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The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.

The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.

The Access EPO Calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

The Access EPO assay is a two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with the paramagnetic particles coated with mouse monoclonal anti-EPO, blocking reagent and the alkaline phosphatase conjugate. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

The provided text describes the 510(k) premarket notification for the Beckman Coulter "Access EPO" assay when run on the Dxl 9000 Access Immunoassay Analyzer. This document outlines the device's technical characteristics, its intended use, and comparative studies against a predicate device. However, it does not describe an AI-powered diagnostic device or a study involving human readers and AI assistance. Instead, it describes an immunoassay for measuring erythropoietin levels. Therefore, many of the detailed points requested in your prompt (e.g., number of experts for ground truth, MRMC study, effect size of AI, standalone AI performance) are not applicable to this specific submission.

Despite this, I will extract and present the available information that aligns with your request regarding acceptance criteria and study details for this non-AI diagnostic device.

Here's the breakdown based on the provided document:

Device Name: Access EPO

Intended Use: The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.

1. Table of Acceptance Criteria and Reported Device Performance

The document defines performance characteristics (acceptance criteria implicitly by demonstrating acceptable results) through various analytical studies.

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

• Method Comparison Test Set: 152 samples (141 native, 11 spiked).
• Imprecision Test Set: 5 samples (4 native, 1 spiked), tested in duplicate in 2 runs per day for 20 days on each of four analyzers (total 80 replicates per sample).
• Data Provenance: The document does not specify the country of origin for the samples or if they were retrospective or prospective. Given it's a 510(k) submission for a laboratory diagnostic, the samples are typically human biological samples collected for validation purposes.

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

Not applicable. This is not an image-based AI diagnostic device requiring expert adjudication of images. The "ground truth" for an immunoassay is typically established through reference methods or analysis of sample characteristics (e.g., known concentrations for spiked samples, or comparison to a cleared predicate device for native samples).

4. Adjudication Method for the Test Set

Not applicable, as it's an immunoassay for quantitative determination of erythropoietin, not a subjective interpretation task that would require 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 device is an automated immunoassay system, not an AI-assisted diagnostic tool that involves human readers.

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

Not applicable in the context of an "algorithm only" AI performance. The performance described here is the "standalone" performance of the immunoassay system (Dxl 9000 Access Immunoassay Analyzer with Access EPO assay reagents).

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation is established through:

• Comparison to a Predicate Device: For the method comparison study, the predicate device (Access EPO Assay on Access 2 Immunoassay System) served as the reference for native samples.
• Known Concentrations: For imprecision and linearity studies, samples of known or targeted concentrations (including spiked samples) are used.
• Reference Standards/Materials: Implied for establishing accurate concentrations for LoB, LoD, and LoQ.

8. The Sample Size for the Training Set

Not applicable. This is an immunoassay, not a machine learning model that requires a "training set" in the conventional sense of AI development. The "training" of the instrument involves calibration using specific calibrators provided with the assay.

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

Not applicable as there is no "training set" for an AI model. The "calibration" of the immunoassay is done using Access EPO Calibrators, which are intended to calibrate the assay. The ground truth for these calibrators would be established by the manufacturer through rigorous analytical methods to assign their precise concentrations.

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The ADVIA Centaur® Erythropoietin (EPO) assay is for in the quantitative measurement of exythropoitin in pediatric and adult human serum or plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Measurement of erythropoietin is used as an aid in the diagnosis of anemias and polycythemias.

The ADVIA Centaur EPO assay is a fully automated, one-step sandwich immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium-ester-labeled monoclonal mouse anti-EPO antibody in the Lite Reagent. The Solid Phase consists of mouse anti-EPO monoclonal antibody-coated paramagnetic microparticles.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the ADVIA Centaur Erythropoietin (EPO) assay:

1. Table of Acceptance Criteria and Reported Device Performance

This table compiles information primarily from the "Summary of Non-Clinical Performance" and "Summary of Clinical Performance" sections.

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

• Linearity: Not specified, but involved three high EPO samples mixed with low EPO human serum.
• Dilution Recovery: 10 samples (containing high EPO levels: 618.63-986.07 mIU/mL).
• Detection Capability (LoD): 323 determinations using 10 low-level samples.
• Cross-reactivity: Not explicitly stated as a "sample size," but involved numerous cross-reactants (e.g., various plasma proteins, epoetin alfa, darbepoetin alfa).
• Interference: Not explicitly stated as a specific "sample size" for each interferent, but involved various substances tested at different concentrations.
• Precision: 7 pooled serum samples. For each sample, there were 80 observations (replicates of 2, in 2 runs/day, over 20 days).
• Specimen Collection Comparison: 65 samples (serum EPO values ranging from 4.39 - 707.81 mIU/mL).
• Method Comparison:
  • Study 1: 216 human serum samples (range: 3.29 – 691.60 mIU/mL).
  • Study 2: 100 human serum samples from US population (range: 4.45 - 407.74 mIU/mL).
  • Study 3 (Multi-site): 327 human serum samples (range: 3.55 - 596.81 mIU/mL), with ≥ 100 samples per site.
• Expected Values (Adult): 251 apparently healthy subjects (128 males, 123 females), older than 21 years of age.
• Expected Values (Pediatric): 266 apparently healthy children (2 to <13 years) and adolescents (13 to <22 years).

Data Provenance:
The document does not explicitly state the country of origin for all data sets, but mentions:

• Method Comparison Study 2: "100 human serum samples from US population".
• Method Comparison Study 3: "3 sites, 2 within Europe and 1 within the US".
• Most studies imply retrospective (samples collected before the study) or prospective (samples collected during the study for specific evaluation), but this is not consistently specified for each study. For establishing expected values, samples were collected prospectively following specific criteria (e.g., healthy subjects, specific age ranges, exclusion criteria).

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

• This device is an in vitro diagnostic assay that measures erythropoietin levels. The "ground truth" for such assays typically comes from the actual concentration of the analyte in the biological sample, often confirmed by a reference method or standardized preparations.
• The document describes traceability to World Health Organization (WHO) International Reference Preparations and Standards (NIBSC codes 67/343 and 11/170). These international standards are established through collaborative studies involving multiple expert laboratories and scientists, but the immediate "ground truth" for the test samples in this submission would be their assigned values based on these standards or the results from the predicate device.
• No "experts" in the sense of radiologists or other clinicians interpreting images or assessments are directly involved in establishing the ground truth for individual test samples for this type of device. The ground truth is biochemical measurement.

4. Adjudication Method for the Test Set

• Not applicable. This is a quantitative diagnostic assay. "Adjudication" typically refers to resolving discrepancies between multiple human readers in diagnostic imaging or clinical assessment studies. For an immunoassay, the "ground truth" is a measured concentration.

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

• Not applicable. This is an immunoassay, not an AI-assisted diagnostic imaging or clinical decision support device involving human readers.

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

• Yes, the performance studies described (Linearity, Dilution Recovery, Measuring Interval, Detection Capability, High Dose Hook, Cross-reactivity, Interference, Precision, Specimen Collection Comparison, Method Comparison, Expected Values) represent the standalone performance of the ADVIA Centaur Erythropoietin (EPO) assay itself, meaning the algorithm/instrument's measurement capabilities without direct human interpretation of the final measurement result for diagnostic purposes. The device directly produces a quantitative EPO value.

7. The Type of Ground Truth Used

• Reference materials/standards: The assay is traceable to WHO International Reference Preparations/Standards for Erythropoietin.
• Predicate device comparison: For method comparison studies, the results from the legally marketed predicate device (Beckman Coulter Access EPO Assay) serve as a comparative "ground truth" to demonstrate substantial equivalence.
• Expert consensus (indirectly): The establishment of reference intervals (expected values) involved defining "healthy" populations based on standard medical criteria, which would implicitly rely on shared medical understanding and the consensus of medical professionals. The CLSI protocols referenced (e.g., EP28-A3) also represent a form of expert consensus on how to establish such values.
• Biochemical measurement: The fundamental ground truth is the actual concentration of EPO in the samples, determined through rigorous biochemical methods and validated against international standards.

8. The Sample Size for the Training Set

• For an immunoassay like this, there isn't a "training set" in the machine learning sense. The device is not learning from data in the same way an AI algorithm would. Instead, the assay's reagents, calibration curves, and analytical procedures are developed and optimized through extensive R&D and internal validation studies. The studies described in the 510(k) are primarily for verification and validation (V&V) of the final device's performance characteristics. Therefore, a specific "training set sample size" as might be provided for an AI/ML device is not applicable or provided.

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

• As above, the concept of a "training set" and its "ground truth" in the context of machine learning is not directly applicable to an immunoassay. The development of the assay involves extensive characterization of reagents, optimization of reaction conditions, and establishment of calibration curves using purified EPO standards of known concentrations, which are themselves traceable to international standards. The "ground truth" during this development phase would be the known concentrations of these standards.

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The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
The Access EPO calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

The Access® EPO assay consists of the reagent pack and calibrators. Other items needed to perform the assay include the Access substrate and wash buffers.

Here's a breakdown of the acceptance criteria and study information for the Access® EPO Assay based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Precision: Not explicitly stated as a separate "test set" in the context of clinical samples, but the study was performed on samples with EPO concentrations ranging from 9 to 475 mIU/mL.
• Dilution Recovery (Linearity): "Multiple human serum and plasma (heparin) samples." The exact number is not provided.
• Methods Comparison:
  • Internal Site Study: N=103
  • External Site Study: N=113
• Analytical Specificity: Not explicitly stated as a numerical sample size, but indicates testing for interference from "therapeutic drugs or similar compounds" and "potential sample contaminants."
• Data Provenance: The studies are described as "Internal Site Study" and "External Site Study," suggesting the data comes from within Beckman Coulter's testing facilities and at least one other external laboratory. The samples were "human serum and plasma (heparin)." The country of origin is not explicitly stated, but the submission is to the FDA (USA). The studies appear to be prospective in nature, as they involve testing the performance of the new Access® EPO assay.

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 an immunoassay, the "ground truth" for the test set is typically established by comparing the device's results to a well-established, often reference, method. In this case, the predicate device (RDS Quantikine ELISA) served as the reference for method comparison. The document does not describe expert adjudication for these numerical results.

4. Adjudication Method for the Test Set:

This is not applicable in the context of an immunoassay performance study focused on quantitative measurements. Adjudication methods (like 2+1, 3+1) are typically used in imaging or diagnostic accuracy studies where expert consensus is required to establish a qualitative or subjective ground truth. Here, the comparison is against an established quantitative predicate 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:

This information is not applicable to this device. The Access® EPO Assay is an in vitro diagnostic (IVD) immunoassay, not an AI-powered diagnostic imaging device or an AI human-in-the-loop system. Therefore, MRMC studies examining human reader performance with or without AI assistance are not relevant here.

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

Yes, the studies presented represent the standalone performance of the Access® EPO Assay. This is an automated immunoassay system; its performance metrics (precision, sensitivity, linearity, methods comparison, specificity, stability) characterize the algorithm and instrument's ability to quantitatively determine EPO levels without direct human interpretation of the assay's core output.

7. The Type of Ground Truth Used:

For the quantitative performance studies, particularly the "Methods Comparison," the ground truth was effectively the results obtained from established predicate devices, specifically the R&D Systems Quantikine IVD Erythropoietin ELISA Kit. These predicate devices are themselves validated diagnostic assays.

8. The Sample Size for the Training Set:

This information is not provided in the document. For an immunoassay, a "training set" in the context of machine learning isn't directly applicable in the same way it would be for an AI algorithm. Instead, "training" for such a system typically involves:

• Assay development and optimization using numerous samples.
• Establishing calibration curves using specific calibrator materials.
• Method validation experiments that might involve hundreds or thousands of samples over time.
  The document refers to "Summary of Performance Studies" as direct validation of the assay's performance attributes rather than detailing a distinct "training set."

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

As mentioned above, the concept of a "training set" with an explicitly established ground truth (like expert consensus or pathology for AI) is not directly applicable to this type of IVD immunoassay. The development and calibration of the assay would rely on:

• Reference materials/standards: The assay is standardized against the "WHO 2nd IRP 67/343" (International Reference Preparation). This serves as a fundamental "ground truth" for the quantitative measurement of EPO.
• Known concentrations: During assay development, samples with known EPO concentrations (often characterized by reference methods or gravimetric methods for primary standards) would be used to build and validate the assay's response curve.
• Cross-validation with existing methods: Early in development, comparison with established methods would help refine the assay's performance.

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IMMULITE EPO is a solid-phase, two-site sequential chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of erythropoietin (EPO) in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis of anemias and polycythemias.

IMMULITE® EPO is a solid-phase, two-site chemiluminescent sequential enzyme immunometric assay for use with the IMMULITE® Automated Immunoassay Analyzer

Here's a breakdown of the acceptance criteria and study information for the IMMULITE® EPO device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence through a method comparison, rather than pre-defined acceptance criteria with specific thresholds for accuracy, sensitivity, or specificity commonly seen with imaging devices. The acceptance criterion is implicit: the new device's performance must be comparable to the predicate device.

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

• Sample Size for Test Set: 130 endogenous serum samples.
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is from "endogenous serum samples," implying human samples. It is retrospective in the sense that these were pre-existing samples used for comparison.

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

• This device measures a quantitative biomarker (EPO levels) in serum/plasma. Its "ground truth" is established by the measurements obtained from a legally marketed predicate device (Incstar's EPO-Trac 125I RIA), which is itself a laboratory assay.
• Therefore, there were no human "experts" in the sense of radiologists reviewing images to establish a ground truth. The predicate device's results served as the reference.

4. Adjudication Method for the Test Set

• Not applicable. This was a quantitative method comparison study against a predicate device, not a study involving human interpretation or adjudication of cases. The comparison was statistical.

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

• No. This is an in vitro diagnostic (IVD) device for quantitative measurement of a biomarker, not an imaging device with AI assistance for human readers. Therefore, an MRMC study is not relevant here.

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

• Yes, this was effectively a standalone performance study. The IMMULITE® EPO system operates as an automated immunoassay analyzer, and its output (EPO concentration) is compared directly to the output of the predicate device (Incstar's EPO-Trac 125I RIA). There is no "human-in-the-loop" performance in the measurement process itself, beyond the initial sample collection and loading.

7. The Type of Ground Truth Used

• Ground Truth: The quantitative EPO concentration values obtained from the predicate device, Incstar's EPO-Trac 125I RIA.

8. The Sample Size for the Training Set

• This document describes a 510(k) submission, which focuses on demonstrating substantial equivalence of a new device to a predicate device. For such devices, training set information for an "algorithm" as understood in AI/ML is typically not provided or relevant. The IMMULITE® EPO system is a chemiluminescent immunoassay, a chemical and biological measurement system, not a machine learning algorithm that requires a "training set" in the computational sense.
• The assay itself is developed and validated, but the term "training set" doesn't apply in the same way as it would for an AI-powered diagnostic.

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

• Not applicable for the reasons mentioned in point 8. The device's calibration and assay parameters would be established through a different set of internal validation experiments and reference materials, not a "training set" with ground truth in the AI sense.

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