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The Atellica® CI Analyzer is an automated, integrated system in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative analysis of various body fluids, using photometry, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use.

The Atellica® IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® CI Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Atellica® CH Albumin BCP (AlbP) assay is for in vitro diagnostic use in the quantitative measurement of albumin in human serum and plasma (lithium heparin, potassum EDTA) using the Atellica® CI Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Atellica® CI Analyzer is an automated, integrated system designed to perform in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use.

The Atellica CI Analyzer with Atellica® Rack Handler supports both clinical chemistry (CH) and Immunoassay (IM) features and contains all the necessary hardware, electronics, and software to automatically process samples and generate results, including sample and reagent dispensing, mixing, and incubating.

The Atellica IM TSH3-UL assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture mouse monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti-TSH mouse monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection

The Atellica CH Albumin BCP (AlbP) assay is an adaptation of the bromocresol purple dy-e binding method reported by Carter and Louderback et al. In the Atellica CH AlbP assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm coenzyme NAD+ functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

The document provided is a 510(k) summary for in vitro diagnostic devices (IVDs), specifically the Atellica® CI Analyzer and its associated assays for Thyroid Stimulating Hormone (TSH3-UL) and Albumin (AlbP). IVDs, by their nature, measure specific analytes in biological samples and are evaluated against performance criteria such as precision, accuracy, linearity, and interference, rather than diagnostic accuracy metrics like sensitivity and specificity that would typically apply to AI/ML software. Therefore, many of the requested elements pertaining to AI/ML acceptance criteria and human-in-the-loop studies are not applicable to this type of device.

Here's a breakdown of the relevant information provided:

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

The document describes the performance characteristics for the Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) assay and the Atellica CH Albumin BCP (AlbP) assay. These are performance criteria, which serve as the acceptance criteria for the device's analytical performance.

Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) Assay:

Atellica CH Albumin BCP (AlbP) Assay:

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

• TSH3-UL Assay:
  • Precision: 80 samples for each type (Serum A-F, EDTA Plasma A-C, Heparin Plasma A-C, Control 1-3).
  • Assay Comparison (Serum): 112 samples.
  • Interferences (Specific substances): Not explicitly stated how many samples per substance, but concentrations tested at two analyte levels.
  • Specimen Equivalency: 64 samples for Plasma (Lithium heparin) and 64 for Plasma (EDTA).
  • Onboard Dilution Recovery: 3 samples (Serum and Plasma) tested at two dilution levels.
  • Linearity: Not explicitly stated, but "at least 14 levels created by mixing high and low serum samples" with N=5 replicates per level.
• AlbP Assay:
  • LoD: 486 determinations (270 blank, 216 low level replicates).
  • LoQ: n=5 replicates using 3 reagent lots over 5 days.
  • Precision: N ≥ 80 for each sample (Serum 1-3, Serum QC 1).
  • Reproducibility: 225 samples for each serum level (assayed n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots).
  • Assay Comparison (Serum): 106 samples.
  • Specimen Equivalency: 76 samples for Plasma (Lithium heparin) and 55 for Plasma (Potassium EDTA).
  • HIL: Not explicitly stated how many samples per interferent, but concentrations tested at two analyte levels.
  • Non-Interfering Substances: Not explicitly stated how many samples per substance, but tested at two analyte concentrations.
  • Linearity: "at least nine levels created by mixing the high and low pools of serum" with N=5 replicates per level.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a medical device intended for broad use, it's highly likely the studies were prospective analytical validation studies conducted under controlled laboratory conditions, typically in multiple sites to ensure robustness.

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):

This information is not applicable to this type of device. The "ground truth" for clinical laboratory assays like TSH and Albumin comes from established analytical methods, reference materials, and accepted scientific principles of chemistry and immunology. It's about measuring the concentration of an analyte, not interpreting an image or diagnosing a condition based on expert consensus. The "experts" involved would be clinical chemists, laboratory scientists, and engineers responsible for assay development and validation, following established guidelines like those from CLSI (Clinical and Laboratory Standards Institute).

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

This is not applicable for this type of device. Adjudication methods are used in studies involving subjective interpretations (e.g., image reading) where multiple readers provide opinions that need to be reconciled to establish ground truth. For quantitative chemical assays, the "truth" is determined by reference methods and the intrinsic properties of the analyte, not by human consensus or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. An MRMC study is designed for evaluating the impact of a system on human readers' diagnostic performance, typically in the context of imaging. This document describes an automated in vitro diagnostic analyzer and its assays, which do not involve human "readers" in the sense of interpreting outputs like medical images.

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

The performance characteristics presented (precision, linearity, assay comparison, interference, etc.) represent the standalone performance of the device and its assays. The Atellica® CI Analyzer and its assays are automated systems designed to perform measurements without human interpretative input beyond setting up the instrument and following standard laboratory procedures for running samples and quality control.

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

The ground truth for these quantitative assays is established through:

• Reference Methods / Comparability: The performance is evaluated by comparing the new device's results to a legally marketed predicate device (Siemens Trinidad systems) which serve as the reference. This establishes the equivalence of the new device to already accepted technology.
• Traceability to International Standards: For TSH3-UL, traceability is to the World Health Organization (WHO) 3rd International Standard for human TSH (IRP 81/565). For AlbP, traceability is to ERM-DA470k Reference Material. These international standards or reference materials provide the "true" or accepted values against which the device's measurements are calibrated and verified.
• Analytical Procedures: The "ground truth" for characteristics like limit of detection, precision, and linearity are determined by rigorous statistical methods and established protocols (e.g., CLSI guidelines EP05-A3, EP07-ed3, EP09c-ed3, EP17-A2, EP06-ED2) during analytical validation.

8. The sample size for the training set:

This information is not applicable in the context of an IVD where "training set" implies machine learning or AI model development. For an IVD, there is a development and validation process. The number of samples for analytical validation studies (which is what is presented) is given under point 2.

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

As this is not an AI/ML device, the concept of a "training set" for an algorithm and its associated ground truth establishment methods (e.g., expert annotations) are not applicable. The "ground truth" or reference for the development and validation of these IVD assays is based on established laboratory practices, chemical principles, certified reference materials, and comparison to predicate devices, as described in point 7.

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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.

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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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