The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

• Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

• Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

• Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

• Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases.

• Creatinine measurements are used in the diagnosis and treatment of renal dialysis, and as a calculation basis for measuring other urine analytes.

The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

The Minicare C300 Clinical Analyzer is an in-vitro diagnostic devices for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

The skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (private label) and Comprehensive Metabolic Panel is an automatic chemistry system intended for use in clinical laboratories or point-of-care locations. The system consists of a portable analyzer and single-use disposable reagent panel discs.

The analyzer utilizes precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel.

The skyla and Minicare Comprehensive Metabolic Panel reagent disc (which contains the Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Blood Urea Nitrogen and Creatinine test systems) is designed to separate a heparinized venous whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

The Lite-On Technology Corp.'s Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, and Minicare C300 Clinical Chemistry Analyzer (K171971) were evaluated for substantial equivalence. The acceptance criteria and performance data are primarily based on precision, matrix comparison, detection limits, linearity, and interference testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's performance and the established clinical laboratory standards (e.g., CLSI guidelines, recovery within 90-110% for interference). The reported device performance aligns with these expectations.

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

• Internal Precision/Reproducibility: 80 runs per level (quadruplicate testing a day for 20 working days) for each of the three serum levels for all 5 analytes. Data provenance is not specified (e.g., country of origin) but refers to "patient serum samples." Implied prospective collection for the study.
• Matrix Comparison: 40 human samples. Data provenance not specified. Implied prospective collection for the study.
• Detection Limit: LoB: 60 measurements of a near-zero sample over 10 days. LoD/LoQ: serum samples containing very low concentrations, tested in triplicate using 2 lots of reagent discs for 10 days. Data provenance not specified. Implied prospective collection.
• Linearity: 9 intermediate dilutions created from high and low human serum pool samples, plus spiked samples. Data provenance not specified. Implied prospective collection.
• Endogenous Interferences: Not explicitly stated, but implies multiple samples to test two different concentrations (normal and abnormal) of analytes against specified interference levels. Data provenance not specified. Implied prospective collection.
• Exogenous Substances: Two concentrations (low and high level) of samples for each of the 10 potential interferents. Data provenance not specified. Implied prospective collection.
• Point-of-Care (POC) Method Comparison: Over 120 heparinized venous whole blood and serum samples for each analyte. Data provenance not specified; likely collected from the three POC sites, implying prospective collection.
• Point-of-Care (POC) Precision Studies: Three levels of human serum samples from POC sites, assayed in quadruplicate twice a day for 20 days. Data provenance not specified. Implied prospective collection.
• Point-of-Care (POC) Whole Blood Precision: Not explicitly stated, but tabular data suggests multiple analyses (mean, SD, CV) for low, medium, and high samples across 3 POC sites and multiple operators (OP1, OP2, OP3).

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

This type of submission (510k for a clinical chemistry analyzer) does not typically involve human experts establishing a "ground truth" for the test set in the same way an image analysis or diagnostic AI device would. Instead, the ground truth is established by:

• Reference Methods/Materials: Traceability to established reference methods (e.g., IFCC reference method for ALT/ALP/AST, CDC reference method for BUN, IDMS Reference Method for CREA) and reference materials (NIST SRM967).
• Comparative Clinical Analyzers: For method comparison studies, the Beckman Coulter AU2700 clinical analyzer served as the comparative (reference) method.

Therefore, the "experts" in this context are the established, validated, and traceable laboratory methods and instruments, rather than individual human practitioners.

4. Adjudication Method for the Test Set

Not applicable. Diagnostic test performance for clinical chemistry analyzers is typically evaluated by statistical comparison to a reference method or established clinical ranges, not by an adjudication process as seen in clinical trial settings for diagnostic imaging.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where multiple human readers interpret cases with and without AI assistance. This submission is for a clinical chemistry analyzer.

However, the "POC Precision studies" did evaluate performance across multiple operators (9 operators) at three POC sites. This demonstrates inter-operator variability, which is a related concept to multi-reader studies in a laboratory context, but it does not measure an "improvement with AI vs. without AI assistance" since the device itself is the primary measurement tool, not an AI assistant to a human reader.

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

Yes, the studies presented are generally "standalone" performance evaluations of the device (skyla/Minicare Clinical Chemistry Analyzer with Comprehensive Metabolic Panel) itself. The device automatically measures analytes and displays results; there isn't an "algorithm only" component separate from the integrated device performance. All performance data (precision, linearity, detection limits, interference) are solely based on the device's output.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through:

• Traceability to Reference Methods/Materials: For calibration and analytical accuracy (e.g., IFCC, CDC, IDMS reference methods, NIST reference materials).
• Comparative Clinical Analyzers: The Beckman Coulter AU2700 served as the comparative method for method comparison studies, essentially acting as the "ground truth" or reference for evaluating the test device's performance on patient samples.
• Known Concentrations: For studies like linearity, detection limits, and interference, samples with known or spiked concentrations are used.

8. The Sample Size for the Training Set

This document does not specify a separate "training set" in the context of machine learning or AI. This device is a traditional in-vitro diagnostic (IVD) clinical chemistry analyzer. Its development would involve internal validation and optimization processes by the manufacturer, which might loosely be considered "training," but it's not described as an AI model training set with a specific size or provenance.

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

As this is a traditional IVD device, the concept of a "training set" for an AI model's ground truth is not applicable in the way it would be for AI-powered diagnostic software. The "ground truth" for the development and internal validation of such a device is established through:

• Chemical Principles and Reactions: The underlying scientific principles of colorimetry and specific reagent reactions form the fundamental 'ground truth' for measurement.
• Calibration Standards: The device is calibrated using standards whose concentrations are traceable to recognized reference methods and materials, ensuring accurate quantitative measurements.
• Quality Control Materials: Known quality control materials are used to ensure the device performs within expected ranges over time.

These elements collectively serve as the basis for ensuring the device's accuracy and reliability during its design, development, and manufacturing phases.

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The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Amylase Reagent is intended for the quantitative determination of α-amylase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

In the ACE Alkaline Phosphatase Reagent assay, alkaline phosphatase catalyzes the hydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganic phosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide form and has a strong absorbance at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphatase activity in the sample.

In the ACE Amylase Reagent assay, α-amylase hydrolyzes the 2-chloro-p-nitrophenyl-α-D-maltotrioside substrate to release 2-chloro-p-nitrophenol and form 2-chloro-p-nitrophenyl-α-D-maltoside, maltotriose and glucose. The rate of increase in absorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional to the α-amylase activity in the sample.

In the ACE ALT Reagent assay, alanine aminotransferase converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate, respectively. Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the cofactor. The rate of conversion of the reduced cofactor to the cofactor can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a function of the activity of ALT in the sample.

In the ACE AST Reagent assay, aspartate aminotransferase converts the L-aspartate and α-ketoglutarate in the reagent to oxaloacetate and L-glutamate, respectively. The oxaloacetate undergoes reduction, with concurrent oxidation of NADH to NAD+ in the malate dehydrogenase-catalyzed indicator reaction. NADH absorbs strongly at 340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST in the sample. Lactate dehydrogenase is added to prevent interference from endogenous pyruvate, which is normally present in blood.

Here's an analysis of the provided information regarding the acceptance criteria and study for the ACE reagents:

Summary of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these in vitro diagnostic reagents (ALP, Amylase, ALT, AST) appear to be primarily demonstrated through comparisons with predicate devices and comprehensive performance characteristics like precision, linearity, and interference. The documentation focuses on demonstrating that the new devices perform equivalently to the existing predicate devices and meet established performance expectations for clinical chemistry assays.

1. Table of Acceptance Criteria and Reported Device Performance

Since this document describes multiple reagents and doesn't explicitly state pass/fail acceptance values for each performance metric, I will summarize the demonstrated performance and what can be inferred as the "acceptance criteria" (i.e., that the results are comparable to established predicate device performance and within acceptable clinical ranges).

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

• Precision (Serum vs. Plasma):
  • In-House: Each dataset (low, mid, high for serum and plasma) involved "n=20" (number of replicates, likely over multiple days, contributing to within-run and total precision calculations).
  • POL Precision (ACE & Alera): For each analyte (ALP, AMY, ALT, AST) and each POL site (POL 1, POL 2, POL 3), there were 2 to 3 sample levels (Low, Mid, High), with a reported "n" for each (e.g., n=24 for ALT/AST in initial in-house, but the POL tables don't explicitly state the 'n' for each specific mean/SD/CV, implying a standard number of replicates as per precision studies).
• Matrix Comparison (Serum vs. Plasma):
  • ALP: ACE (108 pairs), ACE Alera (108 pairs), ACE Axcel (62 pairs).
  • Amylase: ACE (104 pairs), ACE Alera (101 pairs), ACE Axcel (52 pairs).
  • ALT: ACE (54 pairs), ACE Alera (52 pairs), ACE Axcel (56 pairs).
  • AST: The number of pairs for AST in the serum vs. plasma matrix comparison is not explicitly stated in the provided snippet. However, based on the pattern of other analytes, it would likely be similar (e.g., 50+ pairs).
• Method Comparison (In-House vs. POL Sites):
  • ALP: 49-50 samples per site.
  • Amylase: 51 samples per site.
  • ALT: 44-49 samples per site.
  • AST: 50 samples per site.
• Linearity: Not explicitly stated as an "n" for samples, but rather as "low level tested," "upper level tested," and "linear to" values, which typically involve preparing a dilution series from a high concentration sample.
• Data Provenance: The studies are labeled "In-House" and "POL" (Point of Care). This suggests:
  • Country of Origin: Likely the USA, given the FDA 510(k) submission.
  • Retrospective or Prospective: These types of performance studies for IVDs are typically prospective, with samples analyzed specifically for the study. The method comparison data often uses a mix of native patient samples and spiked samples to cover the measuring range.

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

This document describes the performance of IVD reagents on clinical chemistry systems. The "ground truth" here is not subjective, human interpretation (like in imaging AI), but rather the quantitative measurement of analytes.

• Number of Experts: Not applicable in the context of IVD reagent performance. The "ground truth" is established by the analytical method itself, or by comparison to a recognized reference method or a legally marketed predicate device.
• Qualifications of Experts: Not applicable. The "experts" would be qualified laboratory professionals operating the instruments and performing the biochemical assays according to established protocols.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "truth" for these quantitative measurements is derived directly from the biochemical reactions and instrument readings, not subjective human judgment requiring adjudication. The predicate device's established performance serves as a comparative benchmark.

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

No. This is a submission for in vitro diagnostic reagents, not an AI-assisted diagnostic device that involves human readers interpreting images or complex data. Therefore, an MRMC study is not relevant.

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

Yes, in essence, the performance data presented is "standalone" in the context of the device's function. The ACE reagents, when used on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems, operate as an automated system to quantify the target analytes. The performance metrics (precision, linearity, method comparison, interferences) reflect the intrinsic analytical performance of the regent-analyzer combination without human intervention influencing the measurement itself. Human operators are involved in sample loading, quality control, and result review, but not in directly influencing the quantitative output in a way that would require a human-in-the-loop comparison for algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Comparison to Predicate Devices: The primary method is demonstrating substantial equivalence to previously cleared devices (K113253, K931786, K930104, K113436, K113382). This means the new reagents provide results that are analytically comparable to those already accepted by the FDA.
• Expected Analytical Performance: Meeting industry-standard requirements for precision (low CV%), accuracy (linearity, inter-instrument/site agreement via regression analysis), and specificity (minimal interference).
• Expected Values/Ranges: The devices are expected to produce results that align with established "expected values" for healthy individuals.

8. The Sample Size for the Training Set

Not applicable. These are chemical reagents for quantitative diagnostic tests, not machine learning algorithms that require a "training set" in the conventional sense. The "training" for such systems involves analytical validation experiments to define reagent stability, reaction kinetics, and instrument parameters.

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

Not applicable for the same reason as point 8. The "ground truth" for developing and validating these reagents is based on fundamental principles of analytical chemistry, biochemical reactions, and extensive internal testing to ensure the reagents perform as intended within the specified analytical parameters.

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The S TEST Reagent Cartridge Alanine Amino Transferase (ALT) is intended for the quantitative measurement of the activity of the enzyme alanine amino transferase (ALT) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

The S TEST Reagent Cartridge Aspartate Amino Transferase (AST) is intended for the quantitative measurement of the activity of the enzyme aspartate amino transferase (AST) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for glucose.

The Hitachi Chemical Diagnostics S TEST Reagent Cartridges for Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) underwent nonclinical and clinical testing to demonstrate their safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Nonclinical Studies (Internal):
  • Analytical Sensitivity (LoD): Sample sizes not explicitly stated for individual calculations beyond "followed CLSI EP17."
  • Linearity: Sample sizes not explicitly stated beyond "followed CLSI EP-6A."
  • 20-day In-house Precision: 80 replicates per level for AST (ALT not clearly defined due to formatting issues in the document but likely similar).
  • Interference Testing: Sample sizes not explicitly stated.
  • Method Comparisons: 103 serum samples for ALT, 169 serum samples for AST.
  • Matrices Comparisons: Approximately 35 matched serum/plasma samples (28-31 for ALT, 38-39 for AST) per plasma type.
• Clinical Studies (External POL-type sites):
  • External Precision Study: 30 replicates per sample per site (6 times a day for 5 days) for 3 sample levels (A, B, C or D, E, F) at each of 3 sites.
  • External Method Comparisons: 49-50 blinded serum samples for ALT per site; 62-64 blinded serum samples for AST per site tested at 3 POL sites.
• Data Provenance: The document does not explicitly state the country of origin for the data. The studies were conducted internally ("in-house") and at "three external POL-type sites," suggesting the data is retrospective as it was collected before submission.

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

• For the nonclinical and clinical method comparison studies, the "ground truth" was established by "routine laboratory methods" or "traditional methods at the central laboratory."
• The document does not specify the number or qualifications of experts involved in performing these reference methods. It relies on the established accuracy and widely accepted nature of these "traditional" or "routine" methods.

4. Adjudication Method for the Test Set:

• No explicit adjudication method is described. The "ground truth" was derived from measurements by established laboratory methods, and the Hitachi device's results were compared to these.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This submission focuses on the analytical performance of an in vitro diagnostic (IVD) device (reagent cartridges for an analyzer), not a diagnostic imaging or AI-driven decision-support system that typically involves human reader performance. Therefore, there is no mention of human readers, AI assistance, or effect sizes related to human improvement.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

• Yes, this entire submission is effectively a standalone performance study. The device itself is an automated chemical analyzer with reagent cartridges. The studies evaluate the analytical performance of this automated system directly (e.g., sensitivity, linearity, precision, method comparison to reference methods). There is no "human-in-the-loop" component in the operational use or performance evaluation of the ALT/AST test results themselves, beyond the initial sample loading and result interpretation by laboratory personnel.

7. The Type of Ground Truth Used:

• The ground truth used for method comparison and accuracy studies was established by measurements from "routine laboratory methods" or "traditional methods at the central laboratory." This implies a highly accurate and well-established chemical assay, which serves as the reference standard for the analyte concentration or activity.

8. The Sample Size for the Training Set:

• This submission describes a premarket notification (510(k)) for an IVD device (reagent cartridges). It does not involve a machine learning or AI algorithm that typically requires a distinct "training set." Therefore, no training set sample size is reported or relevant in this context. The "training" of the device is inherent in its chemical design and calibration, not in data-driven machine learning.

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

• As stated above, this is an IVD device, not an AI/ML-driven device. Thus, the concept of a "training set" and associated ground truth establishment for such a set does not apply. The device's performance is validated against established laboratory standards and reference methods as described in point 7.

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The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE γ-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry System. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate. Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the cofactor. The rate of conversion of the reduced cofactor to the cofactor can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a function of the activity of ALT in the sample.

In the ACE AST Reagent assay, aspartate aminotransferase in serum converts the L-aspartate and α-ketoglutarate in the reagent to oxalacetate and L-glutamate. The oxalacetate undergoes reduction with simultaneous oxidation of NADH to NAD+ in the malate dehydrogenase catalyzed indicator reaction. NADH absorbs strongly at 340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST in the sample. Lactate dehydrogenase is added to prevent interference from endogenous pyruvate, which is normally present in serum.

In the ACE γ-GT Reagent assay, γ-GT in serum catalyzes the transfer of the γ-glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in the reagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the γ-GT activity in the sample.

This document describes the performance of the ACE ALT, AST, and γ-GT Reagents on the ACE Axcel Clinical Chemistry System. These reagents are intended for the quantitative determination of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (γ-GT) activity in serum, used in the diagnosis and treatment of certain liver and heart diseases.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as distinct from the reported performance. Instead, it presents the results of precision and accuracy studies. The implication is that these results demonstrate acceptable performance for the device. For the purpose of this table, the reported performance values are presented with the understanding that they met the internal requirements of the manufacturer for regulatory submission.

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

• ACE ALT Reagent:

  • Precision: Not explicitly stated as a "test set" sample size for patient samples. Precision was assessed at four ALT levels over 22 days in a lab setting and at three Physician Office Laboratory (POL) sites over 5 days. These studies would typically involve repeated measurements of control materials or pooled patient samples.
  • Accuracy: 102 samples for the main correlation study (ALT values from 4 to 472 U/L) and patient correlation studies conducted at three separate POL sites.
  • Data Provenance: Not explicitly stated, but the mention of Physician Office Laboratory (POL) sites suggests data from clinical settings. It is implied to be prospective data collected for the study, rather than retrospective.

• ACE AST Reagent:

  • Precision: Similar to ALT, assessed at four AST levels over 22 days in a lab and at three POL sites over 5 days.
  • Accuracy: 117 samples for the main correlation study (AST values from 8 to 440 U/L) and patient correlation studies conducted at three separate POL sites.
  • Data Provenance: Not explicitly stated, but implies clinical settings and prospective data.

• ACE γ-GT Reagent:

  • Precision: Similar to ALT and AST, assessed at four γ-GT levels over 22 days in a lab and at three POL sites over 5 days.
  • Accuracy: 128 samples for the main correlation study (γ-GT values from 7 to 902 U/L) and patient correlation studies conducted at three separate POL sites.
  • Data Provenance: Not explicitly stated, but implies clinical settings and prospective data.

The country of origin for the data is not specified, but the manufacturer is based in the US.

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

This information is not applicable as the device is an in vitro diagnostic (IVD) chemistry system that provides quantitative measurements of enzyme activity. The "ground truth" for IVD devices like this is typically established by comparing performance against a reference method or a legally marketed predicate device, rather than expert interpretation of images or clinical assessments.

For accuracy, the device's performance was compared to the Alfa Wassermann ACE Clinical Chemistry System (predicate device K931786).

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human experts interpret results or clinical cases, and a consensus needs to be reached. For quantitative IVD tests, the "ground truth" is the result obtained from a reference method or predicate device.

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. MRMC studies are relevant for medical imaging AI devices where human readers interpret images. This device is an in vitro diagnostic system for chemical analysis and does not involve human readers interpreting cases in the same way.

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

Yes, the performance studies described (precision, accuracy, and detection limit) represent the standalone performance of the ACE ALT, AST, and γ-GT Reagents on the ACE Axcel Clinical Chemistry System. These are objective, quantitative measurements generated directly by the analytical system, without human interpretation in the "loop" of the measurement process itself.

7. The Type of Ground Truth Used:

The ground truth used for the accuracy studies was the measurements obtained from the predicate device, the Alfa Wassermann ACE Clinical Chemistry System (K931786). The new reagents on the ACE Axcel system (y) were compared against the existing reagents on the ACE system (x) using patient samples. This is a common method for demonstrating substantial equivalence for new IVD devices by showing good correlation with an already legally marketed device.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an in vitro diagnostic reagent and system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The reagents and system are developed and optimized through traditional chemical and engineering processes, followed by validation studies as described.

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

This information is not applicable for the same reason as point 8. There is no training set in the machine learning context for this type of device.

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Dimension Vista™ Albumin (ALB) Flex® reagent cartridge: The ALB method is an in vitro diagnostic test for the quantitative measurement of albumin in human serum and plasma on the Dimension Vista™ System. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge: The AST method is an in vitro diagnostic test for the quantitative measurement of aspartate aminotransferase in human serum and plasma on the Dimension Vista™ System. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge: The CRBM method is an in vitro diagnostic test for the quantitative measurement of carbamazepine in human serum and plasma on the Dimension Vista™ System. Carbamazepine measurements may be used in the diagnosis and treatment of carbamazepine overdose and in therapeutic drug monitoring. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.

Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge: The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase in human serum and plasma on the Dimension Vista™ System. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases.

Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge: The TIBC method is an in vitro diagnostic test for the quantitative measurement of total iron binding capacity in human serum and plasma on the Dimension Vista™ System. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade 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 ALB, AST, CRBM, ALT, and TIBC 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 an analysis of the provided text, focusing on the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission for several reagent cartridges for the Dimension Vista™ system. The primary goal of this submission is to demonstrate substantial equivalence to existing predicate devices (Flex® reagent cartridges used on Dimension® clinical chemistry systems) due to a packaging modification. Therefore, the "acceptance criteria" are implicitly tied to the performance of the predicate devices.

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

While explicit numerical acceptance criteria are not provided in the publicly available summary, the general acceptance criteria for this type of submission would be that the performance of the new device (Dimension Vista™ Flex® reagent cartridges) must be comparable or equivalent to the predicate device (Dimension® Flex® reagent cartridges). This comparison typically involves analytical performance characteristics such as:

• Accuracy: How close the measured values are to the true values.
• Precision: The reproducibility of measurements.
• Linearity/Measuring Range: The range over which the device accurately measures the analyte.
• Interferences: The effect of other substances on the measurement.
• Method Comparison: Correlation with the predicate device.

Since the submission states the reagents are the same, and only the packaging is modified for use on a different (but related) instrument, the expectation is that the analytical performance should remain unchanged or within acceptable variations for clinical use.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Study Information:

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

   • Sample Size: Not explicitly stated in the provided summary. The document mentions "Comparative testing described in the protocol included in this submission," but doesn't detail the sample sizes for comparison studies.
   • Data Provenance: Not explicitly stated. For in-vitro diagnostic devices, testing typically involves human serum and plasma samples, likely collected in a clinical laboratory setting. Whether it was retrospective or prospective is not mentioned, but validation studies for IVDs often involve prospective sample collection or the use of archived samples.

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

   • Not applicable as this is an in-vitro diagnostic test. Ground truth for such devices is established by the analytical performance against a reference method or validated calibrators, not by expert consensus in the way image analysis or clinical diagnosis might be.

3. Adjudication method for the test set:

   • Not applicable for an in-vitro diagnostic test. Results are quantitative measurements against established analytical standards.

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 an in-vitro diagnostic device (reagent cartridge for laboratory analysis), not an AI-assisted diagnostic imaging or clinical decision support tool that involves "human readers."

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

   • Yes, this is an inherent aspect of an in-vitro diagnostic device. The "algorithm" here is the chemical assay and instrument processing. The performance reported (e.g., accuracy, precision) is the standalone performance of the device without human interpretation of the primary data, beyond standard laboratory quality control and result reporting.

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

   • For in-vitro diagnostic devices, the "ground truth" for analytical performance studies is typically established by:
     • Reference Methods: Highly accurate and precise methods (e.g., gas chromatography-mass spectrometry for drugs, isotope dilution mass spectrometry for certain analytes) considered the gold standard.
     • Validated Calibrators/Controls: Materials with known, assigned values traceable to reference standards.
     • Clinical Diagnosis/Patient Outcome: For clinical utility, but analytical performance uses the above.
   • The document implies that the ground truth for comparison was the established performance of the legally marketed predicate devices, which would have been validated against such reference methods or standards.

7. The sample size for the training set:

   • Not explicitly stated. For reagent development, a "training set" in the context of machine learning isn't directly applicable. Instead, reagent formulations are optimized through R&D, and their performance is characterized using various samples (e.g., quality control materials, patient samples) during that development phase. The "study" described here is for validation, not training or development.

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

   • As noted above, a "training set" linked to a ground truth in the machine learning sense isn't directly relevant here. However, the development of the original reagents (predicate devices) would have involved extensive analytical characterization against reference methods and clinical samples to establish their performance specifications and clinical utility. The current submission leverages the established ground truth of these existing reagents.

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The Polymedco SpotChem EX and ALT test system is an in vitro diagnostic instrument and procedure intended to measure the activity of the enzyme alanine amino transferase or ALT (also know as a serum glutamic pyruvic transaminase or SGPT) in serum, plasma and whole blood. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Not Found

This document is a 510(k) clearance letter from the FDA for the SpotChem EZ Analyzer and ALT Test. It acknowledges that the device is substantially equivalent to a legally marketed predicate device. However, it does not contain the detailed study information required to answer the prompt thoroughly.

The letter primarily focuses on the regulatory classification and marketing authorization, not on the specific performance studies. Therefore, much of the requested information is absent from this document.

Here's what can be extracted, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in this document.
• Reported Device Performance: Not detailed in this document. The letter only states that the device is "substantially equivalent" to a predicate device, implying its performance should be comparable, but no specific metrics are provided.

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

• Sample Size: Not available in this document.
• Data Provenance: Not available in this document.

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

• Not available in this document.

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

• Not available in this document.

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 device is an in-vitro diagnostic analyzer for enzyme activity (ALT/SGPT), not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• This device is a standalone instrument for measuring enzyme activity. Its performance would inherently be "standalone" in the sense that it doesn't involve a human interpreting its output in the context of an algorithm's assistance. However, the exact study details are not provided.

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

• For an ALT test, the "ground truth" would typically be established by a reference method of ALT measurement, often a well-established enzymatic kinetic assay, which is considered the gold standard for accurately determining enzyme activity in a sample. This document does not specify the method.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device that requires a training set in that context. If we interpret "training set" broadly as the data used to validate the initial assay, that information is not present.

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

• Not applicable for the same reasons as point 8.

Summary of what can be inferred or is explicitly stated:

• Device Name: SpotChem EZ Analyzer and ALT Test
• Intended Use: To measure the activity of the enzyme alanine amino transferase (ALT or SGPT) in serum, plasma, and whole blood for the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
• Regulatory Status: Substantially Equivalent (510(k) clearance) to legally marketed predicate devices.
• Regulatory Class: Class I
• Product Codes: CKA (Alanine amino transferase (ALT/SGPT) test system) and JJF.
• Manufacturer: ARKRAY, Inc.

To fully answer your prompt, you would need to consult the actual 510(k) submission document (K040332) which would contain the detailed pre-market performance data submitted by the manufacturer to the FDA. This letter only provides the outcome of the FDA's review.

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The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.

The ANALETTE™ Chemistry Analyzer is an in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution. It is an "open" System, which can use a variety of commercially manufactured reagents.

The document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Precision Systems™ ANALETTE™ Chemistry Analyzer using STANBIO Laboratory Reagents to its predicate devices (ANALETTE™ using Synermed® Reagents and ANALETTE™ using Medical Analysis Systems Inc® Reagents).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Performance specifications: None established under Section 514." Instead, it refers to "Acceptance Criteria" (Exhibit E and F) but does not detail the specific numerical acceptance criteria within the provided text.

However, the "Results" section (G.) provides the reported performance relative to "acceptable/equivalent results" or "Manufacturers' claim."

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

• Imprecision: Two control serums were used for both within-run and total precision.
  • Within-run: Up to 20 repeats.
  • Total precision: Duplicates for up to 20 days.
• Correlation: "about 100 serums" were used.
• Linearity: "Commercially available linearity material" was assayed.
• Recovery: "Commercial available Controls with assigned values" were used.

Data Provenance: The document does not specify the country of origin for the data or explicitly state if it was retrospective or prospective. However, the nature of the tests (using control serums, commercial linearity material, and patient serums for correlation by assaying them) suggests it was a prospective study conducted for the purpose of this 510(k) submission.

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

This information is not provided in the document. The "ground truth" for the test set appears to be established by comparing the performance of the STANBIO Laboratory Reagents on the ANALETTE™ to the performance of predicate reagents (Synermed® and Medical Analysis Systems Inc® Reagents) on the same ANALETTE™ or to manufacturer's claims for linearity and recovery. This is a comparison study, not a ground truthing exercise with independent experts reviewing clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable as the study described is a laboratory performance study comparing reagent efficacy, not a human reader or image-based diagnostic study requiring adjudication. The performance is assessed against established laboratory methods or manufacturer claims for the predicate reagents.

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 as the device is a chemistry analyzer and reagents, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

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

This is an algorithm-only (standalone) performance study in the sense that it evaluates the analytical performance of the ANALETTE™ Chemistry Analyzer with STANBIO reagents. The purpose is to demonstrate that the device produces accurate measurement results independently. Human intervention is limited to operating the analyzer and interpreting the numerical output.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established by:

• Comparison to Predicate Devices/Reagents: For imprecision and correlation, the performance of the STANBIO reagents is compared to the performance of legally marketed Synermed® and Medical Analysis Systems Inc® reagents on the ANALETTE™ device (which effectively act as the reference standard).
• Manufacturer's Claims/Expected Values: For linearity and recovery, the results are compared against the manufacturer's claims for the reagents or assigned values for commercial controls.

This is therefore a form of comparative analytical performance against established and accepted methods/claims, rather than clinical outcomes or pathology reports.

8. The Sample Size for the Training Set:

This information is not applicable as the ANALETTE™ is a chemistry analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a system would involve instrument calibration and quality control procedures, which are standard for laboratory devices.

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

This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set with established ground truth).

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The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Carbon Dioxide, Amylase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase. Aspartate Aminotransferase; Gamma Glutamyl Transferase, Lipase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets.

An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ANALETTE™ clinical chemistry analyzer and Medical Analysis Systems Reagents:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a submission for substantial equivalence (510(k)) for the ANALETTE™ clinical chemistry analyzer using Medical Analysis Systems (MAS) Reagents, comparing it to the same ANALETTE™ analyzer using Synermeds® 072 reagents (the predicate device). The core of the acceptance criteria here is the demonstration of "substantial equivalence" of the new reagent system to the predicate. Specific quantitative acceptance criteria are not explicitly detailed in the provided text in the form of numerical thresholds for accuracy, precision, or comparison studies. Instead, the performance section broadly states:

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

The document states that "comparative studies" were conducted. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided in the document. For a clinical chemistry analyzer, the ground truth is typically established by reference methods or highly accurate laboratory instruments rather than expert adjudication in the way it would be for image-based diagnostics.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable in the context of a clinical chemistry analyzer's performance evaluation as described. Ground truth is established through analytical measurements, not through human adjudication of diagnostic findings. Therefore, no adjudication method like 2+1 or 3+1 would be used.

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

No, an MRMC comparative effectiveness study was not done for this device. MRMC studies are typically used for diagnostic imaging devices where human interpretation is a critical component, often comparing human readers with and without AI assistance. This device is a clinical chemistry analyzer, which provides quantitative measurements directly.

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

The performance described for the ANALETTE™ clinical chemistry analyzer with MAS reagents is inherently a standalone performance in the context of the instrument measuring analyte concentrations. There is no "human-in-the-loop" performance component in the direct measurement by the analyzer. The comparison is between two reagent systems on the same analyzer, assessing the analytical performance.

7. The Type of Ground Truth Used

The ground truth for this type of device (a clinical chemistry analyzer) would typically be established by:

• Reference standard methods: Highly accurate and precise laboratory methods, often more complex or expensive than routine clinical tests.
• Certified reference materials: Samples with known, validated concentrations of the analytes.
• Comparison to the predicate device: For a 510(k) submission seeking substantial equivalence, the performance of the new device (or reagent system) is directly compared to the legally marketed predicate device using patient samples and/or quality control materials. The predicate device's results serve as the pragmatic "ground truth" for demonstrating equivalence in a clinical setting.

The document implies the latter, stating "Substantially equivalence was established in comparative studies," meaning performance was compared against the predicate system.

8. The Sample Size for the Training Set

This information is not provided in the document. Clinical chemistry analyzers and their associated reagents are developed through analytical validation, which involves extensive testing, but the term "training set" is more commonly associated with machine learning algorithms. If there were any computational models or algorithms within the analyzer's software that required training (which is not explicitly indicated as relevant here beyond basic instrument calibration), the details of such a training set are absent.

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

Since no "training set" in the machine learning sense is explicitly mentioned or detailed, and the focus is on analytical performance comparison (substantial equivalence), the method for establishing ground truth for a training set is not applicable or provided. The development of a clinical chemistry reagent kit involves rigorous analytical validation, where performance characteristics like accuracy, precision, linearity, and interference are established using known standards and patient samples, rather than a "ground truth for training" in the way an AI model would be trained.

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For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease.

CARESIDE ALT cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure ALT activity in anti-coagulated whole blood, plasma, or serum specimens. The CARESIDE® ALT cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of sample to a dry film to initiate the measurement of ALT activity. The patented film cartridge contains all reagents necessary to measure ALT activity.

Each CARESIDE ALT cartridge consists of an ALT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge sample well, closes the lid and inserts the cartridge into the CARESIDE Analyzer.

Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample well into the cartridge channels and chambers. Approximately 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.

The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer uniformly distributes the specimen. As the specimen passes through the spreading and substrate layer, ALT in the specimen catalyzes the reaction of L-aspartate and a-ketotglutaric acid to form pyruvic acid and L-glutamic acid (see Test Reaction Sequence). The pyruvic acid is converted to acetyl phosphoric acid, CO2 and hydrogen peroxide in the reaction layer. Peroxidase in the reaction layer then catalyzes the oxidation of a diaryliminidazole leuco dye by hydrogen peroxide to form a green dye. The rate of change of intensity of the color as measured by the amount of reflected light at 655 directly relates to the amount of ALT activity in the specimen.

The provided document describes the CARESIDE® ALT test system, an in vitro diagnostic device for quantitatively measuring Alanine Aminotransferase (ALT) activity. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device, not to establish new performance criteria. Therefore, the document does not contain an "acceptance criteria" table in the traditional sense of a new clinical trial setting with predefined endpoints that need to be met for device approval. Instead, it presents a comparison of the CARESIDE ALT's performance characteristics against those of the predicate device (Vitros ALT DT Slides) to show "substantial equivalence."

Here's the information extracted and organized based on your request, focusing on the comparative performance data provided:

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

As this is a 510(k) submission showing substantial equivalence, there are no explicitly stated "acceptance criteria" for a new device's clinical performance. Instead, the performance of the CARESIDE ALT is compared to the predicate device and the new device's performance is presented. The implicit "acceptance criterion" is that the CARESIDE ALT performs "as well as or better than" the predicate device.

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

The document does not explicitly state the sample size used for the "test set" (i.e., the number of patient samples or specimens used for the accuracy, precision, linearity, method comparison, and interference studies). It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

This type of information (experts, qualifications, etc.) is typically associated with studies involving human interpretation (e.g., image analysis, diagnoses). The CARESIDE ALT is an in vitro diagnostic device for quantitative chemical measurement. Its "ground truth" would be established by reference methods or laboratory-grade analyzers. Therefore, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant to studies where human readers interpret and classify data, and discrepancies need resolution. This is not applicable to a quantitative in vitro diagnostic device where measurements are compared to reference methods or statistical thresholds for performance.

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

This section is not applicable. The CARESIDE ALT is an in vitro diagnostic device for measuring a chemical analyte, not an AI-powered diagnostic system requiring human interpretation or assistance.

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

The performance data presented (accuracy, precision, method comparison, linearity, interference) describes the standalone performance of the CARESIDE ALT device, as it is an automated quantitative measurement system that does not involve human interpretation for its primary function.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics appears to be established using:

• Reference Method Comparisons: For accuracy and method comparison, the CARESIDE ALT measurements were compared against results from other established analytical methods, such as the "BM/Hitachi 902" analyzer and a "NADH/NAD coupled reduction of pyruvate by lactate dehydrogenase" reference method. The predicate device also refers to the "IFCC, 1978" method.
• Known Concentrations/Spiked Samples: For linearity, "linearity by mixing" was employed, suggesting known concentrations were used. Interference studies involved adding known concentrations of potential interfering substances.
• Statistical Analysis: Precision is determined through statistical analysis of replicate measurements.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical assay, and its development would typically involve optimization and validation runs rather than a distinct "training set" in the computational sense. The document focuses on demonstrating the final product's performance.

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

As no "training set" in the AI/ML sense is mentioned, this question is not applicable to the information provided. The development of a chemical assay involves extensive R&D, optimization using laboratory standards, and clinical validation using patient samples, but these are not typically categorized as "training sets" with associated "ground truth establishment" in the way an AI algorithm would be described.

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The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.

The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer.

While the provided document is a 510(k) clearance letter for the Olympus AU5400 Clinical Chemistry Analyzer, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in the actual 510(k) submission or a scientific publication.

The letter confirms that the device has been found substantially equivalent to predicate devices, meaning it is considered safe and effective for its indicated use. However, it does not explicitly state the specific performance metrics (like sensitivity, specificity, accuracy), the thresholds for acceptance of those metrics, or the specifics of the validation study.

Therefore, I cannot populate all the requested fields from the given text. I can only infer some information based on the nature of a 510(k) submission for a clinical chemistry analyzer.

Here's what I can convey based on the provided document and general understanding of 510(k) submissions for similar devices:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the provided letter. For a clinical chemistry analyzer, acceptance criteria would typically involve demonstrating analytical performance similar to or better than a predicate device across various parameters, including:

  • Accuracy: Agreement with a reference method.
  • Precision (Reproducibility & Repeatability): Consistency of results.
  • Linearity: Accuracy across the analytical measurement range.
  • Detection Limits: Lowest concentration that can be reliably measured.
  • Interference: Lack of significant impact from common interfering substances.
  • Carry-over: Minimal contamination between samples.
  • Stability: Reagent and calibration stability.
  • Correlation: Strong correlation with predicate device or reference method.

• Reported Device Performance: Not explicitly stated in the provided letter. The 510(k) submission would have contained data supporting these performance characteristics, demonstrating that the device meets the established acceptance criteria. The FDA's clearance implies that this evidence was found satisfactory.

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

• Sample Size: Not specified in the provided letter. For a clinical chemistry analyzer, test sets would include a variety of patient samples (normal, abnormal) and spiked samples to assess different analytical aspects.
• Data Provenance: Not specified in the provided letter. Typically, clinical chemistry analyzer validation involves prospective collection of patient samples, often from multiple sites to ensure representativeness, as well as characterization of control materials.

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

• Experts and Qualifications: Not specified in the provided letter. For clinical chemistry analyzers, "ground truth" for analytical performance is typically established through:
  • Reference interval studies: Involving a statistically significant number of healthy individuals.
  • Comparison studies: Against a recognized reference method or a legally marketed predicate device, where the predicate device's results serve as the comparison standard.
  • Control materials and calibrators: With known, certified values.
  • Analytical experts (e.g., clinical chemists, laboratory directors) would be involved in designing and overseeing these studies, and interpreting the results.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the traditional sense for analytical performance of a clinical chemistry analyzer. Adjudication methods (like 2+1, 3+1) are typically used for subjective interpretations, such as image analysis or pathology review, where expert opinion is directly establishing "ground truth." For an automated analyzer, the output is quantitative, and performance is assessed against established analytical standards or comparison methods.

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

• MRMC Study: Not applicable. MRMC studies are used to evaluate human reader performance, often with AI assistance, for tasks involving interpretation (e.g., radiology). The Olympus AU5400 is an automated clinical chemistry analyzer that produces quantitative results, not an AI-assisted diagnostic imaging tool with human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: As an automated analyzer, the device's performance is inherently "standalone" in generating the quantitative results. The entire 510(k) submission would be focused on demonstrating this standalone analytical performance. However, there's no "algorithm only without human-in-the-loop" contrast needed, as the device's function is to perform the chemical analysis automatically.

7. The Type of Ground Truth Used

• Ground Truth Type: For a clinical chemistry analyzer, the "ground truth" is typically established through:
  • Reference methods: Highly accurate and validated analytical methods.
  • Certified reference materials/calibrators: Materials with known, traceable analyte concentrations.
  • Comparison to a legally marketed predicate device: Demonstrating equivalent performance to a device already on the market.
  • Pathology/Outcomes data: Would generally not be the primary "ground truth" for the analytical performance of the analyzer itself, though the results generated by the analyzer would be used in conjunction with such data for clinical decision-making.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable in the conventional machine learning sense. This device is a traditional analytical instrument, not a machine learning or AI model that requires a "training set" to learn its function. Its operational parameters are determined by its design, engineering tolerances, and chemical principles, not by training on a dataset.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for a traditional clinical chemistry analyzer. The device's calibration involves using calibrator materials with known concentrations, but this is part of routine operation and quality control, not "training" in the ML sense.

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