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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 Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is used for the quantitative determination of N-acetylprocainamide in serum or plasma. Measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.

The Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® NAPA Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) which uses a latex particle N-acetylprocainamide conjugate and monoclonal N-acetylprocainamide specific antibody. Nacetylprocainamide present in the sample competes with N-acetylprocainamide on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentrtion of N-acetyl procainamide in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dade Behring Dimension® N-acetylprocainamide (NAPA) Flex® reagent cartridge method:

Summary of Acceptance Criteria and Device Performance:

The document describes a comparative study to demonstrate substantial equivalence to a predicate device, the Dade Behring aca® NAPA analytical test pack (K833378). The primary acceptance criteria appear to be related to the correlation and agreement between the new device and the predicate device.

Study Information:

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

   • Sample Size: 73 samples (n=73) were used for the comparative study between the Dimension® NAPA Flex® method and the predicate aca® NAPA method.
   • Data Provenance: The document does not specify the country of origin. It indicates the study was a "split-sample comparative performance" evaluation, meaning each sample was tested by both methods. It is a retrospective or prospective study from a practical perspective, as 73 samples obtained from patients (human source) would be retrospectively analyzed by both new and predicate methods.

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

   • This type of immunoassay study typically does not rely on "experts" to establish a ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the "ground truth" or reference is the performance of the predicate device, which is an already legally marketed and accepted method for NAPA quantification. No independent experts were involved in establishing the ground truth for the individual sample concentrations.

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

   • No adjudication method was used or needed. The comparison was directly between the quantitative results of the new device and the predicate device.

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

   • No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This is a clinical chemistry immunoassay device, not an imaging device that would involve human readers or AI assistance.

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

   • Yes, the performance presented for the "Dimension® NAPA Flex® reagent cartridge method" is inherently a standalone performance (algorithm/assay only) without human-in-the-loop interaction beyond the standard operation of the clinical chemistry system.

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

   • The "ground truth" in this context is the results obtained from the legally marketed predicate device (Dade Behring aca® NAPA analytical test pack). The study's purpose was to demonstrate substantial equivalence by showing good agreement with this established method.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" for an algorithm. For an immunoassay, the development process involves reagent formulation, assay optimization, and calibration. The presented study data (n=73) would be considered part of the validation/test set used for regulatory submission.

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

   • As there's no mention of a traditional "training set" for an algorithm in the context of this immunoassay, the establishment of ground truth for such a set is not applicable. The assay itself is developed and optimized against known standards and controls, not a large "training set" of patient samples for machine learning.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Not applicable. This is an automated immunoassay, not a device involving human readers or AI assistance.

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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The N-Acetylprocainamide (NAPA) Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of N-acetylprocainamide in human serum or plasma. NAPA is the major metabolite of procainamide. Its pharmacologic activity is almost equal to that of procainamide. Furthermore, serum NAPA concentration may exceed its parent drug concentration. Therefore, simultaneous measurement of procainamide and NAPA serum concentration is critical in achieving optimal procainamide therapy.

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The provided text is an FDA 510(k) clearance letter for an in vitro diagnostic device, the N-Acetylprocainamide (NAPA) Enzyme Immunoassay. This letter primarily focuses on the regulatory clearance process, stating that the device has been found substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain information about:

• Specific acceptance criteria used in a performance study.
• The results of such a study (device performance data).
• Any details regarding sample sizes (test or training sets).
• Data provenance.
• The number or qualifications of experts involved in establishing ground truth.
• Adjudication methods.
• Comparative effectiveness studies (MRMC).
• Standalone algorithm performance.
• The type of ground truth used or how ground truth for training data was established.

Therefore, I cannot provide the requested table or answer the specific questions based on the provided text. The document is strictly a regulatory clearance letter and does not delve into the technical study details that would typically be found in a 510(k) summary or the full submission.

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This in vitro method is intended to quantitatively measure n-acetylprocainamide, the pharmacologically active meabolite for procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® N-Acetylprocainamide Assay on a Bayer Immuno-1 system. Measurements of n-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of n-acetylprocainanide to ensure appropriate therapy.

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Here's an analysis of the provided text to extract the acceptance criteria and study details:

Acceptance Criteria and Device Performance for N-Acetylprocainamide Assay

The provided document describes the N-Acetylprocainamide (NAPA) assay for the Bayer Immuno 1® System, seeking substantial equivalence to a predicate device (Syva EMIT® N-Acetylprocainamide Assay). The acceptance criteria are implicitly defined by the performance characteristics of the predicate device, against which the new device's performance is compared.

1. Table of Acceptance Criteria and Reported Device Performance

Interpretation:

• Minimum Detectable Concentration: The Immuno 1 NAPA Assay demonstrated a lower minimum detectable concentration (0.11 µg/mL) compared to the predicate (0.25 µg/mL), indicating potentially better sensitivity.
• Precision: The precision of the Immuno 1 NAPA Assay is comparable to the predicate, with some points slightly higher (e.g., 5.5% vs 3.9% at 1.7 µg/mL, and 6.5% vs 4.5% at 8.7/10.8 µg/mL) and some slightly lower (4.3% vs 4.5% at 4.2/4.5 µg/mL). Given the slight differences, the overall precision is considered acceptable for substantial equivalence.
• Correlation: The Immuno 1 NAPA Assay shows excellent correlation with the predicate device, with an 'r' value of 0.99, a slope (0.99) very close to 1, and an intercept (-0.03) very close to 0. This indicates strong agreement between the two methods over the tested range.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: n = 99 for the correlation study.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it compares an existing predicate device with the new device using presumably collected samples, but this is not definitively stated.

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

• Not applicable. This study is a method comparison for an in vitro diagnostic assay, not a study involving human interpretation of data by experts. The "ground truth" for the test set is established by the measurements obtained from the predicate device.

4. Adjudication Method for the Test Set

• None. As this is a method comparison study, there is no human adjudication process involved. The performance of the new device is directly compared to the measurements from the predicate device.

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

• No, a MRMC study was not done. This describes an in vitro diagnostic assay, where the performance is based on quantitative measurements, not human reader interpretation. Therefore, the concept of human reader improvement with or without AI assistance is not applicable.

6. Standalone Performance Study

• Yes, a standalone study was done in the sense that the new device's performance characteristics (Minimum Detectable Concentration, Precision, and Correlation) were evaluated independently. While its correlation was measured against a predicate device, its fundamental performance metrics were assessed for the algorithm/device itself.

7. Type of Ground Truth Used

• The "ground truth" for the test set was the measurements provided by the predicate device (Syva EMIT® N-Acetylprocainamide Assay). The study aimed to demonstrate that the new device's measurements are substantially equivalent to those of the predicate.

8. Sample Size for the Training Set

• Not specified. The document does not provide details about a training set. This type of in vitro diagnostic device typically undergoes method validation rather than machine learning model training specific to a "training set" in the AI sense.

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

• Not applicable/Not specified. As there is no mention of a traditional "training set" for a machine learning model, the method for establishing ground truth for such a set is not detailed. The performance validation relies on comparing the new assay's output to an established method (the predicate device) on test samples.

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for the quantitative determination of Nacetylprocainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).

automated fluorescence polarization immunoassays (FPIA).

The provided 510(k) summary for the Abbott AxSYM N-Acetylprocainamide assay details a comparative study against a predicate device, the TDx/TDxFLx N-Acetylprocainamide assay. This document focuses on demonstrating substantial equivalence rather than establishing acceptance criteria against a clinical ground truth or in a standalone clinical performance study as commonly seen with diagnostic imaging or AI devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The 510(k) summary does not explicitly state pre-defined acceptance criteria for these metrics (e.g., "Slope must be between 0.95 and 1.05"). However, the reported values are presented to demonstrate a strong correlation and therefore substantial equivalence. For immunoassays like this, values very close to 1 for slope, 0 for intercept, and high correlation (e.g., >0.95) are generally considered indicative of good agreement between assays measuring the same analyte.

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

• Sample Size: 205
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given it's a comparative study for a medical device submitted in 1996, it's highly likely to be prospective data collected specifically for the purpose of demonstrating equivalence, possibly from patient samples obtained from a hospital or clinical lab.

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

Not applicable. This study compares the performance of a new device against a predicate device (TDx/TDxFLx N-Acetylprocainamide assay), not against a "ground truth" established by experts in the typical sense of clinical interpretation (e.g., radiologists reviewing images). The predicate device's results serve as the reference.

4. Adjudication Method for the Test Set:

Not applicable. There was no expert adjudication involved in establishing an independent ground truth. The comparison is directly between the quantitative results of two different automated assays.

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

Not applicable. This is not a study involving human readers interpreting cases. It's a quantitative comparison of two automated fluorescence polarization immunoassays.

6. Standalone Performance (Algorithm Only without Human-in-the-loop performance):

Yes, this is essentially a standalone performance study. The AxSYM N-Acetylprocainamide assay itself is an automated system that provides quantitative results without human interpretation of raw data. Its performance is evaluated by comparing its output directly to that of another automated system.

7. Type of Ground Truth Used:

The "ground truth" in this context is the results obtained from the predicate device, the TDx/TDxFLx N-Acetylprocainamide assay. This is a comparative "ground truth" rather than an absolute, independent, or expert-adjudicated ground truth.

8. Sample Size for the Training Set:

Not explicitly stated. For an immunoassay like this, there isn't typically a "training set" in the machine learning sense. Instead, the assay involves "calibration" using Abbott calibrators. The document mentions:

• "The AxSYM N-Acetylprocainamide standard calibrators and controls are to be used with the AxSYM N-Acetylprocainamide reagents."
• "The calibrators and controls are prepared gravimetrically using purified material obtained from commercial sources."

These calibrators are used to establish the standard curve against which unknown samples are measured. The number of samples used for initial calibration curve development or verification is not provided.

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

As mentioned above, there isn't a "training set" with an associated ground truth in the machine learning sense. For the calibration process:

• Calibrators and controls are prepared gravimetrically: This means their concentrations are determined by weight, using highly purified reference materials. This is a fundamental metrological principle for establishing quantitative standards.
• Verified using protocols involving multiple instrument testing: This implies internal validation to ensure the calibrators and controls perform as expected across different AxSYM instruments and potentially against reference methods. This process aims to ensure the accuracy of the calibrator values.

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