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The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.

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The provided text is related to a 510(k) premarket notification for a medical device called the "RDI Ferritin Calibrator Set." This document is a letter from the FDA to the manufacturer, confirming substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving device performance in the way typically expected for a diagnostic or AI-based device.

The RDI Ferritin Calibrator Set is a calibrator, meaning it's used to establish a reference for quantitative measurements in a laboratory test (the RDI Ferritin Kit). Its performance is typically assessed by ensuring it produces consistent and accurate calibration curves, which in turn allows the associated assay (the RDI Ferritin Kit) to accurately measure ferritin levels.

Therefore, most of the questions you've asked, which are relevant to clinical studies validating the performance of a diagnostic or AI device (e.g., sample size for test sets, experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device and are not present in this document.

However, I can extract the relevant information from the document:

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

• Not applicable / Not provided in this document. This document is a regulatory approval letter, not a performance study report. The acceptance criteria for a calibrator would typically relate to its ability to accurately calibrate the assay it is designed for, ensuring linearity, precision, and stability. These specific criteria and their fulfillment are not detailed here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable / Not provided in this document. This document does not describe a clinical performance study using patient samples. Test sets as typically understood for diagnostic devices are not relevant here.

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):

• Not applicable / Not provided in this document. Ground truth, in the context of clinical device validation, refers to a definitive diagnosis or measurement. For a calibrator, "ground truth" would relate to the certified values of the calibrator itself, and its ability to correctly calibrate an assay, rather than a clinical expert consensus on patient data.

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

• Not applicable / Not provided in this document.

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 / Not provided in this document. This is a calibrator, not an AI-assisted diagnostic device.

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

• Not applicable / Not provided in this document. This is a physical calibrator set for an in vitro diagnostic assay, not a standalone algorithm.

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

• Not applicable / Not provided in this document. For a calibrator, the "ground truth" would be the assigned values of the calibrator materials themselves, which are established through a rigorous manufacturing and testing process to ensure accuracy and traceability to reference methods. This information is not in the FDA letter.

8. The sample size for the training set:

• Not applicable / Not provided in this document. This device is not an AI algorithm requiring a training set.

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

• Not applicable / Not provided in this document.

Summary of what is in the document:

• Device Name: RDI Ferritin Calibrator Set
• Intended Use: To establish points of reference for the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement, for use with the RDI Ferritin Kit.
• Regulatory Status: Class II device, found substantially equivalent to legally marketed predicate devices.
• Product Code: JIT
• Approval Date: March 13, 2006

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The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.

The Ferritin Calibrator is a liquid bovine albumin-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.

Based on the provided text, the device is a medical calibrator, not an AI or imaging device, so many of the requested fields (like sample size for test/training sets, expert ground truth, MRMC studies) are not applicable or not found in the document. The document focuses on regulatory approval based on substantial equivalence to a predicate device.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic device. Instead, the "acceptance criteria" appear to be met by demonstrating substantial equivalence to an existing predicate device. The performance is assessed by comparing key attributes.

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

• Sample Size for Test Set: Not applicable/Not provided. This is a calibrator, not a diagnostic device evaluated with patient samples. The "test" here is a comparison of product attributes against a predicate.
• Data Provenance: Not applicable/Not provided in the context of patient data. The comparison is based on the characteristics of the calibrator itself.

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

• Not applicable. Ground truth for patient data is not relevant for a calibrator. The "truth" in this context is the stated characteristics of the calibrator and its preparation against a WHO standard.

4. Adjudication method for the test set

• Not applicable. There is no subjective interpretation or adjudication process described as this is a product comparison, not a diagnostic performance study.

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 a calibrator for a clinical chemistry system, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a calibrator, not an algorithm.

7. The type of ground truth used

• For the calibrator values themselves: WHO standard (2nd IS for predicate, 3rd IS for modified device). This refers to the internationally recognized standard for ferritin. The base matrix is bovine albumin, and the ferritin is from human liver.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, there is no training set for this type of device.

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The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.

The Ferritin Calibrator is a lyophilized bovine serum-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.

This document is a 510(k) summary for a Ferritin Calibrator and does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance. The document focuses on establishing substantial equivalence to a predicate device.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria and Reported Device Performance: The document provides a comparison table between the new device and a predicate device, focusing on features like intended use, analytes, matrix, form, volume, and levels. It does not present specific performance metrics (e.g., accuracy, precision, linearity) with defined acceptance criteria that the new device had to meet. It states that the "Ferritin Calibrator is substantially equivalent to the IMx® Ferritin Calibrator based on the comparison discussed above," implying that equivalence in design and intended use is the primary claim, not a separate performance study against pre-defined metrics.

2. Sample Size and Data Provenance: This information is not present. There's no mention of a test set, its size, or the origin of any data.

3. Number and Qualifications of Experts for Ground Truth: Not applicable as there's no mention of a study involving expert assessment for establishing ground truth.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This document pertains to a calibrator, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study: The document doesn't describe a standalone performance study with detailed results for the new Ferritin Calibrator. Its claim is based on comparison to the predicate.

7. Type of Ground Truth Used: Not applicable. For a calibrator, "ground truth" would typically relate to the accuracy of the ferritin concentration itself, which is not detailed here as a study outcome.

8. Sample Size for Training Set: Not applicable. Calibration materials are generally manufactured to specifications, not "trained" in the machine learning sense.

9. How Ground Truth for Training Set Was Established: Not applicable for the same reason as above.

In summary, this document is a regulatory submission for substantial equivalence based on product characteristics and intended use, not a detailed performance study report with acceptance criteria and clinical/technical study results as you've outlined in your query.

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