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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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