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

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

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

Methodology: Colorimetric (Bromocresol Purple)

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. Type of Ground Truth Used:

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

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

8. Sample Size for the Training Set:

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

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

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

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

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The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The assay is intended for professional use only.

For In Vitro Diagnostic use only.

Albumin BCP reagent is ready to use liquid reagent that is supplied in two configurations: fill volume 20 mL in a 20 mL wedge or 50 mL in a 50 mL wedge, 6 wedges/kit.

Here's the breakdown of the acceptance criteria and study information for the Albumin BCP device, based on the provided text:

Acceptance Criteria and Device Performance

Note regarding "Test Set" and "Training Set" terminology: For in vitro diagnostic assays measuring specific analytes, the concepts of "test set" and "training set" (as typically used in machine learning or image analysis) are not directly applicable in the same way. Instead, performance studies use different sample types (e.g., control materials, patient samples, spiked samples) to validate the analytical performance characteristics. The following answers reflect this distinction.

Study Details:

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

   • Limit of Blank (LoB): Not explicitly stated, but performed with three different reagent lots (F0390, F0391, F0480) and one calibrator lot (E0179). LoB is typically determined using replicate measurements of blank samples.
   • Limit of Detection (LoD): Not explicitly stated, but inferred to be similar to LoB determination as it also uses reagent and calibrator lots.
   • Limit of Quantitation (LoQ): Not explicitly stated, inferred to be similar to LoB/LoD determination.
   • Precision Study: 80 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (26.26-26.62 g/L, 40.53-40.67 g/L, 49.96-50.47 g/L) using human serum. An additional lot (90228) used 88 replicates per level (19.10 g/L, 40.18 g/L, 51.33 g/L).
   • Intra Assay Precision Study: 20 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (21.4-21.5 g/L, 35.6-35.8 g/L, 50.2-50.3 g/L) using human serum.
   • Linearity (Measuring Range): Three different reagent lots (F0390, F0391, F0480) were tested across specified ranges (e.g., 4.17 to 78.30 g/L). Number of distinct samples within these ranges not explicitly stated.
   • Endogenous Interferences Study: "2 aliquots of serum pool were prepared (Base and Test pool)" for two albumin concentrations (~35 g/L and ~50 g/L), with the test pool divided into 4 sub-aliquots and diluted. Specific number of interference samples not stated, but covered a range of dilution levels (100% down to 0%).
   • Reagent Stability: Four different lots (F0390, F0391, F0480, 90228) were evaluated across three different concentration levels.
   • Method Comparison: 128 serum samples, including 8 altered samples, covering the measuring interval 6.0 - 70 g/L.
   • Matrix Comparison: 77 paired plasma/serum samples, including 7 altered samples, covering the assay's range, for both Lithium-Heparin plasma and Potassium EDTA plasma.

   Data Provenance: The studies used human serum and plasma samples. The document does not explicitly state the country of origin of the data or whether the samples were collected retrospectively or prospectively. Given the context of a medical device submission, these would typically be from clinical laboratory settings.

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 (IVD) assay for measuring a biochemical analyte (albumin). The "ground truth" for such assays is established by the reference methods or highly characterized materials used to calibrate and validate the assay. It does not involve human experts interpreting images or diagnosing conditions, but rather relies on established analytical standards and predicate devices.

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

   Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., image reading) where disagreement among experts might arise. For quantitative IVD assays, performance is assessed against defined analytical criteria and reference values.

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 device, not an AI-assisted diagnostic tool that would involve human readers.

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

   Yes, the performance studies described are for the standalone functioning of the Albumin BCP assay on the AU680 Automatic Analyzer. This is inherent to the nature of an in vitro diagnostic test, where the device performs the measurement independently.

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

   The "ground truth" for this IVD device is established through:

   • Reference materials and calibrators: Used to ensure accuracy and traceability of measurements (e.g., ERM-DA 470k/IFCC for standardization).
   • Predicate device measurements: The method comparison study used a legally marketed predicate device (Siemens ADVIA 2400, ADVIA® Chemistry Albumin BCP assay) as a comparative standard.
   • Analytical standards: Performance is measured against accepted analytical performance guidelines (e.g., CLSI documents EP17-A2, EP05-A3, EP15-A3, EP6-A, EP07-A2, EP09-A3) which define acceptable limits for various performance characteristics.
   • Known concentrations: For studies like LoB, LoD, LoQ, Precision, and Intra-Assay Precision, samples with known or characterized concentrations (e.g., control materials, spiked samples, serum pools) are used to assess the device's accuracy and reproducibility.

7. The sample size for the training set:

   Not applicable in the machine learning sense. The device is a chemical assay, not an algorithm trained on a dataset. Its analytical characteristics are inherently designed and validated through laboratory studies.

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

   Not applicable. As explained above, this device does not utilize a "training set" in the context of machine learning. The analytical methods and performance targets are established through scientific principles of chemistry and validated using established laboratory practices and reference standards.

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For in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on ADVIA Chemistry systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

For in vitro diagnostic use in the calibration of the ADVIA Chemistry Albumin BCP Assay (ALBP) on ADVIA Chemistry systems.

The Albumin BCP reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry systems. Reagents are supplied in two configurations: fill volume of 18 mL in a 20 mL wedge or 35 mL in a 40 mL wedge, 4 wedges/kit.

The calibrator is a multi-analyte human serum based product containing albumin derived from human serum. The kit consists of 3 vials of one-level calibrator which are lyophilized. The target concentration of this calibrator is 4.3 g/dL. The volume per vial (after reconstitution with deionized water) is 2.0 mL.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for each performance characteristic. Instead, it describes various performance studies and concludes that the results were "acceptable" and support "substantial equivalence" to the predicate device. For the purpose of this analysis, I will infer general acceptance by demonstrating performance comparable to or better than the predicate, or by meeting internal and CLSI guidelines for analytical performance.

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

• Precision:
  • Serum sample pools and serum-based controls were assayed.
  • Each sample was assayed 2 replicates per run, 2 runs per day, for at least 20 days.
  • Number of data points (N) for each control/pool: 80.
  • Provenance: Not explicitly stated, but clinical laboratory studies typically use samples from diverse patient populations to represent the intended use environment. The term "Serum Control" and "Serum Pool" suggest internally generated or purchased control materials, which are representative of human serum. Retrospective, as these are controlled studies based on pre-collected samples or control materials.
• Linearity/Assay Reportable Range:
  • Eleven dilutions across the measuring range.
  • Provenance: Not explicitly stated, but likely laboratory-prepared dilutions of human serum or control materials. Retrospective.
• Limit of Blank, Limit of Detection, Limit of Quantitation:
  • 720 determinations: 240 blank replicates and 480 low-level sample replicates.
  • Provenance: Not explicitly stated, but laboratory-prepared blank and low-level samples. Retrospective.
• Method Comparison with Predicate Device:
  • Sixty-nine (69) serum samples.
  • Provenance: Not explicitly stated, but these would be human serum samples covering a range of albumin concentrations. Retrospective, as samples are collected and then tested.
• Matrix Comparison:
  • Forty-seven (47) paired plasma/serum samples (Lithium Heparin and Potassium EDTA plasma vs. serum).
  • Provenance: Human plasma and serum samples. Retrospective.
• Analytical Specificity (Interference):
  • Not specified, but likely involved multiple spiked samples for each interferent at varying concentrations.
  • Provenance: Laboratory-prepared samples spiked with interferents. Retrospective.

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

This document describes a diagnostic assay for quantitative measurement of albumin. The "ground truth" in this context is the actual albumin concentration in the samples, determined by a reference method or validated control materials, not by expert interpretation of images or clinical cases.

• No human experts are used for establishing "ground truth" in the interpretive sense (e.g., radiologist for imaging).
• The "ground truth" is established analytically:
  • Through the inherent reference values of commercial controls.
  • By the established methodology of the predicate device.
  • By traceability to the ERM-DA470k Reference Material.
  • By preparing samples with known (expected) concentrations for linearity and LoQ studies.
  • The "experts" involved are implied to be laboratory scientists and method developers who establish and validate these analytical reference points based on established scientific principles and guidelines (e.g., CLSI).

4. Adjudication Method for the Test Set:

Not applicable. This is an analytical chemistry assay, not a device requiring human interpretation and multi-reader adjudication for ground truth establishment. The performance is assessed against quantitative analytical targets.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or other interpretive devices where human readers provide diagnoses, and the AI assists or performs the interpretation. This device is a quantitative chemistry assay.

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

Yes, all studies described (precision, linearity, LoB/LoD/LoQ, method comparison, matrix comparison, analytical specificity) are standalone performance evaluations of the ADVIA Chemistry Albumin BCP Assay on the ADVIA 1650 Chemistry system. The device (assay and instrument combination) performs the measurement automatically without human intervention once the sample is loaded.

7. The Type of Ground Truth Used:

The ground truth for the performance studies is primarily derived from:

• Known concentrations: For linearity, LoB, LoD, and LoQ studies, samples are prepared with known (expected) albumin concentrations or are blank.
• Reference materials: Traceability to ERM-DA470k Reference Material provides a foundation for accurate quantification.
• Predicate device measurements: For method comparison, the results from the legally marketed predicate device (Dimension Clinical Chemistry System Albumin Flex® reagent cartridge) serve as a comparative ground truth.
• Validated control materials: Commercial serum controls with established target values.

8. The Sample Size for the Training Set:

The document describes an analytical assay, not an AI/ML algorithm that undergoes a distinct "training" phase. Therefore, there is no explicit "training set" in the context of machine learning. The assay's performance characteristics (e.g., reagent formulations, instrument parameters, calibration curves) are developed and validated through extensive internal R&D and optimization processes, which would involve numerous samples, but these are not referred to as a "training set" in the same way an ML model would have one.

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

As noted above, there isn't a "training set" in the AI/ML sense. The "ground truth" for the development and optimization of the assay and its associated calibrator involves:

• Reference methods for quantifying albumin.
• Gravimetric or optical methods for preparing known concentration standards.
• Traceability to international reference materials like ERM-DA470k.
• Empirical data collected during the assay development process to optimize reagent concentrations, reaction conditions, and instrument parameters to achieve desired analytical performance.

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An albumin test system is an in vitro device intended to measure albumin concentration quantitatively in serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for an "Albumin Reagent" device, indicating that it has been found substantially equivalent to a legally marketed predicate device. It defines the intended use of the device but does not include any performance data or a description of a study.

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THE Albumin BCG reagent is intended for Invitro diagnostic in the quantitative determination of albumin in serum use or plasme.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to A.P. Total Care, Inc. regarding their "Albumin BCG" reagent. This document is a regulatory approval letter and does not contain the detailed information necessary to answer the questions about acceptance criteria and study design for a device.

The letter confirms the device is substantially equivalent to legally marketed predicate devices and is intended for in vitro diagnostic use in the quantitative determination of albumin in serum or plasma. It mentions general regulatory compliance but does not include any specific performance data, study designs, sample sizes, or expert qualifications.

Therefore, I cannot provide the requested information based on the provided text. To answer these questions, a different type of document, such as a summary of safety and effectiveness, a clinical study report, or the 510(k) submission itself, would be required.

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The Albumin BCP is used for the quantitation of albumin in human serum or plasma. Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.

Albumin BCP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum or plasma. The Albumin BCP assay is a clinical chemistry assay in which the albumin in the sample binds to a bromocresol purple dye in acidic media to form a colored complex. The absorbance of the albumin chromophore complex is measured at 604 nm and is directly proportional to the concentration of albumin present in the sample.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the comparative performance studies (method comparison, precision, linearity, and sensitivity). It mentions "two levels of control material" for precision studies, but not the number of individual samples or patient samples.
• Data Provenance: Not explicitly stated. The document refers to "human serum or plasma" for the intended use and "comparative performance studies," implying that the data would be based on human samples. However, the country of origin or whether the data was retrospective or prospective is not mentioned.

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

• Not applicable. This device is an in vitro diagnostic assay that measures a quantitative biomarker (albumin). The "ground truth" for such devices is established through established analytical methods and reference standards, not typically through human expert adjudication as would be the case for image-based diagnostic aids. The performance is assessed against the results of a predicate device (Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer) as the comparative standard.

4. Adjudication Method for the Test Set:

• Not applicable. See explanation above. The comparison is analytical, not based on human judgment requiring adjudication.

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

• No. An MRMC study is not relevant for this type of in vitro diagnostic device. MRMC studies are typically performed for devices that assist human readers (e.g., radiologists, pathologists) in interpreting medical images or complex data. The Albumin BCP assay provides a direct quantitative measurement.

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

• Yes. The performance characteristics presented (correlation, precision, linearity, sensitivity) describe the standalone performance of the Albumin BCP assay itself when run on the AEROSET™ System. There is no human intervention in interpreting the output of this quantitative assay; the result is a numerical value.

7. Type of Ground Truth Used:

• Reference Method/Predicate Device Comparison: The "ground truth" or reference for evaluating this new device's performance was the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic devices.
• Established Analytical Principles: The linearity and sensitivity are determined based on the assay's ability to accurately measure known concentrations or detect low levels of albumin, respectively. Precision is measured by the reproducibility of results for control materials with known concentrations.

8. Sample Size for the Training Set:

• Not applicable. The Albumin BCP assay is a chemical assay, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a device would involve optimizing the chemical reagents and instrument parameters during its development.

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

• Not applicable. As it's not a machine learning model, a training set and its associated ground truth are not relevant concepts. The developmental process would rely on chemical principles and laboratory testing to ensure the assay reagents and methodology produce accurate and reliable quantitative results.

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The Albumin BCP assay is used for the quantitation of albumin in human serum. Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.

Albumin BCP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum. The Albumin BCP assay is a clinical chemistry assay in which the albumin in the sample binds to bromcresol purple. The absorbance of the complex is measured at 600 nm and is directly proportional to the albumin concentration in the sample.

Here's an analysis of the provided text regarding the Abbott Laboratories Albumin BCP assay, structured to address your specific questions about acceptance criteria and the supporting study:

The provided document is a 510(k) summary for the Abbott Laboratories Albumin BCP assay, indicating that it is an in vitro diagnostic assay for the quantitative determination of albumin in human serum. The core of this submission is to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implicitly defined by the sponsor's demonstration of substantial equivalence to a legally marketed predicate device (Boehringer Mannheim Albumin BCP Assay on the Hitachi 717 Analyzer). Therefore, the acceptance criteria are that the new device's performance characteristics are "similar" or "acceptable" in comparison to the predicate. The "reported device performance" refers to the results obtained for the Abbott Albumin BCP assay.

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

The document provides the following information:

• Sample Size: The exact number of samples (individual patient samples) in the "comparative performance studies" for method comparison is not explicitly stated. It mentions "two levels of control material" for precision studies, but this refers to quality control samples, not patient samples for method comparison.
• Data Provenance: The document does not specify the country of origin of the data. The study involved "human serum," but whether it was prospective or retrospective is not explicitly stated. Given that it's a 510(k) for an in vitro diagnostic, these studies are typically performed with collected patient samples, which could be retrospective (archived samples) or prospective (newly collected samples specifically for the study).

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

This type of information is not applicable to this 510(k) submission. For quantitative in vitro diagnostic assays like this, "ground truth" is typically established by:

• Reference Methods: Highly accurate and precise analytical methods.
• Predicate Device: In this case, the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer itself serves as the "standard" against which the new device is compared to establish substantial equivalence.

There were no human experts adjudicating images or clinical outcomes to establish ground truth for this type of device.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used typically in studies involving subjective interpretation (e.g., radiology, pathology slides) to resolve discrepancies between multiple readers. For a quantitative clinical chemistry assay, the output is a numerical value, and comparison is statistical, not based on human expert consensus.

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

This information is not applicable. This submission is for an in vitro diagnostic assay, which is an automated or semi-automated laboratory test, not an AI-powered image analysis or clinical decision support tool designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

Yes, implicitly. The performance characteristics reported (method comparison, precision, linearity, sensitivity) are all standalone performance data of the Abbott Albumin BCP assay. The device itself (the assay and its measurement on the ALCYON™ Analyzer) operates without continuous human intervention in the measurement process to produce the quantitative albumin value.

7. The Type of Ground Truth Used

For method comparison, the "ground truth" was effectively the measurements obtained from the legally marketed predicate device, the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer. The goal was to show that the new device's results are sufficiently similar to those of the predicate. For precision, linearity, and sensitivity, the "ground truth" or reference values are established through rigorous analytical testing using known concentrations or appropriate statistical methods.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the assay itself. For clinical chemistry assays like this, there isn't typically a "training set" in the machine learning sense. The assay method is developed and validated, and its performance characteristics are then evaluated. The term "training set" is more relevant for AI/ML-based devices. Development would involve extensive testing and optimization, but not usually in a "training set" / "test set" paradigm.

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

Since there is no explicit "training set" mentioned in the context of machine learning, this question is not applicable. The "ground truth" for the development and validation of the chemical assay would have been established through established analytical chemistry principles, reference materials, and comparison to other validated methods during the assay's development prior to the 510(k) submission.

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