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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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For the quantitative in vitro determination of Total Bilirubin for serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis.

This in vitro diagnostic device is intended for prescription use only.

The Total Bilirubin kit assay consists of ready to use reagent solutions.

CATALOGUE NUMBER: BR8307

R1. Total Bilirubin R1 4 x 20 mL
R2. Total Bilirubin R2 4 x 8 mL

REAGENT COMPOSITION

Contents Initial Concentration of Solutions
R1. Total Bilirubin R1
Citrate buffer, pH2.9 0.1 mol/L
Detergent 0.9%
Antimicrobial
R2. Total Bilirubin R2
Phosphate buffer, pH 7.0 10 mmol/L
Sodium Metavanadate 4 mmol/L

MATERIALS REQUIRED BUT NOT PROVIDED

Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # K942458 Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # K053153 RX series Saline (Cat. No. SA 8396)

Here's an analysis of the provided text, focusing on the acceptance criteria and the studies conducted to meet them for the Total Bilirubin (T BIL) device.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Precision/Reproducibility: 80 determinations per sample type (LIN Pool, LOQ Pool, QC 1, QC 2, Serum Pool 1-4) across two lots, two RX Daytona plus systems, over 20 non-consecutive days with 2 replicates per run. Data provenance is not specified, but the study design suggests prospective testing of control materials and human serum samples (spiked or diluted).
   • Linearity/Assay Reportable Range: 11 levels, each run in replicates of five across two lots of reagent on one RX Daytona plus system. Data provenance is not specified.
   • Detection Limit: 240 determinations (for LoD) using 4 low-level samples. Data provenance is not specified.
   • Analytical Specificity (Interference): Not explicitly stated how many samples or replicates per interferent. Samples were spiked with interferents and compared to control samples. Data provenance is not specified.
   • Method Comparison: 106 serum patient samples spanning 0.21 to 26.9 mg/dL. Data provenance is not specified, but these are "patient samples," suggesting retrospective or prospective clinical samples.
   • Matrix Comparison: A minimum of 40 matched patient sample pairs (serum and lithium heparin plasma). Data provenance is not specified, but these are "patient samples," suggesting retrospective or prospective clinical samples.
   • Expected values/Reference range: Human serum from 30 normal donors. Data provenance is not specified. The study was prospective in nature, testing new samples.

2. 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 is an in vitro diagnostic device for quantitative chemical analysis. The "ground truth" is established by the analytical reference methods or established values of control materials, or comparison to a predicate device. There is no mention of human experts defining ground truth through consensus in the way a radiological study might. For the method comparison, the predicate device (Siemens Healthcare Diagnostic Inc, Total Bilirubin 2 reagent, K063845) serves as the reference, which itself would have undergone rigorous analytical validation.

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

   • Not applicable. This is an analytical chemistry device, not an imaging device requiring human adjudicated interpretations. The performance is assessed by quantitative analytical metrics.

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 is an analytical chemistry device, not an AI-assisted diagnostic tool involving human readers.

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

   • This is an in vitro diagnostic assay, which by nature operates "standalone" in terms of measurement. The results are then interpreted by a clinician, but the device itself generates a quantitative result without human-in-the-loop performance influencing the measurement. Performance studies like precision, linearity, and analytical specificity are inherently "standalone" evaluations of the device's analytical function.

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

   • Reference Methods/Materials: For linearity and precision, the ground truth is based on gravimetrically prepared samples, known concentrations of control materials, or dilutions with expected values.
   • Predicate Device: For method comparison, the results from the legally marketed predicate device (Siemens Healthcare Diagnostic Inc, Total Bilirubin 2 reagent, K063845) serve as the comparative ground truth.
   • Literature/Guidelines: For reference range verification, established normal ranges from scientific literature (e.g., "Tietz Clinical Guide to laboratory Tests") and guidelines (NCCLS C28-A3) are used.

7. The sample size for the training set

   • Not applicable. This is an analytical chemistry device, not a machine learning model that requires a training set.

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

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

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The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma of adults and neonates on the ARCHITECT c8000 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 gall bladder block. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

The Total Bilirubin reagent kit contains Reagent 1 and Reagent 2. Reagent 1 contains Surfactants and HCl. Reagent 2 contains 2, 4-dichloroaniline, HCl, Sodium nitrite, and Surfactant. The principles of the procedure involve total (conjugated and unconjugated) bilirubin coupling with a diazo reagent in the presence of a surfactant to form azobilirubin. The increase in absorbance at 548 nm due to azobilirubin is directly proportional to the total bilirubin concentration. The detection of the analyte is end-point colorimetric.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Total Bilirubin device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for each test in a formal table, but rather describes the methodology and then reports the results. I will infer the acceptance criteria from the statements provided about what is considered acceptable or how performance supports the claims.

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

• Limit of Quantitation (LOQ), Limit of Detection (LOD), Limit of Blank (LOB):
  • Zero-analyte samples: 4 samples. Tested in a minimum of 5 replicates on 5 separate runs.
  • Low-analyte samples: Minimum of 2 samples gravimetrically prepared at 8 target concentrations. Tested in a minimum of 10 replicates on 5 separate runs.
  • Data Provenance: Not explicitly stated (e.g., country of origin) but "human serum albumin" and "unconjugated bilirubin" are used. The study is prospective in nature, as samples are prepared for the purpose of the test.
• Linearity: 12 levels per pool in each of three combined bilirubin pools. Tested in a minimum of 4 replicates.
  • Data Provenance: "combined bilirubin pools" from "conjugated bilirubin stock" and "unconjugated bilirubin stock", "serum". Prospective.
• Within-Laboratory Precision: 4 control materials (Bio-Rad serum based). Tested in a minimum of 2 replicates, 2 times per day for 20 days.
  • Data Provenance: Commercial control materials (Bio-Rad Lyphochek Unassayed Chemistry Control, Bio-Rad Liquichek Pediatric Control). Prospective.
• Interference: Not specified.
  • Data Provenance: Not specified, but uses "bilirubin concnetrations". Prospective.
• Method Comparison:
  • Adult patient specimens: 124. 4 spiked.
  • Neonatal patient specimens: 64. 4 spiked.
  • Data Provenance: Patient specimens. Not specified if retrospective or prospective or country of origin, but generally method comparison studies use collected patient samples.
• Reference Range: 40 adult patient serum samples.
  • Data Provenance: Fresh, adult patient serum samples from a clinically healthy population. Stored at 2-8°C, protected from light. Assumed to be prospective as samples were collected for the study.
• Automated Dilution Protocol versus Manual Dilution Procedure: Not specified (samples were pooled to create desired concentrations).
  • Data Provenance: "Fresh serum specimens" obtained and pooled. Prospective.
• Specimen Tube Type (Matrix Equivalence): Minimum of 40 samples from adult subjects for each tube type. (Serum glass N=41, SST N=40, EDTA N=39, Lithium Heparin N=40, PST N=40, Sodium Heparin N=39).
  • Data Provenance: "Fresh or frozen sample sets" from subjects. Assumed to be prospective as these are explicitly collected to test tube types.

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

• This device is an in vitro diagnostic (IVD) for quantitative measurement. The "ground truth" for such devices is typically established through analytical methods, reference materials, gravimetric preparation, or comparison to a gold standard reference method/device, rather than expert human interpretation.
• Therefore, the concept of "experts used to establish the ground truth" as it applies to image-based AI or clinical diagnostic interpretation by physicians is not applicable here. The ground truth is the chemical concentration of bilirubin.

4. Adjudication Method for the Test Set:

• Again, as this is a quantitative chemical measurement, adjudication methods for expert interpretation (like 2+1, 3+1) are not applicable. The "adjudication" is inherent in the analytical process (e.g., repeating measurements, using certified reference materials, performing statistical analysis of replicates).

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 an in vitro diagnostic (IVD) device. MRMC studies, which assess human reader performance with and without AI assistance, are typically conducted for AI-powered medical image analysis or clinical decision support systems.
• Therefore, an MRMC comparative effectiveness study is not applicable to this type of device. There are no "human readers" interpreting an output in the same way a radiologist reads an image.

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

• Yes, this entire submission is a standalone performance evaluation of the assay (the "algorithm only" in a broader sense of the measurement procedure). The device is designed to quantitatively measure bilirubin, and the tests (LOQ, linearity, precision, interference, method comparison) evaluate its analytical performance without direct human interpretive intervention beyond running the instrument and analyzing the data.

7. The Type of Ground Truth Used:

• For LOQ, LOD, LOB: Gravimetrically prepared samples (human serum albumin and unconjugated bilirubin) provide the known "ground truth" concentrations.
• For Linearity: Combined bilirubin pools with known proportional compositions.
• For Precision: Commercial control materials with established (though perhaps unassayed) target ranges, tested repeatedly.
• For Method Comparison: The predicate device's measurements are used as the comparative "ground truth" or reference, as the goal is to show substantial equivalence.
• For Reference Range: Clinical health status of the adult population samples.
• For Automated Dilution: Known target concentrations and manual dilution results.
• For Specimen Tube Type: The control tube type (serum plastic tube) serves as the reference for comparison.

8. The Sample Size for the Training Set:

• This document describes the analytical validation of a re-agent kit for an existing instrument (ARCHITECT c8000 System). It's not an AI model that undergoes "training" in the conventional sense.
• Therefore, the concept of a "training set" for an AI algorithm is not applicable. The development of the reagent and its underlying chemical principles involved R&D and optimization, but not machine learning training on a dataset.

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

• As explained above, there is no "training set" in the context of an AI algorithm described here. The "ground truth" used during the development of the assay would have been based on established clinical chemistry principles, reference methods, and gravimetric preparations to ensure accurate concentration measurements during formulation and optimization.

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For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma.

Measurement of Total Bilirubin is used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin.

Not Found

This is a 510(k) clearance letter for a device called "Total Bilirubin L3K, Model 295-10 and 295-30," which is an in vitro diagnostic (IVD) test system. The document states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document primarily focuses on:

• Device Name: Total Bilirubin L3K, Model 295-10 and 295-30
• Regulation Number/Name: 21 CFR Sec. 862.1110, Bilirubin (total or direct) test system
• Regulatory Class: Class II
• Product Code: CIG
• Submission Date: December 5, 2008 (Received December 8, 2008)
• Clearance Date: December 16, 2008
• Manufacturer: Genzyme Diagnostics P.E.I. Inc.
• Intended Use: For the in vitro quantitative measurement of Total Bilirubin in serum and plasma, used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases, and disorders involving the metabolism of bilirubin.

To answer your specific questions, I would need access to the actual 510(k) submission document (K082210) itself, which would detail the performance data, acceptance criteria, and study methodologies used to demonstrate substantial equivalence. This clearance letter is merely the FDA's decision based on that submission.

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The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of total bilirubin in human serum or plasma of adults and neonates. Total (conjugated and unconjugated) bilirubin couples with the diazo reagent in the presence of a surfactant to form azobilirubin. The increase in absorbance at 548 nm due to azobilirubin formation is directly proportional to the total bilirubin concentration.

The provided document is a 510(k) summary for the Abbott Laboratories Total Bilirubin assay. It describes the device, its intended use, and performance characteristics compared to a predicate device.

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

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

The document does not explicitly state "acceptance criteria" in a table format. Instead, it describes performance characteristics and considers them "substantially equivalent" if they show strong correlation and acceptable precision compared to a legally marketed predicate device. The implied acceptance criteria are high correlation coefficients (close to 1), acceptable slopes (close to 1), and small Y-intercepts (close to 0) when compared to the predicate.

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

• Adult Application Test Set: 137 serum samples.
• Neonate Application Test Set: 52 serum samples.
• Data Provenance: The document does not specify the country of origin. The study appears to be retrospective, as it used collected serum samples to compare the new device's performance against an existing, legally marketed predicate device (Roche Total Bilirubin assay on the Hitachi 717 Analyzer).

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

This information is not applicable and therefore not provided in the document. For in vitro diagnostic assays like this, the "ground truth" for the test set is established by the measurements from the predicate device (Roche Total Bilirubin assay on the Hitachi 717 Analyzer), which is assumed to be accurate and reliable. No human experts are involved in establishing the "ground truth" for these types of quantitative measurements.

4. Adjudication method for the test set

This information is not applicable. As explained above, the ground truth is based on quantitative measurements from a predicate device, not on expert interpretations needing 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

This is not applicable. The device is an in vitro diagnostic assay for measuring total bilirubin levels, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers.

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

This concept is not directly applicable in the context of this device. The "Total Bilirubin" assay is a chemical reaction-based system performed by an automated analyzer (AEROSET System and ARCHITECT c8000 System). Its "performance" inherently represents the "standalone" or "algorithm only" (in the sense of the instrument's automated process) result without human interpretation of the primary measurement itself. The human-in-the-loop aspect would be in clinical decision-making based on the numerical result, not in the measurement process. The study evaluates the performance of this automated system.

7. The type of ground truth used

The ground truth for comparison was the measurements obtained from a legally marketed predicate device: the Roche Total Bilirubin assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices.

8. The sample size for the training set

The document does not specify a separate training set. For 510(k) submissions of IVD assays based on substantial equivalence, the focus is typically on validating the performance of the new device against a predicate using clinical samples (the "test set"). There isn't typically a machine learning "training set" in the conventional sense for this type of chemical assay.

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

As no explicit training set is mentioned in the context of machine learning, this question is not applicable. The comparison data rely on the established performance of the predicate device.

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This product is to be used in a diagnostic laboratory setting, by qualified laboratory personnel, for the quantitative determination of direct and total bilirubin in human serum. It is intended for in vitro diagnostic use only. Studies suggest that direct and total bilirubin measurements provide information to assist in the assessment of liver function and conditions such as hemolytic and obstructive jaundice.

Not Found

This is a premarket notification for a Class II medical device, not a study. Therefore, the information requested in the prompt (acceptance criteria, study design, sample sizes, ground truth establishment, etc.) is not applicable in the typical sense of a clinical or performance study. The 510(k) process is about demonstrating substantial equivalence to a predicate device, not necessarily proving new performance against set acceptance criteria through a standalone study.

However, based on the provided text, I can extract information relevant to the device and its intended use, and explain why the study-related questions are not directly answerable from this document.

Device Name: Hitachi Direct Bilirubin/Hitachi Total Bilirubin

Regulation Number: 21 CFR 862.1110

Regulation Name: Bilirubin (total or direct) test system

Regulatory Class: Class II

Product Code: CIG

Here's an attempt to address the prompt, noting the limitations of the provided document:

1. A table of acceptance criteria and the reported device performance
   • This document does not specify quantitative "acceptance criteria" in the way a clinical study protocol would, nor does it present "reported device performance" against such criteria. The 510(k) submission mechanism demonstrates substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device performs as well as, or comparably to, the predicate device across various metrics (e.g., precision, accuracy, linearity, interferences). However, the specific data for this comparison is not included in this FDA clearance letter.

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

   • This information is not available in the provided FDA clearance letter. Such details would be part of the manufacturer's 510(k) submission, which is not publicly disclosed in this summary form. The clearance letter only states that the device was found substantially equivalent based on the submitted information.

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)

   • Not applicable/Not provided. For an in vitro diagnostic (IVD) assay like bilirubin measurement, the "ground truth" would typically be established by reference methods or highly accurate laboratory methods, not by expert consensus in the way a diagnostic imaging study might. The specifics of how accuracy/truth was ascertained for the test samples used in the 510(k) submission are not in this document.

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

   • Not applicable/Not provided. This typically refers to adjudication of discrepancies among human readers or expert interpretations, which is not directly relevant for an automated IVD assay's performance evaluation against a reference method.

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 device is an automated in vitro diagnostic test for bilirubin, not an AI-assisted diagnostic imaging device or an AI tool meant to improve human reader performance. Its purpose is to quantitatively measure bilirubin levels in serum.

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

   • Yes, in a sense. The device is a "standalone" automated assay intended for use "in a diagnostic laboratory setting, by qualified laboratory personnel, for the quantitative determination of direct and total bilirubin in human serum." The performance shown in the 510(k) submission would have been the device's output (quantitative bilirubin levels) compared to reference methods or a predicate device. It is not an "algorithm only" in the modern AI sense, but an automated chemical analysis system. The human involvement is in operating the instrument and interpreting the results within a clinical context, not in directly forming the diagnostic output.

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

   • For an IVD bilirubin assay, the "ground truth" for evaluating accuracy would typically be established by:
     • Reference methods: Highly accurate and precise laboratory methods (e.g., ID-LC-MS/MS, or established spectrophotometric methods).
     • Comparison to a legally marketed predicate device: This is the primary method for a 510(k) submission, where the new device's results are compared to those of an already cleared device across a range of samples.
   • The specific method used for the Hitachi device is not detailed in this clearance letter.

8. The sample size for the training set

   • Not applicable. This device is a chemical analyzer, not a machine learning or AI model that requires a "training set" in the computational sense. The "development" would involve chemical and engineering principles, calibration, and optimization, not data-driven machine learning training.

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

   • Not applicable, as there is no "training set" in the context of this type of device.

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The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum and plasma. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of total bilirubin in human serum and plasma. Total (conjugated and unconjugated) bilirubin couples with the diazo reagent in the presence of a surfactant to form azobilirubin. The increase in absorbance at 548 nm due to azobilirubin formation is directly proportional to the total bilirubin concentration.

Here's an analysis of the provided 510(k) summary regarding the Total Bilirubin assay, structured to address your questions.

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical target format (e.g., "correlation coefficient must be >=X"). Instead, it demonstrates substantial equivalence by showing that the new device's performance characteristics are "similar" and "acceptable" when compared to a legally marketed predicate device. The implied acceptance is that the correlation and precision results are sufficiently close to generally accepted standards for a diagnostic assay and comparable to the predicate.

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

• Sample Size for Test Set: The document does not explicitly state the number of samples used for the comparative performance studies (method comparison). For precision studies, four levels of control material were used, but the number of replicates per level is not specified.
• Data Provenance: Not specified. It's common for such studies to use a mix of patient samples and spiked controls to cover the assay range, but the origin (e.g., country, specific populations) and whether they were retrospective or prospective are not mentioned. Given the date of submission (2002), it's highly likely these were retrospective samples or controlled proficiency testing samples.

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

Not applicable. This is an in vitro diagnostic (IVD) assay for a quantitative measurement (total bilirubin). The "ground truth" for method comparison studies in IVDs is typically established by comparing the new device's results to a legally marketed predicate device (the Roche Total Bilirubin assay in this case), often itself validated against a reference method. It does not involve human expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set:

Not applicable for a quantitative IVD assay. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective interpretation (e.g., radiology, pathology) to reach a consensus ground truth. For this device, the "truth" is the measured concentration.

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

No, an MRMC study was not done. MRMC studies are used to evaluate the impact of a system (often AI) on human reader performance, typically in diagnostic imaging. This device is a standalone quantitative lab assay.

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

Yes, the performance characteristics described (correlation, precision, assay range, sensitivity) represent the standalone performance of the Total Bilirubin assay itself on the specified automated systems (AEROSET and ARCHITECT c8000), without human interpretation as part of the primary measurement.

7. The Type of Ground Truth Used:

The primary "ground truth" for the comparative performance study was the results obtained from the legally marketed predicate device, the Roche Total Bilirubin assay on the Hitachi 717 Analyzer, combined with established analytical methods for precision and sensitivity. For IVD assays, predicate comparison is a common method for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is a traditional IVD assay, not an AI/ML algorithm that requires a "training set" in the computational sense. The assay is based on a well-established chemical reaction (diazo reagent coupling) rather than a learned model from data.

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

Not applicable. As mentioned, there is no "training set" in the context of an AI/ML algorithm for this type of device. The assay's performance is driven by its chemical formulation and instrument calibration.

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Ask a specific question about this device

Total Bilirubin is intended for the quantitative determination of total bilirubin in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Total Bilirubin Reagent

This document is a 510(k) clearance letter from the FDA for a Total Bilirubin Reagent. This type of document does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's performance was compared to a predicate device already on the market, and the FDA determined it was substantially equivalent, allowing it to be marketed. The detailed study results, acceptance criteria, sample sizes, and ground truth information are typically found in the 510(k) submission itself, which is a much larger document and not provided here.

Therefore, I cannot provide the requested information from this document.

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