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The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Uric acid measurements 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE BUN/Urea Reagent assay, urea in serum is hydrolyzed in the presence of urease to yield ammonia and carbon dioxide. The ammonia formed then reacts in the presence of glutamate dehydrogenase with 2-oxoglutarate and NADH to yield glutamate and NAD. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rate of decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportional to the urea concentration in the sample.

In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkaline medium to form a red-orange colored complex, which absorbs strongly at 505 nm. The rate of complex formation, determined by measuring the increase in absorbance bichromatically at 505 nm/573 nm during a fixed time interval, is directly proportional to the creatinine concentration in the sample.

In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by uricase to allantoin and hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple dichlorohydroxybenzene sulfonic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex, which absorbs strongly at 505 nm. The amount of chromogen formed is determined by measuring the increase in absorbance bichromatically at 505 nm/610 nm, and is directly proportional to the uric acid concentration in the sample.

In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK in the sample.

Here's a summary of the acceptance criteria and supporting studies for the Alfa Wassermann ACE Reagents (BUN/Urea, Creatinine, Uric Acid, CK), based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from comparisons to a predicate device (Alfa Wassermann ACE K930104 reagents) and performance characteristics such as precision, accuracy (correlation/regression with predicate), linearity, detection limits, and interference. The reported device performance is from in-house studies and Point-of-Care (POL) studies.

Note: The document does not explicitly state "acceptance criteria" numerical targets. Instead, it presents performance data for the candidate device, implying that the data's comparability to the predicate and established analytical standards is the basis for acceptance. I will present the reported performance, which demonstrates the device's meeting the necessary equivalency.

Studies Proving Acceptance Criteria:

The studies are described under "Performance Data" and "Device Comparison with Predicate" sections of the 510(k) summary. These studies aim to demonstrate substantial equivalence to the previously cleared predicate device (Alfa Wassermann ACE BUN/Urea Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, and ACE CK Reagents, K930104).

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

• Test Set (Matrix Comparison: Serum vs. Plasma):

  • BUN: 95 pairs (ACE), 96 pairs (Alera), 51 pairs (Axcel)
  • Creatinine: 102 pairs (ACE), 102 pairs (Alera), 55 pairs (Axcel)
  • Uric Acid: 97 pairs (ACE), 95 pairs (Alera), 55 pairs (Axcel)
  • CK: 94 pairs (ACE), 96 pairs (Alera), 55 pairs (Axcel)
  • Data Provenance: The document states "In-House Precision" and "In-House Matrix Comparison". This typically implies that the data was generated within the manufacturer's laboratory or a testing facility under their control. The country of origin is not explicitly stated but is implicitly the US, given the 510(k) submission to the FDA. The data is retrospective, as it's being used to characterize reagent performance.

• Test Set (POL - Method Comparison):

  • BUN: 53-54 samples per POL lab for comparison with In-House ACE.
  • Creatinine: 51 samples per POL lab for comparison with In-House ACE.
  • Uric Acid: 49 samples per POL lab for comparison with In-House ACE.
  • Creatinine Kinase: 48-50 samples per POL lab for comparison with In-House ACE.
  • Data Provenance: "POL - Method Comparison" indicates data from Physician Office Laboratories (POLs), likely external to the main testing facility but still considered part of the overall validation. The document refers to "In-House ACE (x) vs. POL 1 ACE (y)", "POL 2 ACE (y)", etc., indicating comparisons against internal reference methods. The data is retrospective.

• Test Set (Detection Limits, Linearity, Interferences, Alera Precision): The sample sizes for these specific studies are not explicitly detailed in the provided summary beyond "Low level tested," "Upper level tested," and "number of replicates for precision measurements (i.e. '3.2, 4.0%') implies multiple measurements. These are likely in-house, retrospective studies.

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

This information is not provided in the document. For in vitro diagnostic devices like these reagents, the "ground truth" is typically established by reference methods or validated comparative methods, often run on established clinical chemistry analyzers. The expertise lies in operating these reference instruments and ensuring proper laboratory practices, rather than expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective interpretations (e.g., medical image analysis by radiologists) where discrepancies among readers need to be resolved to establish ground truth. For quantitative IVD reagents, the reference method provides a direct numerical result, not a subjective interpretation requiring adjudication.

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

This is not applicable to this type of device. MRMC studies are used to assess the effectiveness of an AI system (or any diagnostic aid) for human readers, particularly in medical imaging. The current device is a diagnostic reagent, which directly measures chemical concentrations, not an AI intended to assist human interpretation of cases.

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

This is not applicable in the context of an IVD reagent. The "algorithm" here is the chemical reaction and photometric measurement itself. The performance data presented (precision, linearity, method comparison, etc.) is the standalone performance of the reagent on the specified analyzers, without human interpretive input altering the result.

7. Type of Ground Truth Used

The ground truth for all performance studies (precision, matrix comparison, method comparison, linearity) is established by comparison against a reference method or a substantially equivalent predicate method performed on existing, validated clinical chemistry analyzers (specifically, the predicate ACE Clinical Chemistry System and the candidate ACE, ACE Alera, and ACE Axcel systems themselves acting as the "reference" for their own performance claims, and for method comparisons, the "In-House ACE" results). This is a common and accepted approach for demonstrating substantial equivalence for IVD reagents.

8. Sample Size for the Training Set

This information is not provided and is generally not applicable in the way it is asked for AI/ML devices. These are chemical reagents, not AI/ML algorithms that require "training sets" in the conventional sense of machine learning. The development process would involve formulation, optimization, and internal testing to define assay parameters, which is a different concept than an AI training set.

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

As stated above, the concept of a "training set" with established ground truth in the AI/ML sense is not applicable to these chemical reagents. The "ground truth" during their development and optimization would be based on established analytical chemistry principles and performance measurements against known standards or reference materials.

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The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum using the ACE Axcel Clinical Chemistry 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum using the ACE Axcel Clinical Chemistry System. Uric acid measurements 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum using the ACE Axcel Clinical Chemistry System. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE BUN/Urea Reagent assay, urea in serum is hydrolyzed to yield ammonia and carbon dioxide in the presence of urease. The ammonia formed then reacts with 2-oxoglutarate and NADH in the presence of glutamate dehydrogenase to yield glutamate and NAD. Two moles of NADH are oxidized for each mole of urea present. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rate of decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportional to the urea concentration in the sample.

In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkaline medium to form a red-orange colored complex, which absorbs strongly at 505 nm. The rate of complex formation, determined by measuring the increase in absorbance bichromatically at 505 nm/573 nm during a fixed time interval, is directly proportional to the creatinine concentration in the sample.

In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by uricase to allantoin and hydrogen peroxide. The hydrogen peroxide then acts to oxdatively couple dichlorohydroxybenzene sulfonic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex, which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/610 nm, is directly proportional to the uric acid concentration in the sample.

In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK in the sample.

The ACE BUN/Urea Reagent consists of a single reagent bottle. The reagent contains alpha-ketoglutarate, urease, glutamate dehydrogenase, adenosine diphosphate (ADP), nicotinamide adenine dinucleotide and reduced (NADH).

The ACE Creatinine Reagent consists of two reagent bottles (Sodium Hydroxide Reagent and Picric Acid Reagent). The Sodium Hydroxide Reagent (R1) contains sodium hydroxide. The Picric Acid Reagent (R2) contains picric Acid.

The ACE Uric Acid Reagent consists of a single reagent bottle. The reagent contains 4-aminoantipyrine, dichlorohydroxybenzene sulfonic acid, peroxidase and uricase.

The ACE CK Reagent consists of two reagent bottles (Buffer and Substrate). The Buffer Reagent (R1) contains: imidazole buffer, glucose, N-acetyl-cysteine, magnesium acetate, EDTA, NADP and hexokinase. The Substrate Reagent (R2) contains: creatine phosphate, ADP, AMP, diadenosine pentaphosphate, EDTA and glucose-6-phosphate dehydrogenase.

This 510(k) summary describes the analytical performance of the Alfa Wassermann ACE BUN, Creatinine, Uric Acid, and CK Reagents when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to a predicate device by evaluating precision, accuracy, and detection limits.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The acceptance criteria for this type of device are generally understood to be that the performance of the new device (ACE Axcel System with new reagents) should be comparable to or better than a legally marketed predicate device (Alfa Wassermann ACE Clinical Chemistry System). While explicit numerical acceptance criteria are not strictly stated as "acceptance criteria" but rather as "reported performance," the goal is to show the device performs within acceptable analytical limits for clinical chemistry assays and is strongly correlated with the predicate.

Note: Acceptance criteria are implied based on typical expectations for clinical chemistry assays and the intent to demonstrate substantial equivalence to a predicate device. Specific numerical targets for acceptance were not explicitly stated in the provided text, but the strong correlation and low CVs indicate meeting such criteria.

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

• ACE BUN/Urea Reagent:

  • Accuracy (Correlation Study): 113 samples (clinical laboratory), and patient correlation studies at three Physician Office Laboratory (POL) sites (number of samples not explicitly stated for POL, but implied to be sufficient for regression analysis).
  • Precision: Four BUN levels over 22 days (laboratory study), and three POL sites over 5 days (levels not specified for POL).
  • Data Provenance: Not explicitly stated, but clinical laboratory and Physician Office Laboratory (POL) settings are mentioned, suggesting human serum samples. Whether these were retrospective or prospective is not specified, but typically, method comparison studies use prospective or collected retrospective clinical samples.

• ACE Creatinine Reagent:

  • Accuracy (Correlation Study): 136 samples (clinical laboratory), and patient correlation studies at three POL sites (number of samples not explicitly stated for POL).
  • Precision: Four creatinine levels over 22 days (laboratory study), and three POL sites over 5 days (levels not specified for POL).
  • Data Provenance: Not explicitly stated, but clinical laboratory and POL settings are mentioned, suggesting human serum samples.

• ACE Uric Acid Reagent:

  • Accuracy (Correlation Study): 106 samples (clinical laboratory), and patient correlation studies at three POL sites (number of samples not explicitly stated for POL).
  • Precision: Four uric acid levels over 22 days (laboratory study), and three POL sites over 5 days (levels not specified for POL).
  • Data Provenance: Not explicitly stated, but clinical laboratory and POL settings are mentioned, suggesting human serum samples.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of chemical analytes (BUN, Creatinine, Uric Acid, CK) in serum. The 'ground truth' for such devices is established by a reference method or a legally marketed predicate device, not by expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an IVD device for quantitative chemical analysis. Adjudication methods are typically used for qualitative or interpretive diagnostic devices where human expert disagreement might occur (e.g., radiology, pathology). Here, the comparison is directly numerical between the candidate device and the predicate device.

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

Not applicable. This is an IVD device for laboratory chemical analysis, not an imaging or interpretive diagnostic device that involves human readers or AI assistance in interpretation.

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

Yes, in a sense. The described studies evaluate the performance of the algorithm/system only (the ACE Axcel Clinical Chemistry System with the new reagents) in quantifying the analytes in serum. The performance data (precision, accuracy, detection limit) are intrinsic to the device's analytical capability, independent of human interpretation of the results for the purpose of generating the values themselves. While trained personnel operate the system, the analytical performance is measured as a standalone function of the device.

7. The Type of Ground Truth Used

The "ground truth" for the accuracy studies was established by comparing the results from the Alfa Wassermann ACE Axcel Clinical Chemistry System (the new device, 'y') to a legally marketed predicate device, the Alfa Wassermann ACE Clinical Chemistry System ('x'). This is a common method for IVD substantial equivalence, where the predicate is considered the accepted reference for performance. For detection limits, it would typically involve analyzing samples with known, very low concentrations of the analytes or diluting higher concentration samples to determine the lowest measurable level.

8. The Sample Size for the Training Set

The provided text describes performance validation studies, not the development or training of an algorithm in the machine learning sense. Therefore, there is no "training set" for an algorithm to learn from in this context. The study focuses on verifying the performance of the already-developed reagent and instrument system.

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

Not applicable, as there is no "training set" in the machine learning sense for this type of IVD device submission.

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System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers

Measurements of Uric Acid 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.

Not Found

The provided text focuses on the FDA's 510(k) clearance of the Olympus Uric Acid Reagent, establishing its substantial equivalence to a predicate device. However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies.

Therefore, I cannot populate the table or provide specific answers to most of your questions based solely on the provided text. The document is a regulatory clearance letter, not a scientific study report.

Here's what I can extract and what is missing:

Information Present:

• Device Name: Olympus Uric Acid Reagent
• Intended Use: Quantitative determination of Uric Acid in human serum, heparinized plasma, and urine on OLYMPUS analyzers.
• Clinical Utility: Used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and patients receiving cytotoxic drugs.
• Regulatory Clearance: 510(k) clearance (K062862) issued on April 6, 2007.

Information NOT Present (and why it's typically in a study report, not a clearance letter):

• Acceptance Criteria and Reported Device Performance Table: The document doesn't list specific performance metrics (like accuracy, precision, linearity, limits of detection) or the thresholds for acceptable performance. It only states the device is substantially equivalent, implying its performance is comparable to an existing device.
• Sample Size for Test Set and Data Provenance: This information would be detailed in a validation study report.
• Number of Experts and Qualifications: Not relevant for a chemistry reagent validation; typically for image-based diagnostics where human interpretation is involved.
• Adjudication Method: Not relevant for a chemistry reagent.
• MRMC Comparative Effectiveness Study: Not relevant for a chemistry reagent. This applies to diagnostic tools where human interpretation is augmented by AI.
• Standalone Performance: While the "device" (reagent) performs standalone, the document doesn't provide the specific performance data.
• Type of Ground Truth Used: For a chemistry assay, the ground truth would typically be established using a reference method or certified reference materials with known uric acid concentrations. The document doesn't specify this.
• Sample Size for Training Set: Not applicable in the context of a chemical reagent validation in the same way it would be for a machine learning model.
• How Ground Truth for Training Set was Established: Again, not applicable as there's no "training set" in the machine learning sense for this type of device.

Conclusion:

The provided document is a regulatory approval letter. While it confirms the device's market readiness and intended use, it does not contain the detailed technical specifications or study results required to answer your specific questions about acceptance criteria and performance study design. This information would typically be found in the 510(k) submission summary or a separate validation study report, which is not included here.

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The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of uric acid in serum and plasma. Uric acid results may be used for 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 Vitalab Uric Acid Reagent is a two-part for use with the Vitalab Selectra Analyzer. This reagent determines uric acid through enzymatic oxidation by uricase linked to a Trinder indicator reaction utilizing N-ethyl-N-(bydroxy-3sulfopropyl)-toluidine (TOOS) and 4-aminoantipyrine.

Here's a breakdown of the acceptance criteria and study information for the Vitalab Uric Acid Reagent, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linear Range: n = 40 (number of recovery samples for linearity standards)
• Detection Limit: n = 30 (normal saline assays)
• Precision: n = 60 for each of the 3 serum samples (total 180 individual measurements).
• Correlation: n = 60 serum specimens and n = 60 heparinized plasma specimens (total n = 120 patient specimens).
• Data Provenance: The text states, "Sixty serum specimens ranging from 3.6 to 10.2 mg/dL uric acid and 60 heparinized plasma specimens ranging from 2.1 to 10.6 mg/dL uric acid were collected from adult patients..." This indicates the data is prospective (collected for the study) from adult patients, but the country of origin is not specified.

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

• This device is a reagent for diagnostic testing, not an imaging or AI system that requires expert interpretation to establish ground truth for performance evaluation.
• The "ground truth" (or reference method) for the correlation study was "another commercially available method" (the predicate device). No human experts were explicitly involved in establishing "ground truth" in the manner of medical imaging interpretation.

4. Adjudication Method for the Test Set

• Not applicable. This is a chemical reagent and an analytical performance study, not an imaging or diagnostics study requiring adjudication of interpretations. The performance is assessed by comparing results to a reference method (the predicate device) or by intrinsic analytical measures (precision, linearity).

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 a study of a chemical reagent, not an AI-based diagnostic tool requiring human-in-the-loop evaluation or MRMC studies.

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

• Not applicable. This is a study of a chemical reagent, not an algorithm. The performance described is the standalone analytical performance of the reagent on the Vitalab Selectra Analyzer.

7. The Type of Ground Truth Used

• Linear Range: The ground truth was based on the known concentrations of "linearity standards."
• Detection Limit: The ground truth was normal saline (assumed to have 0 mg/dL uric acid).
• Precision: The ground truth was the known mean concentration of "commercially available control serum."
• Correlation: The ground truth was established by the results from a "another commercially available method" (the predicate device). This serves as the reference method against which the new device's performance is compared.

8. The Sample Size for the Training Set

• Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set." The performance characteristics are determined through analytical testing.

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

• Not applicable, as there is no "training set" for a chemical reagent.

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The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Unc acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gour, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of the sample.

The provided text describes the ATAC PAK Uric Acid Reagent Kit and its performance studies as part of a 510(k) submission. It's important to note that this is a diagnostic reagent, not an AI-based device, so some of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance" or "adjudication method") are not applicable in the context of this product. I will address the relevant information as presented in the document.

Acceptance Criteria and Reported Device Performance for ATAC PAK Uric Acid Reagent Kit

The studies were conducted to demonstrate the substantial equivalence of the ATAC PAK Uric Acid Reagent Kit to a legally marketed predicate device (Roche Uric Acid Reagent Kit) on the ATAC 8000 Random Access Chemistry System.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linearity/Recovery: n = 30 (for regression statistics, representing standard values/recoveries). No information on provenance (e.g., country of origin, retrospective/prospective) is provided, but it pertains to the behavior of the reagent with known standard concentrations.
• Precision: n = 60 for each of the three serum control samples. This implies 60 replicate measurements for each control. No information on provenance for these commercially available control sera.
• Method Comparison: n = 120 (mixed serum and plasma specimens). No information on country of origin. The data provenance is described as "collected from adult patients," suggesting prospective or freshly collected samples for the purpose of the study.
• Detection Limit: n = 30 (for within-run precision study of a diluted serum pool).
• Reagent Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.
• Calibration Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.

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

Not applicable. This is a chemical assay, not an imaging device requiring expert interpretation. The "ground truth" for linearity and precision is based on known concentrations of standards and control materials. For method comparison, the "ground truth" is established by a "commercially available method" (the competitive reagent), and the goal is to show agreement between the two methods, rather than an expert ground truth.

4. Adjudication method for the test set

Not applicable. As noted above, this is a chemical assay.

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 a diagnostic reagent, not an AI-based system or an imaging device requiring human reader interpretation. No AI component is described.

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

The performance data presented are for the "ATAC PAK Uric Acid Reagent Kit on the ATAC 8000 Random Access Chemistry System." This represents the standalone performance of the reagent kit and analyzer system in determining uric acid levels in samples. Human involvement is limited to operating the instrument, performing calibration/quality control, and interpreting quantitative numerical results provided by the system.

7. The type of ground truth used

• Linearity/Recovery: Known concentrations of "linearity standards."
• Precision: Assays of "commercially available control serum" with expected target ranges/values.
• Method Comparison: Results from a "commercially available method" (predicate device or similar). This serves as the reference for comparison, rather than an absolute "ground truth" in the sense of pathology or outcome data.
• Detection Limit: A "diluted serum pool" and its statistical properties.
• Stability Studies: "Serum controls" with known target values.

8. The sample size for the training set

Not applicable. This is a chemical reagent and analyzer system, not an algorithm that requires a "training set." The system's operation is based on established chemical principles and pre-programmed instrument parameters, not machine 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 Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum, plasma or urine on both automated and manual systems.

The Sigma Diagnostics INFINJTY™ Uric Acid Reagent is a device intended to measure uric acid in serum, plasma or urine. Measurements obtained by the 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.

This reagent is based upon the methods of Trivedi and Kabasakalland with a modified Trinder peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB).

The series of reactions involved in the assay system is as follows:

• Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1 .
  Uric Acid + O2 + H2O _ Uricase _ Allantoin + CO2 + H2O2

• The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample.
  HoOs + 4-AAP + TBHB Peroxidase \ Ouinoneimine + H2O

Here's a breakdown of the acceptance criteria and study information for the Sigma Diagnostics INFINITY™ Uric Acid Reagent, Procedure 684, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For an in vitro diagnostic (IVD) like this, specific analytical performance characteristics (e.g., precision, accuracy, linearity, lower limit of detection, upper limit of quantitation, interference) would typically be detailed in the full 510(k) submission but are not explicitly presented as acceptance criteria or reported performance values in this summary. The submitted information focuses on substantial equivalence to a predicate.

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

• Test Set Sample Size: 126 samples were used for the correlation study.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. Given the nature of a correlation study comparing a new reagent to an existing one, it's generally conducted prospectively using fresh or banked clinical samples. The use of "plasma samples" suggests human biological samples.

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

This information is not applicable and not provided in the document.

For an IVD like a uric acid reagent, the "ground truth" for the test set is established by the reference method (the predicate device, in this case, Sigma Diagnostics Uric Acid Reagent, Procedure No. 685). The accuracy of the predicate device is assumed based on its prior clearance and validation. Clinical experts are not typically involved in establishing the "ground truth" for individual quantitative measurements in such a direct comparison study; instead, the existing, validated method serves as the comparator.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document.

Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretations (e.g., image-based diagnosis) where multiple human readers assess cases and a consensus or tie-breaking mechanism is needed to establish ground truth. For a quantitative chemical assay, the comparison is directly between the numerical results of two different analytical methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided in the document.

MRMC studies and the concept of "human readers improving with AI assistance" pertain to artificial intelligence (AI) systems designed to aid human interpretation, particularly in image analysis. This document describes a chemical reagent for quantitative laboratory measurement, not an AI-assisted diagnostic tool for subjective human interpretation.

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

This information is not applicable and not provided in the document, as it describes a chemical reagent, not a software algorithm. The "device performance" refers to the analytical performance of the reagent system.

7. The Type of Ground Truth Used

The "ground truth" for the correlation study was the measurement of uric acid levels obtained by the predicate device, Sigma Diagnostics Uric Acid Reagent, Procedure No. 685 (K853357). This can be considered a form of reference method comparison or comparative measurement data.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document.

Chemical reagents like this do not typically have "training sets" in the sense of machine learning algorithms. Their performance characteristics are established through analytical validation studies (e.g., linearity, precision, accuracy, interference studies) and then compared to a predicate using clinical samples (the "test set" in this context). The formulation and optimization of the reagent itself would involve R&D, but not a "training set" of data in the AI sense.

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

This information is not applicable and not provided in the document for the reasons stated in point 8.

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The Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum or urine on both automated and manual systems.

The Sigma Diagnostics INFINITY™ Uric Acid Reagent is a device intended to measure uric acid in serum. Measurements obtained by the 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.

This reagent is based upon the methods of Trivedi and Kabasakallan with a modified Trinder peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB).

The series of reactions involved in the assay system is as follows:

• Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1.
  Uric Acid + O2 + H2O Uricase > Allantoin + CO2 + H2O2

• The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample.
  H2O2 + 4-AAP + TBHB Peroxidase > Quinoneimine + H2O

The Sigma Diagnostics INFINITY™ Uric Acid Reagent (Procedure No. 684) is a device intended for the in vitro quantitative determination of uric acid in human serum or urine. It is explicitly indicated for use in the diagnosis and treatment of numerous renal and metabolic disorders. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo clinical study report with acceptance criteria and performance data. Therefore, many of the requested elements for a detailed study report are not explicitly available in the provided text.

Based on the provided information, here's a breakdown of the available details:

Acceptance Criteria and Reported Device Performance

The 510(k) summary states that the INFINITY™ Uric Acid Reagent is "substantially equivalent to, and is the same product as the TRACE Scientific Uric Acid Reagent kit cleared by the FDA as K971485." This implies that the acceptance criteria for this 510(k) submission were met by demonstrating this substantial equivalence, often through comparison of analytical performance characteristics (e.g., precision, accuracy, linearity, measuring range) to the predicate device. However, the specific quantitative acceptance criteria and the reported performance against these criteria are not detailed in the provided summary.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

As this is a 510(k) summary, it focuses on substantial equivalence rather than a detailed standalone clinical study report. Therefore, specific details about sample sizes, ground truth establishment, or expert involvement for a de novo study are not present. The "study" here refers to the comparisons made to establish substantial equivalence with the predicate device (TRACE Scientific Uric Acid Reagent kit, K971485).

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

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified in the provided text. This type of information would typically be in a more detailed study report, outlining the samples used for comparison studies against the predicate.

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

   • Not applicable/Not specified. For a diagnostic reagent, ground truth is typically established by reference methods or established laboratory standards, not by human expert interpretation in the same way it would be for an imaging AI device.

3. Adjudication method for the test set:

   • Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in human expert interpretations, which is not relevant for a quantitative chemical reagent.

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 a chemical reagent, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, MRMC studies are not relevant.

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

   • Yes, implicitly. A chemical reagent operates as a "standalone" analytical system, producing a quantitative result without human interpretive input beyond sample handling and instrument operation. The substantial equivalence demonstration would have evaluated the performance of the reagent directly.

6. The type of ground truth used:

   • For a chemical assay, the "ground truth" for demonstrating substantial equivalence typically involves comparison against:
     • Reference method/materials: Established analytical methods or certified reference materials with known uric acid concentrations.
     • Predicate device results: Direct comparison of results obtained with the new device versus the predicate device on the same set of patient samples.
   • The specific method used is not detailed in the provided text, but it would fall into one of these categories.

7. The sample size for the training set:

   • Not applicable/Not specified. Chemical reagents do not typically have "training sets" in the same sense as machine learning algorithms. Their formulation and optimization are based on chemical principles and experimental validation, not iterative training on data.

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

   • Not applicable/Not specified, as there is no "training set" in the context of a chemical reagent.

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