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The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal destruction of red blood cells, are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block.

The ALKP test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

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This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically for VITROS XT Chemistry Products TBIL-ALKP Slides. The provided text is a regulatory communication and does not contain the acceptance criteria or study details for the device's performance.

To answer your request, I would need access to the actual 510(k) summary, often referred to as a "510(k) Premarket Notification." This document typically includes the performance data, acceptance criteria, and study designs to demonstrate substantial equivalence to a predicate device.

The information you've provided only states:

• Device Name: VITROS XT Chemistry Products TBIL-ALKP Slides
• Intended Use: Quantitative measurement of total bilirubin (TBIL) and alkaline phosphatase (ALKP) in serum and plasma using VITROS XT 7600 Integrated Systems.
• Regulatory Class: Class II
• Product Code: CIG (Bilirubin (total or direct) test system), CJE (Alkaline phosphatase test system)
• Date of Clearance: April 26, 2019

Without the 510(k) summary or a similar technical document, I cannot extract the specific acceptance criteria, study details, sample sizes, or ground truth information you've requested.

Therefore, I cannot provide the requested table and study details based solely on the provided text.

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The Alkaline Phosphatase assay is intended to measure alkaline phosphatase in serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Alkaline Phosphatase is an in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum or plasma. Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. 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 text describes specific performance characteristics of the AlkP (Alkaline Phosphatase) assay, focusing on its substantial equivalence to a previously cleared device. Here's a breakdown of the acceptance criteria and study details based on the input:

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

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

• Sample Size:
  • For the AEROSET system method comparison with Hitachi 717: 40 samples were run on each of the three AEROSET systems, for a total of 120 samples.
  • For the ARCHITECT c8000 system method comparison with AEROSET system: The number of samples is not explicitly stated in the provided text, only that three ARCHITECT c8000 Systems were used. (It's possible it was also 40 samples per system, but not specified).
  • For 20-day precision studies: The number of samples for each level of control material is not specified, only that "two levels of control material" were used.
  • For 5-day precision studies: The number of samples for each control material level with original and modified parameters is not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The study seems to be conducted by the manufacturer, Abbott Laboratories.

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

Not applicable. This study involves an in vitro diagnostic assay for quantitative determination of a biomarker (alkaline phosphatase). The "ground truth" or reference is established by established, cleared predicate devices (Roche Alkaline Phosphatase assay on Hitachi 717 Analyzer and the AEROSET System itself), not by human expert consensus or interpretation of images.

4. Adjudication method for the test set

Not applicable. As noted above, this study does not involve human interpretation or subjective assessment that would require an adjudication method. The comparisons are quantitative measurements against predicate devices.

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 device study, not an AI-assisted diagnostic imaging or human-in-the-loop study.

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

Yes, the studies described are standalone performance evaluations of the modified AlkP assay. The results (correlation, slope, intercept, precision, linearity, limit of quantitation) directly reflect the analytical performance of the device itself.

7. The type of ground truth used

The "ground truth" in this context is the quantitative measurement obtained from legally marketed predicate devices. Specifically:

• For the AEROSET system, the predicate was the Roche Alkaline Phosphatase assay on the Hitachi 717 Analyzer.
• For the ARCHITECT c8000 System, the predicate was the AEROSET System (which itself was compared to the Hitachi 717).

8. The sample size for the training set

Not applicable. This is a traditional in vitro diagnostic assay with modifications to existing parameters, not a machine learning model that requires a "training set" in the conventional sense. The "training" here would be the development and optimization process by R&D engineers, not a data-driven model training.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The development and optimization of such assays typically rely on extensive chemical and biological experimentation, calibration using reference materials, and iterative improvements to assay formulation and parameters, rather than a labeled training dataset.

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The Alkaline Phosphatase assay is intended to measure alkaline phosphatase in serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Alkaline Phosphatase is an in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum or plasma. Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. 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.

Here's an analysis of the acceptance criteria and study information for the K981806 device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to the predicate device, the Boehringer Mannheim® Alkaline Phosphatase/AMP assay (K823213) on the Hitachi® 717 Analyzer. The study aims to show that the new Abbott AlkP assay performs similarly to the predicate.

Study Details:

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

   • Test set sample size: Not explicitly stated. The document mentions "comparative performance studies" and "precision studies" using "two levels of control material" but does not specify the number of patient samples or replicates used for these tests.
   • Data provenance: Not explicitly stated, though it's an in vitro diagnostic assay for human serum or plasma. The country of origin is not mentioned, and it is a prospective study as these are performance characteristics being evaluated for a new device.

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

   • Not applicable. For an in vitro diagnostic assay like Alkaline Phosphatase, ground truth is typically established by reference methods or validated calibrated instruments/materials, not by expert interpretation in the same way it would be for imaging diagnostics. The comparison is against a legally marketed predicate device (Boehringer Mannheim Alkaline Phosphatase/AMP assay).

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

   • Not applicable. This is a quantitative chemical assay, not an interpretation task 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 is an in vitro diagnostic assay and does not involve human readers for interpretation.

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

   • Yes, this study represents a standalone performance evaluation of the Abbott AlkP assay on the AEROSET™ System. There is no human-in-the-loop component mentioned; it's an automated quantitative assay.

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

   • The "ground truth" for demonstrating substantial equivalence is the performance of the predicate device (Boehringer Mannheim Alkaline Phosphatase/AMP assay on the Hitachi 717 Analyzer). The new device's results are compared directly to this established method. For precision, the ground truth is often tied to certified reference materials or internal quality control materials with known target values.

7. The sample size for the training set:

   • Not applicable. This is a chemical assay, not an algorithm that requires a "training set" in the machine learning sense. The device is likely calibrated using standardized calibrators, but these are not referred to as a "training set."

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

   • Not applicable, as there's no "training set" in the context of this device. Calibrators for such assays are typically prepared using gravimetric or volumetric methods with highly pure chemical substances, and their ground truth concentrations are established through analytical chemistry techniques.

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Measurement of BAP is intended for use as an aid in the:

management of postmenopausal osteoporosis and Paget's disease.

monitoring of postmenopausal women on hormonal or bisphosphonate therapy

prediction of skeletal response to hormonal therapy in postmenopausal women.

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I am sorry, but the provided text from the FDA 510(k) letter for the Alkphase-B® Assay Kit does not contain information about the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA letter granting substantial equivalence, not a detailed study report. Therefore, I cannot generate the requested table and paragraphs based on this input.

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The Alkaline Phosphatase assay is intended to measure alkaline phosphatase in serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Alkaline Phosphatase is an in vitro diagnostic assay for the quantitative determination of alkaline phosphatase in human serum or plasma. Alkaline phosphatase in serum catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. The rate of absorbance increase at 405 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AlkP (Alkaline Phosphatase) device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the "Performance Characteristics" section, we can infer the criteria used for substantial equivalence. The primary criterion is strong correlation and similar clinical results to the predicate device.

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

The document does not explicitly state the sample size used for the "comparative performance studies" or "precision studies." It only refers to "two levels of control material" for precision.

The data provenance is not specified regarding country of origin. The studies appear to be retrospective in the sense that they are conducted on samples and controls to characterize the device's performance, rather than on new patient cohorts specifically for this submission.

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

This document describes an in vitro diagnostic assay, which measures a biochemical marker (alkaline phosphatase) in human serum or plasma. It does not involve human interpretation of images or other subjective data that would require a ground truth established by experts. The "ground truth" for this type of device is the actual concentration of the analyte, which is measured using a reference method or validated control materials.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device, as there is no subjective interpretation requiring adjudication among experts.

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 assay, not an AI-powered image analysis or diagnostic support tool for human readers.

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

Yes, the studies described are for the standalone performance of the AlkP assay (the device itself, which is a chemical assay run on an automated analyzer). The "algorithm" here is the chemical reaction and photometric measurement process. The "without human-in-the-loop" refers to the assay's direct measurement capability.

7. The Type of Ground Truth Used

For method comparison, the Roche Cobas Mira Plus Automated Chemistry System Alkaline Phosphatase assay served as the reference standard or "ground truth" for relative performance. For precision studies, control materials with known (or established) values were used. The document implies that these control materials represented different levels of alkaline phosphatase.

8. The Sample Size for the Training Set

Not explicitly stated. For an in vitro diagnostic assay, there isn't typically a "training set" in the machine learning sense. The assay's parameters (reagent concentrations, incubation times, measurement wavelengths) are developed and optimized through R&D without a distinct "training set" as understood in AI/ML. The provided data focuses on validation (test set performance).

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

Not applicable in the machine learning sense. The "ground truth" for developing and optimizing an in vitro diagnostic assay would be based on established biochemical principles, extensive laboratory testing, calibration against reference methods/materials, and analytical validation during the assay development process to ensure it accurately measures the analyte.

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