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The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers.

The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.

The QMS® Tobramycin 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- tobramycin monoclonal antibody and R2: tobramycin -coated microparticles. A six-level set of QMS® Tobramycin Calibrators (A through F) is used to calibrate the assay.

Here's a breakdown of the acceptance criteria and study information for the Seradyn QMS® Tobramycin assay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

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The Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy.

The Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

The Dimension Vista™ Phosphorus (PHOS) Flex® reagent cartridge is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

The Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

The Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

The Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

The Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

The Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Vade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ 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.

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Dimension Vista™ Flex® reagent cartridges, based on the provided 510(k) summary:

This device submission is a Special 510(k) for a packaging modification, meaning the core technology and reagents are the same as previously cleared devices. Therefore, the primary goal of the study is to demonstrate substantially equivalent performance after the packaging change, rather than to establish initial performance claims for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or specific performance metrics (e.g., accuracy, precision values) for each analyte. Instead, it relies on a comparative equivalency approach to a predicate device.

The overarching acceptance criterion is "substantially equivalent performance" to the predicate Dimension® Flex® reagent cartridges.

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."

• Sample Size for Test Set: This information is not explicitly stated in the provided summary. The summary refers to a "protocol included in this submission," which would contain these details.
• Data Provenance: This information is not explicitly stated in the provided summary.
• Retrospective or Prospective: This information is not explicitly stated. However, given the nature of in-vitro diagnostic testing for performance comparison, it would typically involve prospective testing on patient samples or spiked samples.

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

This is an in-vitro diagnostic device for quantitative measurement of analytes in human samples (serum, plasma, urine, CSF). The ground truth for such devices is established by:

• Reference Methods: Highly accurate and precise laboratory methods, often gold standards like GC-MS, HPLC, or other well-validated enzymatic or spectrophotometric methods.
• Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analytes.

Therefore, the concept of "experts" in the clinical imaging or diagnostic interpretation sense (e.g., radiologists) is not applicable here. The ground truth is laboratory-based and instrumental.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. Ground truth is established by reference methods or certified materials, not by expert consensus or adjudication.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an in-vitro diagnostic reagent cartridge, not an AI-powered diagnostic imaging tool or a system designed for human interpretation with or without AI assistance. The performance is measured instrumentally.

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

• Yes, the performance evaluated is inherently "standalone" in the context of an automated analytical instrument. The Flex® reagent cartridges are designed to be used on the Dimension Vista™ Integrated system, a "fully automated, microprocessor-controlled, integrated instrument system." The performance of the reagent (device) is measured by its output on this automated system.
• There is no "human-in-the-loop" decision-making component for the measurement process itself, although clinical interpretation of the results by a healthcare professional is expected.

7. The Type of Ground Truth Used

The ground truth for this type of in-vitro diagnostic device would typically involve:

• Reference Method Assays: Using established, highly accurate, and precise laboratory methods (e.g., a recognized primary reference measurement procedure or a well-characterized predicate device itself) to determine the true concentration of the analytes in the test samples.
• Certified Reference Materials: Commercial or internal standards with known, traceable concentrations of the analytes.
• Sample Matrix: Patient samples (serum, plasma, urine, CSF) with concentrations spanning the analytical range.

The summary states "Comparative testing... demonstrates substantially equivalent performance." This strongly implies that the new device's measurements were compared against the measurements obtained by the predicate device on the same samples, which serves as the "reference" or "ground truth" for the equivalence claim.

8. The Sample Size for the Training Set

This device is a reagent cartridge for an in-vitro diagnostic test, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to learn. The reagents and their chemical reactions are based on established scientific principles.

Therefore, the concept of a "training set" as understood in machine learning is not applicable to this device.

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

As noted above, the concept of a "training set" is not applicable to this device. The ground truth for the performance evaluation (test set) would be established by reference methods or comparison to the predicate device, as described in point 7.

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The ONLINE TDM Tobramycin assay is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in human plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The ONLINE TDM Tobramycin assay is for the quantitative determination of tobramycin in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Tobramycin reagent kits.

This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the "ONLINE TDM Tobramycin" assay to a predicate device.

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state quantitative acceptance criteria for all performance characteristics. However, it states that "All of the evaluation studies gave acceptable results compared to the predicate device." The table below summarizes the reported performance for precision and method comparison.

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

• Method Comparison Test Set (ONLINE TDM Tobramycin Vs. COBAS FP Tobramycin):

  • Sample Size: N=55
  • Range: 0.2 - 9 µg/ml
  • Data Provenance: Not explicitly stated, but typically these studies are conducted with human serum or plasma samples within a lab setting. It is not specified if the data is retrospective or prospective.

• Method Comparison Test Set (COBAS FP Tobramycin Vs. COBAS FARA II - likely predicate's original validation data, included for context):

  • Sample Size: N=196
  • Range: 0.23 - 10 ug/ml
  • Data Provenance: Not explicitly stated.

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

• This information is not provided in the document. For in vitro diagnostic assays, "ground truth" is typically established by reference methods or comparison to a well-established, legally marketed predicate device, rather than expert consensus on individual cases.

4. Adjudication method for the test set:

• This information is not applicable/not provided as the study design focuses on quantitative comparison of assay results rather than subjective interpretations 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:

• This is not an MRMC comparative effectiveness study involving human readers and AI assistance. The device is an in vitro diagnostic assay for quantitative measurement, not an imaging or interpretive AI device.

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

• Yes, the performance data presented (precision, method comparison) represents the standalone performance of the ONLINE TDM Tobramycin assay (algorithm/assay only) without human intervention in the result generation process, beyond standard laboratory procedures for running the assay.

7. The type of ground truth used:

• The ground truth (or reference standard) for evaluating the ONLINE TDM Tobramycin assay was the results obtained from the predicate device, COBAS INTEGRA Tobramycin (K964457). For method comparison, the predicate device's results are treated as the reference against which the new device's results are compared.

8. The sample size for the training set:

• This information is not applicable/not provided. The ONLINE TDM Tobramycin assay is a chemical assay, not an AI or machine learning model that requires a "training set" in the conventional sense. The "training" for such an assay involves the development and optimization of the reagent formulation and assay protocols, which is not quantified by a "sample size."

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

• This information is not applicable/not provided as the concept of a "training set" and "ground truth for training" does not directly apply to the development of this type of chemical assay. Assay development involves analytical validation against known standards and reference materials to ensure accuracy and precision.

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1. For in vitro diagnostic use only. VITROS Chemistry Products TOBRA Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure tobramycin (TOBRA) concentration in human serum and plasma. Serum or plasma tobramycin measurements are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
2. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 14 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of tobramycin (TOBRA).
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 TOBRA on VITROS Chemistry Systems.

The VITROS Chemistry Products TOBRA Reagent, VITROS Chemistry Products Calibrator Kit 14, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS TOBRA assay. VITROS Chemistry Products TOBRA Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure tobramycin.

VITROS Chemistry Products Calibrator Kit 14 and TDM Performance Verifiers are packaged and sold separately.

VITROS Chemistry Products Calibrator Kit 14 is a liquid ready to use calibrator set for tobramycin. 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).

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the VITROS Chemistry Products TOBRA Reagent:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document primarily uses the predicate device's characteristics and performance as the benchmark for demonstrating substantial equivalence. The specific "acceptance criteria" are therefore derived from the predicate's known performance and characteristics.

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

• Sample Size: Not explicitly stated as a number but refers to "patient samples."
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that it compares performance to an existing predicate device using a set of samples. Given the submission date and the context, it's highly likely to be US-based, but this is not confirmed.

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

Not applicable. This is an IVD device measuring a chemical substance. The "ground truth" for the test set would be established by the reference method (the predicate device) or a known reference standard, not by human expert consensus or interpretation.

4. Adjudication method for the test set

Not applicable. Refer to 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

Not applicable. This is an In Vitro Diagnostic (IVD) device for quantitative measurement of a substance, not an imaging or diagnostic aid for human readers/clinicians, nor does it typically involve AI assistance in the context of human interpretation.

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

Yes, the study describes the standalone performance of the VITROS TOBRA assay. The device measures tobramycin concentration without direct human-in-the-loop diagnostic interpretation of results (though results are interpreted by healthcare professionals). The performance evaluation involved comparing its measurements directly to those of the predicate device and assessing core analytical performance characteristics.

7. The type of ground truth used

The primary "ground truth" for comparison was assumed to be the readings from the predicate device (SYVA Emit 2000 Tobramycin Assay) using patient samples. Additionally, analytical studies (precision, linearity, specificity) would rely on known concentrations of tobramycin standards/samples.

8. The sample size for the training set

Not applicable in the context of this traditional IVD device. The VITROS TOBRA assay is based on a homogeneous enzyme immunoassay principle, not a machine learning algorithm that requires a "training set" in the conventional sense. Its "training" is inherent in its chemical design and calibration process.

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

Not applicable. Refer to point 8.

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

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

Here's an analysis of the provided text regarding the IMMULITE® 2000 Tobramycin device, structured to address your specific questions:

Acceptance Criteria and Study Details for IMMULITE® 2000 Tobramycin

The provided document describes the performance equivalence of the IMMULITE® 2000 Tobramycin device to a predicate device, Abbott AxSYM® Tobramycin, through a method comparison study. The primary acceptance criteria appear to be based on the statistical results of this comparison, demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the document implies acceptance based on the statistical outcomes of the method comparison demonstrating substantial equivalence to the predicate device.

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

• Sample Size for Test Set: 41 patient samples.
• Data Provenance: The document does not specify the country of origin. It indicates it was a comparison between the IMMULITE 2000 Tobramycin procedure and a "commercially available assay," suggesting clinical samples. The study is retrospective in the sense that the samples were collected and then analyzed by both methods for comparison.

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

• Not applicable. This was a method comparison study between two quantitative diagnostic devices. The "ground truth" for the test set was established by the measurements obtained from the predicate device (Abbott AxSYM® Tobramycin) rather than human expert interpretation or a separate gold standard.

4. Adjudication Method for the Test Set

• Not applicable. As this is a quantitative method comparison between two devices, there was no adjudication method involving human experts. The comparison relies solely on the numerical output of each analyzer.

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

• No. A MRMC comparative effectiveness study was not done. This device is a quantitative immunoassay with an automated analyzer, not an imaging device requiring human interpretation alongside AI assistance. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.

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

• Yes. The study presented is effectively a standalone performance study. It evaluates the IMMULITE® 2000 system's ability to measure tobramycin concentrations on its own, with its results directly compared to another standalone device (Abbott AxSYM® Tobramycin). There is no human intervention or "in-the-loop" component discussed for the measurement process itself.

7. Type of Ground Truth Used

• The "ground truth" in this context is the measurements obtained from the legally marketed predicate device (Abbott AxSYM® Tobramycin). This is a common approach for demonstrating substantial equivalence for quantitative diagnostic assays.

8. Sample Size for the Training Set

• The document does not provide information regarding a separate training set or its sample size. The description focuses on the method comparison study using 41 patient samples. For immunoassay development, calibration and validation are typically performed using standards, controls, and characterized samples, but explicit "training set" details as might be described for AI/ML algorithms are not presented.

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

• As no training set is explicitly mentioned or detailed in the provided text, the method for establishing its "ground truth" is not available. Immunoassays like this are developed using established reference materials and chemical standards for calibration rather than a "ground truth" derived from expert consensus on complex data.

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The Chiron Diagnostics ACS:180 Tobramycin Assay is for the quantitative determination of tobramycin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Monitoring the patient's serum or plasma tobramycin levels is important both to ensure that the drug is present in therapeutic concentrations and to avoid toxicity.

The Chiron Diagnostics ACS:180 Tobramycin assay is a competitive immunoassay using direct, chemilumenescent technology. Tobramycin in the patient sample competes with acradinium ester-labeled tobramycin in the Lite Reagent for a limited amount of monoclonal mouse anti-tobramycin antibody, which is covalently coupled to the paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of tobramycin present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.

Here's a summary of the acceptance criteria and study details for the Chiron Diagnostics ACS:180 Tobramycin Assay, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 293 samples.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

   • Not applicable/Not provided. The "ground truth" for the accuracy study was an "alternate fluorescence polarization (FPIA) method," which is a laboratory method, not expert-based.

3. Adjudication method for the test set:

   • Not applicable. The comparison was against a laboratory method.

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:

   • No. This device is an automated immunoassay for drug level measurement, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.

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

   • Yes. The performance described for the ACS:180 Tobramycin assay is its standalone, automated performance.

6. The type of ground truth used:

   • Alternative Method Comparison: The accuracy of the ACS:180 Tobramycin assay was assessed by comparing its results against an "alternate fluorescence polarization (FPIA) method." This constitutes a comparative method study, where the FPIA method serves as the reference or "ground truth."

7. The sample size for the training set:

   • Not provided. The document describes performance data, but does not detail the development or training of the assay (which, in this context, refers to the development of the immunoassay reagents and calibration, not an AI model).

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

   • Not provided. As this is not an AI/machine learning model in the conventional sense, the concept of a "training set" and its "ground truth establishment" as typically applied to AI does not directly apply in the same way. The development of an immunoassay involves optimizing reagent concentrations, antibody specificity, and calibration using known standards, but these details are not in the provided summary.

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The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in coniunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of tobramycin in human serum or plasma by rate nephelometric inhibition immunoassay.

Becknan Drug Calibrator 3 Plus, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE™ Immunochemistry Systems for the calibration of Gentamicin and Tobramycin test systems.

The IMMAGE Immunochemistry System (TDM) GEN and TOB Reagents in conjunction with Beckman Drug Calibrator 3 Plus, are intended for use in the quantitative determination of gentamicin and tobramycin concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.

The provided document describes the IMMAGE™ Immunochemistry System Therapeutic Drug Monitoring Reagents for Gentamicin (GEN) and Tobramycin (TOB). This document is a "Summary of Safety & Effectiveness" submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92. It is a 510(k) premarket notification.

However, it does not contain specific "acceptance criteria" for performance that would typically be described with explicit thresholds (e.g., "sensitivity must be >X%", "specificity must be >Y%"). Instead, it presents performance data (method comparison, stability, and imprecision) and states that this data supports "substantial equivalence to chemistry test systems already in commercial distribution." The "acceptance criteria" here appear to be implied by successful demonstration of equivalence to the predicate device (Abbott TDx Gentamicin and Tobramycin Reagents).

Here's an attempt to extract and interpret the information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, explicit acceptance criteria are not provided in the typical sense of quantitative minimums/maximums. The goal is "substantial equivalence" to the predicate device. The performance data presented are used to demonstrate this equivalence.

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

• Gentamicin: 135 samples
• Tobramycin: 94 samples
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the context of a 510(k) submission for a clinical diagnostic device implies these would be human serum/plasma samples, likely from a clinical setting. The specific nature (e.g., healthy vs. disease, patient demographics) is not detailed. The term "method comparison" suggests these were patient samples run on both the new device and the predicate device.

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

This type of device (therapeutic drug monitoring reagent) does not typically involve "experts" establishing a ground truth in the way an imaging AI device would. The "ground truth" for method comparison is the measurement obtained from the predicate device, the Abbott TDx system, which is an already marketed and accepted device for these analytes. There are no radiologists or similar experts involved in this type of ground truth establishment for a chemical assay.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is the predicate device's measurement. There is no human adjudication process involved in comparing two quantitative chemical assays in this manner.

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 reagent for an automated immunoassay system, not an AI-assisted diagnostic tool that involves human readers interpreting results in a comparative study against an AI. The device itself performs the quantitative determination.

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

This is essentially the case. The IMMAGE system (including its reagents and internal algorithms for signal processing to determine concentration) operates as a standalone system to provide quantitative results for gentamicin and tobramycin. The data presented ("Method Comparison Study Results") reflects the performance of this system directly against the predicate.

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

The ground truth for the method comparison study was the measurements obtained from the predicate device, the Abbott TDx Gentamicin and Tobramycin Reagents systems. This is a common and accepted "ground truth" for demonstrating substantial equivalence of a new diagnostic assay to an established one.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning. This device is a chemical immunoassay system, not an AI/ML algorithm that undergoes explicit training in the way typically discussed for image recognition or predictive models. The system's "performance" is based on its chemical reactions and optical measurement principles. If there were any internal calibrators or controls used for system calibration or quality control, these are inherent to the system's operation but not a separate "training set" as in AI.

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

Not applicable, as there's no mention or indication of an AI/ML "training set" in the document. The "ground truth" inherent to the system's operation would be defined by the known concentrations of calibrated reference materials and controls used to ensure accurate measurement by the immunoassay.

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COBAS INTEGRA Gamma- Glutamyltransferase - IFCC: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2, y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTI, 0-562).

COBAS INTEGRA Lactate Dehydrogenase - IFCC: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of LDH (EC 1.1.1.27; L-lactate: NAD oxidoreductase ) in serum and plasma (test LDHI, 0-181).

COBAS INTEGRA Total Protein - urine and CSF: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the total protein concentration in urine and cerebrospinal fluid (tests TPU, 0-123 and TPC, 0-223).

COBAS INTEGRA Lactate: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid (tests LACT, 0-22 and LACTC, 0-122).

COBAS INTEGRA Tobramycin: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of tobramycin in serum or heparinized plasma (test TOBR, 0-92).

COBAS INTEGRA Immunoglobulin A: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin A in serum. In addition to the standard application (test IGA, 0-075), the sensitive application (test IGAP, 0-175) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples.

COBAS INTEGRA Immunoglobulin G: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin G in serum. In addition to the standard application (test IGG, 0-076), the sensitive application (test IGGP, 0-176) is designed for the quantitative determination of low IgG concentrations in e.g. pediatric samples.

COBAS INTEGRA Immunoglobulin M: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin M in serum. In addition to the standard application (test IGM, 0-077), the sensitive application (test IGMP, 0-177) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples.

Through this submission it is the intention of Roche to gain clearance of an additional 5 new COBAS INTEGRA Reagent Cassettes and a modified version of 3 previously cleared reagent cassettes. All of the COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8 °C. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number, the expiration date and the number of tests.

Here's an analysis of the provided text regarding acceptance criteria and device performance:

Overview of the Device:

The document describes several COBAS INTEGRA Reagent Cassettes, including 5 new ones and 3 modified versions of previously cleared reagent cassettes, all intended for use with the COBAS INTEGRA Analyzer for quantitative determination of various analytes (Gamma-Glutamyltransferase, Lactate Dehydrogenase, Total Protein, Lactate, Tobramycin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M).

The claims of substantial equivalence are based on comparisons to legally marketed predicate devices. The acceptance criteria are implicit in the performance characteristics and comparisons presented against these predicate devices. The study is a non-clinical in vitro diagnostic reagent system performance evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets (e.g., "Accuracy must be > 0.95"). Instead, the document presents comparative performance data against predicate devices or generally accepted analytical performance metrics (like precision and assay range). The implicit acceptance criterion is that the new or modified COBAS INTEGRA reagents perform equivalently to or better than the identified predicate devices, or demonstrate acceptable analytical performance for their intended use.

Below is a combined table showing the reported device performance, with the implicit acceptance criteria being that these values are acceptable for the intended use and comparable to or better than the predicate devices' performance.

Note: "Acceptance Criteria" here refers to the desirable performance characteristics expected for such diagnostic assays, inferred from the general context and comparison with predicate devices. The document does not explicitly state quantitative "acceptance criteria" but rather presents the performance achieved by the device and a predicate for comparison.

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

The sample sizes for the studies are provided in the "Accuracy" section for each analyte, indicating the number of samples ($n$) used for method correlation. The data provenance is generally implied as clinical and non-clinical studies for in vitro diagnostic assays. No specific countries of origin are mentioned, nor is it explicitly stated whether the studies were retrospective or prospective, though the nature of these tests (evaluating analytical performance) typically involves prospective or controlled laboratory studies.

• Gamma-Glutamyltransferase - IFCC: n = 202
• Lactate Dehydrogenase - IFCC: n = 106
• Total Protein - urine and CSF: n = 274 (for urine accuracy), no specific n for CSF accuracy is given separately though precision data is provided for CSF.
• Lactate: n = 224
• Tobramycin: n = 196
• Immunoglobulin A (Modified): n = 400 (standard application), n = 204 (pediatric application)
• Immunoglobulin G (Modified): n = 244 (standard application), n = 212 (pediatric application)
• Immunoglobulin M (Modified): n = 400 (standard application), n = 214 (pediatric application)

Data Provenance: "Clinical and nonclinical studies performed using the COBAS INTEGRA Reagent Cassettes." (Page 3). No further detail on country or retrospective/prospective nature.

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

This type of submission (510(k) for an in vitro diagnostic reagent cassette) does not typically involve human experts establishing ground truth in the way described for imaging or clinical decision support AI systems. The "ground truth" for these comparative studies is established by the predicate devices and well-established analytical methods. The performance of the new device is compared to these existing, legally marketed and validated methods. Therefore, the concept of "number of experts" and "qualifications of experts" like radiologists is not applicable here.

4. Adjudication Method for the Test Set

Since this is an in vitro diagnostic assay comparing quantitative measurements, adjudication methods like 2+1 or 3+1 (common in medical imaging for clinical endpoints) are not relevant. The "adjudication" is inherent in the analytical methods themselves, where the results from the new device are mathematically compared (e.g., using correlation coefficients and regression equations) against a reference method (the predicate device) or established laboratory standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic tools that involve human interpretation of medical images or other complex data where reader variability is a factor. The COBAS INTEGRA Reagent Cassettes are automated in vitro diagnostic tests, where the result is a quantitative analytical value from an instrument, not a human interpretation. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.

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

Yes, in a sense, the entire performance evaluation presented for each reagent cassette is a "standalone" study of the algorithm (i.e., the reagent's analytical method) without human intervention. The COBAS INTEGRA Analyzer is an automated system, and the reported precision and accuracy directly reflect the performance of the reagent and instrument system, which is analogous to an "algorithm only" performance. The device provides a quantitative result without a human interpreting an image or complex patterns.

7. Type of Ground Truth Used

The ground truth for these studies is established by comparison with legally marketed predicate devices using established analytical methodologies. For each assay:

• Gamma-Glutamyltransferase - IFCC: Compared against Roche COBAS INTEGRA, GGT (TRIS)
• Lactate Dehydrogenase - IFCC: Compared against Roche COBAS INTEGRA, LD (Lactate - Pyruvate)
• Total Protein - urine and CSF: Compared against SIGMA Diagnostics, Microprotein-PR
• Lactate: Compared against Boehringer Mannheim, Lactate
• Tobramycin: Compared against Abbott Diagnostics, TDX / TDX Flex Tobramycin
• Immunoglobulin A, G, M (Modified): Compared against Behring Diagnostics, N and NA Reagents (and implicitly, the previously marketed COBAS INTEGRA versions).

This approach relies on the well-established performance of predicate devices as the "ground truth" or reference standard for analytical accuracy.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or "training set size." This is characteristic of traditional in vitro diagnostic device submissions, which do not typically employ machine learning or AI models that require distinct training and test data sets. The studies described are performance validation studies for the finished reagent product.

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

As there is no explicitly mentioned "training set" in the context of machine learning, this question is not directly applicable. The performance characteristics of these reagents are validated using standard analytical chemistry and immunoassay principles, with reference to the performance of predicate devices established through similar rigorous analytical validation.

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