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The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.

The Access Ferritin assay is a sandwich immunoenzymatic assay. The Access Ferritin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Ferritin assay reagent pack, Access Ferritin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

Device Name: Access Ferritin

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size (Method Comparison): 147 samples
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the method comparison samples. It only mentions "patient samples" in the context of the CLSI guidance document referenced (CLSI EP09c: Measurement Procedure Comparison and Bias Estimation Using Patient Samples).
• Test Set Sample Size (Precision, LoB, LoD, LoQ):
  • Precision: 80 replicates for each of the 6 concentration levels (1.2, 13, 147, 289, 560, 1276 ng/mL) are reported in the table. The study design mentions "tested multiple samples in duplicate in 2 runs per day for a minimum of 20 days," which would result in 80 measurements (2 replicates x 2 runs/day x 20 days).
  • LoB: 75 replicates of native samples.
  • LoD: Five to nine serum samples containing low levels of Ferritin analyte, tested over five days with one run per day and nine replicates per run for each pack lot (resulting in ≥ 40 replicates minimally required for LoD estimation for each sample on each pack lot tested).
  • LoQ: Eight to twelve serum samples containing low levels of Ferritin analyte, tested in replicates of nine per run with one run per day and five total days on each pack lot and instrument (resulting in a minimum of 40 replicates for each sample on each pack lot).
• Provenance for Precision, LoB, LoD, LoQ: Not specified, other than "native samples" or "serum samples."

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

This device is an in-vitro diagnostic (IVD) immunoassay for quantitative determination of ferritin levels. Ground truth for such devices is typically established through reference methods or established laboratory gold standards rather than expert consensus on interpretive tasks. The document does not mention any involvement of human experts or radiologists in establishing ground truth for the test set performance evaluation. The "ground truth" here would be the actual ferritin concentration as determined by the predicate device (for method comparison) or highly controlled, characterized samples (for precision, linearity, limits).

4. Adjudication Method for the Test Set

Not applicable. As an IVD immunoassay, the "ground truth" or reference values are determined by laboratory measurements, not by human expert adjudication in the traditional sense (e.g., 2+1 for image interpretation).

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

No. An MRMC study is relevant for diagnostic imaging or similar interpretive tasks involving multiple human readers. This document describes the performance evaluation of an automated immunoassay system, which does not involve human readers interpreting results in the same way.

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

Yes. The entire study describes the standalone performance of the Access Ferritin assay on the Dxl 9000 Access Immunoassay Analyzer. This is an automated system; the performance metrics (method comparison, precision, linearity, limits) are intrinsic to the assay and instrument combination without human intervention in the result generation or interpretation other than standard lab operating procedures.

7. The Type of Ground Truth Used

• Method Comparison: The "ground truth" or reference values for the method comparison study were obtained from the predicate device, the Access Ferritin assay run on the Access Immunoassay System (K926221/K052082).
• Precision, Linearity, LoB, LoD, LoQ: Ground truth for these studies was established using characterized samples (e.g., samples with known or carefully prepared concentrations, native low-level samples, or blank samples). These are standard practices in IVD analytical performance evaluation.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. This is an immunoassay, not a device that uses AI models that require traditional training data. The development of the assay and its associated reagents/software would have involved internal R&D studies, but these are not described as a "training set" in the common AI sense.

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

Not applicable, as this is not an AI/ML device with a distinct "training set" as described in AI development. The "ground truth" for developing the assay itself would have involved extensive biochemical and analytical characterization in a laboratory setting.

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The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

The Access Ferritin reagents, Access Ferritin Calibrators and the Access Wash Buffer used in conjunction with the Access Immunoassay Analyzers (Access, Access 2, Synchron LX® 725, and UniCel DxI™ 800) comprise the Access Immunoassay Systems for the quantitative determination of ferritin levels in human serum and plasma (heparin).

The 510(k) summary provided describes the "Ferritin on the Access® Immunoassay Systems" device and a modification to it. The modification involves the addition of an auto-dilution feature and a change to the assay protocol file for improved particle mixing and reagent aspiration. The document asserts that these changes do not affect assay performance characteristics.

However, the provided text does not include a detailed study that proves the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested. What is provided is a statement of substantial equivalence to a predicate device, based on the absence of changed performance characteristics due to the modification.

Therefore, many of the requested elements for describing the acceptance criteria and study are not available in the provided document.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria (e.g., precision, accuracy, linearity targets) and their corresponding achieved performance values are explicitly stated in the provided text. The document states:

• "The change does not affect assay performance characteristics."
• "The changes do not affect assay reaction kinetics."

This implies that the modified device's performance is expected to be substantially equivalent to the predicate device, but no quantitative performance data or specific acceptance criteria are presented.

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

• Sample size for test set: Not mentioned.
• Data provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

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

Not applicable, as no study establishing ground truth for a test set is described. The submission focuses on modifications to an existing device, asserting that performance characteristics are unchanged.

4. Adjudication method for the test set

Not applicable, as no study establishing ground truth for a test set is described.

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 for human readers.

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

This is an automated immunoassay system, so its inherent mode of operation is "standalone" in terms of direct measurement. However, no specific "standalone performance study" with detailed metrics is described beyond the assertion that performance characteristics are unchanged.

7. The type of ground truth used

Not explicitly stated for any evaluation related to the auto-dilution feature or assay protocol file modification. The primary justification for substantial equivalence is that the modifications do not affect the established performance of the predicate device.

8. The sample size for the training set

Not mentioned. This type of device (immunoassay) generally relies on calibration materials and quality control samples rather than a "training set" in the machine learning sense.

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

Not applicable, as no "training set" in the machine learning sense is described. Calibrators are mentioned (Human liver ferritin at various levels), which would have their values established by a reference method, but the details are not in the document.

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Immunological.in. vitro immunoturbidometric.test for the quantitative determination of ferritin.in . .... human serum and plasma using clinical-chemistry analyzers.

The Ferritin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing ferritin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution containing fine latex particles coated with polyclonal anti-human ferritin antibodies (R₂ reagent) is added to mixture of the first step. The antibody-coated particles will bind to the ferritin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of ferritin present in the sample.

The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of ferritin in the sample is directly proportional to the amount of turbidity formed.

The provided text describes the "Tina-quant® Ferritin Assay" and its substantial equivalence to a predicate device, the "Enzymun-Test® Ferritin assay." It includes performance characteristics and comparisons, which serve as the acceptance criteria and the results of the study.

Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" as a set of pass/fail thresholds. Instead, it presents the performance characteristics of the new device (Tina-quant® Ferritin) and compares them to the predicate device (Enzymun-Test® Ferritin). The implied acceptance criteria are that the performance of the Tina-quant® Ferritin assay should be comparable to or better than the predicate device.

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

• Precision:
  • Intra-Assay: 21 samples for each of the three levels (Low, Mid, High).
  • Inter-Assay: 2 samples (Sample 1, Sample 2).
• Method Comparison: 44 samples (N=44) for comparison against the Enzymun-Test® Ferritin using Passing/Bablok and Least Squares methods.
• Interfering Substances: The document does not specify the exact sample size for interfering substances, but it indicates "No interference at" certain concentrations.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It is a submission to the U.S. Food and Drug Administration (FDA), implying it was conducted for regulatory purposes in the US. The context suggests these were performance studies conducted with the device, likely prospective for the purpose of demonstrating performance.

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

This is an in-vitro diagnostic (IVD) device for quantitative determination of Ferritin. The "ground truth" for such devices is typically established through reference methods or highly accurate analytical techniques, not by human expert assessment in the same way an imaging device would be.

• The document mentions the use of NIBSC standard 80/602 and 80/578 (human liver and spleen) for calibration. These are recognized international standards for Ferritin, which serve as a form of "ground truth" for accuracy and calibration.
• No human experts are mentioned for establishing ground truth for the analytical performance of this type of quantitative assay.

4. Adjudication method for the test set

Not applicable for an in-vitro diagnostic analytical assay where ground truth is established chemically/biochemically using reference standards and methods, not through human interpretation requiring 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 is an in-vitro diagnostic device, not an AI-powered image analysis or diagnostic support system for human readers.

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

Yes, the performance characteristics provided (Precision, Detection Limit, Linearity, Method Comparison, Interfering Substances, Specificity) are measurements of the standalone performance of the Tina-quant® Ferritin assay. This device is designed to provide quantitative results directly from a clinical chemistry analyzer, without requiring human interpretation or "human-in-the-loop" decision-making for each result.

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

The ground truth for this in-vitro diagnostic assay is established through:

• Reference standards: NIBSC standard 80/602 and 80/578 (human liver and spleen) are used for calibration and presumably for validating accuracy.
• Comparative methods: The device's performance is compared against another legally marketed device (Enzymun-Test® Ferritin assay), which implies using the results from the predicate as a reference for method comparison studies.
• Known concentrations: For studies like linearity and interfering substances, samples with known concentrations of ferritin or interfering substances would be used.

8. The sample size for the training set

Not explicitly stated. For IVDDs, particularly those based on established immunoturbidimetric principles, "training sets" in the AI sense are not typically used. The development process involves optimizing reagents and reaction conditions, followed by validation studies. However, the data for optimization or early development are generally not referred to as a "training set" in the context of this type of device.

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

Not applicable in the AI sense of a "training set." For method development and optimization, ground truth would be established similarly to the test set: using reference materials, spiked samples with known concentrations, and comparisons to established analytical methods.

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Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" us intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

The Elecsys® Ferritin employs a sandwich test principle with monoclonal antibodies directed against ferritin and with streptavidin microparticles and electrochemiluminescence detection. Total duration of assay: 18 minutes. • 1st Incubation: 15 µl of sample a biotinylated monoclonal ferritin-specific antibody and a monoclonal ferritin-specific antibody labeled with a ruthenium complex react to form a sandwich complex. • 2nd Incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

The provided text is a 510(k) summary for the Elecsys® Ferritin device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, and performance data typically found in a clinical study report or a more comprehensive regulatory submission.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets, data provenance, expert details, or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone performance.
• Details on how ground truth was established for training and test sets.

The document is purely a summary for regulatory clearance, stating the device's function and its substantial equivalence to a previously approved device (Enzymun-Test® Ferritin), without going into the specifics of performance studies required to demonstrate that equivalence against pre-defined criteria.

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The FERR Flex™ reagent cartridge is used on the Dimension™ RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma.

The FERR Flex™ Reagent Cartridge is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles, coated with monoclonal anitbodies specific for ferritin and conjugate reagent consisting of B-galactosidase labeled monoclonal antibodies specific for a second binding site on ferritin to form a particle-ferritin-conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound Bgalactosidase is combined with a chromogenic substrate chlorophenl red-b-dgalactopyranoside (CPRG). Hydrolvsis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of ferritin in the original sample.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Summary of Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 60 clinical patient samples
• Data Provenance: The text states "clinical patient samples," implying human samples, but the country of origin is not specified. The study is retrospective, as it compares the new device with an existing predicate device using collected samples.

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

• This information is not provided in the text. The ground truth appears to be established by comparison to a predicate device, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

• None directly mentioned in the context of expert review. The "adjudication" is essentially the statistical comparison (correlation, slope, intercept) between the new device and the predicate device.

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

• No. This type of study is not relevant for this device, which is an in-vitro diagnostic (IVD) measurement system, not an imaging or diagnostic aid for human readers.

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

• Yes. The study evaluates the performance of the "Ferritin Flex™ Reagent Cartridge" on the "Dimension™ RxL clinical chemistry system" in a standalone manner by comparing its output to a predicate device. There is no human intervention in generating the measurement results from either device once the sample is loaded.

7. The Type of Ground Truth Used

• The ground truth (or reference standard) is the measurement obtained from the Abbott Laboratories IMx® Ferritin assay, which is the predicate device.

8. The Sample Size for the Training Set

• This information is not provided in the text. As this is an immunoassay reagent cartridge, there might not be a "training set" in the machine learning sense. The device developers would have characterized the reagent performance during R&D, but the text does not detail those internal studies.

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

• This information is not provided in the text. Similar to point 8, the concept of a "training set" ground truth isn't applicable in the same way as for AI/ML algorithms. The predicate device's performance would have been established through its own validation studies.

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