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The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

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

The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.

In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.

In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid, forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.

Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A surfactant system is included to remove protein interference.

The provided text describes several in vitro diagnostic reagents (ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent) and their associated performance data. There isn't information about an AI-powered device or software. Therefore, questions related to AI aspects like multi-reader multi-case studies, effect size of AI assistance, or standalone algorithm performance are not applicable.

The acceptance criteria are not explicitly stated as clear thresholds in the provided document; rather, the document presents detailed performance data (precision, linearity, interference, and method comparison) that demonstrates the device's capability to perform as intended and to be substantially equivalent to its predicate devices. The "reported device performance" is presented directly through tables and statistical analyses for each reagent.

Here's an attempt to structure the available information based on the request, interpreting "acceptance criteria" as the performance demonstrated to support substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit "acceptance criteria" (i.e., predefined thresholds for performance metrics) are not provided in the document, the "Reported Device Performance" below represents the data presented that presumably met the internal criteria for demonstrating substantial equivalence. The document primarily focuses on precision, linearity, interference, and method comparison with predicate devices and between different systems (ACE, ACE Alera, ACE Axcel).

ACE Carbon Dioxide (CO2-LC) Reagent

ACE Direct Bilirubin Reagent

ACE Total Bilirubin Reagent

ACE Magnesium Reagent

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

The document describes several types of studies:

• In-House Precision:

  • CO2-LC: Low, Mid, High serum and plasma samples were tested (number of replicates per sample and runs is implicitly part of SD/CV calculation, but not explicitly stated).
  • Direct Bilirubin: Low, Mid, High serum and plasma samples.
  • Total Bilirubin: Low, Mid, High serum and plasma samples.
  • Magnesium: Low, Mid, High serum and plasma samples.
  • Data Provenance: In-house (Alfa Wassermann Diagnostic Technologies, LLC, West Caldwell, NJ), prospective testing.

• POL (Physician Office Laboratory) Precision: Studies conducted at 3 POL sites.

  • CO2-LC: 3 samples at each of 3 POL sites and in-house.
  • Direct Bilirubin: 3 samples at each of 3 POL sites and in-house.
  • Total Bilirubin: 3 samples at each of 3 POL sites and in-house.
  • Magnesium: 3 samples at each of 3 POL sites and in-house.
  • Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions).

• In-House Matrix Comparison (Serum vs. Plasma):

  • CO2-LC: 53-54 pairs (serum/plasma) on ACE and ACE Alera; 51 pairs on ACE Axcel.
  • Direct Bilirubin: 102 pairs on ACE; 101 pairs on ACE Alera; 56 pairs on ACE Axcel.
  • Total Bilirubin: 102 pairs on ACE and ACE Alera; 56 pairs on ACE Axcel.
  • Magnesium: 101 pairs on ACE and ACE Alera; 55 pairs on ACE Axcel.
  • Data Provenance: In-house, retrospective (presumably collected for a range of values).

• POL Method Comparison (In-House ACE vs. POL ACE/Alera):

  • CO2-LC: 45-46 samples per POL site comparison.
  • Direct Bilirubin: 49-51 samples per POL site comparison.
  • Total Bilirubin: 48-50 samples per POL site comparison.
  • Magnesium: 50-52 samples per POL site comparison.
  • Data Provenance: Not explicitly stated but inferred to be from POLs in the USA (prospective testing under typical POL conditions) compared against in-house data.

• Detection Limits (LoB, LoD, LoQ), Linearity, Interferences (ACE Alera):

  • Sample sizes for detection limits and linearity: Not explicitly stated, typically involves multiple replicates at various concentrations.
  • Sample sizes for interferences: Not explicitly stated, typically involves samples spiked with various concentrations of interferents.
  • Data Provenance: In-house.

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

This information is not provided in the document. For in vitro diagnostic assays, the "ground truth" is typically the reference method or established clinical laboratory results obtained from a highly accurate and calibrated instrument or laboratory using validated methods, rather than human expert consensus for image or clinical interpretation. The document compares performance against other (presumably established) methods and predicate devices.

4. Adjudication Method for the Test Set

This concept (e.g., 2+1, 3+1 for resolving discrepancies) is not applicable to these types of in vitro diagnostic device studies. Performance is measured numerically and objectively.

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

No. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device.

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

Not applicable. This is not an AI algorithm. The performance data presented are for the reagent and instrument system.

7. The Type of Ground Truth Used

For precision studies, the "ground truth" is the true concentration of the analyte in the control material or patient sample, which is established by reference methods or manufacturing specifications of the control materials. For method comparison studies, the predicate device's results or an established in-house method are used as the comparative reference. The document states the intended use is for "quantitative determination" of analytes, implying comparison to a quantitative gold standard.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context. The development of reagents and the establishment of their performance characteristics do not involve machine learning training sets.

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

Not applicable, as there is no "training set" for these reagents in the context of AI/ML.

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The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

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

In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.

In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.

In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid. forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.

Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample.

This document describes the performance of the ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to the predicate device, the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are implicitly established by demonstrating comparability to the predicate device. The performance data presented are the results obtained for the current device and reagents.

The study demonstrates that the ACE Axcel Clinical Chemistry System with the listed reagents achieves precision and accuracy comparable to the predicate device, supporting substantial equivalence.

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

The studies conducted are primarily accuracy (correlation) and precision studies.

• ACE Carbon Dioxide (CO2-LC) Reagent:
  • Accuracy (correlation study): 120 samples.
  • Accuracy (patient correlation studies): Conducted at three separate Physician Office Laboratory (POL) sites; the number of samples per POL site is not specified, but the total across all sites for CO2 values ranged from 3.2 to 47.6 mEq/L.
  • Precision: Four CO2 levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Direct Bilirubin Reagent:
  • Accuracy (correlation study): 116 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Direct Bilirubin values ranged from 0.2 to 12.5 mg/dL.
  • Precision: Four direct bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Total Bilirubin Reagent:
  • Accuracy (correlation study): 117 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Total Bilirubin values ranged from 0.2 to 34.8 mg/dL.
  • Precision: Four total bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Magnesium Reagent:
  • Accuracy (correlation study): 108 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Magnesium values ranged from 0.6 to 5.5 mg/dL.
  • Precision: Four magnesium levels tested for 22 days; three separate POL sites tested for 5 days.

Data Provenance: The document does not explicitly state the country of origin for the data. The "POL sites" (Physician Office Laboratory sites) suggest these are real-world clinical samples, likely from within the United States given the 510(k) submission. The data appears to be prospective in nature, as indicated by the description of testing conducted over 22 days and 5 days at different sites for precision and the collection of samples for correlation studies.

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

This is a clinical chemistry device for quantitative determination. The ground truth is established by comparing the device's measurements against a predicate device (Alfa Wassermann ACE Clinical Chemistry System). Therefore, no human experts are explicitly mentioned as establishing a "ground truth" in the diagnostic interpretation sense. The predicate device itself serves as the reference standard.

4. Adjudication method for the test set

Not applicable. This study involves quantitative measurements by a device and comparison to a predicate device, not qualitative interpretations requiring human 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 a clinical chemistry analyzer and reagent system, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Yes, the performance data presented are for the standalone algorithm/device (ACE Axcel Clinical Chemistry System with the specified reagents) measuring analytes in samples, compared directly against a predicate device. There is no human-in-the-loop component mentioned in the context of the reported performance data.

7. The type of ground truth used

The type of ground truth used is comparison to a legally marketed predicate device. The ACE Axcel Clinical Chemistry System and its reagents were compared to the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786). The predicate device's measurements serve as the reference for established accuracy.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that typically involves a distinct "training set." The device's performance is based on established chemical reactions and detection methods. The studies described are for validation/testing of the device's performance against a predicate, not for training an algorithm.

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

Not applicable, as there is no training set in the context of this 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 ATAC Total Bilirubin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results are used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

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

The ATAC Total Bilirubin Reagent determines total bilirubin through its reaction with diazotized sulfanilic acid in the presence of dimethylsulfoxide to form a red-purplex. The resulting increase in absorbance at 546 nm is proportional to the total bilirubin concentration in the sample.

The "ATAC Total Bilirubin Reagent Kit" is a device intended for the quantitative determination of total bilirubin in serum and plasma. The following information outlines its acceptance criteria and the studies performed to demonstrate its effectiveness.

1. Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set for Linearity: n = 18 (for the linear regression of standard factors). The data provenance is not explicitly stated as country of origin, but it is for "linearity standards," implying laboratory-prepared standards.
• Test Set for Precision: n = 36 for each of the three serum samples tested (total of 108 replicates). The data provenance is "commercially available control serum."
• Test Set for Method Comparison: n = 107. The data provenance is "Mixed serum and plasma specimens, collected from adult patients." The country of origin is not specified. It is likely prospective for the purpose of the study.
• Test Set for Detection Limit: 30 replicates of a diluted serum pool.

3. Number of Experts and Qualifications for Ground Truth

• This document describes the performance characteristics of an in-vitro diagnostic reagent kit (ATAC Total Bilirubin Reagent Kit) and does not involve image analysis or clinical interpretation by human experts to establish ground truth in the typical sense for a medical device that outputs diagnoses or classifications.
• The ground truth for the performance studies (linearity, precision, method comparison, detection limit, stability) is based on:
  • Known concentrations for linearity standards.
  • Assigned values for commercially available control serum.
  • Results from a "commercially available method" (predicate device or similar) for method comparison.
• Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as it applies to image interpretation or clinical diagnosis does not directly apply here. The "experts" are the analytical chemists and laboratory professionals who establish the values of standards and controls, and run the comparative assays.

4. Adjudication Method

• Adjudication methods like 2+1 or 3+1 are typically used in studies where there is subjective human interpretation involved (e.g., radiologists reviewing images).
• For the performance studies of this in-vitro diagnostic reagent, the "ground truth" or reference values are established through quantitative chemical analysis and metrological traceability. Therefore, an adjudication method in the human consensus sense is not applicable. Discrepancies would be resolved through re-testing, calibration verification, or investigation of analytical errors, not expert consensus.

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

• An MRMC study is not mentioned and is not applicable to the evaluation of an in-vitro diagnostic reagent kit like the ATAC Total Bilirubin Reagent Kit. These studies are relevant for devices that assist human readers in tasks like image interpretation or clinical decision-making.

6. Standalone Performance

• Yes, this document primarily reports on the standalone performance of the ATAC Total Bilirubin Reagent Kit when used with the ATAC 8000 Random Access Chemistry System. The results presented (linearity, precision, detection limit, stability) are measures of the algorithm's (reagent kit's) performance independent of human-in-the-loop diagnostic interpretation.
• The "method comparison" study essentially compares the standalone performance of the ATAC kit to another standalone, commercially available method.

7. Type of Ground Truth Used

The types of ground truth used are:

• Reference Standards/Known Concentrations: For linearity and stability studies, the performance is evaluated against solutions with established concentrations of total bilirubin.
• Assigned Values of Control Materials: For precision studies, the device's repeatability and reproducibility are measured against commercially available control sera with pre-determined mean values.
• Results from a Legally Marketed Predicate/Comparative Device: For method comparison, the results from the ATAC Total Bilirubin Reagent are compared against those obtained from the "Beckman Synchron Total Bilirubin Reagent, product 442745" or another "commercially available method," which serves as the reference ground truth for agreement.

8. Sample Size for the Training Set

• This document describes validation studies of a chemical reagent kit, not a machine learning or AI model. Therefore, the concept of a "training set" in the context of AI is not applicable. The development of the reagent itself would involve formulation, optimization, and initial testing, but these are not referred to as "training sets."

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

• As the concept of a "training set" for an AI model is not applicable here, the question of how its ground truth was established is also not relevant. The studies focus on verifying the analytical performance of the finished reagent kit against established laboratory and regulatory standards.

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The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Total bilirubin, in the presence of a suitable solubilizing agent, is coupled with a diazonium ion in a strongly acid medium (ph 1 - 2).

Bilirubin + diazonium ion acid -> Azobilirubin

The intensity of the color of the azobilirubin formed is proportional to the total bilirubin concentration and can be measured photometrically.

The provided document describes a 510(k) premarket notification for the "Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent." This is an in vitro diagnostic device, and the evaluation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML devices do not directly apply.

However, I can extract the relevant performance characteristics and details provided for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic such as a reagent, "acceptance criteria" are typically related to analytical performance characteristics like accuracy, precision, linearity, and correlation with a predicate device. The document primarily focuses on demonstrating that the new liquid reagent performs similarly to the predicate device.

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

The 510(k) Summary document does not explicitly state the sample size used for performance testing (e.g., patient samples for method comparison or clinical studies) nor the data provenance (e.g., country of origin, retrospective/prospective). It refers to "Specific data on the performance of the system [that have] been incorporated into the draft labeling in Section V of this submission," which is not included in the provided text.

For this type of IVD, performance data would typically involve:

• Method comparison studies: Comparing results from the new device to the predicate device using a range of patient samples.
• Precision studies: Assessing within-run, between-run, and total precision.
• Linearity studies: Verifying the analytical measurement range.
• Interference studies: Testing for substances that might affect results.

Without the "Section V" labeling, these specific details are unavailable.

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

This document describes a diagnostic reagent, not an AI/ML algorithm. Therefore, "ground truth" for the test set is established through analytical methods and comparison to a legally marketed predicate device (and often to reference methods if available), not by human expert opinion or consensus in the context of imaging or clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable in the context of an IVD reagent's analytical performance.

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 IVD reagent, not an AI-assisted diagnostic tool for human readers.

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

This refers to an IVD reagent, which inherently operates "standalone" in the sense that it measures a specific analyte. Its performance is evaluated against analytical standards and predicate devices, not as an "algorithm only" in the AI sense.

7. The Type of Ground Truth Used

For this IVD reagent, the "ground truth" for its performance evaluation would primarily be:

• Results from the legally marketed predicate device: The new device's measurements are compared to those obtained from the predicate to demonstrate substantial equivalence.
• Reference methods (if applicable and used in internal studies): Highly accurate, often more complex, methods used to determine true analyte concentrations.
• Known concentrations in control materials: Used for precision, linearity, and calibration verification.

8. The Sample Size for the Training Set

Not applicable in the context of a chemical reagent and its analytical evaluation. This is not an AI/ML device that uses a "training set."

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

Not applicable, as there is no "training set" for an AI/ML algorithm in this submission.

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The Synermed® Total Billirubin reagent is intended for use in the quantitative determination of total bilirubin in serum or plasma. The reagent kit is intended for in vitro diagnostic use only.

Elevated serum biliruhin levels are observed in a variety of conditions including hemolytic disorders, biliary obstruction, cholestasis, hepatitis, cirrhosis and decreased conjugation (e.g. neonatal jaundice).

Total Bilirubin Reagent Kit

I am sorry, but the provided text from the FDA letter for the Synermed Total Bilirubin Reagent Kit (K972716) is a clearance letter and does not contain the detailed information required to describe acceptance criteria and a study proving device effectiveness. The letter confirms substantial equivalence to a legally marketed predicate device but does not provide performance data, study design, or ground truth establishment.

Therefore, I cannot extract the following information from the given text:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. Multi Reader Multi Case (MRMC) comparative effectiveness study results or effect size
6. Standalone algorithmic performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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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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Ask a specific question about this device