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1. VITROS Chemistry Products CRBM Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5.1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
2. VITROS Chemistry Products CREA Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Product CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
3. VITROS Chemistry Products TBIL Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block.
4. VITROS XT 7600 Integrated System: Rx Only. For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest.

The VITROS XT 7600 Integrated System is a fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid. The System operates in conjunction with reagents, calibrators and controls designed for use with the System in the MicroSlide, MicroTip or MicroWell format.

The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, and VITROS Chemistry Products TBIL Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CRBM, CREA, and TBIL assays.

The document describes the performance of the VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, and the VITROS XT 7600 Integrated System. The main purpose of the study is to demonstrate substantial equivalence to legally marketed predicate devices.

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

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

The document does not explicitly state acceptance criteria in a dedicated table format for each performance metric, but rather describes how results were evaluated in the "Specificity" section and implies acceptance based on the comparison to predicate devices and established guidelines. For the method comparison, precision, linearity, and detection limits, the "reported device performance" is the direct result of the testing.

Given the nature of the submission (510(k) for substantial equivalence in an in-vitro diagnostic device), the acceptance criteria would typically revolve around demonstrating comparable performance to the predicate devices and adherence to established clinical laboratory standards (CLSI guidelines).

Below is a table summarizing the reported performance, with implied acceptance criteria based on standard practices for demonstrating substantial equivalence for in-vitro diagnostic devices.

Table of Acceptance Criteria and Reported Device Performance

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

• Method Comparison Test Set:

  • CRBM: 118 human serum samples.
  • CREA: 116 human serum samples and 122 human urine samples.
  • TBIL: 125 human serum samples.
  • Data Provenance: The document states "human serum samples" and "human urine samples," implying these are clinical samples. The country of origin and whether the data is retrospective or prospective is not specified.

• Precision Test Set: For each assay (CRBM, CREA serum, CREA urine, TBIL), the study involved:

  • 80 replicates (N=80) for each of the multiple fluid levels (e.g., 6 for CRBM, 6 for CREA serum, 6 for CREA urine, 5 for TBIL). The total number of analyses is much higher (e.g., 80 replicates x 6 levels = 480 for CRBM).
  • The samples used were Quality Control fluids and human-based precision fluids.
  • Data Provenance: Not specified.

• Linearity Test Set: A series of eleven proportionally related admixtures of low and high test fluids. Each sample was tested in triplicate.

  • Data Provenance: Not specified.

• Detection Limits (LoB, LoD, LoQ) Test Set:

  • LoB: 4 blank samples, tested in replicates of 6 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 216 observations (72 results per reagent lot).
  • LoD: 4 pools of human samples with analyte concentrations close to the expected detection limit, tested in replicates of 6 over 3 days, using 3 lots of reagents, with the 4 human sample pools every day, for a total of 216 observations (72 results per reagent lot).
  • LoQ: 4 pools of low level samples, tested in replicates of 4 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 144 observations (48 results per reagent lot).
  • Data Provenance: The LoD and LoQ studies used "human samples." The country of origin and whether the data is retrospective or prospective is not specified.

• Specificity (Interference) Test Set: Chemical interferents, common chemical substances, and claimed non-interferents, including hemoglobin, bilirubin, and intralipid. Testing employed "paired-difference" assessment at a minimum of two analyte levels.

  • Data Provenance: Not specified.

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)

This device measures quantitative concentrations of specific analytes (Carbamazepine, Creatinine, Total Bilirubin). Ground truth for these types of in vitro diagnostic devices usually refers to the reference method (predicate device in this case) or a highly accurate reference standard rather than expert interpretation in the way it applies to image analysis or clinical diagnosis. The document does not mention human experts establishing ground truth in the context of radiologists or similar clinical diagnosticians. The ground truth for the method comparison study was established by the predicate device, VITROS 5600 Integrated System.

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

None mentioned. Adjudication methods are typically used when there's a subjective element to ground truth establishment, often involving multiple human readers for diagnostic image interpretation. For quantitative measurements in clinical chemistry, the "truth" is established by reference methods, precision, and linearity studies, not by human adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, particularly in radiology or pathology, and often involves AI assistance. This document describes an automated in-vitro diagnostic device for quantitative chemical measurements, where human interpretation of results is direct measurement rather than subjective assessment. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

Yes, the studies described are, in essence, standalone performance evaluations of the VITROS XT 7600 Integrated System itself, with the VITROS Chemistry Products slides, operating automatically without continuous human intervention during the measurement process. The system performs the tests, generates results, and its performance (method comparison, precision, linearity, detection limits, specificity) is evaluated. The comparison is against a predicate device, which is also an automated system.

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

The ground truth for the test set, especially for the method comparison, was established by comparison to the legally marketed predicate device (VITROS 5600 Integrated System), which itself would have been previously cleared based on demonstrating accuracy against established reference methods or accepted gold standards for each analyte. For precision, linearity, and detection limits, the ground truth is established by the known characteristics of reference materials and statistical analysis.

8. The sample size for the training set

The document does not mention a training set. This is because the device described is not an AI/ML-based diagnostic algorithm that learns from data. It is a traditional in-vitro diagnostic instrument with chemical reagent slides. The studies are validation studies for the performance of the integrated system, not for training an algorithm.

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

Since there is no training set mentioned or used for this type of device, this question is not applicable.

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VITROS® Automation Solutions is intended to automate pre-analytical sample processing in the clinical laboratory. VITROS® Automation Solutions allows the consolidation of software, automation modules and clinical analyzers, such as VITROS® Systems into a unified workstation to perform a variety of assays such as total T4, carbamazepine and gentamicin.

Carbamazepine measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. Gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. Total thyroxine (T4) measurements are used to aid in the differential diagnosis of thyroid disease.

VITROS® Automation Solutions is a configurable, scalable laboratory automation system (LAS) designed to streamline pre and post analytical processes in the clinical laboratory. VITROS® Automation Solutions is comprised of personal computer (PC) Kit(s) (including software and hardware), sample conveyors with turns, parallel and perpendicular bypasses, storage module, single-tube entry, rack entry and exit, centrifuge, de-capper modules and clinical analyzers.

In the basic configuration, patient sample tubes are loaded onto the automation track to be centrifuged, de-capped, and sorted for further processing on clinical analyzers such as the VITROS® Systems. Additional modules may be added to enable aliquot capability, sample capping, and refrigerated storage.

Parallel and perpendicular bypasses are extensions of the automation track that link with an analyzer's existing laboratory automation system (LAS) interface. These bypasses support on-track metering at the analyzer based on point-in-space pipetting technology and robotic interface module (RIM). With point in space pipetting, the automation performs the sample bar code read function, presents the sample identification to the connected analyzer, and then signals for direct sampling of the open tube by the connected analyzer at an aspiration point on the automation track. With robotic interface modules, the sample tube is transferred to the analyzer and the analyzer will read the bar code to identify the sample, aspirate sample from the tube and perform the test(s) requested and then return the tube to the LAS.

VITROS® Automation Solutions allows the establishment of a connection with clinical analyzers such as VITROS® Systems to enable sample routing based on reagent and calibration status. The clinical analyzers, such as VITROS® Systems, will perform all functions with respect to result generation, including sample metering, assay processing and reporting for the assays.

The VITROS® Systems are fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid.

The VITROS® Systems operate in conjunction with VITROS® Immunodiagnostic and Chemistry Products, reagents, calibrators and controls designed for use with the systems in the MicroSlide, MicroTip or MicroWell format. Representative assays (carbamazepine, gentamicin and total thyroxine) are used to demonstrate acceptable performance.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document is a 510(k) summary for a laboratory automation system. It focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria in the same way a clinical trial for a diagnostic algorithm might. Therefore, some of the requested information (like effect size for MRMC studies, details of expert qualifications, or sample size for training sets) is not directly present as it's not typically required for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the VITROS® Automation Solutions as a standalone device with specific performance metrics (e.g., sensitivity, specificity). Instead, it aims to demonstrate substantial equivalence by showing that assay performance characteristics remain consistent whether samples are introduced manually or via the automation system. The acceptance criterion is implied to be that the automated method should produce results comparable to the manual method.

Conclusion from document: "The test results showed no clinically significant difference in assay performance between the two sample processing methods. This data demonstrates substantial equivalence between VITROS® Automation Solutions and the stand-alone analyzer, VITROS® Systems."

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

• Sample Size for Test Set:
  • CRBM: 70 samples
  • GENT: 55 samples
  • Total T4: 57 samples
• Data Provenance: The study used "patient samples." The country of origin is not specified, but the applicant (Ortho-Clinical Diagnostics, Inc.) is based in Rochester, New York, USA. The study design is retrospective in the sense that existing patient samples were used for comparative testing. It is not explicitly stated if these were left-over clinical samples or prospectively collected for the study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information (number and qualifications of experts) is not relevant or provided for this submission. The "ground truth" here is the result obtained from manual processing on the VITROS® System itself, which is a standardized and validated analytical method, not expert interpretation.

4. Adjudication Method

Not applicable. This study compares analytical results from an automated process versus a manual process using the same analyzer. There's no human interpretation or adjudication involved in establishing the "correct" value, as it's a quantitative measurement compared against another quantitative measurement.

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

No, an MRMC study was not done. This device is a laboratory automation system, not an AI or imaging diagnostic tool that involves human readers. The study focuses on the analytical performance of the automated sample processing system compared to manual processing.

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

Yes, in a sense, the performance shown for the automated system is "standalone" to the degree that it measures the impact of the automation on the analyzer's performance, independent of human intervention beyond loading samples onto the system. The automation itself does not produce a "reading" that a human would then confirm or interpret; rather, it handles the pre-analytical processing to feed into existing, validated analyzers. The data presented demonstrates the performance of tests conducted via the automation solution, which then provides results without further human modification.

7. Type of Ground Truth Used

The ground truth was established by:

• Comparison to manual processing results: The "ground truth" or reference method was the results obtained from samples manually introduced to the standalone VITROS® System (referred to as "off track" in the document). This is a validated and established method on a legally marketed device.

8. Sample Size for the Training Set

This information is not applicable and not provided. This submission is for a laboratory automation system, not a machine learning model that requires a training set. The system's functionality is based on mechanical and software-driven processes, not adaptive learning.

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

Not applicable, as there is no training set for this type of device.

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The ARK™ Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy.

The ARK™ Oxcarbazepine Metabolite Calibrator is intended for use in calibration of the ARK Oxcarbazepine Metabolite Assay.

The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material intended for use in quality control of the ARK Oxcarcarbazepine Metabolite Assay.

For prescription use only. Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.

The ARK Oxcarbazepine Metabolite Assay is a homogeneous immunoassay based on competition between drug in the specimen and Oxcarbazepine Metabolite labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenyzme NAD functions only with the bacterial enzyme used in the assay.

The ARK Oxcarbazepine Metabolite Assay consists of reagents R1 anti-Oxcarbazepine Metabolite polyclonal antibody with substrate and R2 Oxcarbazepine Metabolite labeled with bacterial G6PDH enzyme. The ARK Oxcarbazepine Metabolite Calibrator consists of a six-level set to calibrate the assay, and the ARK Oxcarbazepine Metabolite Control consists of a three-level set used for quality control of the assay.

The provided document describes the performance characteristics of the ARK™ Oxcarbazepine Metabolite Assay, Ark Oxcarbazepine Metabolite Calibrator, and Ark Oxcarbazepine Metabolite Control. This is a 510(k) premarket notification for a medical device (an in-vitro diagnostic assay), not an AI/ML powered device, therefore the information typically requested for AI/ML device studies (such as number of experts, adjudication methods, multi-reader multi-case studies, separate training/test sets with ground truth establishment methods for AI/ML models) are not applicable.

The acceptance criteria and performance data are detailed for several analytical validation studies.

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

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

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

• LOQ: Not explicitly stated how many unique samples, but "mean of six (6) replicate measurements" for recovery at different enantiomer ratios.
• Recovery: Not explicitly stated how many unique samples, but "mean of six (6) replicate measurements" of Oxcarbazepine Metabolite was tabulated as a function of the enantiomer ratio.
• Linearity: Not explicitly stated how many unique samples other than a "60.0 µg/mL serum sample was prepared and dilutions were made proportionally."
• Method Comparison: 190 samples.
• Precision: 3 levels of ARK Control (N=160 each) and 3 human serum pooled specimens (N=160 each). This means for each of the 6 material types, 160 measurements were taken (quadruplicate twice a day for 20 days).
• Interfering Substances: Not explicitly stated the number of unique human serum samples, but substances were tested "in serum with known levels of Oxcarbazepine Metabolite (approximately 3 and 30 µg/mL)."
• Specificity & Drug Interference: Not explicitly stated how many unique human serum samples, but tested with spiked compounds into normal human serum with known Oxcarbazepine Metabolite levels.
• Sample Stability & Calibration Curve Stability: "supporting data" cited, but specific sample sizes are not provided within this document.

Data Provenance: The document does not specify the country of origin of the human serum samples. The studies are analytical validations performed retrospectively in a laboratory setting (e.g., Beckman Coulter AU480® automated clinical chemistry analyzer). It's not a prospective clinical trial with patient data.

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

This is an analytical chemistry assay validation, not a diagnostic imaging AI/ML model. Therefore, "experts" in the sense of physicians establishing ground truth for patient cases are not applicable. The "ground truth" for the test set (e.g., concentration of Oxcarbazepine Metabolite) is established by highly accurate reference methods such as LC-MS/MS (for method comparison) or by precise gravimetric/volumetric preparation of controls and calibrators using certified reference materials. The qualifications of the personnel performing these analytical tests are implicitly assumed to be those typical for a laboratory setting conducting such validations.

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

Not applicable. This is an analytical validation of an in-vitro diagnostic assay measuring a chemical concentration, not a study involving human readers or subjective interpretations requiring adjudication.

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

Not applicable. This is an analytical validation of an in-vitro diagnostic assay, not an AI-assisted diagnostic device for human readers.

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

The device itself is an "algorithm only" in the sense that it is an automated chemical assay system. Its performance (quantification of Oxcarbazepine Metabolite) is assessed independently through the various analytical studies (e.g., LOQ, linearity, precision, method comparison against LC-MS/MS). Human "human-in-the-loop" performance is not a direct component of the assay's function, though human operators are involved in running the assay and interpreting the results.

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

The "ground truth" for the analytical performance studies is primarily:

• Reference Method: For method comparison, LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is used as the reference "ground truth" method. LC-MS/MS is a highly accurate and precise analytical technique for quantifying specific compounds in complex mixtures.
• Gravimetric/Volumetric Preparation: For calibrators and controls, the "ground truth" concentrations are established by precise gravimetric addition of certified Oxcarbazepine Metabolite powder to solvents. Purity is determined by NMR and elemental analysis.

8. The sample size for the training set

This is an immunoassay, not a machine learning or AI algorithm in the traditional sense that requires a "training set" for model development. The "training" of the assay refers to its calibration. The calibrators are prepared and value-assigned as described (e.g., "Two calibrated runs are performed using the Master Calibrator. In each run, five replicates of Master Lot (reference) and Test Lot are tested as matched pairs for each calibrator level.").

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

As described above, for an immunoassay, the "training set" is the calibrator set. The ground truth for the calibrators is established through:

• Traceability to certified powder: The calibrators are traceable to certified Oxcarbazepine Metabolite powder. "The purity of Oxcarbazepine Metabolite in the certified raw material is determined by NMR and elemental analysis as performed by the supplier of the certified powder."
• Gravimetric Addition: "Bulk solutions of the ARK Oxcarbazepine Metabolite Calibrator are prepared volumetrically using a stock solution prepared by gravimetric addition of powder to solvent."
• Value Assignment: "Testing is performed with the ARK Oxcarbazepine Metabolite Assay on the Beckman Coulter AU480® automated analyzer. Two calibrated runs are performed using the Master Calibrator. In each run, five replicates of Master Lot (reference) and Test Lot are tested as matched pairs for each calibrator level. Mean values for ten replicates are calculated." This process ensures consistency and accuracy against a master reference.

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In vitro test for the quantitative determination of carbamazepine in serum and plasma on Roche/Hitachi cobas c systems.

Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.

The ONLINE TDM Carbamazepine Gen. 4 assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. It is a homogeneous microparticle agglutination immunoassay based on the kinetic interaction of microparticles in solution (KIMS). Biotinylated drug hapten serves as the binding partner to anticarbamazepine antibody and streptavidin coated latex beads. A competitive reaction to a limited amount of specific anti-carbamazepine antibody takes place between the hapten and free carbamazepine in the sample. A decrease in the apparent signal produced by the microparticle agglutination is proportional to the amount of drug present in the sample.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving the device meets them:

Device Name: ONLINE TDM Carbamazepine Gen.4

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Detection Limit (LoB): 60 measured values (10-fold determinations per run on one instrument, 6 runs over 3 days).
• Detection Limit (LoD): 36 determinations (5 samples, 2-fold determination per run, 6 runs over 3 days).
• Detection Limit (LoQ): Not explicitly stated, but "Nine samples are prepared... tested in two aliquots over at least three days on one analyzer, 2 runs per day for 3 lots." This implies a significant number of data points.
• Precision: "Two runs per day for ≥ 21 days on the same analyzer." This amounts to at least 42 runs for each sample type. Numerous samples were tested (TDM Controls 1, 2, 3 and Human Serums 1-5).
• Linearity: "Eleven levels (including the high concentration pool and diluent)." Tested for both human serum and plasma.
• Matrix Comparison: "33 full tubes" of paired serum and plasma samples from single donors.
• Interferences (Endogenous): Two human sample pools, varying concentrations of interfering substances.
• Interferences (Drugs): Two human sample pools, spiked with 16 different drugs.
• Cross-reactivity: Two carbamazepine concentrations (3 µg/mL and 12 µg/mL) tested against 27 different compounds.
• Method Comparison to Predicate: "One hundred single native human samples of patients taking carbamazepine."

Data Provenance: The document does not explicitly state the country of origin for the samples. It mentions "human serum," "human serum sample pool," and "single native human samples of patients." It is implied to be a retrospective analysis of samples collected for the purpose of testing, but it's not explicitly stated as retrospective or prospective.

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

Not applicable. This device is an in-vitro diagnostic (IVD) for quantitative determination of a drug concentration. The "ground truth" for these tests is established by reference methods, calibrators, and known concentrations, not by expert interpretation of images or clinical cases. For example, LoQ uses LC/MS as the expected/target value.

4. Adjudication Method for the Test Set:

Not applicable. As this is an IVD for quantitative measurement, there is no subjective interpretation requiring adjudication among experts. The "ground truth" is determined by analytical methods with known accuracy and precision (e.g., LC/MS for LoQ).

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

No, an MRMC study was not done. This type of study is relevant for imaging devices or tests where human readers interpret results, often with and without AI assistance. This device is an automated quantitative assay, so human reader involvement in the primary measurement is not a factor.

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

Yes, the entire performance evaluation presented is a standalone (algorithm/device-only) performance assessment. The device quantifies carbamazepine levels directly from samples. The results are compared against established analytical standards and a predicate device.

7. The Type of Ground Truth Used:

The ground truth for the performance studies is established by:

• Reference Methods: For LoQ, LC/MS (Liquid Chromatography/Mass Spectrometry) is explicitly stated as the method for determining the expected or target value.
• Known Concentrations: Samples with known concentrations of carbamazepine are used for various tests like detection limits, precision, linearity, and interference studies.
• Predicate Device Comparison: The reference standard for the "Method Comparison to Predicate" is the results obtained from the predicate device (ONLINE TDM Carbamazepine, K031902) on the cobas c 501.
• USP Reference Standards: The traceability for the assay calibration is stated as being standardized against USP reference standards.

8. The Sample Size for the Training Set:

Not applicable. This device is an immunoassay (KIMS technology), not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. The "training" of such a system would involve optimizing assay reagents and parameters during development, not a data-driven training dataset for an AI model.

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

Not applicable for the same reasons as point 8. The device's "training" is in its chemical and biological design, optimization, and manufacturing, rather than data-driven ground truth establishment for a training set.

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The Abbott Carbamazepine assay is used for the in vitro quantitative measurement of carbamazepine in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.

The Carbamazepine Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Carbamazepine Assay kit is packaged in a rectangular cardboard box divided into three sections. One section will contain three bottles of Antibody Reagent (R1), one section will contain three bottles of Microparticle Reagent (R2), and the last section will contain the package insert. Each kit is sufficient for 300 tests.

Here is a summary of the acceptance criteria and the study details for the Abbott Carbamazepine Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size for Method Comparison (vs. HPLC): 105 samples
• Sample Size for Method Comparison (vs. Predicate): 103 samples
• Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin of the data. The context of a 510(k) submission for an in vitro diagnostic usually implies controlled laboratory studies.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• This device is an in vitro diagnostic assay, where "ground truth" is typically established by reference methods or instruments rather than expert human interpretation of images/cases.
• For the method comparison studies, the "ground truth" was established by comparing the device's results to:
  • HPLC (High-Performance Liquid Chromatography): This is a gold standard analytical chemistry technique for quantifying carbamazepine. The document does not specify human experts or their qualifications for interpreting HPLC results; the HPLC itself serves as the reference.
  • Abbott Aeroset® Carbamazepine Assay (K993028): This is the legally marketed predicate device, used as a comparative reference.

4. Adjudication Method for the Test Set

• Not applicable. As described above, "ground truth" for this type of device is established by instrumental reference methods (HPLC) or comparison to a predicate device, rather than human adjudication of cases.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI algorithms that assist human readers in making diagnostic interpretations. The Abbott Carbamazepine Assay is an in vitro diagnostic for quantitative measurement of a drug in bodily fluids and does not involve human readers interpreting "cases" in the same way.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance assessment was conducted. The "device performance" metrics listed in the summary (Functional Sensitivity, Precision, Spike Recovery, Method Comparison, Linearity, Stability, etc.) directly reflect the performance of the assay system (reagents plus ARCHITECT cSystems instrument) without human-in-the-loop interpretation. The device's output is a quantitative measurement, not an interpretation requiring human assistance.

7. Type of Ground Truth Used

• The ground truth primarily used for evaluating the device's performance was:
  • Reference method data (HPLC): For accuracy and recovery studies.
  • Predicate device data (Abbott Aeroset® Carbamazepine Assay): For method comparison to demonstrate substantial equivalence.
  • Internal analytical standards and controls: For precision, linearity, and stability studies.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" sample size. For an in vitro diagnostic assay, development typically involves extensive characterization and optimization of reagents and assay parameters rather than training a machine learning algorithm with a distinct dataset. The "development" or "optimization" samples are integral to method formulation, but aren't typically referred to as a "training set" in the context of device submission for this type of product.

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

• Not applicable / Not explicitly described as a "training set" with established ground truth in the traditional sense. For IVD assays, the process involves calibrating the assay using known concentrations of the analyte (carbamazepine calibrators) that serve as a reference for quantifying unknown samples. These calibrators and controls have precisely defined concentrations, which act as the "ground truth" for establishing the assay's curve and performance characteristics during development and ongoing use. The development process itself ensures the assay yields accurate results against these known standards.

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The ARCHITECT iCarbamazepine assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma (collected in lithium heparin, sodium heparin, dipotassium EDTA or sodium EDTA tubes) on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.

The ARCHITECT iCarbamazepine Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma.

The ARCHITECT iCarbamazepine assay is a one-step immunoassay for the quantitative measurement of carbamazepine in human serum or plasma using CMIA technology with flexible assay protocols referred to as Chemiflex.

In the ARCHITECT iCarbamazepine assay, sample, anti-carbamazepine coated paramagnetic microparticles, and carbamazepine acridinium-labeled conjugate are combined to create a reaction mixture. The anti-carbamazepine coated microparticles bind to carbamazepine present in the sample and the carbamazepine acridinium-labeled conjugate. After washing, pre-trigger and 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 carbamazepine in the sample and the RLUs detected by the ARCHITECT i System optics.

The provided 510(k) summary (K103627) describes the ARCHITECT iCarbamazepine assay, an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine in human serum or plasma.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines analytical performance studies but does not explicitly state specific numerical acceptance criteria for each study (e.g., a required correlation coefficient for linearity or specific CV% for precision). Instead, it lists the types of studies performed to demonstrate substantial equivalence to the predicate device, the AxSYM Carbamazepine assay. The overall conclusion is that the ARCHITECT iCarbamazepine assay "is substantially equivalent to the AxSYM Carbamazepine assay in terms of analytical performance data."

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

The document does not specify the sample sizes used for the test sets in any of the analytical performance studies.
The document also does not mention the country of origin of the data or whether the studies were retrospective or prospective. These are typically detailed in the full 510(k) submission but are not present in this summary.

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

The document does not refer to "experts" or "ground truth" in the context of clinical interpretation or decision-making, as this is a quantitative immunoassay device. The "ground truth" for this type of device would be established by reference methods or comparison to a legally marketed predicate device, as seen in the "Method Comparison (Correlation)" study. Therefore, the concept of qualified experts establishing ground truth in the way it might apply to image-based diagnostic AI is not relevant here.

4. Adjudication Method for the Test Set:

Not applicable, as the device performs quantitative measurements and does not involve human interpretation requiring adjudication.

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 typically performed for diagnostic devices that assist human readers (e.g., radiologists for medical images). The ARCHITECT iCarbamazepine assay is a standalone quantitative measurement device, not an AI assistant for human readers.

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

Yes, the studies described are inherently standalone performance evaluations of the ARCHITECT iCarbamazepine assay. The device provides a quantitative measurement of carbamazepine levels directly, without human interpretation of the assay results in the way one would interpret an image. The "Method Comparison (Correlation)" study, for instance, directly compares the device's quantitative output to that of the predicate device.

7. The Type of Ground Truth Used:

For a quantitative diagnostic device like this, the "ground truth" for performance evaluation is typically established through:

• Reference methods: Highly accurate and precise methods known to provide true values.
• Comparison to a legally marketed predicate device: This is explicitly stated in the document ("Method Comparison (Correlation)") where the ARCHITECT iCarbamazepine assay's results are compared to those of the AxSYM Carbamazepine assay (K935374).
• Known concentrations: For studies like linearity, sensitivity, and recovery, samples with precisely known concentrations of the analyte are used.

8. The Sample Size for the Training Set:

The document does not mention a "training set" as this device does not appear to employ machine learning or artificial intelligence in a way that requires a distinct training phase. It is a traditional immunoassay, and its performance is determined by its chemical and mechanical design, not by learning from a dataset.

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

Not applicable, as there is no mention of a training set for this traditional immunoassay device.

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The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.

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

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

Here's a breakdown of the acceptance criteria and study information based on the provided text for the ARCHITECT iValproic Acid assay:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample size used for the clinical performance study (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that clinical performance demonstrated substantial equivalency with a correlation coefficient of 0.986.

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

The provided text does not include information on experts, ground truth establishment, or their qualifications for the clinical performance study. This type of information is typically not required for an immunoassay 510(k) where the comparison is against an existing, legally marketed device. The "ground truth" in this context would likely be the measurements from the predicate device itself.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method. This is expected as the study is a comparison between two quantitative assays, not a study involving subjective interpretations that would require adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a quantitative immunoassay meant for direct measurement, not an imaging device or diagnostic tool that involves human readers interpreting results in a comparative effectiveness setting. The study focused on the analytical performance of the new assay compared to a predicate device.

6. Standalone Performance

The clinical performance summary describes the standalone performance of the ARCHITECT iValproic Acid assay by demonstrating its correlation with the predicate AxSYM Valproic Acid assay. The correlation coefficient of 0.986 directly reflects the algorithm's (immunoassay's) performance in measuring valproic acid.

7. Type of Ground Truth Used

The "ground truth" for the clinical performance study was the measurements obtained from the legally marketed predicate device, the AxSYM Valproic Acid assay. The study aimed to show substantial equivalency of the new device's measurements to those of the predicate device.

8. Sample Size for the Training Set

The provided text does not specify a sample size for the training set. Immunoassay development typically involves extensive internal validation and optimization, but the regulatory submission focuses on the performance of the final assay.

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

The provided text does not detail how ground truth was established for a training set. For an immunoassay, training would involve optimizing reagents, protocols, and calibration curves using known concentrations or reference materials. The "ground truth" for these processes would be the expected or known concentrations of valproic acid in standards and controls used during development and calibration, rather than expert consensus on patient data.

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The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy.

The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy.

TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer.

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The provided text describes the 510(k) submission for Thermo Fisher Scientific Oy's Carbamazepine and Valproic Acid test systems and TDM Calibration set B. The document outlines the intended use, indications for use, and a comparison with predicate devices to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily in comparison to a predicate device, focusing on similar performance characteristics. The document presents performance data for "New device #1" (Thermo Fisher Scientific Oy's device) and "Predicate device #1" (Microgenics Corporation CEDIA® Carbamazepine II/Valproic Acid II).

Carbamazepine Assay:

Valproic Acid Assay:

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

• Carbamazepine:
  • Method Comparison (test set): N = 134 samples (Carbamazepine).
  • Provenance: Not explicitly stated, but clinical chemistry assays typically use de-identified human serum samples. The document doesn't specify if the data is retrospective or prospective, or the country of origin.
• Valproic Acid:
  • Method Comparison (test set): N = 136 samples (Valproic Acid).
  • Provenance: Not explicitly stated, but clinical chemistry assays typically use de-identified human serum samples. The document doesn't specify if the data is retrospective or prospective, or the country of origin.
• Precision (Carbamazepine & Valproic Acid): Tested at multiple levels (3 for each assay). The number of replicates or runs to achieve the reported SD and CV values is not explicitly stated in this summary but is typically part of the full validation report.

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 these types of quantitative in vitro diagnostic devices, "ground truth" is typically established by comparing the device's measurements against a recognized reference method or a predicate device that has established accuracy, rather than expert consensus on a clinical diagnosis. The predicate device's performance data is used as the comparative "truth" for demonstrating substantial equivalence.

4. Adjudication method for the test set

This is not applicable/provided as the study focuses on quantitative measurement comparison rather than diagnostic interpretation requiring adjudication. The method comparison studies for both Carbamazepine and Valproic Acid used Deming regression to compare the new device's measurements against the predicate device's measurements.

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. This document describes an in vitro diagnostic device (a laboratory test for drug levels) and not an imaging or interpretive AI-driven diagnostic system that would involve human readers.

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

This document describes a standalone in vitro diagnostic system (reagents and an analyzer) which performs quantitative measurements of drug concentrations. The results are then used by healthcare professionals for diagnosis and treatment. In this context, the "standalone" performance refers to the analytical performance of the device itself (precision, measuring range, method comparison) as detailed in the tables. There isn't an "algorithm only" component in the sense of a software-AI device, but rather a chemical assay coupled with an automated analyzer.

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

The "ground truth" for the method comparison studies was the measurements obtained from the predicate devices (CEDIA® Carbamazepine II and a commercially available fluorescence polarization immunoassay for Valproic Acid). For precision studies, "truth" is established by the known concentrations of quality control materials. The overall goal is to demonstrate that the new device's measurements correlate closely with these established methods.

8. The sample size for the training set

This information is not provided in the summary. For in vitro diagnostic assays, "training set" is usually not explicitly defined in the same way as for AI/ML models. Assay development and optimization involve extensive testing with various samples, but this isn't typically presented as a distinct "training set" in 510(k) summaries for traditional IVDs.

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

This information is not provided for the reasons mentioned in point 8.

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The ONLINE TDM Valproic Acid assay is for the quantitative determination of valproic acid in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements muman serain of paintine were used in the diagnosis and treatement of valproic acid overdose and in monitoring the levels of valproic acid to help ensure appropriate therapy.

The ONLINE TDM Valproic Acid assay is for the quantitative determination of valproic acid 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 Valproic Acid reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of valproic acid (free and protein-bound) 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.

This submission describes the Roche ONLINE TDM Valproic Acid assay, an in-vitro diagnostic device. As such, the concept of "acceptance criteria" and "study" in the context of imaging devices or algorithms with human interpretation is not directly applicable in the same way.

Instead, for this device, the "acceptance criteria" are based on demonstrating substantial equivalence to a predicate device (Roche COBAS INTEGRA Valproic Acid, K951595) through performance characteristics typically evaluated for quantitative assays.

Here's an analysis based on the provided text, reinterpreting the questions for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this in-vitro diagnostic, "acceptance criteria" are implied by acceptable ranges for analytical performance characteristics that demonstrate substantial equivalence to the predicate. The study aimed to show that the new device's performance aligns with or is comparable to the predicate.

Note: The document doesn't explicitly state numerical acceptance criteria, but rather implies that the results should be "acceptable" and comparable to the predicate device to establish substantial equivalence. For precision, the values are compared directly. For method comparison, linearity, high correlation, and a near-zero intercept with a slope near one are generally expected.

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

• Precision Studies:
  • The sample size per control level for precision studies is not explicitly stated in the summary table. It only shows "Mean", "SD", and "CV%", which are derived from multiple measurements.
  • Data provenance is not specified (e.g., country of origin, retrospective/prospective).
• Method Comparison Study:
  • N=54 samples were used for the comparison between ONLINE TDM Valproic Acid and COBAS FP Valproic acid.
  • N=207 samples were used for the predicate comparison against COBAS FARA II (this is the predicate device's historical comparison, not the new device's).
  • Data provenance is not specified (e.g., country of origin, retrospective/prospective). The samples are human serum or plasma.

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

This type of information is not applicable for this device. For an in-vitro diagnostic assay that measures a chemical concentration, the "ground truth" is typically established by reference methods or highly accurate analytical techniques, not by expert consensus or interpretation of images. The comparison is made against the predicate device, which itself has an established accuracy.

4. Adjudication Method for the Test Set

This is not applicable for this type of in-vitro diagnostic device. Adjudication typically refers to resolving discrepancies between multiple human readers or between human readers and an AI, which is not relevant here.

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 for this device. This assay is a standalone chemical measurement device, not an imaging device or an AI designed to assist human readers.

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

Yes, the studies presented are effectively standalone performance studies of the device (the "algorithm" being the assay's chemical reaction and detection system). The reported precision and method comparison data reflect the performance of the device itself, without human interpretation as part of the measurement outcome.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurement obtained from the predicate device (COBAS FP Valproic acid) or, indirectly, from a well-established reference method or a previously validated assay against which the predicate itself was compared (e.g., COBAS FARA II in the predicate's comparison). The goal is to show agreement with an already accepted method for quantifying valproic acid.

8. The Sample Size for the Training Set

This is not applicable as this is not a machine learning or AI-based device that requires a training set in the conventional sense. The "training" of the assay involves optimizing its chemical reagents and reaction conditions, which is part of the assay development process, not a data-driven training set for an algorithm.

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

This is not applicable as there is no "training set" for an algorithm in this context.

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The Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy.

The Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

The Dimension Vista™ Phosphorus (PHOS) Flex® reagent cartridge is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

The Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

The Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

The Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

The Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

The Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

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

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

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Dimension Vista™ Flex® reagent cartridges, based on the provided 510(k) summary:

This device submission is a Special 510(k) for a packaging modification, meaning the core technology and reagents are the same as previously cleared devices. Therefore, the primary goal of the study is to demonstrate substantially equivalent performance after the packaging change, rather than to establish initial performance claims for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or specific performance metrics (e.g., accuracy, precision values) for each analyte. Instead, it relies on a comparative equivalency approach to a predicate device.

The overarching acceptance criterion is "substantially equivalent performance" to the predicate Dimension® Flex® reagent cartridges.

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

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

• Sample Size for Test Set: This information is not explicitly stated in the provided summary. The summary refers to a "protocol included in this submission," which would contain these details.
• Data Provenance: This information is not explicitly stated in the provided summary.
• Retrospective or Prospective: This information is not explicitly stated. However, given the nature of in-vitro diagnostic testing for performance comparison, it would typically involve prospective testing on patient samples or spiked samples.

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

This is an in-vitro diagnostic device for quantitative measurement of analytes in human samples (serum, plasma, urine, CSF). The ground truth for such devices is established by:

• Reference Methods: Highly accurate and precise laboratory methods, often gold standards like GC-MS, HPLC, or other well-validated enzymatic or spectrophotometric methods.
• Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analytes.

Therefore, the concept of "experts" in the clinical imaging or diagnostic interpretation sense (e.g., radiologists) is not applicable here. The ground truth is laboratory-based and instrumental.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. Ground truth is established by reference methods or certified materials, not by expert consensus or adjudication.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an in-vitro diagnostic reagent cartridge, not an AI-powered diagnostic imaging tool or a system designed for human interpretation with or without AI assistance. The performance is measured instrumentally.

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

• Yes, the performance evaluated is inherently "standalone" in the context of an automated analytical instrument. The Flex® reagent cartridges are designed to be used on the Dimension Vista™ Integrated system, a "fully automated, microprocessor-controlled, integrated instrument system." The performance of the reagent (device) is measured by its output on this automated system.
• There is no "human-in-the-loop" decision-making component for the measurement process itself, although clinical interpretation of the results by a healthcare professional is expected.

7. The Type of Ground Truth Used

The ground truth for this type of in-vitro diagnostic device would typically involve:

• Reference Method Assays: Using established, highly accurate, and precise laboratory methods (e.g., a recognized primary reference measurement procedure or a well-characterized predicate device itself) to determine the true concentration of the analytes in the test samples.
• Certified Reference Materials: Commercial or internal standards with known, traceable concentrations of the analytes.
• Sample Matrix: Patient samples (serum, plasma, urine, CSF) with concentrations spanning the analytical range.

The summary states "Comparative testing... demonstrates substantially equivalent performance." This strongly implies that the new device's measurements were compared against the measurements obtained by the predicate device on the same samples, which serves as the "reference" or "ground truth" for the equivalence claim.

8. The Sample Size for the Training Set

This device is a reagent cartridge for an in-vitro diagnostic test, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to learn. The reagents and their chemical reactions are based on established scientific principles.

Therefore, the concept of a "training set" as understood in machine learning is not applicable to this device.

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

As noted above, the concept of a "training set" is not applicable to this device. The ground truth for the performance evaluation (test set) would be established by reference methods or comparison to the predicate device, as described in point 7.

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