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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 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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The ADVIA IMS® Digoxin method is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.

Not Found

The Bayer ADVIA IMS® Digoxin assay is intended for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. This product is used as an aid in diagnosing digoxin overdose and monitoring therapeutic levels of digoxin for appropriate therapy.

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. However, the study aims to demonstrate substantial equivalence to the predicate device, the Immuno 1 Digoxin Assay. Therefore, the "reported device performance" is compared directly against the predicate device's performance, implying that performance comparable to or better than the predicate is the de facto acceptance criterion.

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The SERADYN OMS™ DIGOXIN assay is used for the quantitation of digoxin in human serum or plasma on the Abbott AEROSET® System.
Digoxin is a potent cardiac glycoside widely prescribed for the treatment of patients suffering from congestive heart failure, as well as some types of cardiac arrhythmias. Digoxin intoxication is a common and serious problem in the clinical setting. This is, in part, a result of the fact that cardiac glycosides have a low therapeutic ratio (a very small difference between therapeutic and tissue toxic levels). Coupled with the narrow therapeutic range is a marked patient variability in response to the same dosage of drug, often resulting in unpredictable serum drug levels. Intoxication symptoms are often indistinguishable from the original condition for which the drug was prescribed. It may not be immediately apparent whether the patient has been under or overdosed.
Monitoring serum digoxin levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmful toxic dosage levels.

The Seradyn QMS™ Digoxin Assay is a homogeneous Particle Enhanced Turbidimetric Immunoassay used for the quantitation of digoxin in serum or plasma. The assay is intended for use on the Abbott AEROSET® System, using the Seradyn QMS Digoxin Calibrators (previously cleared as Digoxin Immunoassay K983323.
The reagent system components are 1) digoxin coated microparticle reagent, and 2) the antibody reagent which consists of a mouse monoclonal antibody specific for digoxin.
The technology is based on competition between the digoxin in the sample and digoxin coated onto the microparticles, for the antibody-binding sites of the anti-digoxin antibody reagent. In the absence of digoxin in the sample, the specific antibody in the antibody reagent binds the digoxin on the particle, and results in rapid agglutination of the microparticles. In the presence of digoxin in the sample, the digoxin in the sample competes for antibody binding sites of the specific antibody in the antibody reagent, and partially inhibits the agglutination of the microparticles. The rate of agglutination (turbidity) is directly proportional to the rate in absorbance change of incident light and is measured spectrophotometrically by the Abbott AEROSET® System at a wavelength of 700 nm.
A six level Seradyn QMS™ Digoxin Calibrator set, with known digoxin concentrations is used to quantitate the assay. An internal concentration-dependent calibration curve is generated by the AEROSET® System, by measuring the rate of absorbance change of each calibrator level. Maximum absorbance rate is at the lowest digoxin concentration and the lowest absorbance rate at the highest digoxin concentration.
By monitoring the change in rate of a specimen with unknown digoxin concentration, and comparing to the internal calibration curve, a sample's concentration can readily be obtained and reported as digoxin concentration in either ng/ml or nmol/L.

Here's an analysis of the Seradyn QMS™ Digoxin assay's acceptance criteria and the studies performed, based on the provided text:

Acceptance Criteria and Device Performance for Seradyn QMS™ Digoxin on the Abbott AEROSET® System

1. Table of Acceptance Criteria and Reported Device Performance

Note on Interfering Substances: The document states "Acceptance criteria are recoveries of 100±12% for hemoglobin, 100±10% for hemoglobin、100 ±20% for lipids". There appears to be a typo, possibly intending 100±10% for bilirubin and 100±12% for hemoglobin, or vice-versa, given the reported values. I have used the written acceptance criteria as provided.

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

• Specificity (Cross-reactivity): Not explicitly stated, samples were "spiked" with specific compounds. Data provenance: Not explicitly stated, but implies laboratory-prepared samples.
• Accuracy by Recovery: Not explicitly stated how many samples were used, but "human serum" was spiked at four different concentrations. Data provenance: Not explicitly stated, but implies laboratory-prepared human serum.
• Sensitivity: Not explicitly stated how many samples or what method, only the "lowest Digoxin concentration that can be distinguished from zero with 95% confidence."
• Accuracy & Linearity by Dilution: The 5.0 ng/mL Digoxin Calibrator was diluted at 80%, 60%, 40%, and 20%. The "diluted samples, as well as the 5.0 ng/mL calibrator" were analyzed. Data provenance: Laboratory-prepared dilutions from a calibrator.
• Precision: "A tri-level human serum based commercial control containing digoxin was assayed in duplicate twice a day for twenty days." This means n=80 (3 levels * 2 replicates/day * 20 days) for each level presented in the table. Data provenance: Laboratory testing using commercial control.
• Method Comparison: "55" clinical specimens. Data provenance: Not explicitly stated, but "clinical specimens" suggests patient samples.
• Interfering Substances: "Abnormal bilirubin levels were prepared by adding to human serum pool... Abnormal hemoglobin levels were prepared by addition of red blood cell lysate... Abnormal lipid levels were prepared by addition of Intralipid®". N=2 for each tested interfering substance. Data provenance: Laboratory-prepared human serum pools.
• HAMA Interference: "A normal human serum pool (control), and HAMA type 1 and HAMA type 2 samples were spiked with the same amounts of digoxin." Each of these was assayed "in duplicate". Data provenance: Laboratory-prepared human serum and HAMA samples.
• Instrument On-board Stability: Controls were assayed "twice weekly for a period of 60 days". Specific 'n' not given, but implies multiple measurements over time. Data provenance: Laboratory testing.
• Instrument Calibration Stability: Data from on-board stability study was used.

In summary, the test set primarily consists of laboratory-prepared samples (spiked human serum, diluted calibrators, commercial controls, prepared interfering substance samples), with one study (Method Comparison) using "clinical specimens." The country of origin is not specified but is likely the US, given the submission to the FDA. All studies appear to be prospective experimental studies conducted by the manufacturer.

3. Number of Experts and Qualifications for Ground Truth

• None stated. The studies described are analytical performance studies focused on the intrinsic characteristics and measurement accuracy of the device. They do not involve human interpretation or diagnostic decision-making that would typically require expert ground truth establishment. The ground truth for these studies is based on theoretical concentrations (for recovery, linearity, spiking) or established reference methods (for method comparison).

4. Adjudication Method for the Test Set

• None applicable. As stated above, these are analytical performance studies, not studies involving human interpretation or subjective assessments that would require adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The studies are analytical performance assessments of the assay itself, comparing its measurements to known values or a predicate device. There is no human reader component to this type of device (an in-vitro diagnostic assay).

6. Standalone Performance Study (Algorithm only without human-in-the-loop)

• Yes, all reported studies are standalone performance studies. The Seradyn QMS™ Digoxin assay is a fully automated immunoturbidimetric assay on the Abbott AEROSET® System. Its performance characteristics (specificity, accuracy, precision, etc.) are measured directly from the output of the instrument, without human intervention in the measurement process itself, beyond sample preparation and loading. The results are numerical concentrations.

7. Type of Ground Truth Used

The ground truth used varies by study:

• Specificity (Cross-reactivity): Theoretical concentration of spiked cross-reactants.
• Accuracy by Recovery: Theoretical concentrations of digoxin spiked into human serum.
• Sensitivity: Defined statistically as the lowest concentration distinguishable from zero with 95% confidence.
• Accuracy & Linearity by Dilution: Theoretical concentrations based on serial dilutions of a known calibrator.
• Precision: Mean concentrations of commercial controls.
• Method Comparison: Results from the predicate device (Roche Tina-quant assay on the Hitachi 717) using clinical specimens.
• Interfering Substances: Theoretical concentrations of spiked interfering substances.
• HAMA Interference: Mean concentration of the control normal human serum.
• Instrument On-board Stability & Calibration Stability: Reference measurements at Day 0, against which subsequent measurements are compared.

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated. This device is an in-vitro diagnostic assay rather than an AI/ML algorithm that undergoes a distinct "training phase." Calibration for such assays involves using a multi-level calibrator set to establish a standard curve. The document mentions a "six level Seradyn QMS™ Digoxin Calibrator set" used to generate an "internal concentration-dependent calibration curve." This calibrator set essentially serves the function of "training" the instrument to interpret absorbance changes into digoxin concentrations.

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

• For calibration: The ground truth for the "training set" (the six-level calibrator set) is established by the known digoxin concentrations assigned to each calibrator level. These concentrations are determined by the manufacturer (Seradyn, Inc.) through a rigorous process, typically involving reference methods (e.g., mass spectrometry) or traceability to international reference materials. While not detailed in this 510(k) summary, the previous clearance of "Digoxin Immunoassay K983323" for the QMS Digoxin Calibrators suggests their concentrations were already established and accepted by the FDA.

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The IMMULITE® 2000 Digoxin assay is for in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of digoxin in serum or heparinized plasma, as an aid in monitoring the therapeutic administration of this cardioglycoside, while avoiding toxicity.

IMMULITE® 2000 Digoxin is a solid phase, chemiluminescent enzyme-labeled competitive immunoassay for use with the IMMULITE® 2000 Automated Analyzer. The solid phase is a polystyrene bead coated with a monoclonal murine anti-digoxin antibody. The patient sample and alkaline phosphatase-conjugated digoxin are simultaneously introduced into the Reaction Tube containing the bead, and incubated for approximately 30 minutes at 37 degrees C with intermittent agitation. During this time, digoxin in the sample competes with the enzyme-fairched digoxin for a limited number of antibody binding sites on the bead. Unbound enzyme conjugate is then removed by a centrifugal wash, after which substrate is added and the Reaction Tube is incubated for a further 5 minutes. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of digoxin in the sample.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of predefined thresholds for performance metrics. Instead, it demonstrates performance equivalence to a predicate device. The performance is presented as a method comparison, and the acceptance is implied by the FDA's granting of substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 97 samples
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a common omission in older 510(k) summaries for in-vitro diagnostics where the focus is on analytical performance, not clinical data from specific populations. It's safe to assume the samples were collected specifically for this method comparison study.

3. Number of Experts and Qualifications for Ground Truth

This type of study (method comparison for an in-vitro diagnostic device) does not typically involve human experts establishing ground truth in the way an imaging algorithm might. The "ground truth" for this test set is the measurement provided by the established, commercially available predicate device (IMMULITE® Digoxin).

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a direct comparison to a reference method, not an expert-based adjudication process.

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

No, an MRMC comparative effectiveness study was not done. This device is an automated in-vitro diagnostic assay, not an imaging or diagnostic aid that involves human readers.

6. Standalone Performance Study

Yes, a standalone study was performed. The "Method Comparison" section directly evaluates the IMMULITE® 2000 Digoxin's performance against a predicate device using analytical samples. This is an assessment of the algorithm/device itself without human-in-the-loop interaction for interpretation.

7. Type of Ground Truth Used

The ground truth used was the results from a legally marketed predicate device (IMMULITE® Digoxin). This is a common and accepted method for demonstrating substantial equivalence for new in-vitro diagnostic devices.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its size. For this type of competitive immunoassay, training would typically refer to the internal development and calibration of the assay. The 97 samples mentioned are for the method comparison (often considered a validation or test set), not an explicitly stated training set for an AI/algorithm.

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

Not applicable/not explicitly stated as a distinct "training set" with established ground truth in the same way an AI model would have. The "training" in the context of an immunoassay development involves optimizing reagent concentrations, reaction conditions, and calibration procedures to achieve desired analytical performance characteristics. The "ground truth" for calibration would be provided by purified digoxin standards of known concentrations.

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