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The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The Calcium2 assay is an automated clinical chemistry assay. Arsenazo III dye reacts with calcium in an acid solution to form a blue-purplex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.

Methodology: Arsenazo III

The provided text describes the performance validation of the Calcium2 assay, specifically for its use in quantitating calcium in human serum, plasma, or urine on the ARCHITECT c System. This is a Class II medical device (Calcium test system), regulated under 21 CFR 862.1145, product code CJY.

Here's an analysis based on the request:

Device: Calcium2 assay
Intended Use: Quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System. Used in the diagnosis and treatment of parathyroid disease, various bone diseases, chronic renal disease, and tetany.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly outline a pre-defined table of "acceptance criteria" against which each test result is measured, as would be common for AI/ML performance studies. Instead, it presents various performance characteristics with their measured values, often referencing CLSI guidelines for the methodology. The "acceptance" can be inferred from the reported values and the conclusion of substantial equivalence. For quantitative assays like this, performance is typically assessed against established industry standards for precision, accuracy, linearity, and interference.

However, we can infer some "acceptance criteria" implicitly from the context of "acceptable performance" and the ranges presented.

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

The provided information is for an in-vitro diagnostic (IVD) test, not an AI/ML model for image analysis. Therefore, the "test set" and "training set" terminology from an AI/ML perspective doesn't directly apply in the same way. Instead, the studies involved various types of samples (controls, panels, human serum/plasma/urine samples) tested under specific experimental designs.

• Precision Studies (Serum & Urine, 20-Day):
  • Sample Size: 80 replicates per sample type (2 controls, 3 human panels) for each of the 3 reagent lot/calibrator lot/instrument combinations in the 20-day study. (e.g., 5 samples * 80 replicates = 400 total data points per combination shown in the table).
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies are "within-laboratory" meaning they were conducted in a controlled lab setting, likely at the manufacturer's site or a designated testing facility. The nature of these samples (human serum/urine panels) suggests they are likely representative, but the specific collection method or origin (retrospective/prospective collection from patients) is not detailed.
• System Reproducibility Studies (Serum & Urine):
  • Sample Size: 90 replicates per sample type (2 controls, 3 human panels).
  • Data Provenance: Same as above, not explicitly stated.
• Accuracy Study:
  • Sample Size: Not explicitly stated for replicates, but involved 2 concentrations of NIST SRM 956d standard.
  • Data Provenance: NIST standard reference material, a highly controlled and traceable source.
• Lower Limits of Measurement Studies (Serum & Urine):
  • Sample Size: n ≥ 60 replicates for zero-analyte and low-analyte level samples for LoB, LoD, and LoQ determination.
  • Data Provenance: Not explicitly stated.
• Linearity Studies (Serum & Urine):
  • Sample Size: Not explicitly stated how many points were measured across the range, but demonstrated linearity from 2.0 to 24.0 mg/dL.
  • Data Provenance: Not explicitly stated.
• Interference Studies (Serum & Urine):
  • Sample Size: Not explicitly stated how many replicates, but each substance was tested at 2 levels of the analyte.
  • Data Provenance: Not explicitly stated.
• Method Comparison Studies (Serum & Urine):
  • Sample Size: 120 serum samples, 112 urine samples.
  • Data Provenance: Patient samples. Not explicitly stated if retrospective or prospective collection.
• Tube Type Equivalence Study (Serum):
  • Sample Size: Samples from 78 donors.
  • Data Provenance: Donor samples. Not explicitly stated if retrospective or prospective.
• Dilution Verification (Urine):
  • Sample Size: 5 samples prepared with calcium stock. Replicates for dilution recovery and imprecision were performed but the exact number isn't specified beyond "demonstrated acceptable performance."
  • Data Provenance: Prepared samples.

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

This type of IVD device (quantitative chemical assay) relies on objective measurement against a known reference (e.g., NIST standard) or internal validated methods, rather than subjective expert consensus. Therefore, "ground truth" is established through highly controlled laboratory procedures and certified reference materials, not typically through multiple human experts adjudicating results. The "experts" involved are likely laboratory scientists and metrologists operating under strict quality systems (CLSI guidelines, ISO standards).

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

Not applicable for a quantitative chemical assay. Results are objectively measured by the instrument and verified through calibration and quality control. There is no subjective interpretation requiring adjudication.

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

Not applicable. This is an in-vitro diagnostic test, not an AI/ML-driven imaging or diagnostic tool that assists human readers.

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

This is a standalone quantitative assay. The Calcium2 device automatically measures calcium concentration. Human involvement is in sample preparation, loading, and interpreting the numerical output. Its performance is evaluated entirely as an automated system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance validation is established primarily through:

• Reference Materials: For accuracy (e.g., NIST SRM 956d for bias estimation).
• Known Concentrations: For linearity, lower limits of measurement, and dilution verification, samples are prepared with known concentrations of calcium or spiked with calcium.
• Comparative Methods: For method comparisons, the "ground truth" is implicitly the performance of the legally marketed predicate device (Abbott Clinical Chemistry Architect/Aeroset Calcium, K062855), which serves as the comparator.
• Statistical Models/Guidelines: CLSI guidelines (EP05-A3, EP09c, EP17-A2, EP06, EP07, EP34) provide the statistical framework and methodology for validating performance characteristics like precision, linearity, and interference.

8. The Sample Size for the Training Set

Not applicable in the typical AI/ML sense. This is a chemistry assay, not a machine learning model that undergoes a "training" phase with a large dataset. The "training" for such a device involves rigorous engineering, chemical formulation, and calibration development, rather than data-driven model training.

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

As above, "training set" is not a concept for this type of device. The accuracy and reliability of the assay are built into its chemical design, reagent formulation, and instrument calibration process. These processes rely on highly accurate reference standards (like NIST) and established analytical chemistry principles to ensure the device measures calcium correctly across its analytical range.

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The Alkaline Phosphatase2 assay is used for the quantitation of alkaline phosphatase in human serum or plasma on the ARCHITECT c System.

Measurements of alkaline phosphatase or its isoenzymes are to be used as an aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

The Alkaline Phosphatase2 assay is an automated clinical chemistry assay for the quantitation of alkaline phosphatase in human serum or plasma on the ARCHITECT c System. Alkaline Phosphatase in a sample catalyzes the hydrolysis of colorless para-nitrophenyl phosphate (p-NPP) to give para-nitrophenol (yellow phenoxide form at alkaline pH) and inorganic phosphate. The rate of absorbance increase at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample.

The provided document is a 510(k) Premarket Notification for a clinical chemistry assay (Alkaline Phosphatase2) and does not describe an AI medical device. Therefore, the questions related to AI-specific acceptance criteria, ground truth establishment by experts, adjudication methods, multi-reader multi-case studies, and human-in-the-loop performance are not applicable.

The document focuses on the analytical performance of the Alkaline Phosphatase2 assay, demonstrating its substantial equivalence to a legally marketed predicate device. The information details various non-clinical performance studies to establish the device's reliability and accuracy for quantitating alkaline phosphatase in human serum or plasma.

Here's a breakdown of the relevant information from the document, tailored to the context of a diagnostic assay's performance evaluation, substituting the AI-specific questions with applicable details:

Acceptance Criteria and Device Performance for Alkaline Phosphatase2 Assay

This submission (K223317) is for a clinical chemistry assay, not an AI medical device. The acceptance criteria and performance studies are focused on the analytical performance of the assay to demonstrate its intended use for quantitative measurement of alkaline phosphatase.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" for regulatory review, but it details various performance studies with implicit acceptance ranges. The reported device performance metrics are presented instead.

Performance Metrics of Alkaline Phosphatase2 Assay (Representative Values)

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The Total Bilirubin2 assay is used for the quantitation of total bilirubin in human serum or plasma, of adults and neonates, on the ARCHITECT c System.

Measurement of total bilirubin, an organic compound formed during the normal destruction of red blood cells, is used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and disorders of the biliary tract. In newborn infants, the Total Bilirubin2 assay is intended to measure the levels of total bilirubin (conjugated and unconjugated) in serum or plasma to aid in the diagnosis and management of neonatal jaundice and hemolytic disease of the newborn.

The Total Bilirubin2 assay (subject device) is an automated clinical chemistry assay for the quantitation of total bilirubin in human serum or plasma, of adults and neonates, on the ARCHITECT c System. Total (conjugated and unconjugated) bilirubin couples with a diazo reagent in the presence of a surfactant to form azobilirubin. The diazo reaction is accelerated by the addition of surfactant as a solubilizing agent. The increase in absorbance at 548 nm due to azobilirubin is directly proportional to the total bilirubin concentration. The methodology is Diazonium salt.

The provided text describes a 510(k) premarket notification for a medical device called "Total Bilirubin2", an in vitro diagnostic assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through the extensive studies typically associated with AI/ML diagnostic tools. Therefore, the questions related to AI/ML specific criteria (like MRMC studies, number of experts for ground truth, sample size for training sets, etc.) are not applicable in this context.

The document primarily details the analytical performance of the Total Bilirubin2 assay.

Here's an analysis based on the information provided, adhering to the request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this in vitro diagnostic device are typically defined by ranges of acceptable analytical performance, following established CLSI (Clinical and Laboratory Standards Institute) guidelines. The reported device performance is compared against these internal acceptance criteria.

Study Details:

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

   • Precision (Within-Laboratory): 80 replicates for each control/panel (on a representative combination out of 3 multi-lot/instrument combinations).
   • Reproducibility (System): 84 replicates for each control/panel.
   • Lower Limits of Measurement: ≥ 60 replicates for LoB and LoD for each of 3 lots on 2 instruments.
   • Interfering Substances: Not explicitly stated, but "Each substance was tested at 2 levels of the analyte."
   • Method Comparison:
     • Serum: 167 samples
     • Neonatal serum: 163 samples
   • Tube Type: Samples collected from a minimum of 40 donors.
   • Dilution Verification: 5 samples prepared with varying concentrations.
   • Data Provenance: Not explicitly stated regarding country of origin or whether retrospective/prospective. However, given the nature of in vitro diagnostic analytical studies, samples are typically acquired prospectively or from biobanks for specific analytical testing purposes.

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

   • For in vitro diagnostic devices like this bilirubin assay, "ground truth" is established by reference methods or highly characterized calibrators/control materials, not by expert human readers. The accuracy study, for example, compares results to material standardized to the Doumas Total Bilirubin reference method, which represents the "ground truth" for bilirubin measurement. Therefore, expert readers/adjudicators as typically seen in imaging AI studies are not applicable here.

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

   • Not applicable. This is an in vitro diagnostic assay, and its performance is evaluated against analytical measurements, not human interpretations requiring adjudication.

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

   • Not applicable. This device is an in vitro diagnostic test, not an AI/ML-driven imaging or diagnostic algorithm designed to assist human readers.

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

   • Not applicable. This is an assay performed on an automated system, providing a quantitative result. Its "performance" is inherently "standalone" in generating the numerical value, but it's not an AI algorithm in the sense of image interpretation or complex diagnostic inference.

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

   • For analytical performance studies, the "ground truth" for bilirubin concentration is established by reference methods (e.g., the Doumas method for accuracy) or by using certified reference materials and calibrators with known concentrations. This is the gold standard for quantitative in vitro diagnostic measurements.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The device's performance is a function of its reagents, instrument, and established methodology, not a learned algorithm.

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

   • Not applicable. See above.

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The Cholesterol2 assay is used for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System. The Cholesterol2 assay is to be used as an aid in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Cholesterol2 assay is an automated clinical chemistry assay for the quantitation of cholesterol in human serum or plasma on the ARCHITECT c System. Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase to cholesterol and free fatty acids. Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase to cholest-4-ene-3-one and hydrogen peroxide. The hydrogen peroxide oxidatively couples with N,N-Bis(4-sulfobutyl)-3-methylaniline (TODB) and 4-aminoantipyrine to form a chromophore (quinoneimine dye) which is quantitated at 604 nm.

The provided text describes the Abbott Cholesterol2 assay, an in vitro diagnostic device for quantifying cholesterol in human serum or plasma.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for each performance characteristic. Instead, it presents the results of various studies as proof of device performance. The table below summarizes the reported performance, which implicitly serves as the "met" criteria.

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

• Precision Study: 2 controls and 3 human serum panels were tested. Each sample was tested in duplicate, twice per day for 20 days. This means 80 measurements per sample (2 duplicates x 2 times/day x 20 days).
• Lower Limits of Measurement Study: n ≥ 60 replicates for LoB, LoD, and LoQ determinations. They used low-analyte level samples and zero-analyte samples.
• Linearity Study: The number of samples for the linearity study is not explicitly stated, but it covered the range of 5 to 748 mg/dL.
• Interference Studies: Each endogenous substance was tested at 2 analyte levels (approximately 150 mg/dL and 220 mg/dL). Exogenous substances were tested at various specified interferent levels. The number of samples for each interferent is not provided.
• Method Comparison Study: 138 serum samples were used.
• Tube Type Study: Samples were collected from a minimum of 40 donors.
• Dilution Verification: 8 human serum samples.

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the context of medical device regulatory submission, these are typically prospective studies conducted in a controlled laboratory environment. The "human serum panels" and "human serum samples" imply human-derived biological samples.

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

This device is an in vitro diagnostic (IVD) chemistry assay. The concept of "experts establishing ground truth" as it applies to image interpretation or clinical diagnosis by medical professionals (like radiologists) does not directly apply here in the same way.

For IVDs like this, the "ground truth" or reference values are established through:

• Reference methods: The Cholesterol2 reagent is certified to be traceable to the National Reference System for cholesterol, against the Abell-Kendall reference method in a CDC-Certified Cholesterol Reference Method Laboratory Network (CRMLN). The Abell-Kendall method is considered the gold standard for cholesterol measurement.
• Analytically Validated Methods: For values outside the AMI but within the EMI, samples were "value assigned using the analytically validated method."
• Known concentrations: For studies like linearity, spiked samples with known concentrations are used.

Therefore, the "experts" are the methodologists and laboratory professionals overseeing and validating the reference methods and the analytical validation processes. No specific number or qualification of clinical experts (e.g., radiologists) is relevant for establishing the ground truth for a quantitative chemistry assay.

This is a standalone performance evaluation of the assay itself, demonstrating its analytical accuracy, precision, and robustness.

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

The concept of "adjudication" (e.g., 2+1, 3+1 where multiple human readers agree or have a tie-breaker by an expert) is not applicable to this type of quantitative diagnostic assay. The results are numerical values generated by the automated instrument and reagents. Deviations or discrepancies would be resolved through re-testing, quality control, or investigation into instrument or reagent issues, rather than human expert adjudication of a "diagnosis."

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

No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Its output is a quantitative measurement of cholesterol, not an interpretation that requires human "reading" or decision support.

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

Yes, a standalone performance evaluation of the device (Cholesterol2 assay on the ARCHITECT c8000 System) was done. The studies described (reportable interval, precision, lower limits of measurement, linearity, interference, method comparison, tube type, dilution verification) all evaluate the analytical performance of the assay and instrument directly, without human interpretation as part of the primary outcome measure. The output is a numerical concentration of cholesterol.

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

The ground truth used for this quantitative assay primarily relies on:

• Reference Methods: Specifically, the Abell-Kendall reference method, which is considered the gold standard for cholesterol measurement and is used in CDC-Certified Cholesterol Reference Method Laboratory Networks (CRMLN). The device's traceability to this method is explicitly stated.
• Analytically Validated Methods: For verifying values in the extended measuring interval.
• Known Spiked Concentrations: For studies such as linearity and dilution verification, where samples are prepared with precisely known concentrations.

This is an analytical ground truth, not a clinical ground truth derived from pathology or patient outcomes.

8. The sample size for the training set

This document does not describe a typical "training set" in the context of machine learning or AI. This is a chemistry assay that uses reagents and enzymatic reactions, not an algorithm that is "trained" on data. Therefore, the concept of a training set as used in AI development is not applicable here. The assay's analytical characteristics are determined through standard laboratory validation studies.

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

As explained above, there is no "training set" in the AI sense for this device. The analytical accuracy and reliability are established through comparisons to certified reference methods and known standard concentrations, as described in point 7.

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The Urea Nitrogen2 assay is used for the quantitation of Urea Nitrogen in human serum, plasma, or urine on the ARCHITECT c System.

The Urea Nitrogen2 assay is to used as an aid in the diagnosis and treatment of certain renal and metabolic diseases.

The Urea Nitrogen2 assay is an automated clinical chemistry assay. The Urea Nitrogen2 assay is a modification of a totally enzymatic procedure. The test is performed as a kinetic assay in which the initial rate of the reaction is linear for a limited period of time. Urea in the sample is hydrolyzed by urease to ammonia and carbon dioxide. The second reaction, catalyzed by glutamate dehydrogenase (GLDH), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340 nm is proportional to the urea concentration in the sample.

The provided document is a 510(k) premarket notification for a new in vitro diagnostic device, the Urea Nitrogen2 assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical effectiveness studies as might be seen for novel devices. Therefore, the information provided primarily concerns non-clinical performance characteristics of the assay itself, rather than human-in-the-loop performance or diagnostic accuracy evaluated in a clinical setting with patient outcomes.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Core Purpose of the Submission: To demonstrate that the Urea Nitrogen2 assay is substantially equivalent to the predicate device (Urea Nitrogen assay, K981918) for the quantitative measurement of urea nitrogen in human serum, plasma, and urine on the ARCHITECT c System. This means proving the new device performs similarly and is as safe and effective as the predicate.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from established clinical laboratory standards (CLSI guidelines) and comparison to the predicate device's known performance. The performance metrics evaluated are standard for in vitro diagnostic assays.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

The studies described are primarily analytical performance studies, characteristic of a 510(k) submission for an in vitro diagnostic device, especially a chemical analyzer assay. They demonstrate the device's technical specifications and how it performs compared to a reference method or the predicate device.

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

• Precision Studies (Within-Laboratory):
  • Serum/Plasma: 3 human serum panels + 2 controls. Each tested in duplicate, twice per day, for 20 days on 3 reagent lot/calibrator lot/instrument combinations. For a representative combination, n=80 per sample/control.
  • Urine: 3 human urine panels + 2 controls. Each tested in duplicate, twice per day, for 20 days on 3 reagent lot/calibrator lot/instrument combinations. For a representative combination, n=80 per sample/control.
  • Data Provenance: Not explicitly stated but inferred to be laboratory-based analytical studies, likely from the manufacturer's R&D facilities. No country of origin is specified. The studies are retrospective analytical evaluations of manufactured samples and controls.
• Accuracy (Bias): 3 concentrations of standard across 3 reagent lots, 2 calibrator lots, and 1 instrument. (NIST SRM 912b is the standard).
• Lower Limits of Measurement (LoB, LoD, LoQ): n ≥ 60 replicates of zero-analyte samples for LoB, n ≥ 60 replicates of low-analyte level samples for LoD/LoQ. Conducted using 3 reagent lots on 2 instruments over a minimum of 3 days.
• Linearity: Not explicitly stated sample count, but typically involves preparing a dilution series of samples across the range.
• Interference: "Each substance was tested at 2 levels of the analyte (approximately 10 mg/dL and 30 mg/dL for serum/plasma; 700 mg/dL and 1500 mg/dL for urine)." No specific N for how many replicates or individual samples are run per interferent level, but implied to be sufficient for statistical analysis (e.g., 95% CI).
• Method Comparison:
  • Serum: n=124 samples.
  • Urine: n=121 samples.
  • Data Provenance: Not explicitly stated, but these would be clinical or proficiency samples analyzed side-by-side with the predicate.
• Tube Type: Samples collected from a minimum of 40 donors.
• Dilution Verification: 5 human serum samples (spiked with urea). Each sample tested with automated dilution and 3 manual dilutions (by 2 technicians). Tested in replicates of 5.

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

• For this type of in vitro diagnostic device (a quantitative chemical assay), "ground truth" is established by:
  • Reference materials: e.g., NIST SRM 912b for accuracy. This is a primary standard, not established by human experts.
  • Predicate device measurements: For method comparison, the predicate device provides the comparative 'truth' (or established method performance).
  • Clinical laboratory professional consensus/guidelines: Standards like CLSI (Clinical and Laboratory Standards Institute) guidelines (EP05-A3, EP17-A2, EP06-A, EP07, EP09-A3, EP34) serve as the "expert consensus" on how to conduct and interpret these analytical studies. These are published by committees of experts in laboratory medicine, clinical chemistry, and statistics.
• No "expert readers" in the traditional sense (e.g., radiologists interpreting images) are involved in establishing ground truth for this type of device. The validation is based on metrological traceability to standards and comparison to an established analytical method.

4. Adjudication Method for the Test Set

• Not applicable as this is an analytical performance study of a chemical assay, not a diagnostic accuracy study relying on human interpretation of subjective data (like imaging or pathology). Results are quantitative measurements read by the instrument.

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

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., AI-assisted image interpretation) and aim to show an improvement in human reader performance. This device is a quantitative chemical assay that provides a numerical result; there is no human "reader" to assist in the primary measurement. The comparison is between the new assay's performance and the predicate assay's performance, as well as against analytical standards.

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

• Yes, effectively. The entire submission details the standalone analytical performance of the Urea Nitrogen2 assay system (reagents + ARCHITECT c System instrument). Its performance (precision, accuracy, linearity, etc.) is evaluated independently of human interpretation of the final numerical result, beyond the standard operation and quality control typically performed in a clinical lab.

7. The Type of Ground Truth Used

• Analytical Standards and Reference Methods/Predicate Device:
  • NIST SRM 912b: Used as the true value for accuracy determination.
  • Predicate Device (Urea Nitrogen assay): Used as the comparative reference for method comparison studies, demonstrating substantial equivalence.
  • CLSI Guidelines: Act as the "ground truth" for the methodologies and acceptance criteria applied to evaluate the analytical performance (e.g., how LoQ is defined and determined, how precision is calculated).

8. The Sample Size for the Training Set

• For this type of in vitro diagnostic assay, there isn't a "training set" in the machine learning sense (where an algorithm learns from data). The "training" for such an assay primarily refers to:
  • Reagent formulation and optimization: This involves extensive R&D to achieve desired chemical reactions and stability.
  • Instrument calibration: The ARCHITECT c System is calibrated using specific calibrators (Consolidated Chemistry Calibrator mentioned, which is itself traceable to standards) to ensure accurate measurement across the range.
• The "training" is inherent in the chemical and engineering development of the assay and the instrument, rather than an algorithmic learning process on a large dataset. Therefore, a specific "training set sample size" as one would discuss for an AI model is not applicable.

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

• As explained above, there isn't a "training set" with ground truth in the AI/ML context for this device. Instead, the assay's performance characteristics (calibration, linearity, reaction kinetics, etc.) are optimized and confirmed through:
  • Chemical principles and R&D: The enzymatic reaction (urease, GLDH kinetics) is based on established biochemical mechanisms.
  • Quality control materials and calibrators: These materials have assigned values, often traceable to international standards (like NIST SRM), and are used to "train" or calibrate the instrument system.
  • Iterative laboratory testing and optimization: The assay's components and instrument parameters are refined through repeated experiments to meet performance specifications.

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The Amylase2 assay is used for the quantitation of amylase in human serum, plasma, or urine on the ARCHITECT c System. The Amylase2 assay is to be used primarily as an aid in the diagnosis and treatment of pancreation of the pancreas).

The Amylase2 assay is an automated clinical chemistry assay. The Amylase2 assay is a two-part reaction. Ethylidene-4-NP-G7 (EPS) is hydrolyzed by a-amylase to form 4,6ethylidene-α-(1,4)-D-glucopyranosyl-Gx and 4-nitrophenyl-α-(1,4)-glucopyranosyl-G(7-x). The 4-nitrophenyl-a-(1,4)-glucopyranosyl-G(7-x) is then hydrolyzed into glucose monomers and the assay chromophore (4-nitrophenol) by a-glucosidase. The resulting change in absorbance at 404 nm is proportional to the a-amylase concentration in the sample. Methodology: Enzymatic/Colorimetric. The device is a reagent kit.

Here's a breakdown of the acceptance criteria and the study details for the Amylase2 device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" in a singular table, but rather presents the results of various performance studies. I've extracted the performance metrics and their corresponding observed results to form this table, interpreting the reported successful values as meeting implicit acceptance criteria for substantial equivalence.

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

The document provides details on various studies, each with its own sample size and design:

• Precision (Serum/Plasma & Urine - Within-Laboratory):
  • Sample Size: For each of the controls (2 levels) and panels (3 for serum/plasma, 5 for urine), N=80 data points were collected. This involved testing samples in duplicate, twice per day for 20 days.
  • Provenance: Human serum/plasma and human urine panels were used. No specific country of origin is mentioned, but the context implies an in-vitro diagnostic study conducted under CLSI guidelines, likely in a controlled laboratory setting. It is a prospective study as samples were tested according to a pre-defined protocol.
• System Reproducibility (Serum/Plasma & Urine):
  • Sample Size: For each of the controls (5 for serum/plasma, 4 for urine), N=90 data points were collected. This involved testing samples in a minimum of 3 replicates at 2 separate times per day on 5 different days across 3 instruments and 3 technicians.
  • Provenance: The study used controls, implying commercially prepared materials or pooled biological samples. It is a prospective study.
• Accuracy:
  • Sample Size: Not explicitly stated but implies a set of calibrator materials and potentially patient samples based on "material standardized to the Certified Reference Material IRMM/IFCC-456."
  • Provenance: Relies on certified reference materials and likely patient samples.
• Lower Limits of Measurement (LoB, LoD, LoQ):
  • Sample Size: n ≥ 60 replicates of zero-analyte and low-analyte level samples for each determination (LoB, LoD, LoQ).
  • Provenance: Control materials or spiked biological samples designed to have specific low analyte levels. Prospective.
• Linearity:
  • Sample Size: Not explicitly stated, but typically involves a series of diluted/spiked samples to cover the analytical range.
  • Provenance: Spiked or diluted biological samples. Prospective.
• Potentially Interfering Substances (Serum/Plasma & Urine):
  • Sample Size: Not explicitly stated, but each substance was tested at 2 levels of the analyte (approximately 50 U/L and 200 U/L for serum/plasma; 450 U/L and 1400 U/L for urine). This implies numerous replicates for each interferent and analyte level.
  • Provenance: Biological samples (serum/plasma/urine) spiked with various endogenous and exogenous substances. Prospective.
• Method Comparison:
  • Sample Size: 124 serum samples and 103 urine samples.
  • Provenance: Human serum and urine samples. The description doesn't explicitly state if prospective or retrospective, but typically such studies involve prospectively collected samples from a diverse patient population. No country of origin specified.
• Tube Type:
  • Sample Size: Samples collected from a minimum of 40 donors.
  • Provenance: Human blood samples collected into different tube types. Prospective.
• Dilution Verification:
  • Sample Size: 5 human serum samples and 5 urine samples, each tested in replicates of 5 after automated and manual dilution.
  • Provenance: Human serum and urine samples spiked with α-amylase from porcine pancreas. Prospective.

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 an in-vitro diagnostic device, "ground truth" often refers to the true concentration of the analyte, which is usually established by highly precise reference methods, certified reference materials, or by comparison with a well-established predicate device, rather than expert consensus on images or clinical diagnoses. The document indicates standardization against IRMM/IFCC-456, which is a reference material for amylase, and comparison to a predicate device (AMY, K981653). These serve as the "ground truth" or reference for the device's performance.

4. Adjudication Method for the Test Set

This section is not applicable as this is an in-vitro diagnostic (IVD) device for quantitative measurement of amylase. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of medical images or subjective evaluations, where multiple experts independently assess data and discrepancies are resolved. For an IVD, the "ground truth" is measured quantitatively against a reference standard or predicate.

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

This information is not provided and is not applicable to this device. An Amylase2 assay is an automated clinical chemistry assay, not an AI-powered diagnostic imaging device that requires human "readers" or involves AI assistance in interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.

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

The Amylase2 assay is an automated clinical chemistry assay, meaning its performance is inherently "standalone" in the sense that it provides a quantitative result without direct human intervention in the measurement process itself, beyond sample loading and general instrument operation. The studies described (precision, accuracy, linearity, interference, method comparison) are all evaluating the algorithm/reagent system's performance independently.

7. The Type of Ground Truth Used

The ground truth for the Amylase2 device's performance studies relies on:

• Reference Materials: For accuracy, the device was compared against "material standardized to the Certified Reference Material IRMM/IFCC-456."
• Predicate Device: For method comparison, the Amylase2 assay was compared to the predicate device, Amylase assay (List Number 7D58), which serves as the established reference standard in this context.
• Spiked Samples: For linearity, lower limits of measurement, interference, and dilution verification, samples were often "spiked" with known concentrations of α-amylase or interfering substances to create samples with a known "true" value.
• Commercial Controls: For precision and reproducibility studies, commercially available controls with known target ranges were used.

8. The Sample Size for the Training Set

The document describes studies for validation and verification purposes (test sets). For an IVD like Amylase2, the "training set" would refer to the data used by the manufacturer during the assay development phase to optimize reagents, calibrate the instrument response, and refine the measurement algorithms. This specific information about the development/training data size is not provided in the 510(k) summary, as the summary focuses on the performance of the final device.

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

Similar to point 8, the specific details on how ground truth was established for any internal "training set" used during development are not provided. Typically, for such IVDs, this would involve a rigorous process of using purified analytes, gravimetric/volumetric standards, certified reference materials, and comparison to established reference methods to assign "true" values to a large panel of samples during the assay's development and optimization.

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The Creatinine2 assay is used for the quantitation of creatinine in human serum, plasma, or urine on the ARCHITECT c System.

The Creatinine2 assay is to be used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The Creatinine2 assay is an automated clinical chemistry assay. At an alkaline pH, creatinine in the sample reacts with picric acid to form a creatinine-picrate complex that absorbs at 500 nm. The rate of increase in absorbance is directly proportional to the concentration of creatinine in the sample.

The provided document describes the Abbott Creatinine2 assay, an in vitro diagnostic device, and its performance relative to a predicate device. The information needed to answer the request is primarily found in Section 5: 510(k) Summary (Summary of Safety and Effectiveness), specifically subsections VIII (Summary of Nonclinical Performance) and VII (Comparison of Technological Characteristics).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined column. Instead, it presents the results of various performance studies. The "Reported Device Performance" below is extracted directly from the study results presented in the document. The comparable predicate device values are included for context where available.

Creatinine2 Assay - Performance Summary

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

The document describes several nonclinical laboratory studies.

• Precision (Within-Laboratory): For both Serum/Plasma and Urine, the studies tested 80 replicates per sample type for each of the two controls and three human panels (5 samples total). This was done in duplicate, twice per day, on 20 days. The provenance of the human panels (e.g., country of origin, retrospective/prospective) is not specified, but they are referred to as "human serum panels" and "human urine panels." This data is ex vivo laboratory testing.
• Accuracy: No specific sample size of "patient samples" is given. The study was performed using "material standardized to the Certified Reference Material NIST SRM 967a" for serum/plasma and "material standardized to the Certified Reference Material NIST SRM 914a" for urine.
• Lower Limits of Measurement (LoB, LoD, LoQ): n ≥ 60 replicates for zero-analyte and low-analyte level samples for LoB/LoD, and for low-analyte level samples for LoQ.
• Linearity: The sample size for linearity is not explicitly stated in terms of number of unique samples, but it covers the analytical measuring interval by spiking and dilution.
• Method Comparison:
  • Serum: 128 samples
  • Urine: 129 samples
    The provenance of these clinical samples (e.g., country of origin, retrospective or prospective) is not explicitly stated.
• Interference: "Each substance was tested at 2 levels of the analyte." No specific sample size (n) for the number of replicates per interference test is given beyond this, nor is the provenance of the base samples used.
• Tube Type: "Samples were collected from a minimum of 40 donors." The provenance is not explicitly stated.

The studies described are nonclinical laboratory studies, primarily involving analytical performance evaluation rather than clinical patient studies.

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

This information is not applicable (N/A) to this specific device (Creatinine2 assay). The device is an in vitro diagnostic for quantitative measurement of creatinine, not an imaging device or a device requiring expert interpretation of complex clinical data to establish ground truth for its performance evaluation (e.g., a diagnosis of a disease from imaging). The "ground truth" for its analytical accuracy is typically established against certified reference materials (NIST SRM 967a for serum/plasma and NIST SRM 914a for urine) or reference methods, not by human experts adjudicating cases for a test set.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for the same reasons as #3. Clinical adjudication by multiple experts (like 2+1, 3+1) is typically used for devices that rely on human interpretation of outputs (e.g., medical images, pathology slides) where consensus or expert opinion defines the ground truth for diagnostic accuracy. This device measures a biochemical analyte.

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 medical devices where human readers or interpreters are part of the diagnostic workflow, such as imaging-based AI tools. The Creatinine2 assay is an automated clinical chemistry assay that directly measures creatinine levels in biological samples and does not involve human image interpretation or a "human-in-the-loop" effectiveness study as typically understood in the context of MRMC studies.

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

The Creatinine2 assay is a standalone (algorithm only) device in the sense that it performs a quantitative measurement without a human-in-the-loop for interpreting the output of the device to arrive at the creatinine value. The performance metrics described (precision, accuracy, linearity, lower limits of measurement, interference, method comparison) are all tests of the device's performance directly, independent of human interpretation or assistance in generating the result.

7. The Type of Ground Truth Used

The ground truth for the performance evaluation of the Creatinine2 assay was primarily established using:

• Certified Reference Materials: NIST SRM 967a for serum/plasma and NIST SRM 914a for urine were used for accuracy studies.
• Predicate Device/Reference Method: The Creatinine assay (K083809; List No. 3L81) was used as a comparator for the method comparison study to assess substantial equivalence.
• Defined Standards/Controls: For precision and lower limits of measurement, studies used control materials and low-analyte level samples with known or established concentrations to determine repeatability, detection, and quantitation limits.

8. The Sample Size for the Training Set

This information is not applicable (N/A). The Creatinine2 assay is a chemical assay, not a machine learning or AI-based device that requires a "training set" in the computational sense. Its performance is based on the chemical reaction and analytical methods described.

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

This information is not applicable (N/A) for the same reasons as #8.

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The Albumin BCP2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCP2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Albumin BCP2 assay is an automated clinical chemistry assay. The Albumin BCP2 procedure is based on the binding of bromocresol purple specifically with human albumin to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.

Methodology: Colorimetric (Bromocresol Purple)

This document is a 510(k) premarket notification for a new in vitro diagnostic device, the Albumin BCP2 assay, which measures albumin in human serum or plasma. It seeks to prove substantial equivalence to a predicate device, Albumin BCP.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table with pass/fail thresholds for each performance characteristic. Instead, it describes various studies conducted and reports the results, implying that meeting standard analytical performance metrics demonstrates acceptable performance and substantial equivalence.

However, we can infer the acceptance criteria from the reported performance and the context of typical FDA 510(k) submissions for in vitro diagnostic assays. The studies are designed to demonstrate the new device performs comparably to established standards and the predicate device.

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

The document describes test methods rather than specific "test sets" in the context of an AI/ML algorithm that might have a dedicated validation dataset. Instead, for an in-vitro diagnostic device, studies are conducted across various analytical performance characteristics.

• Precision Study: "2 controls and 3 human serum panels were tested in duplicate, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations." This means 80 data points for each control/panel (2 tests/day * 20 days * 2 replicates).
• Accuracy Study: "2 lots of the Albumin BCP2 reagent, 2 lots of the Consolidated Chemistry Calibrator, and 1 instrument." (No specific sample count for patient samples, but implied to be sufficient for bias estimation against a reference material).
• Lower Limits of Measurement: "n ≥ 60 replicates of zero-analyte samples" for LoB, and "n ≥ 60 replicates of low-analyte level samples" for LoD and LoQ.
• Linearity: No specific sample size mentioned, but typically involves preparing multiple dilutions.
• Interference Study: "Each substance was tested at 2 levels of the analyte (approximately 3.5 g/dL and 5.0 g/dL)."
• Method Comparison: 127 serum samples.
• Tube Type: "Samples were collected from a minimum of 40 donors".
• Dilution Verification: 5 human serum samples prepared by spiking.

Data Provenance: The document doesn't explicitly state the country of origin for the human samples used in the studies. Given that Abbott Ireland Diagnostics Division submitted the application, the studies were likely conducted in a setting compliant with international standards, possibly in Ireland or the US given the FDA submission. The studies described are nonclinical laboratory studies, not human clinical trials. They are retrospective or prospective in the sense of laboratory-controlled experiments designed to evaluate performance characteristics.

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

This section is not applicable as this is an in-vitro diagnostic (IVD) device, specifically a clinical chemistry assay, not an AI/ML diagnostic software. The "ground truth" for an IVD device is established through:

• Reference Methods: Using highly accurate and precise laboratory methods (e.g., mass spectrometry, enzymatic methods, or other established validated assays) or certified reference materials (like ERM-DA470k/IFCC for accuracy testing).
• Standardization: Traceability to international standards (like IFCC).
• Analytical Performance: Rigorous testing against defined analytical parameters (precision, linearity, limits of detection/quantitation).

There is no "ground truth" derived from human expert consensus for this type of device.

4. Adjudication Method for the Test Set:

This is not applicable for the same reasons as #3. Adjudication methods (like 2+1, 3+1) are common in AI/ML studies where human readers are establishing ground truth for image interpretation or similar tasks. For an IVD assay, performance is judged against analytical accuracy and precision, not human consensus on results.

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

This is not applicable. MRMC studies are specific to AI/ML software that assists human readers (e.g., radiologists, pathologists) in interpreting medical images or data. This device is a quantitative laboratory assay. There is no human "reader" assisted by this device in the same way. The device directly measures a biochemical analyte.

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

This isn't an "algorithm" in the AI/ML sense but rather a chemical assay method run on an automated analyzer. The entire performance data presented (precision, accuracy, linearity, interference, method comparison) represents the "standalone" analytical performance of the assay without human intervention influencing the measurement itself. Human involvement is in the operation of the instrument, quality control, and interpretation of the results, but not in the measurement process being evaluated here.

7. Type of Ground Truth Used:

The ground truth for this chemical assay is primarily established by:

• Standard Reference Materials (SRMs): For accuracy, the device's results are compared against ERM-DA470k/IFCC, which are certified reference materials with highly accurate assigned values.
• Reference Measurement Procedures: Implied by the use of standard methods and CLSI (Clinical and Laboratory Standards Institute) guidance, which dictates how analytical performance (e.g., LoB, LoD, LoQ, linearity, precision) should be determined using robust statistical methods and replicates.
• Predicate Device Comparison: For method comparison, the "ground truth" (or comparative truth) is the performance of the legally marketed predicate device (Albumin BCP) on patient samples.

8. Sample Size for the Training Set:

This concept of a "training set" is specific to AI/ML models. For an IVD assay, calibration and internal method development (which could be analogous to "training") would involve various reagent lots, calibrators, and QC materials provided by the manufacturer. The document does not specify a "training set size" in the AI/ML context because the development of a chemical assay follows different principles.

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

Again, this is not applicable in the AI/ML sense. For chemical assays, the establishment of the assay (analogous to "training") involves:

• Reagent Formulation and Optimization: Developing the chemical reagents (Bromocresol Purple, buffers, etc.) to ensure proper reaction kinetics, stability, and specificity.
• Calibrator Assignment: Assigning accurate values to calibrator materials used by the assay, often traceable to international standards (like ERM-DA470/IFCC).
• Method Development on Platform: Optimizing the assay parameters (volumes, incubation times, temperatures, wavelength) on the specific ARCHITECT c System to achieve optimal performance.
• Internal Validation: Initial testing during development to ensure the assay performs as expected before formal verification and validation studies are conducted for regulatory submission. This internal validation would use similar principles of analytical testing as described in Section 8 (e.g., accuracy, precision, linearity using reference materials and pooled human samples).

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The Albumin BCG2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCG2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Albumin BCG2 assay is an automated clinical chemistry assay. The Albumin BCG2 procedure is based on the binding of bromocresol green in the assay reagent specifically with albumin in the patient sample to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.

Methodology: Colorimetric (Bromocresol Green)

The device in question is the Albumin BCG2 assay, used for the quantitation of albumin in human serum or plasma.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Within-Laboratory Precision: For each of the 2 controls and 3 human serum panels, 80 replicates were tested (2 duplicates per day for 20 days). The provenance of the human serum panels is not specified (e.g., country of origin, retrospective or prospective).
• Accuracy: The sample size for the accuracy study is not specified, but it involved determining bias relative to a standard reference material.
• Lower Limits of Measurement: For LoB, LoD, and LoQ, n ≥ 60 replicates of zero-analyte (LoB) or low-analyte (LoD, LoQ) samples were used.
• Linearity: The sample size for the linearity study is not explicitly stated.
• Potentially Interfering Substances: The sample size for this study is not explicitly stated.
• Method Comparison: 128 serum samples were used. The provenance of these samples is not specified.
• Tube Type: Samples were collected from a minimum of 40 donors. The provenance of these samples is not specified.

The studies described are non-clinical laboratory studies, suggesting they were conducted in a controlled lab setting rather than directly on patient data in a clinical environment. Whether the data is retrospective or prospective is not explicitly stated, but the nature of the studies (e.g., precision, linearity) typically involves prospective experimental designs.

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

This information is not applicable to the Albumin BCG2 assay studies described. This device is an in vitro diagnostic (IVD) quantitative assay, and its performance is evaluated against analytical benchmarks, reference materials, or a predicate device, not by expert interpretation of images or clinical outcomes that require a ground truth established by human experts.

4. Adjudication Method

Not applicable for this type of IVD device and studies. Performance is measured using quantitative analytical methods, not involving human adjudication of results.

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

Not applicable. This is a quantitative laboratory assay, not an imaging device or AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies of the Albumin BCG2 assay. The results reflect the algorithm/device's analytical performance (precision, accuracy, linearity, etc.) without human intervention in the result generation or interpretation to arrive at the reported quantitative values. The "human-in-the-loop" for this type of device typically refers to standard laboratory procedures for running samples and interpreting flagged results, which is inherent to its use but not a part of the core performance metrics discussed here.

7. Type of Ground Truth Used

• Accuracy: The ground truth for accuracy was established using a standard reference material: European Reference Materials Standard Reference Material - DA470k/ International Federation of Clinical Chemistry and Laboratory Medicine (ERM - DA470k/IFCC).
• Method Comparison: The predicate device, Albumin BCG (K981758; List No. 7D53), served as the reference for comparison, effectively acting as a "ground truth" or established method against which the new device's measurements were assessed for agreement.
• For other analytical performance characteristics (precision, linearity, limits of measurement, interference), the "ground truth" is understood as the expected or known concentrations in spiked samples, controls, or reference materials, or ideal analytical behavior.

8. Sample Size for the Training Set

Not applicable. This document describes a traditional in vitro diagnostic device, not one utilizing machine learning or artificial intelligence that would typically involve a "training set."

9. How Ground Truth for the Training Set Was Established

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

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