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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 Dade Behring Dimension® Procainamide (PROC) Flex® reagent cartridge method is used for the quantitative determination of procainamide in serum or plasma. Measurements may be used in the diagnosis and treatment of procainamide overdose, and in therapeutic drug monitoring.

The Dade Behring Dimension® Procainamide (PROC) 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® PROC Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbidimetric inhibition immunoassay (PETINIA) which uses a latex particle procainamide conjugate and monoclonal procainamide specific antibody. Procainamide present in the sample competes with procainamide on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of 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, focusing on the acceptance criteria and the study details:

Acceptance Criteria and Device Performance

Note on Acceptance Criteria: The document describes acceptance criteria primarily through comparison to a legally marketed predicate device (Dade Behring aca® PROC analytical test pack). The acceptance criteria for the new device are implicitly met if its performance characteristics (Intended Use, Assay Range, and comparative performance data) are substantially equivalent to the predicate. The "good agreement (correlation)" is the primary measure for equivalence in this context.

Study Details

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

   • Sample Size: 89 samples.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense of comparing against an existing method, but the samples themselves could be prospective or retrospective clinical samples. The document refers to "split-sample comparative performance," which implies that 89 patient samples were divided and tested by both methods simultaneously.

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

   • Not applicable/Not mentioned. For this type of in vitro diagnostic device (quantitative measurement of a drug level), the "ground truth" is typically the measurement by a comparative method (the predicate device in this case), not an expert consensus on a qualitative diagnosis.

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

   • Not applicable/None. This is a quantitative assay comparison, not a diagnostic task where expert adjudication of images or clinical findings would be necessary. The comparison is directly between the numerical results of two different analytical methods.

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

   • No. This is not an AI/human reader study; it's a comparison of two in vitro diagnostic (IVD) systems for measuring drug concentration.

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

   • Yes, in essence. The Dimension® Procainamide (PROC) Flex® reagent cartridge method is an automated in vitro diagnostic test. Its performance data (Assay Range, correlation, slope, intercept) were generated by the device itself, without a human "reading" or interpreting the raw data in a way that would be analogous to a radiologist interpreting an image. The human element would be in operating the instrument and processing the samples, but the core measurement is algorithmic.

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

   • The "ground truth" for evaluating the new device was the measurement obtained from the predicate device, the Dade Behring aca® PROC analytical test pack method. This is a common approach for new IVDs claiming substantial equivalence.

7. The sample size for the training set:

   • Not specified. The document describes a performance evaluation study (test set), but does not explicitly mention a separate training set. For commercially available immunoassay kits, the "training" (calibration, optimization, etc.) is typically done during the product development and manufacturing phase, often on a larger, internal dataset, not usually detailed in 510(k) summaries for comparison studies.

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

   • Not specified, as a training set is not explicitly mentioned in the context of this 510(k) summary. If one existed, it would likely involve established reference methods or highly characterized samples.

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This in vitro diagnostic procedure is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno 17M system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of procainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.

This in vitro method is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® Procainamide Assay on a Bayer Immuno-19 system.

The provided document describes the Procainamide Assay for Bayer Immuno 1 System and its comparison to a predicate device, the Syva EMIT® Procainamide Assay.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

Note on Acceptance: The document states that the Immuno 1 Procainamide Assay was found substantially equivalent to the predicate device. This implies that the reported performance metrics of the Immuno 1 assay were deemed acceptable in comparison to the Syva EMIT® Procainamide Assay, even if they are not identical. For instance, the minimum detectable concentration is higher for the Immuno 1, and the precision categories (Total vs. Between-Run) are different, but the overall performance was considered sufficient for substantial equivalence.

Study Information

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

   • Sample Size: The correlation study involved n = 99 samples.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

2. 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, "ground truth" for the test set is typically established by comparative analysis against a validated reference method or another already cleared device (in this case, the predicate Syva EMIT® Procainamide Assay). The study is the comparison against a predicate device, so expert consensus on individual results isn't typically part of this specific type of submission.

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

   • This information is not applicable/provided. The study relies on quantitative assay results, not subjective interpretations requiring adjudication.

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:

   • This information is not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

   • The study described is inherently a standalone performance evaluation of the Immuno 1 Procainamide Assay system (which includes reagents, instrument, and method) against a predicate device. There is no human-in-the-loop component mentioned for the analytical performance of the assay itself.

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

   • The "ground truth" for this substantial equivalence submission is the performance of the legally marketed predicate device (Syva EMIT® Procainamide Assay). The study directly compares the new device's measurements to those obtained from the predicate device to demonstrate similar performance characteristics.

7. The sample size for the training set:

   • This information is not provided. IVD assays typically don't have a "training set" in the machine learning sense. The assay is developed and optimized, then validated.

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

   • This information is not provided and is generally not applicable for this type of IVD device. The methods for establishing the performance characteristics (e.g., linearity, precision, accuracy) during development and optimization would rely on calibrators and controls with known concentrations, potentially traceable to a primary reference standard, rather than a "ground truth" derived from a separate clinical set in the way AI models are trained.

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Immunoassay for the in vitro quantitative determination of N-acetylprocainamide in human serum and plasma.

The CEDIA® N-acetylprocainamide Assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, N-acetylprocainamide in the sample competes with analyte conjugated to one inactive frayment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.

The Boehringer Mannheim Corporation's CEDIA® N-acetylprocainamide Assay is a homogeneous enzyme immunoassay for the quantitative determination of N-acetylprocainamide in human serum and plasma. The study aimed to demonstrate its substantial equivalence to the predicate device, the Abbott TDx® N-acetylprocainamide Assay (K830206).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device. The performance characteristics of the CEDIA® Assay are presented and compared to those of the Abbott TDx® Assay.

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

• Precision: For precision studies, 120 measurements were performed for each of three levels (Level 1, Level 2, Level 3) for the CEDIA® assay. This is comparable to the 120 measurements for each of three levels reported for the predicate TDx assay.
• Method Comparison: A sample size of N=125 was used for the method comparison of the CEDIA® Assay against the Abbott TDx® N-acetylprocainamide.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is implied to be a prospective study conducted by the manufacturer for regulatory submission.

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

This type of immunoassay device does not typically involve expert review for establishing ground truth in the same way as imaging or diagnostic interpretation devices. The ground truth for quantitative assays is established through reference methods or the performance of a well-established predicate device. In this comparison study, the Abbott TDx® N-acetylprocainamide Assay served as the reference for method comparison.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative immunoassay device. The results are numerical values, and direct comparison to a reference method or predicate device provides the basis for evaluation, not expert adjudication of classifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on reader performance is evaluated. The CEDIA® Assay is a quantitative laboratory test.

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

Yes, the performance data presented (precision, lower detection limit, linearity, method comparison, interfering substances, specificity) are all characteristics of the device itself, functioning in a standalone capacity (i.e., the "algorithm" or assay chemistry) without human intervention in the result determination beyond operating the instrument.

7. The Type of Ground Truth Used

The ground truth for the CEDIA® N-acetylprocainamide Assay's performance was established primarily through:

• Comparison to a Predicate Device: The Abbott TDx® N-acetylprocainamide Assay served as the reference standard for method comparison.
• Internal Validation Studies: Precision, linearity, lower detection limit, interfering substances, and specificity were likely determined through internal validation studies following standard laboratory practices and guidelines (e.g., NCCLS).

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an in vitro diagnostic device like this, the development process involves extensive research and development to optimize the assay's chemistry and components (reagents, enzyme fragments, antibodies). However, there isn't a "training set" in the machine learning sense. The assay's parameters are established through laboratory experimentation and optimization.

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

As there isn't a "training set" in the conventional machine learning sense, the concept of establishing ground truth for it doesn't directly apply. The "ground truth" for developing the assay's performance characteristics is intrinsically built into the chemical and biological principles of the assay and its optimization process by ensuring accurate and reliable measurement of N-acetylprocainamide concentrations. This involves:

• Using known concentrations of N-acetylprocainamide for calibration and quality control.
• Testing various reagent formulations to achieve desired sensitivity, specificity, and precision.
• Comparing preliminary assay results against established reference methods or known concentrations.

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Immunoassay for the in vitro quantitative determination of procainamide in human serum and plasma.

The CEDIA® Procainamide Assay is based on the bacterial enzyme ßgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, procainamide in the sample competes with analyte conjugated to one inactive fragment of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.

This document describes the Boehringer Mannheim CEDIA® Procainamide Assay, a homogeneous enzyme immunoassay for the quantitative determination of procainamide in human serum and plasma. The information provided outlines the device's technical characteristics and performance compared to a predicate device, the Abbott TDx® Procainamide Assay.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in this summary. Instead, the performance characteristics of the CEDIA® Procainamide Assay are presented and implicitly compared to those of the predicate device (Abbott TDx® Procainamide Assay) to demonstrate substantial equivalence. The "acceptance criteria" can be inferred to be performance comparable to or better than the predicate device.

Summary of Performance vs. Inferred Criteria:

• Precision: The CEDIA® assay demonstrates better or comparable precision (lower %CV) across all levels compared to the predicate device.
• Lower Detection Limit: The CEDIA® assay's lower detection limit (0.4 µg/dL) is higher than the predicate's (0.1 µg/dL), indicating potentially slightly less sensitivity at very low concentrations.
• Linearity: The linearity range is similar, though the CEDIA's lower bound is 0.4 µg/dL compared to 0.0 µg/dL for the predicate.
• Method Comparison: A strong correlation (r=0.9914) is shown between the CEDIA® assay and the predicate TDx assay, indicating good agreement.
• Interfering Substances: The CEDIA® assay shows improved tolerance to bilirubin interference and comparable tolerance to hemoglobin and lipemia, with different protein interference concentrations reported.
• Specificity/Cross-reactivity: The cross-reactivity for N-Acetyl-procainamide is identical, and for Desethyl-procainamide, it is very similar. Additional cross-reactivity for Procaine HCl is reported for CEDIA®.

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

• Precision Test Set:
  • N: 120 for each of 3 levels (Total N = 360 individual runs for CEDIA® assay precision testing).
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a common omission in 510(k) summaries for in-vitro diagnostics where the studies are typically conducted internally by the manufacturer using controlled samples. It is implied to be prospective testing conducted for the submission.
• Method Comparison Test Set:
  • N: 122 samples for the comparison between CEDIA® Procainamide and Abbott TDx Procainamide.
  • Data Provenance: Not explicitly stated. Likely prospective testing given the nature of method comparison studies.
• Interfering Substances, Specificity/Cross-reactivity, Lower Detection Limit, Linearity: No specific N values are given for these tests, but they involve a series of experiments.

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

This type of information is generally not applicable for an in-vitro diagnostic (IVD) assay like the CEDIA® Procainamide Assay.

• For IVDs that measure an analyte concentration, the "ground truth" is typically the reference method (e.g., mass spectrometry, or in this case, the predicate device if it's considered a reliable standard) or the known concentration within a manufactured control sample.
• There are no "experts" establishing ground truth in the sense of image interpretation or clinical diagnosis. The "truth" is the measured chemical concentration.

4. Adjudication Method for the Test Set

This is not applicable for this type of IVD performance study. Adjudication methods (like 2+1, 3+1) are used in clinical trials or studies where human interpretation or consensus is required to establish a clinical endpoint or diagnosis, not for analytical performance testing of an enzyme immunoassay measuring circulating drug levels.

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

This is not applicable. An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation is a key component. This document describes an automated laboratory assay for measuring drug levels, which does not involve human readers interpreting results in the same way an imaging study would.

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

Yes, this entire submission describes the standalone performance of the CEDIA® Procainamide Assay. This is an automated diagnostic test that provides a quantitative result based on its internal enzymatic reactions and spectrophotometric measurements. There isn't a "human-in-the-loop" in the sense of interpreting raw output, but rather a human operating the instrument and using the numeric result for clinical decision-making.

7. The Type of Ground Truth Used

The ground truth used for these analytical studies is:

• Known concentrations: For precision, linearity, lower detection limit, interfering substances, and cross-reactivity, the "ground truth" is typically established by preparing samples with known, precise concentrations of the analyte (procainamide) and potential interferents. These concentrations are usually verified by a primary reference method if available.
• Predicate Device/Reference Method: For method comparison, the "ground truth" for patient samples is essentially the result obtained from the predicate device (Abbott TDx® Procainamide Assay), which is considered the established method for comparison in this context. While not explicitly stated, it's implied that the Abbott TDx® assay served as the comparative standard. The TDx assay itself would have a foundation in comparison to a more definitive "gold standard" method when it was first cleared.

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the CEDIA® Procainamide Assay is a biochemical assay, not a machine learning or AI model that requires a dedicated training set. The assay's performance is based on its chemical and enzymatic design, not on patterns learned from data.

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

As there is no "training set" in the context of this biochemical assay, this question is not applicable.

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

automated fluorescence polarization immunoassays (FPIA).

This 510(k) summary (K955444) for the Abbott AxSYM Procainamide assay describes a comparison study against a predicate device, the TDx/TDxFLx Procainamide assay, to demonstrate substantial equivalence. It does not contain information typically found in studies for AI-powered diagnostic devices with "acceptance criteria" in the sense of accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" here are implicitly related to the statistical similarity between the new device and the predicate.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to the predicate device. For a correlation study, slopes close to 1, intercepts close to 0, and high correlation coefficients are generally desired to show agreement between two methods.

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

• Sample Size: 205
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only mentions "human serum or plasma."

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

This type of information is not applicable to this 510(k) summary. The "ground truth" for this device is the measurement provided by the predicate TDx/TDxFLx Procainamide assay. There were no human experts evaluating images or making diagnoses that required ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison of analytical measurements between two automated systems, not a diagnostic task requiring human adjudication.

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

No, an MRMC study was not done. This is a comparison of two automated laboratory assays, not a diagnostic imaging device where human readers would interpret results.

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

Yes, in a sense. The study compares the performance of the AxSYM Procainamide assay (the algorithm/device) directly against the TDx/TDxFLx Procainamide assay (another algorithm/device) without human intervention in the measurement process. It's a standalone comparison of the two automated systems.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurement obtained from the predicate device, the TDx/TDxFLx Procainamide assay. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices when a recognized predicate exists.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a traditional immunoassay validation. The AxSYM Procainamide assay itself was developed and calibrated, but the document does not detail specific training sample sizes for an algorithm. It mentions:

• "The AxSYM Procainamide standard calibrators and controls are to be used with the AxSYM Procainamide reagents."
• "Calibrators and controls are prepared gravimetrically using purified material obtained from commercial sources."
• "The calibrators and controls are verified using protocols involving multiple instrument testing."

These suggest internal validation and calibration processes, not a "training set" for predictive modeling.

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

Not applicable for this type of device and study. The calibrators and controls for the AxSYM system are described as "prepared gravimetrically using purified material obtained from commercial sources" and "verified using protocols involving multiple instrument testing." This refers to the analytical accuracy of the calibrators themselves, which is different from establishing ground truth for a diagnostic algorithm's training data.

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