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The K-ASSAY RF Calibrator Set is intended to be used for the calibration of the K-ASSAY RF immunoturbidimetric assay for quantitating Rheumatoid Factor in serum samples.

K-ASSAY Rheumatoid Factor Calibrator Set

This document is a 510(k) clearance letter from the FDA for a device called "K-ASSAY Rheumatoid Factor Calibrator Set." It is not a study report or a pre-market approval application with detailed device performance data. Therefore, the information requested in your prompt regarding acceptance criteria and study details cannot be fully extracted from this document.

The document states that the FDA "reviewed your Section 510(k) notification of intent to market the device... and we have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device met the criteria for substantial equivalence, primarily by demonstrating that it is as safe and effective as a legally marketed predicate device.

However, the specific "acceptance criteria" for performance metrics and the "study that proves the device meets the acceptance criteria" with the level of detail you've requested are not provided in this regulatory clearance letter. Such information would typically be found in the 510(k) submission itself, which is not this document.

Based on the provided document, here's what can be inferred or explicitly stated, and what cannot:

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

   • Cannot be provided. This letter does not contain a table of acceptance criteria or performance metrics for the K-ASSAY RF Calibrator Set. The substantial equivalence determination implies that the device's performance was deemed acceptable in comparison to a predicate, but the specific numerical targets or results 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):

   • Cannot be retrieved. The document doesn't mention any specific test set sample sizes or data provenance for a study.

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):

   • Cannot be retrieved. This information is related to a clinical study, which is not detailed in this clearance letter.

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

   • Cannot be retrieved. This information is related to a clinical study, which is not detailed in this clearance letter.

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 calibrator set, not an AI-assisted diagnostic imaging device. MRMC studies are typically for imaging devices with human interpretation.

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

   • Likely applicable, but details unknown. As a calibrator set for an immunoturbidimetric assay, its performance would be evaluated in a "standalone" analytical context (i.e., how accurately it calibrates the assay system), but the specifics of such a study are not in this document.

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

   • Cannot be retrieved. For a calibrator, "ground truth" would likely relate to reference standards or known concentrations, but the specifics are not mentioned here.

8. The sample size for the training set:

   • Not applicable/Cannot be retrieved. As a calibrator set, it typically doesn't involve "training sets" in the machine learning sense. If there were method development or validation sets, their sizes are not disclosed.

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

   • Not applicable/Cannot be retrieved. Similar to point 8, this concept doesn't directly apply as described for a calibrator. Ground truth for calibration materials would involve traceability to reference measurement procedures or certified reference materials, but the specific methods are not provided.

In summary, this document is an FDA clearance letter confirming substantial equivalence to a predicate device for a calibrator set. It does not provide the detailed scientific study data, performance metrics, or clinical trial information that would allow full answers to your questions. This detailed information would have been part of the manufacturer's 510(k) submission to the FDA.

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The K-ASSAY Rheumatoid Factor is intended to be used for the quantitative determination of human rheumatoid factor in human serum by immunoturbidimetric assay.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "K-ASSAY Rheumatoid Factor." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information required to answer the questions about acceptance criteria and a study proving device performance in the manner requested.

The FDA 510(k) process primarily evaluates a new device's "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as an already legally marketed device. It does not typically require the submission of detailed clinical trials with specific acceptance criteria and outcome measures as one might find in a Premarket Approval (PMA) application or a comprehensive scientific publication.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the document:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The letter states the device is "substantially equivalent" to predicate devices, but it does not provide specific performance metrics or acceptance criteria used in the equivalence determination.

2. Sample size used for the test set and the data provenance: This information is not present. The type of study (if any, beyond equivalency testing) and details about the test set (sample size, origin, retrospective/prospective) are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. Ground truth establishment details are not part of this regulatory letter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present.

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 or present. The device is an in vitro diagnostic (IVD) for quantitative determination of rheumatoid factor, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device appears to be a standalone in vitro diagnostic assay for laboratory use, but the details of its "standalone" performance (e.g., sensitivity, specificity, accuracy) are not provided in this regulatory letter. The performance data would have been part of the 510(k) submission, but is not detailed here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present. For IVDs, ground truth typically involves reference methods or established clinical diagnoses, but the specifics are not in this letter.

8. The sample size for the training set: This information is not present. IVDs are typically "trained" through assay development and validation, not in the same way an AI algorithm has a distinct "training set."

9. How the ground truth for the training set was established: This information is not present.

In summary, this document is a regulatory approval and confirms the device's substantial equivalence to existing devices. It does not provide the underlying technical and clinical study details that would address the requested questions about acceptance criteria and performance studies. Those details would typically be found in the full 510(k) submission or associated technical documentation, which is not provided here.

Ask a specific question about this device