Search Results

The Ammonia II assay is an enzymatic in vitro test for the quantitative determination of ammonia in human plasma on Roche/Hitachi cobas c systems.

Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

The Ammonia II (NH3L2) assay is an enzymatic in vitro test for the quantitative determination of ammonia in human plasma on Roche/Hitachi cobas c systems. The Ammonia II assay is an enzymatic method, with glutamate dehydrogenase.

This document describes the Ammonia II assay for the quantitative determination of ammonia in human plasma. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative ("All data passed the predetermined acceptance criteria") rather than specific numerical thresholds presented in a consolidated table. However, the reported performance data for each test indicates the values achieved. Based on the provided text, a summary of performance can be extracted:

Ammonia II Assay Performance Summary

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

• Precision: Not explicitly stated as a "test set" in the context of diagnostic accuracy but involves replicate measurements of various controls and human plasma samples over 21 days.
• LoB, LoD, LoQ:
  • LoB: One analyte-free sample measured with three lots in 10-fold determination in 6 runs (60 measurements per lot).
  • LoD: Five samples with low-analyte concentration measured with three lots in two-fold determination in 6 runs (60 measurements per lot).
  • LoQ: A low-level sample set (7 human plasma samples) tested in 5 replicates per sample on 5 days.
• Linearity: Not explicitly stated, typically involves a range of spiked samples.
• Endogenous Interferences: Pooled human plasma samples spiked with varying levels of interferent (10 dilution steps per sample), tested in triplicate.
• Exogenous Interferences (Drugs): Two sample pools (low and high NH3L2), each divided into aliquots. Reference aliquot (not spiked) tested n=3. Spiked aliquots tested in triplicate.
• Matrix Comparison: 52-53 tubes of K2 EDTA plasma and 52-53 tubes of K3 EDTA plasma for each of 3 reagent lots (total of ~156-159 tubes per anticoagulant type).
• Method Comparison to Predicate: 112 human plasma samples.

Data Provenance: The document generally refers to "human plasma" samples, suggesting human subjects. The country of origin is not specified but given the submitter is Roche Diagnostics (with registration numbers for Mannheim, Germany, Penzberg, Germany, and the United States), the data could be from multiple regions. The studies are prospective performance evaluations of the device conducted according to CLSI guidelines.

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

Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement. The "ground truth" for the performance characteristics (precision, limits, linearity, interference) is established by analytical methods and reference materials, not by expert interpretation of images or clinical cases.

4. Adjudication method for the test set

Not applicable. This is an IVD assay, and the studies are analytical performance evaluations, not clinical studies involving expert adjudication of diagnostics results or images.

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 IVD assay for quantitative ammonia measurement, not an AI-powered diagnostic imaging device or a decision support system for human readers.

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

Yes, directly. The studies described (Precision, LoB/LoD/LoQ, Linearity, Interference, Matrix Comparison, Method Comparison) evaluate the analytical performance of the Ammonia II assay itself, without a human-in-the-loop component for result generation. The device (Ammonia II assay on Roche/Hitachi cobas c systems) performs the quantitative determination of ammonia.

7. The type of ground truth used

The ground truth used for these analytical studies is based on:

• Reference materials and spiked samples: For linearity, LoB/LoD/LoQ, and interference studies, known concentrations of analyte or interferents are used to challenge the assay.
• Statistical methods: For precision, calculations of SD and CV reflect the inherent variability.
• Comparative methods: For method comparison, the results are compared against a legally marketed predicate device (Beckman Coulter Ammonia assay) using statistical regression.
• Clinical Laboratory Standards Institute (CLSI) guidelines: These guidelines (EP05-A3, EP17-A2, EP06-A) provide standardized methodologies for establishing analytical performance, which inherently define how "ground truth" is approached for these types of assays.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a distinct "training set." The performance studies are analytical evaluations of a chemical assay.

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

Not applicable, as there is no "training set" in the context of this device.

Ask a specific question about this device

The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension Vista® System. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome.

The CHEM 3 CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (CO2) and Ethyl Alcohol (ETOH) methods on the Dimension Vista" System.

The Dimension Vista® Ammonia assay (AMM) is an enzymatic method that uses glutamate dehydrogenase (GLDH) and a stabilized NADPH analog. Ammonia reacts with a-ketoglutarate and reduced cofactor to form L-glutamate and the cofactor. The reaction is catalyzed by glutamate dehydrogenase. The decrease in absorbance due to the oxidation of the reduced cofactor is monitored at 340/700 nm and is proportional to the ammonia concentration.

The Dimension Vista® Ammonia (AMM) Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge for use on the Dimension Vista® System.

The Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) is a two level, liquid calibrator. It is packaged as a kit of six vials with 2.5 mL per vial. The product is a multi-analyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol.

The provided document describes the Siemens Dimension Vista® Ammonia Flex® reagent cartridge (AMM) and Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) and their performance characteristics. As a laboratory assay and calibrator, the concept of "acceptance criteria" and "device performance" relates to analytical performance metrics rather than diagnostic accuracy as would be the case for an AI medical device. Similarly, concepts like "sample size used for the test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "ground truth" are not directly applicable in the context of validating an in vitro diagnostic reagent and calibrator kit.

However, I can extract the relevant analytical performance characteristics and compare them to accepted standards (often implied by the CLSI guidelines referenced).

Here's an interpretation of the requested information, adapted to the context of an in vitro diagnostic (IVD) reagent and calibrator:

Acceptance Criteria and Study to Prove Device Meets Criteria

The studies conducted for the Siemens Dimension Vista® Ammonia Flex® reagent cartridge (AMM) and Dimension Vista® Chemistry 3 Calibrator (CHEM 3 CAL) evaluate their analytical performance against established guidelines (primarily CLSI standards). The 'acceptance criteria' are generally understood to be meeting these established analytical performance benchmarks to demonstrate substantial equivalence to predicate devices and ensure reliable test results.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Method Comparison: 100 patient samples. Provenance is not explicitly stated (e.g., country of origin) but inferred to be clinical laboratory samples. Data type is prospective, as fresh samples were tested.
• Plasma Equivalency: 49 fresh matched lithium heparin and EDTA plasma samples. Provenance is not explicitly stated. Data type is prospective.
• Precision: Not explicitly stated as "sample size" in the context of unique patient samples, but testing involved "three levels of Liquicheck™ Ethanol/Ammonia control" tested over 20 days, two separate runs with two test samples for each test material (effectively 3 levels * 20 days * 2 runs * 2 replicates = 240 measurements for each level during repeatability and within-lab assessment).
• Linearity, LoB, LoD, LoQ: The number of unique patient samples is not specified. Studies utilized specific control materials and diluted samples tested across multiple days, runs, and replicates (e.g., for LoB, 4 blank samples tested for 3 days, 1 run/day, 2 replicates/run).
• Interference: Tested with specific concentrations of interfering substances (e.g., 75 mg/dL Hemoglobin) and tested at two analyte concentrations (85 µg/dL and 426 µg/dL). The number of unique patient samples for interference testing is not explicitly stated for all tests, but for certain endogenous interferents which exceeded 10% bias, an aliquot of a patient sample containing the potential interferent was mixed with a plasma pool.

Data provenance is from laboratory studies performed at Siemens Healthcare Diagnostics, Inc. on Dimension Vista® 1500 System, implying a retrospective analysis of collected lab data or controlled prospective lab studies.

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

This concept is not applicable to the validation of an IVD reagent and calibrator. The "ground truth" for analytical performance studies is typically established by:

• The results from a legally marketed predicate device (for method comparison).
• Defined reference materials (e.g., control solutions, calibrators).
• Known concentrations in spiked samples.
• Established clinical laboratory reference intervals.

4. Adjudication Method for the Test Set

Not applicable. This concept relates to expert consensus in interpreting complex data (e.g., images) to establish a "ground truth" for a diagnostic model, which is not relevant for analytical performance studies of a laboratory reagent.

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

Not applicable. MRMC studies are used for diagnostic devices that involve human interpretation of results (e.g., radiology images). This document describes an automated laboratory assay. The closest equivalent is the "Method Comparison" study, which compares the new device's analytical results to those of an established predicate device.

• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no human-in-the-loop AI component is demonstrated.

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

Yes, the studies presented are all "standalone" in the sense that they evaluate the analytical performance of the assay and calibrator on the Dimension Vista® System without direct human judgment influencing the output of the measurement. The results reported (e.g., correlation, precision, linearity) represent the performance of the device itself.

7. The Type of Ground Truth Used

• Method Comparison: The predicate device, Dimension® Ammonia (AMON) assay (K863840), served as the reference or "ground truth" for comparison.
• Plasma Equivalency: Matched samples of different plasma types were compared, with one type serving as a reference point.
• Precision: Standardized control materials (Liquicheck™ Ethanol/Ammonia control) with known or expected ranges.
• Linearity, LoB, LoD, LoQ: Serial dilutions of samples with known concentrations or blank samples, evaluated against expected analytical behavior.
• Interference: Control samples without interferent compared to test samples with known concentrations of potential interferents.
• Reference Interval: Transference of reference interval from widely accepted literature (Textbook of Clinical Chemistry by NW Tietz) and validated through CLSI C28-A3 guidelines.

8. The Sample Size for the Training Set

Not applicable. This device is an IVD reagent and calibrator, not an AI/ML algorithm that requires a "training set" in the computational sense. The development of such reagents involves chemical and enzymatic research, formulation, and optimization rather than data-driven machine learning training.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for performance evaluations (as described in point 7) is based on established analytical chemistry principles, predicate device performance, and reference materials.

Ask a specific question about this device

The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma (heparin or EDTA) on the Dimension® clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome.

The Dimension® Ammonia assay (AMM) is an enzymatic method that uses glutamate dehydrogenase (GLDH) and a stabilized NADPH analog. Ammonia reacts with a-ketoglutarate and reduced cofactor to form L-glutamate and the cofactor. The reaction is catalyzed by glutamate dehydrogenase. The decrease in absorbance due to the oxidation of the reduced cofactor is monitored at 340/700 nm and is proportional to the ammonia concentration.

Here's a summary of the acceptance criteria and the study details for the Dimension® Ammonia Flex® reagent cartridge (AMM), based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the Dimension® Ammonia Flex® reagent cartridge (AMM) are not explicitly stated as pass/fail thresholds in the provided document. Instead, the document describes the performance characteristics that were "evaluated" or "determined" and compares them to the predicate device or established guidelines. The device demonstrates substantial equivalence based on these performance characteristics.

Here is a table summarizing the reported device performance for key characteristics:

Study Details

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

   • Method Comparison: 127 patient samples for comparison between AMM and predicate AMON.

   • Plasma Comparison: 50 matched lithium heparin and EDTA plasma samples.

   • Reference Interval: 30 healthy adults (17 men and 13 women) for validation of reference interval.

   • Precision: Not explicitly stated as "sample size" but involved multiple runs (20 days, two runs per day, two test samples for each of 3 control levels).

   • Linearity: Not explicitly stated as number of samples, but determined according to CLSI EP-6A which involves multiple dilutions/levels.

   • Analytical Specificity/Interferences: Various concentrations of interferents tested at two ammonia levels (85 µg/dL and 426 µg/dL), and for certain endogenous interferents, patient samples containing the interferent were mixed with a plasma pool. The exact number of samples for each interferent test is not specified, but the methodology follows CLSI EP7-A2.

   • LoB, LoD, LoQ:

     • LoB: 4 samples of calibrator (zero level) over 3 days (1 run/day, 2 replicates/run).
     • LoD: 4 low level samples over 3 days (1 run/day, 2 replicates/run).
     • LoQ: 3 ammonia standards diluted to 17 µg/dL [10 µmol/L] over 3 days (1 run/day, 3 replicates/run).

   • Data Provenance: The document does not explicitly state the country of origin for the patient or control samples. Given Siemens Healthcare Diagnostics, Inc. is based in Newark, DE (USA), it is likely the data were collected in the United States. The studies are described as typically performed by Siemens, indicating prospective collection in a laboratory setting for regulatory submission.

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

   • Not applicable as this is an in vitro diagnostic (IVD) device for quantitative measurement. The "ground truth" for the test samples is their measured ammonia concentration, determined by established laboratory methods, specifically the predicate device and the new device itself. There are no human expert adjudicators involved in determining the "truth" of an ammonia level.
   • The reference interval (expected values) was validated using the predicate device's established therapeutic range and a literature reference (Textbook of Clinical Chemistry by NW Tietz).

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in image-based AI studies where human readers might disagree on a diagnosis and a consensus mechanism is needed. For an IVD device, the "truth" value for a sample is its chemical concentration, determined by the measurement system rather than human interpretation or consensus.

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

   • Not applicable. This is not an AI-assisted diagnostic imaging device or a device involving human interpretation of results in a clinical read environment. It is an automated in vitro diagnostic test for quantitative chemical measurement.

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

   • Yes, this is essentially a standalone device performance study. The Dimension® Ammonia Flex® reagent cartridge (AMM) is an automated system for quantitative measurement. Its performance characteristics (linearity, precision, interference, LoB/LoD/LoQ, and comparison to a predicate device) are evaluated intrinsically, without human-in-the-loop performance influencing the measurement results themselves. Human involvement would be in operating the instrument and interpreting the numerical output.

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

   • The "ground truth" is established by direct chemical measurement.
     • For Method Comparison, the predicate device (Dimension® Ammonia (AMON)) served as the reference method for comparison.
     • For Precision, commercially available control materials (Liquichek™ Ethanol/Ammonia control) with known target values were used.
     • For Linearity, LoB, LoD, LoQ, studies were performed using calibrators and diluted standards/samples, with the "truth" being the calculated or theoretical concentration values.
     • For Interference studies, the "truth" for bias calculation was the measurement of control samples without the interferent, which then established the baseline against which the interferent's effect was measured.
     • For Reference Interval, the established therapeutic range of the predicate (Dimension® AMON) and a textbook reference (NW Tietz) provided the basis for the expected values.

7. The sample size for the training set:

   • Not applicable in the conventional sense of machine learning/AI models. This is a chemical assay, and thus there is no "training set" like in deep learning for image recognition. The "development" or "optimization" of such an assay involves chemical formulation and engineering, not data-driven model training.

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

   • Not applicable for the reason stated above. The "ground truth" for chemical assays is based on established analytical chemistry principles, reference methods, and certified calibrators/controls, rather than a labeled training set.

Ask a specific question about this device

The AMON method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension Vista™ System.

The Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge is an in vitro device intended to measure ammonia levels in plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Dade Behring Dimension Vista™ 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 Vista™ system was previously cleared with seven associated test methods (K051087). This Special 510(k) is submitted for a packaging modification to the Dimension® Ammonia (AMON) Flex® reagent cartridge (K863840), an in-vitro diagnostic device that has been cleared under the 510(k) process. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Ammonia (AMON) Flex® reagent cartridges are the same as those contained in the Ammonia (AMON) 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 device, nor does it alter the fundamental scientific technology of the device.

The provided text is a 510(k) summary for a medical device (Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance data for a new device.

Therefore, much of the requested information cannot be found in the provided text. The document is about a packaging change for an already cleared device, allowing it to be used on a new instrument system. The "study" mentioned is comparative testing to demonstrate substantially equivalent performance to the predicate device.

However, I can extract what is available:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance as it's a submission for a packaging change and not a new diagnostic algorithm. The primary "criterion" for this submission is substantial equivalence to the predicate device.

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

• Sample size: Not specified in the provided text. The document mentions "comparative testing described in the protocol included in this submission," but the protocol details (including sample size) are not part of this summary.
• Data provenance: Not specified (e.g., country of origin of data, retrospective or prospective).

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

This information is not applicable and not provided in the context of this 510(k) submission. This submission is for an in vitro diagnostic device (a reagent cartridge), whose "ground truth" would typically refer to the accuracy of its measurement capability against known standards or reference methods. The evaluation here is for chemical measurement performance, not expert-interpreted images or clinical decisions.

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

This information is not applicable and not provided. Adjudication methods like 2+1 are typically used for expert consensus in image interpretation or clinical outcomes, which is not the nature of this device's evaluation.

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 as the device is an in vitro diagnostic reagent cartridge for chemical analysis, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable. The device itself is the "algorithm" (the chemical assay). The performance is inherent to the assay and the instrument system it runs on. The "standalone" performance is its ability to accurately measure ammonia levels. The document states "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance" regarding this, but the specific performance metrics (e.g., accuracy, precision) are not detailed in the summary.

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

The "ground truth" for an in vitro diagnostic for ammonia levels would typically be:

• Reference methods for ammonia measurement.
• Known concentration standards.
• Correlation with clinically relevant ammonia levels in patient samples, often compared to an existing, cleared diagnostic device (the predicate).

While not explicitly stated as "ground truth," the comparison to the Dimension® AMON Flex® reagent cartridge (K863840) serves as the primary reference point (predicate device) for establishing equivalent performance.

8. The sample size for the training set:

This is not applicable as this is not an AI/machine learning device with a training set.

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

This is not applicable as this is not an AI/machine learning device with a training set.

Ask a specific question about this device

The Ammonia Ultra is intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome. The Ammonia Controls are intended as a means of monitoring Sentinel Ammonia Ultra assay method.

The Sentinel Ammonia Ultra Diagnostic Assay described in this 510(k) submission is composed by reagent, calibrator and controls, packaged and distributed in different kits. The device is intended to be sold as an in-vitro test for professional use. The Ammonia Ultra is an enzymatic in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. Ammonia, in the presence of glutamate dehydrogenase (GLDH), combines with alpha-ketoglutarate and NADH to yield glutamate and NAD*. The decrease in absorbance due to the NADH oxidation, at 340 nm, is proportional to the ammonia concentration in the examined plasma. The reagent contains lactate dehydrogenase (LDH) in excess, to rapidly reduce endogenous pyruvate so that it does not interfere with the assay system. The actual concentration of ammonia is determined multiplying the rate of absorbace per the calibration factor obtained during the calibration with the ammonia standard of 500 microgram/dL included in the kit. To ensure a correct determination during quantification of ammonia samples, a quality control procedure is required. The Ammonia Controls are liquid controls at 3 levels, prepared in bovine albumin matrix, and are used to verify the performance of the Ammonia Ultra assay. The value and range assigned to each level is specific for each lot and has been determined in rigorously standardized condition by the calculation of the median obtained in multiple determinations using reagents and standard relative to the Ammonia Ultra.

This document describes the Sentinel Ammonia Ultra Diagnostic Assay, an in-vitro diagnostic device for the quantitative determination of ammonia in human plasma. The information provided in the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific acceptance criteria and the comprehensive study results to prove device performance against those criteria. Therefore, several requested categories cannot be fully addressed from the provided text.

Here's the available information:

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

The document does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it mentions that "Performance evaluations included sensitivity, intra- and inter-assay imprecision, and method comparison." The conclusion states that "The performance and safety data presented in this premarket notification support a finding of substantial equivalence between the Sentinel Ammonia Ultra Diagnostic Assay and the predicate devices specified in this submission." This implies that the performance measured for sensitivity, imprecision, and method comparison was deemed acceptable relative to the predicate devices. Without the full study report, specific acceptance criteria and detailed quantitative performance values are not available.

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

The document does not specify the sample sizes used for sensitivity, intra- and inter-assay imprecision, or method comparison studies. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).

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. The "ground truth" for an in-vitro diagnostic device like this would typically be established by a reference method or known concentrations of ammonia in control samples. Expert interpretation of results is usually less relevant than the analytical accuracy against a gold standard.

4. Adjudication method for the test set

This information is not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which are not the primary focus for an enzymatic in-vitro diagnostic assay's performance evaluation.

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

An MRMC study is not applicable to this device. This is an in-vitro diagnostic assay for quantitative determination of ammonia, meaning there are no "human readers" or "AI assistance" involved in interpreting results in the way they would be in an imaging or diagnostic support system. Its performance is based on analytical accuracy.

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

This device is a standalone algorithm (an enzymatic assay, which functions like an algorithm in its chemical reactions and measurement). Its performance is inherently "standalone" in the context of its operation (i.e., it determines ammonia concentration without human-in-the-loop interpretation influencing the measurement result itself). The performance studies mentioned (sensitivity, imprecision, method comparison) would be a direct assessment of its standalone capability.

7. The type of ground truth used

For an in-vitro diagnostic device measuring a specific analyte like ammonia, the "ground truth" for performance evaluations would generally be:

• Known concentrations: For sensitivity and imprecision, this would involve using commercially available or custom-prepared control samples with a precisely known concentration of ammonia.
• Reference method comparison: For method comparison, it would involve testing patient samples using both the Sentinel Ammonia Ultra Diagnostic Assay and a legally marketed, well-established reference method (predicate device in this case) or a recognized gold standard method to assess concordance.

The document states that "The reagent contains lactate dehydrogenase (LDH) in excess, to rapidly reduce endogenous pyruvate so that it does not interfere with the assay system. The actual concentration of ammonia is determined multiplying the rate of absorbace per the calibration factor obtained during the calibration with the ammonia standard of 500 µg/dL included in the kit." This implies using a calibrated standard for accurate quantification, which serves as a form of ground truth for instrument calibration.

8. The sample size for the training set

The concept of a "training set" in the context of machine learning is not directly applicable to this enzymatic in-vitro diagnostic assay. These assays are based on established biochemical reactions, and their performance is optimized through reagent formulation, calibration, and validation, not typically through machine learning model training on large datasets in the conventional sense. Therefore, no "training set sample size" is reported.

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

As explained above, there isn't a "training set" in the machine learning sense for this type of device. The accuracy of the assay is based on the chemical principle (enzymatic reaction converting NADH) and the use of a calibrated standard (500 µg/dL ammonia standard) to establish the relationship between absorbance change and ammonia concentration.

Ask a specific question about this device

For the IN VITRO quantitative determination of Ammonia in plasma. Anmonia measurements are used in the clagaosis and treatment of severe liver disorders, such as circhosis, and Reve s Syndrome. For the IN VITRO quantitative dctermination of Anumonia in plasma

Ammonia-L3K @ Assay, Cat. No. 233

This document is a 510(k) clearance letter from the FDA for a device called "Ammonia-L-3K Assay." This type of document is a notification of the agency's decision that the device is substantially equivalent to a predicate device and can be legally marketed. It is not a study report and therefore does not contain information about acceptance criteria or specific study results as requested in the prompt.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval rather than technical performance data.

Ask a specific question about this device

The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with α-ketoglutarate and NADPH in the presence of qlutamate dehydrogenase (GLDH) to vield glutamate and NADP*. The corresponding decrease in absorbance at 340mm is proportional to the concentration of ammonia in the plasma. Ammonia measurememts are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis and Reye's Syndrome. This application sheet has been developed for the Advia 1650 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Limited Ammonia Test Kit is an in vitro diagnostic assay for the quantitative determination of ammonia in plasma. During the assay ammonia combines with α-ketoglutarate and NADPH in the presence of qlutamate dehydrogenase (GLDH) to vield glutamate and NADP*. The corresponding decrease in absorbance at 340mm is proportional to the concentration of ammonia in the plasma.

I am sorry, but the provided text from the FDA 510(k) approval letter for the "Randox Ammonia" device does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets them.

The document is primarily focused on the FDA's determination of substantial equivalence to a predicate device, which allows the "Randox Ammonia" kit to be marketed. It states the indications for use and mentions the assay's mechanism but does not include:

• A table of acceptance criteria or reported device performance metrics.
• Details about sample sizes for test or training sets, data provenance, or expert qualifications.
• Information on ground truth establishment, adjudication methods, or MRMC studies.

Therefore, I cannot extract the specific information you requested from this document.

Ask a specific question about this device

The Bayer ADVIA 1650 Ammonia method and calibrator is an in vitro diagnostic device intended to quantitatively measure ammonia levels in human plasma (heparin or EDTA). Such measurements are used in assessing hepatic function and diagnosis of Reye's syndrome.

The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).

The provided document describes the safety and effectiveness summary for the Bayer ADVIA® 1650™ Ammonia assay. This device is an in vitro diagnostic device used to quantitatively measure ammonia levels in human plasma. The information pertains to an analytical performance study rather than an AI/ML medical device. Therefore, several sections of the requested output (2, 3, 4, 5, 6, 7, 8, and 9) related to AI/ML and human experts are not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but presents performance data for imprecision, correlation, and interfering substances, comparing the ADVIA 1650 to a predicate device (Roche Ammonia on Hitachi). The acceptance is implied by the presentation of the data itself against the predicate device's performance.

• 3.8% (at 69.7 ug/dL)
• 1.7% (at 150.6 ug/dL)
• 0.7% (at 387.9 ug/dL) |
  | Correlation | Strong linear correlation (r value close to 1) and low Syx compared to Roche (On Hitachi) | $Y = 1.05x + 7.19$
  (where Y = ADVIA 1650, X = Roche)
  Syx = 62.18
  r = 0.98 |
  | Interfering Substances Recovery | Recovery % should be within an acceptable range (typically 90-110% or similar) despite interferents | Hemoglobin: 105.18%
  Bilirubin conj: 95.30%
  Bilirubin unconj: 100.48%
  Intralipid: 91.06%
  TRIG Concentrate: 108.98% |
  | Analytical Range | 25 to 1300 ug/dL (This is the stated range, implying it meets internal criteria) | 25 to 1300 ug/dL (Serum/Plasma(Lithium heparin)) |

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

• Sample Size for Correlation Test: 94 plasma specimens (N=94).
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

Not applicable. This is an analytical performance study of an in vitro diagnostic device, not an AI/ML medical device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" (or reference method) for comparison is the predicate device's measurement.

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

Not applicable. This is an analytical performance study of an in vitro diagnostic device. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials with human readers.

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 analytical performance study of an in vitro diagnostic device, not an AI/ML assisted diagnostic tool.

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

Yes, the study describes the standalone analytical performance of the ADVIA 1650 Ammonia assay. The performance metrics (imprecision, correlation, interference) are inherent to the device's measurement capabilities.

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

The "ground truth" or reference for comparison in this analytical study is the measurements obtained from the predicate device, the Roche Ammonia assay (on Hitachi).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device is a chemical analyzer.

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

Not applicable. Refer to point 8.

Ask a specific question about this device

The Bayer ADVIA IMS Ammonia (NH3) assay is an in vitro diagnostic device intended to measure Ammonia in human plasma (K3EDTA). Measurements of ammonia are used as an aid in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.

The Bayer ADVIA IMS Ammonia method is an in vitro diagnostic device intended to measure ammonia levels in human plasma. Such measurements are used in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.

Not Found

Here's a breakdown of the acceptance criteria and the study details for the Ammonia method for ADVIA® IMS™, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device (Sigma Ammonia) and the determination that the ADVIA IMS Ammonia Assay's performance is "equivalent" and "within proposed manufacturing specifications." The provided data serves as the basis for demonstrating this equivalency.

Study Details

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

   • Sample Size: 51 specimens for the correlation study.
   • Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin. The specimens are "human plasma (K3EDTA)".

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

   • Not applicable/Not provided. This device is a quantitative assay, and the "ground truth" for the test set is established by the comparative system (predicate device), not expert consensus.

3. Adjudication method for the test set:

   • Not applicable. As a quantitative assay compared to a predicate device, adjudication methods by experts are not relevant here.

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, an MRMC study was not done. This is a submission for an in vitro diagnostic device, not an AI-assisted diagnostic tool involving human readers.

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

   • Yes, this is a standalone device performance study. The "algorithm" here refers to the chemical assay method performed by the ADVIA IMS system. The performance metrics (imprecision, correlation, interference, analytical range) reflect the device's capability without human interpretation or intervention in the results beyond standard laboratory operation.

6. The type of ground truth used:

   • Comparative Reference Method: The predicate device, Sigma Ammonia, run on a Fara II system, served as the comparative reference for establishing the performance characteristics, particularly for correlation. The performance is deemed "equivalent" to this predicate.

7. The sample size for the training set:

   • Not applicable/Not provided. This is a conventional chemical assay, not a machine learning or AI-based device that would typically have a separate "training set" in the computational sense. The development of the assay would involve various experimental and optimization phases, but these are not referred to as a "training set" in this context.

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

   • Not applicable. See point 7. The development of the assay would rely on established biochemical principles and analytical chemistry methodologies.

Ask a specific question about this device

For in vitro diagnostic use with the CARESIDE Analyzer™ to measure ammonia from anti-coagulated whole blood or plasma specimens to aid in the diagnosis and treatment of patients with severe liver disorders such as cirrhosis, hepatitis, and Reye's syndrome.

CARESIDE™ Ammonia cartridges are used with the CARESIDE Analyzer™ to measure ammonia in anti-coagulated whole blood or plasma specimens. The CARESIDE™ Ammonia cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of plasma to a dry film to initiate the measurement of ammonia The film cartridge (patent pending) contains all reagents necessary to measure ammonia.

Each CARESIDE™ Ammonia cartridge consists of an ammonia-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer™.

Once loaded, the CARESIDE Analyzer™ scans the cartridge barcode, brings the cartridge and the contained specimen to 37°C, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 microliters of sample remains in the metering passage. Any excess sample flows into the Overflow Well.

The 8.5 microliters of sample is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film before the sample moves through the reaction, porous, and detection layers where a blue-green dye forms in the presence of ammonia. The color intensity of the resulting blue-green dye, as measured by the amount of reflected light at 590 nanometers, directly relates to the ammonia concentration of the specimen.

As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate ammonia concentration.

Here's an analysis of the acceptance criteria and study information for the CARESIDE™ Ammonia device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the provided text does not explicitly state pre-defined acceptance criteria in terms of thresholds for satisfactory performance. Instead, it presents the comparative performance characteristics of the CARESIDE™ Ammonia device alongside the predicate device (Vitros NH3 DT Slides) and implicitly argues for substantial equivalence based on these comparisons.

Therefore, the "acceptance criteria" listed below are inferred from the demonstrated performance and the context of establishing substantial equivalence to a legally marketed predicate device. The underlying acceptance is likely that the device performs as well as or better than the predicate device for key analytical metrics.

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

• Test Set Sample Size: The document does not explicitly state the sample size used for the performance comparison studies (accuracy, precision, method comparison, linearity, interference).
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• This information is not provided in the text. As an in vitro diagnostic device for quantitative measurement, the "ground truth" would typically come from a reference method of known accuracy rather than expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

• This information is not applicable for this type of analytical device performance study, which relies on quantitative measurements and comparison to a reference method, rather than subjective expert adjudication.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic tests that involve human interpretation of results. The CARESIDE™ Ammonia device is an automated, quantitative in vitro diagnostic, so human "readers" are not directly involved in interpreting the result to the same extent as in, for example, radiology.

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

• Yes, a standalone performance study was done. The entire "Comparative Performance Characteristics" section describes the performance of the CARESIDE™ Ammonia device (algorithm/system only) in generating quantitative results. The device measures ammonia automatically and provides a µmol/L NH3 value. There is no indication of human intervention or interpretation required during the test process itself.

7. Type of Ground Truth Used

• The ground truth for the performance studies was established using a reference method, specifically the Glutamate dehydrogenase method. This is explicitly stated as the "Reference Method." For the method comparison study, it was compared against a "RAICHEM" method, suggesting another established analytical method.

8. Sample Size for the Training Set

• This information is not provided in the text. The document describes a specific analytical method and its performance, but not the development or "training" of an algorithm in the sense of machine learning, which would typically involve a separate training set. The "standard curve" is mentioned as lot-specific, which is a form of calibration rather than algorithm training with a large dataset.

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

• This information is not provided as a "training set" in the context of machine learning algorithms is not discussed. For traditional analytical devices like this, calibration (which uses a set of known standards to establish the relationship between signal and concentration) is the equivalent of "training," and the ground truth for this would be the precisely known concentrations of the calibrator materials. The text notes "# Calibration information bar-coded on each cartridge. Calibration information may change with each lot." This implies known calibrator values are used for establishing the standard curve.

Ask a specific question about this device