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The xTAG® Cystic Fibrosis 39 kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the worlds most common and North Americanprevalent mutations. The xTAG Cystic Fibrosis 39 kit v2 is a qualitative genotyping test which provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.

The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.

The xTAG CFTR 39 kit v2 includes the following components:

• PCR Primer Mix v2 including dNTPs designed to simultaneously produce 23 amplimers of the CFTR gene (24 in the presence of CFTR del 2, 3).
• ASPE Mix A v2 including dNTPs contains primers designed to hybridize to either wild-type or mutant alleles ◆ with proprietary sequences at their 5' ends designed to specifically hybridize to complementary sequences coupled to a given bead population in Bead Mix A.
• Bead Mix A v2 contains spectrally distinguishable populations of polystyrene beads internally dyed with red and . infrared fluorochromes coupled to proprietary DNA sequences designed to specifically hybridize to complementary sequences on the ASPE primers in ASPE Mix A v2.
• 10X Buffer
• Platinum® TFI DNA Polymerase .
• Platinum® TFI Reaction Buffer .
• TFI MgCl2 .
• Shrimp Alkaline Phosphatase .
• Exonuclease I .
• Strepavidin-Phycoerythrin Conjugate .
• xTAG Data Analysis Software (TDAS) CFTR .

Here's a breakdown of the acceptance criteria and study details for the xTAG® Cystic Fibrosis 39 kit v2, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the "overall accuracy" and "agreement with comparator" percentages, which were consistently 100% or very close to it across various sample types and individual alleles, especially after any allowed reruns.

2. Sample Sizes Used for Test Set and Data Provenance

• Test Set Sample Size:
  • Clinical Samples: 319 independent clinical samples.
  • Cell Lines: 8 cell lines.
  • Plasmids: Number of plasmids tested is not explicitly stated for the accuracy study calculation, but they were used to supplement samples.
  • Per Allele Reproducibility: Varied per allele, ranging from 6 to 468 total calls across all sites (e.g., 36 calls for G85E, 468 for dF508).
• Data Provenance: The majority of samples consisted of left-over, anonymized, banked whole-blood specimens. These were supplemented with genomic DNAs from EBV-transformed lymphoid cell lines and custom-designed plasmids. Archived clinical genomic DNA samples were obtained from a variety of sources. The document does not specify the country of origin, but study sites included Hartford Hospital, Connecticut, USA; Luminex Molecular Diagnostics, Toronto, Canada; and Hospital for Sick Children, Toronto, Canada, suggesting a North American provenance. The nature of the samples (archived clinical genomic DNA, banked specimens) indicates a retrospective study design.

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

The document does not explicitly mention the use of "experts" to establish ground truth in the traditional sense of medical image interpretation or clinical diagnosis. Instead, the ground truth was established by comparison with a predicate device. The "FDA cleared xTAG Cystic Fibrosis Kit (K043011 and K060627)" was used as the comparator for all clinical specimens. No human experts are described as part of ground truth establishment for the test set.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by comparison with a predicate device, not by human expert consensus requiring adjudication. The study mentions "allowable re-runs" for device performance, but this is an internal process, not an adjudication of a human expert ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is typically performed for AI systems that aid human readers in diagnostic tasks, such as medical image interpretation. The xTAG® Cystic Fibrosis 39 kit v2 is a laboratory diagnostic test for gene mutation detection, which does not involve human readers interpreting images with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this was a standalone study of the device. The device, which includes "xTAG Data Analysis Software (TDAS) CFTR," processes MFI signals from the Luminex instrument to "provide a final qualitative genotype for the sample." The performance evaluation focuses on the accuracy and reproducibility of this automated process against a comparator device, without human intervention in the interpretation phase for the reported performance metrics.

7. Type of Ground Truth Used

The ground truth was established by comparison with a predicate device ("FDA cleared xTAG Cystic Fibrosis Kit (K043011 and K060627)"). This indicates that the established genotypes of the samples (both positive and negative for various mutations/variants) were determined using another FDA-cleared CFTR mutation detection system.

8. Sample Size for the Training Set

The document does not provide details on a separate "training set" or its size. This is common for traditional in vitro diagnostic (IVD) kits, where performance is typically validated through studies demonstrating accuracy, precision, and reproducibility, rather than through machine learning model training. The device uses "proprietary software," but the development and validation process is likely based on established molecular diagnostics principles and analytical validation rather than a machine learning training/validation split.

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

Not applicable, as a distinct training set (in the machine learning sense) and its ground truth establishment are not discussed in the provided document. The device's performance evaluation focuses on its accuracy against a predicate device and its internal reproducibility.

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The Tag-It™ Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the worlds most common and North American-prevalent mutations. The Tag-It™ Cystic Fibrosis Kit is a qualitative genotyping test which provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.

The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.

Tag-It™ Cystic Fibrosis Kit includes the following components:

• Multiplex PCR Primer Mix including dNTPs designed to simultaneously produce 16 amplimers of the CFTR gene
• Multiplex ASPE Primer Mix including dNTPs (86 primers designed to hybridize to either wild-type or mutant alleles with proprietary sequences at their 5' ends designed to specifically hybridize to complementary sequences coupled to the bead component of the kit)
• Coupled Bead Suspension (86 spectrally distinguishable populations of 5.0 micron polystyrene beads internally dyed with red and infrared fluorochromes coupled to proprietary DNA sequences designed to specifically hybridize to complementary sequences on the ASPE primers)
• 10X Wash Buffer
• Tag-It™ Data Analysis Software (TDAS CF-I)

The provided text is a 510(k) summary for the Tag-It™ Cystic Fibrosis Kit and describes a modification to an already cleared device. It states that "The Tag-It™ Cystic Fibrosis Kit performance parameters remain unchanged" and "Performance data from validation testing supports equivalency."

Therefore, the document does not contain explicit acceptance criteria for the modified device, nor does it detail a new study with specific performance metrics for this particular submission (K060627). It relies on the previously cleared device's performance data (K043011) to establish substantial equivalence for the unchanged performance parameters.

Given this, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory submission affirming that performance parameters are unchanged, rather than reporting new performance data against acceptance criteria for the current submission.

If I were to infer, the "acceptance criteria" would be that the performance parameters of the modified device are equivalent to those of the predicate device (K043011). The "study" for this submission is essentially the demonstration that the modification does not alter performance, which is stated as "Performance data from validation testing supports equivalency," but no details of this validation testing are provided.

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The eSensor® Cystic Fibrosis Carrier Detection (CFCD) System is a device for the detection of carrier status for cystic fibrosis for all adult couples contemplating pregnancy, regardless of ethnicity. It is a qualitative genotyping assay that simultaneously detects mutations currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG). The eSensor® CFCD System is not indicated for prenatal screening or for diagnostic purposes, and is for Rx only professional use within the confines of a licensed laboratory, as defined by the Clinical Laboratory Improvement Amminents (CLIA) of 1988.

The eSensor® Cystic Fibrosis Carrier Detection System is an in vitro diagnostic test for the detection and genotyping of a selected panel of 24 cystic fibrosis mutations from DNA isolated from human whole blood.

The CFCD System is a clinical multiplex genetic test system which includes reagents for polymerase chain reaction amplification, exonuclease digestion and hybridization of target DNA, instrumentation and software. The CFCD System uses electrochemical detection to determine the carrier status of patient blood specimens for the ACOG/ACMG recommended panel of 24 cystic fibrosis mutations. Sample preparation for genotyping involves converting each blood specimentions: "Bunp genomic DNA (gDNA); then using multiplex PCR amplification followed by exonuclease digestion to convert the gDNA into a set of single-stranded targets. The genotyping reaction is set up with the combination of the single-stranded targets with appropriate buffers containing allele-specific signal probes differentially labeled with electrochemical signaling molecules, called ferrocenes. This mixture is then loaded into cartridges that contain single-stranded capture probes bound to an array of electrodes, with each electrode containing capture probess specific for a single mutation. Cartridges are inserted into the eSensor 4800 Instrument where the single-stranded targets hybridize to the complementary sequences of the carture probes and signal probes. Detection of the target/probe complexes is achieved using alternating current voltammetry that generates specific electrical signals from the hybridized signal probes. The eSensor® DNA Detection System Application Software then classifies the signals from each mutation and generates a report for each specimen that describes the carrier or non-carrier status of each of the cystic fibrosis panel mutations.

The requested information is detailed below, based on the provided text:

Acceptance Criteria and Device Performance for eSensor® Cystic Fibrosis Carrier Detection System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the entire system's performance metrics (e.g., a target percentage for overall agreement). However, it reports the performance observed in the studies. Given the context of a 510(k) submission, the "performance characteristics" section details the metrics used to demonstrate substantial equivalence. I will present the reported performance as if they implicitly represent the achieved acceptance criteria based on the clearance.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set:
  • Method Comparison: 486 samples (freshly collected and banked) were used.
  • Reproducibility: Genomic DNA samples from one non-carrier cell line and 20 carrier cell lines (expressing all 23 panel mutations) were used. This set was tested repeatedly.
  • Input DNA Requirements: 96 tests were performed with 10 ng gDNA samples.
• Data Provenance: The document does not explicitly state the country of origin of the data. It refers to "freshly collected and banked samples" for the method comparison, implying a retrospective component to the data collection, potentially combined with prospectively collected samples.

3. Number and Qualifications of Experts for Ground Truth

The document does not mention the number or specific qualifications of experts used to establish the ground truth.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned in the provided text. The device is for laboratory use, not image interpretation by human readers.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Method Comparison" section directly compares the CFCD System's results to DNA sequencing, which serves as the reference standard, demonstrating the algorithm's performance without direct human-in-the-loop intervention during the genotyping output.

7. Type of Ground Truth Used

The primary type of ground truth used for performance evaluation was DNA sequencing. This is considered a highly reliable and definitive method for genetic mutation detection.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. The performance data focuses on validation and comparison.

9. How Ground Truth for the Training Set Was Established

The document does not describe how ground truth was established for a training set, as a specific training set size is not mentioned. It is common for such systems to be developed and optimized using a variety of known samples, but the specifics are not provided in this summary. The ground truth for the validation test set was established by DNA sequencing.

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