typically involve prospective testing with controlled samples or clinical specimens.

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)

Not applicable. For an in vitro diagnostic assay like this (measuring N-Acetylprocainamide levels), "ground truth" is established through highly accurate reference methods or clinical outcomes, not typically by expert consensus of imaging or pathology. The determination of N-Acetylprocainamide levels is an objective measurement.

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

Not applicable. This is not a study requiring human adjudication of results in the conventional sense (e.g., for image interpretation). Analytical measurements are typically verified against established standards or validated reference methods.

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 automated immunoassay, not a device involving human readers or AI assistance.

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

This is a standalone algorithm/device. The Emit® 2000 N-Acetylprocainamide Assay is an automated immunoassay system (reagents used on OLYMPUS® analyzers) that quantitatively measures N-Acetylprocainamide. Its performance is entirely determined by the chemical reaction and instrument measurement, without human interpretive input affecting the fundamental result.

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

For an in vitro diagnostic test measuring a specific analyte, "ground truth" (or analytical true value) is typically established by:

• Reference Methods: Highly accurate and precise analytical methods (e.g., GC-MS, HPLC) that are considered the gold standard.
• Certified Reference Materials: Solutions with known, certified concentrations of the analyte.
• Interlaboratory Comparisons: Though less about "ground truth" and more about comparative performance.

While not explicitly stated in the summary, given it's an assay for N-Acetylprocainamide, the ground truth would have been established using one or a combination of these analytical approaches.

8. The sample size for the training set

Not applicable. This is a chemical immunoassay, not a machine learning or AI-based device that typically requires a "training set" in the computational sense. The "training" of the assay system itself comes from its chemical design and optimization steps during development, and calibration against known standards.

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

Not applicable, as there isn't a "training set" in the machine learning sense. The assay's analytical performance (linearity, precision, accuracy) is calibrated and validated using reference materials or samples with known, analytically determined concentrations (as described in point 7).

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