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For in vitro diagnostic use in the quantitative determination of digoxin in serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP systems.

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

The ADVIA Centaur Digoxin assay reagents come in the following configurations:
5 ReadyPack primary reagent packs containing ADVIA Centaur DIG Lite Reagent and Solid Phase, ADVIA Centaur DIG Master Curve card (250 Tests)
1 ReadyPack primary reagent pack containing ADVIA Centaur DIG Lite Reagent and Solid Phase, ADVIA Centaur DIG Master Curve card (50 Tests)

The ReadyPack consists of the following:
ADVIA Centaur DIG ReadyPack® primary reagent pack; Lite Reagent: 2.5 ml/reagent pack monoclonal mouse anti-digoxin antibody (~26.4 ng/mL) labeled with acridinium ester in protein buffered saline with sodium azide (0.11%) and preservatives.
ADVIA Centaur DIG ReadyPack primary reagent pack; Solid Phase Reagent: 12.5 mL/reagent pack digitoxin (~2 ng/mL) covalently coupled to paramagnetic particles in protein buffered saline with sodium azide (0.11%) and preservatives.

The provided document pertains to the 510(k) summary for the ADVIA Centaur Digoxin assay, specifically regarding the addition of plasma sample types (EDTA and lithium heparin) to its indications for use. It's a submission for an in vitro diagnostic (IVD) device, not an AI/ML-based medical device that relies on complex image analysis or similar algorithms. Therefore, many of the requested details about acceptance criteria, test sets, expert ground truth, MRMC studies, standalone performance, and training sets are not applicable to this type of device and its regulatory submission.

The "acceptance criteria" for this device are demonstrated through analytical performance studies, specifically specimen equivalency and interference studies, to confirm that adding plasma as a sample type does not negatively impact the assay's performance compared to the previously cleared serum sample type.

Here’s an attempt to structure the available information relevant to your request, while highlighting the parts that are not applicable to this specific device (as it's an IVD test, not an AI/ML diagnostic system):

Device: ADVIA Centaur® Digoxin assay

Purpose of Study: To demonstrate substantial equivalence for the addition of plasma (EDTA and lithium heparin) as a valid sample type for the ADVIA Centaur® Digoxin assay.

1. Table of Acceptance Criteria and Reported Device Performance

For an IVD assay like the ADVIA Centaur Digoxin assay, "acceptance criteria" are typically defined by precision, accuracy (often assessed through method comparison/equivalent methods), interference, linearity, and analytical sensitivity. The provided document focuses on demonstrating specimen equivalency and interference for the new sample types.

Lithium heparin plasma vs. Serum:
Regression Equation: y = 1.06x - 0.03 ng/mL
Correlation Coefficient (r): 0.990 |
| Interference | Clinically insignificant bias (e.g., less than a certain percentage) when interfering substances are present at relevant concentrations. | Canrenone: 2.7% (at 1.11 ng/mL Digoxin), -0.5% (at 2.12 ng/mL Digoxin)
Dipotassium EDTA: -0.4% (at 0.91 ng/mL Digoxin), -1.1% (at 3.12 ng/mL Digoxin)
Heparin: 8.9% (at 0.61 ng/mL Digoxin), -1.7% (at 3.66 ng/mL Digoxin)
Potassium Canrenoate: 2.8%, -1.0%
Spironolactone: 1.0%, 2.5% |

Note: The document implies that the observed regression statistics and low bias values are acceptable for demonstrating substantial equivalence.

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

• Dipotassium EDTA plasma: 51 samples
• Lithium heparin plasma: 50 samples
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Typically, such analytical validation studies for IVDs are prospective and conducted in a controlled lab environment.

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

N/A. This is an IVD assay measuring a chemical concentration. "Ground truth" is established by the analytical method itself and comparison to a reference method or validated primary sample type (serum in this case). It does not involve expert interpretation of images or clinical data in the way an AI diagnostic would require. The "experts" are the analytical chemists and lab professionals performing and validating the assay.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are common in clinical trials or studies where human interpretation or consensus is required to establish ground truth from ambiguous or complex data (e.g., radiology images). For an IVD assay, the comparison is against an established analytical method (serum) or reference standard; there's no need for adjudication of readings.

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

N/A. MRMC studies are used to assess the effectiveness of diagnostic tools, particularly imaging, by comparing the performance of multiple human readers across multiple cases, often with and without AI assistance. This is not applicable to a quantitative biochemical assay.

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

The entire test (ADVIA Centaur Digoxin assay) is a standalone system for measuring digoxin concentration. Its performance is measured directly (e.g., accuracy, precision). There is no "human-in-the-loop" performance in the sense of clinical decision support from an AI. The device directly produces a numerical result.

7. The Type of Ground Truth Used

The "ground truth" for specimen equivalency was the measurement of digoxin in serum samples using the predicate ADVIA Centaur Digoxin assay (which was already cleared). The new plasma results were compared against these serum results. For interference, the ground truth is the known concentration of digoxin in the spiked samples.

8. The Sample Size for the Training Set

N/A. This is an IVD assay, not an AI/ML model that requires training data. The assay's reagents and methodology are developed through R&D, not trained on a dataset.

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

N/A. (See point 8).

Conclusion from the Document:

The study concludes that the modified ADVIA Centaur® Digoxin assay, with the addition of plasma sample types, is substantially equivalent in principle and performance to the Predicate Device (ADVIA Centaur® Digoxin assay cleared under 510(k) K931213). This equivalence is based on the analytical performance data, specifically the specimen equivalency and interference studies.

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Immunoassay for the in vitro quantitative determination of digoxin in human serum and plasma. Measurements are used in the diagnosis and treatment of digoxin overlose and in monitoring levels of digoxin to ensure proper therapy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

The Elecsys Digoxin assay employs a competitive test principle using a monoclonal antibody specifically directed against digoxin. Digoxin in the sample competes with the added digoxin derivative labeled with biotin for the binding sites on the ruthenylated antibody-complex. Results are determined via a calibration curve which is instrument- specifically generated by 2point calibration and a master curve provided via the reagent barcode. The reagent working solutions include: RackPack (kit placed on instrument) M: Streptavidin-coated microparticles, R1: Anti digoxin AbRu(bpy) 3+ and R2: Digoxin-derivativebiotin. PreciControl Cardiac II is a lyophilized control serum based on human serum in two concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys CK MB, CK MB STAT, Myoglobin, Myoglobin STAT, proBNP II, proBNP II STAT, and Digoxin immunoassays.

The provided document is a 510(k) summary for the Elecsys Digoxin Immunoassay and Elecsys PreciControl Cardiac II. It describes the device, its intended use, and various performance evaluations conducted.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document lists performance characteristics in a comparative table (Table 1 and Table 2) between the "Predicate Device Elecsys Digoxin Immunoassay (K973112)" and the "Candidate Device Elecsys Digoxin Immunoassay." While specific acceptance criteria are not explicitly stated for each test, the reported performance data for the candidate device can be listed. The comparison to the predicate device implies that the candidate device's performance should be equivalent or better.

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The Randox Laboratories Digoxin Assay is an in vitro diagnostic test for the quantitative determination of Digoxin in human serum or plasma. Quantitative measurements are used in the diagnosis and treatment of Digoxin overdose and in monitoring levels of Digoxin to ensure appropriate therapy. This device has been developed for the ADVIA system and is intended for prescription use only.

Not Found

The provided text is related to the FDA clearance of the "Randox Digoxin Assay" and specifically mentions its "Indication for Use" and a 510(k) number (K102346). However, the document does not contain the detailed information required to fill out the requested table regarding acceptance criteria, device performance, study details (sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details).

This type of FDA clearance letter confirms substantial equivalence to a predicate device but typically does not include the raw data or detailed study reports. Those would be found in the 510(k) submission itself, which is not provided here.

Therefore, I cannot provide the requested information from the given text.

To answer your request, I would need a detailed study report, a summary of the 510(k) submission materials, or a document specifically outlining the performance data and acceptance criteria for the Randox Digoxin Assay.

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

The DRUG 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) method on the Dimension Vista® System.

Method: The DIGXN method is a homogeneous, sequential, chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated F(ab')2 fragment of an anti-Digoxin mouse monoclonal antibody. The first bead reagent (Chemibeads) is coated with ouabain, a weaker binding analog of digoxin, and contains a photosensitizer dye. In a first step, sample is incubated with biotinylated F(ab')> which allows digoxin from the sample to saturate a fraction of the biotinylated F(ab')2 that is directly related to the digoxin concentration. In a second step, ouabain chemibeads are added and form bead/biotinylated F(ab')> immunocomplexes with the non-saturated fraction of the biotinylated F(ab')>. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemilyminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the digoxin concentration in the sample.

Calibrator: The DRUG 4 Calibrator is a 5 level, liquid calibrator. It is packaged as a kit of ten vials, two vials per level (A, B, C, D and E), 2.5 mL per vial. The product matrix is human serum.

Here's a summary of the acceptance criteria and study details for the Dimension Vista® LOCI Digoxin Flex® Reagent Cartridge (K6435) and Dimension Vista® DRUG 4 Calibrator (KC460), based on the provided text:

Acceptance Criteria and Device Performance

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

The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma.

For in vitro diagnostic use.

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

1. Acceptance Criteria and Reported Device Performance:

The provided document describes a 510(k) submission for the ARCHITECT iDigoxin assay, claiming substantial equivalence to a predicate device. The primary performance metric reported is based on this equivalence.

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size used for the clinical performance study or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "non-clinical performance data" and "clinical performance data" without specifying details about the clinical study itself.

3. Number and Qualifications of Experts for Ground Truth:

The document does not mention the use of experts to establish ground truth for the test set. For in vitro diagnostic devices like the ARCHITECT iDigoxin, the ground truth is typically clinical samples analyzed by a reference method or the predicate device itself, rather than expert interpretation of images or clinical scenarios.

4. Adjudication Method:

The document does not mention any adjudication method, as it doesn't describe a scenario where expert consensus or conflict resolution would be required. The clinical performance is assessed by comparing results to a predicate device.

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

An MRMC study was not performed or described. This type of study is typically relevant for interpretative devices where human readers assess cases (e.g., radiology images). The ARCHITECT iDigoxin is a quantitative immunoassay, not an interpretative device, so an MRMC study is not applicable. Therefore, there is no effect size reported for human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

The device itself is a standalone algorithm (an immunoassay system). The "performance" section describes the device's ability to measure digoxin levels in comparison to a predicate device. So, the clinical performance reported (Pearson correlation coefficient of 0.993) is the standalone performance of the ARCHITECT iDigoxin assay against the predicate device.

7. Type of Ground Truth Used:

For the clinical performance study, the "ground truth" was established by the measurements obtained from the legally marketed predicate device, Aeroset Multigent Digoxin. The ARCHITECT iDigoxin's readings were correlated with the readings from this established device.

8. Sample Size for Training Set:

The document does not explicitly state the sample size used for any training set. For an immunoassay, "training" might involve calibrating the system and optimizing reagents, but details on sample sizes for these internal processes are not provided in this regulatory summary.

9. How Ground Truth for Training Set was Established:

The document does not explicitly describe how ground truth for a training set was established. Immunoassays are typically "trained" or calibrated using a series of calibrator materials with known concentrations. The ARCHITECT iDigoxin Calibrators (A-F) are mentioned, which would be used for the calibration process. The ground truth for these calibrators would be established through a traceable reference method by the manufacturer.

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The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to help ensure proper therapy.

The ONLINE TDM Procainamide assay is for the quantitative determination of procainamide 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 Procainamide reagent kits.

The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of procainamide in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ONLINE TDM Procainamide device:

Acceptance Criteria and Reported Device Performance

The device is evaluated for substantial equivalence to a predicate device (COBAS INTEGRA Procainamide, K951595). The acceptance criteria are implicitly defined by comparing the performance characteristics of the new device to the established performance of the predicate device, aiming for comparable or acceptable results. While specific numerical thresholds for "acceptable" are not explicitly stated, the context of substantial equivalence implies that the performance should be within a clinically acceptable range relative to the predicate.

Study Details:

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

   • Precision Studies: The number of runs for the precision studies (within-run and total precision) is not explicitly stated, but the NCCLS guidelines typically involve a specific number of replicates over several days. The data provenance is not specified (e.g., country of origin), but it is a laboratory evaluation in the context of device development. It would be considered prospective for the device under evaluation.
   • Method Comparison (ONLINE TDM Procainamide vs. COBAS FP Procainamide): N = 51 serum or plasma samples. Data provenance is not specified. Likely prospective laboratory evaluation.
   • Method Comparison (COBAS FP Procainamide vs. COBAS FARA II): N = 156 samples. This is a comparison for the predicate device, not the new device directly, but demonstrates the predicate's performance. Data provenance is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This device is an in-vitro diagnostic (IVD) for quantitative measurement of procainamide in human serum or plasma. The "ground truth" here is the actual concentration of procainamide. This is established by validated laboratory reference methods or by the predicate device itself, not typically by expert interpretation in the way a diagnostic imaging device would. Therefore, the concept of "experts" establishing ground truth in the traditional sense for image interpretation or pathology does not directly apply. The predicate device (COBAS INTEGRA Procainamide) served as the reference for comparison in the method comparison study.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable (N/A) for this type of IVD device. "Adjudication" refers to resolving disagreements among multiple human readers or experts, which is not relevant for quantitative chemical measurements.

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 (N/A). This is an IVD device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation system.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, this study represents a standalone performance evaluation of the ONLINE TDM Procainamide assay. The device itself is an automated clinical chemistry analyzer which quantitatively determines procainamide levels directly from samples. There isn't a human-in-the-loop component in the measurement process, though a human still interprets the results in the clinical context.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth for the new device's performance was established by comparison to a legally marketed predicate device (Roche COBAS INTEGRA Procainamide, K951595), which itself is presumed to have undergone rigorous validation against established analytical methods. For method comparison, the values obtained from the predicate device served as the reference for linearity and correlation. For precision, the "true" mean values for controls are set during their manufacturing and quality control.

7. The sample size for the training set:
   Not applicable (N/A). This device is based on a homogeneous enzyme immunoassay technique, not a machine learning or AI algorithm that requires a "training set." It's a chemical assay.

8. How the ground truth for the training set was established:
   Not applicable (N/A), as there is no "training set" in the context of an enzyme immunoassay.

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The ONLINE TDM N-acetylprocainamide assay is for the quantitative determination of Nacetylprocainamide in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained from this device are used in the diagnosis and treatement of Nacetylprocainamide overdose and in monitoring the levels of N-acetylprocainamide to help ensure appropriate therapy.

The ONLINE TDM N-acetylprocainamide assay is for the quantitative determination of N-acetylprocainamide 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 N-acetylprocainamide reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of N-acetylprocainamide in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay.

Here's a breakdown of the acceptance criteria and study information for the ONLINE TDM N-acetylprocainamide device based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document doesn't explicitly state numerical "acceptance criteria" in the typical sense (e.g., "sensitivity must be >90%"). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device, meaning its performance characteristics (precision, method comparison, etc.) are "acceptable" and comparable to the predicate. Therefore, the "reported device performance" is the direct evidence of meeting this established equivalence.

Study Conclusion: The document states, "All of the performance characteristics including precision, lower detection limit, specificity, and interfering substances, method comparisons, and linearity provided acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM N-acetylprocainamide assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA N-acetylprocainamide assay."

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

• Sample Sizes:
  • Precision (NCCLS): The sample size for controls for the precision study is not explicitly stated as a number of individual samples, but NCCLS guidelines for precision studies typically involve multiple replicates (e.g., 20 or more) tested over several days. The results are reported as Means, Standard Deviations (SD), and Coefficient of Variation (CV%) for three different control levels.
  • Method Comparison: N = 54 patient samples were used for the comparison between the ONLINE TDM N-acetylprocainamide and the COBAS FP N-acetylprocainamide (predicate).
• Data Provenance: The document does not specify the country of origin for the data or whether the data was retrospective or prospective. Typically, for a 510(k) submission of this type, the data would be generated from internal laboratory studies (prospective) using a mix of patient samples and spiked controls.

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

This information is not applicable to this type of device (an in vitro diagnostic assay for drug level measurement). For these devices, "ground truth" for method comparison is established by comparing the candidate device's results against a previously cleared, established, and accepted method (the predicate device) or a reference method. It does not involve human expert consensus in the way a diagnostic imaging or pathology device might.

4. Adjudication Method for the Test Set:

This is not applicable as there is no human interpretation or subjective assessment involved that would require an adjudication process. The comparison is objective (numerical results from an automated analyzer).

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

This is not applicable. This is an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic support tool for human readers. Therefore, no MRMC study was performed, and there is no "human-in-the-loop" component in the interpretation of the results from this device.

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

The performance shown (precision, method comparison, etc.) is the standalone performance of the assay on the automated clinical chemistry analyzers. As an in vitro diagnostic test, the device provides a quantitative numerical result; its "performance" is inherently "algorithm only" in the sense that it automates the measurement process. There is no human interpretation of the assay's direct output (e.g., reading a strip or visually interpreting a color change that would require a human-in-the-loop consideration).

7. The Type of Ground Truth Used:

The "ground truth" for the method comparison study was the results obtained from the predicate device, the COBAS INTEGRA N-acetylprocainamide (K951595). For precision studies, the "ground truth" is the inherent precision observed when repeatedly testing known control materials.

8. The Sample Size for the Training Set:

This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic assays like this one. These assays are based on established biochemical reactions (homogeneous enzyme immunoassay) and spectrophotometric measurement, not on machine learning models that require "training sets." The development and optimization of such assays involve rigorous chemical and laboratory testing to define reagent formulations, reaction conditions, and calibration curves, but this isn't referred to as a "training set" in the machine learning sense.

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

As discussed above, the concept of a "training set" and "ground truth" for it, in the AI/machine learning sense, does not apply to this type of traditional IVD device. The assay's performance and accuracy are established through analytical validation studies (like precision, linearity, method comparison) against known standards and predicate methods.

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

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

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The 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 AxSYM Digoxin III assay is a microparticle enzyme immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

The AxSYM Digoxin III Reagent Pack is composed of the following reagent components: • Digoxin: Alkaline Phosphatase Conjugate • Anti-digoxin (Rabbit) Coated Microparticles • MEIA Buffer • Digoxin III Probe Wash Solution
The AxSYM Digoxin III Calibrators contain six bottles of accurately measured amounts of digoxin prepared in recalcified human plasma, nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2.
The AxSYM Digoxin III Controls contain three bottles of accurately measured amounts of digoxin prepared in recalcified human plasma, nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing attributes and performance characteristics. While explicit "acceptance criteria" in a traditional sense (e.g., specific thresholds for accuracy, precision) are not fully detailed as a separate section, the comparison points serve as acceptance criteria for demonstrating equivalence.

The overall conclusion is: "Results of laboratory testing demonstrate that the performance of the Abbott AxSYM Digoxin III assay is acceptable and comparable to the performance of the predicate device, when used according to its intended use." This statement confirms all criteria were met to achieve substantial equivalence.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Results of laboratory testing."

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 an in vitro diagnostic device like this, the "ground truth" would likely be established through reference methods or highly accurate comparative assays rather than expert interpretation.

4. Adjudication method for the test set:

This information is not provided.

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 an in vitro diagnostic device (IVD) for quantitative measurement of a drug in serum/plasma. It is not an AI-assisted diagnostic imaging device or one that involves human "readers" in the context of interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

The AxSYM Digoxin III assay is an automated in vitro diagnostic device. The performance data presented (e.g., interference, control ranges) represent the standalone performance of the assay system itself, without direct human intervention in the interpretive process of the result once generated by the instrument.

7. The type of ground truth used:

While not explicitly detailed, for an IVD test measuring drug levels, the "ground truth" would typically be established by:

• Reference Methods: Highly accurate and validated analytical techniques (e.g., mass spectrometry) to determine the true concentration of digoxin in samples.
• Known Concentrations: Use of samples with precisely known concentrations of digoxin (e.g., spiked samples, certified reference materials).

8. The sample size for the training set:

The document does not provide information about a "training set" or its sample size. For an IVD assay like this, development typically involves method optimization and validation rather than machine learning training sets in the computational sense.

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

As no training set is discussed or implied, this information is not provided.

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