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The provided document is an FDA 510(k) clearance letter for a medical device called "xTAG CYP2D6 Kit V3". This type of document does not contain the detailed technical information about acceptance criteria, study methodologies, or performance data that would be necessary to answer your request.

The letter confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to a legally marketed predicate device. It informs the manufacturer about regulatory obligations but does not include the specifics of the performance studies.

To get the information you are looking for (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.), you would typically need to refer to documents like:

• The 510(k) summary or 510(k) Traditional submission itself, which is often publicly available through the FDA's database.
• The device's Instruction for Use (IFU) or Product Insert, which usually contains performance data.
• Scientific publications if the study results were published in peer-reviewed journals.

Therefore, based solely on the provided document, I cannot fulfill your request for: a table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details.

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The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from an EDTA or citrate anticoagulated whole blood sample. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand- alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

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This document is a 510(k) clearance letter for a medical device called the xTAG® CYP2D6 Kit v3. It indicates the device is substantially equivalent to legally marketed predicate devices. However, it does NOT contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets them.

The letter primarily covers the regulatory approval of the device and its intended use. It does not include:

• A table of acceptance criteria and reported device performance: This sort of data would typically be found in the 510(k) summary or the pivotal study report, not in the clearance letter itself.
• Sample sizes used for the test set and data provenance: Again, this detailed study information is not part of the clearance letter.
• Number of experts and their qualifications for ground truth: This pertains to the study design, not the FDA's regulatory decision letter.
• Adjudication method for the test set: Study design detail absent from this document.
• MRMC comparative effectiveness study details (effect size): This device is a genotyping kit, not an AI-assisted diagnostic imaging device for human readers, so an MRMC study with human readers would not be relevant or performed.
• Standalone algorithm performance: This is a lab kit, not an "algorithm" in the sense of AI software. Its performance is evaluated biochemically/molecularly.
• Type of ground truth used: While the ground truth for genetic testing is typically highly reliable reference methods (e.g., Sanger sequencing, alternative validated genotyping assays), the clearance letter doesn't specify this for this particular study.
• Sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set in that context.
• How ground truth for the training set was established: Not applicable.

In summary, the provided document does not contain the information requested in your prompt regarding acceptance criteria and study details. To find this information, you would typically need to consult the 510(k) summary submitted by the manufacturer to the FDA, which often contains a more detailed description of the performance studies.

Ask a specific question about this device

The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or nonresponse.

The xTAG CYP2D6 Kit v3 includes the following components:

• xTAG® 2D6 v3 PCR Primer Mix A
• xTAG® 2D6 v3 PCR Primer Mix B
• xTAG® 2D6 v3 ASPE Primer Mix
• xTAG® 2D6 v3 Bead Mix
• xTAG® 10x Buffer
• xTAG® Shrimp Alkaline Phosphatase
• xTAG® Exonuclease I
• xTAG® Streptavidin, R-Phycoerythrin Conjugate
• Platinum TI Exo(-) DNA Polymerase
• Platinum® Tfl Reaction Buffer, 5x
• Tfi 50mM MgCl3
• xTAG® Hot Start Taq (Long Acting)
• xTAG® 10x Tag Buffer (Long Acting)
• xTAG® Data Analysis Software (TDAS) CYP2D6

The provided document describes the xTAG® CYP2D6 Kit v3, a qualitative genotyping assay for detecting nucleotide variants and gene rearrangements in the CYP2D6 gene. The performance characteristics focus on accuracy, reproducibility, detection limit, analytical specificity, and matrix comparison, using bidirectional DNA sequencing as the comparator.

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Accuracy Study (Test Set): 459 clinical samples.
• Data Provenance: The majority of samples were "left-over, anonymized, banked extracted DNA from EDTA or citrate anticoagulated whole-blood specimens." For rare alleles, the sample set was supplemented with "blended" samples where linearized plasmid DNA was quantitatively added to genomic DNA to mimic heterozygous samples. The country of origin is not explicitly stated, but the applicant is based in Toronto, Canada. Given the nature of banked specimens, it implies retrospective data.

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

The ground truth was established by bidirectional DNA sequencing, which is a laboratory method, not human expert interpretation in this context. Therefore, the concept of "number of experts" and their "qualifications" for ground truth establishment does not directly apply here. The sequencing results themselves are considered the gold standard.

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

There is no mention of an adjudication method used in this report. The comparison is directly between the device's results and the bidirectional DNA sequencing results. Discrepancies were "re-tested," but a formal adjudication process involving multiple readers/reviewers is not 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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a qualitative genotyping assay, not an AI-assisted diagnostic tool that would involve human readers interpreting images or results with and without AI. The output is a qualitative genetic call.

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

Yes, the accuracy and reproducibility studies represent the standalone algorithm performance (referred to as "device performance"). The xTAG® CYP2D6 Kit v3, with its associated Data Analysis Software (TDAS), performs the genotyping and provides qualitative calls. While human operators are involved in the laboratory procedures, the final "call" or genotype determination is made by the system, as evidenced by the method comparison against sequencing. The intended use also states, "This kit is not indicated for stand-alone diagnostic purposes," referring to clinical diagnosis, not the algorithmic performance itself.

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

The type of ground truth used was bidirectional DNA sequencing. This is a molecular biology technique considered highly accurate for determining DNA sequences and identifying genetic variants, serving as the gold standard for genetic genotyping in this context.

8. The sample size for the training set

The document does not explicitly state a sample size for a training set. Given the nature of a laboratory assay, it's likely that internal validation and optimization were performed during development, but these are not reported as distinct "training sets" in the context of machine learning, which is where that term is most commonly applied. The "Performance Characteristics" section details validation studies (accuracy, reproducibility, etc.) which act as a test of the final product.

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

Since a distinct training set is not explicitly mentioned or characterized, the method for establishing its ground truth is not provided. If internal developmental samples were used for optimization, it is highly probable that similar gold standard methods, such as DNA sequencing, would have been employed.

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