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HemosIL FII & FV DNA Control is intended for in vitro diagnostic use as a heterozygous quality control to monitor analytical performance of the extraction, amplification and detection steps of the Xpert™ HemosIL FII & FV genotyping assay on the GeneXpert® Dx System used in the detection of both the Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.

HemosIL FII & FV DNA Control is synthetic Factor V DNA suspended in a non-infectious blood-like matrix. Each vial includes normal and mutated Factor II and Factor V DNA sequences and is configured as a heterozygous control for both Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.

The quality control material is validated for use with Xpert™ HemosIL® FII & FV genotyping assay on the GeneXpert® Dx System and is processed exactly as whole blood samples during the extraction, amplification and detection steps.

The HemosIL® FII & FV DNA Control is a quality control material intended to monitor the analytical performance of the Xpert™ HemosIL FII & FV genotyping assay on the GeneXpert® Dx System.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this quality control device appear to be the consistent and correct genotyping of the FII and FV mutations. The performance data below supports this. While explicit percentage cutoffs for "acceptance" are not stated, 100% correct genotyping across all tests strongly indicates that the device met these criteria.

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

• Sample Size for Test Set: A total of 201 tests were performed with the HemosIL FII & FV DNA Control.
• Data Provenance: The testing was conducted both internally at the control manufacturer and externally at multiple sites.
  • External Sites: Seven external sites participated, including two clinical laboratory sites in Europe, one site at the instrument/assay manufacturer (Cepheid), one site at Instrumentation Laboratory Co., and three clinical laboratory sites in the United States. This indicates a mix of clinical and manufacturing settings.
  • Retrospective or Prospective: The study design described (testing manufactured lots, using a specific assay) suggests a prospective study, specifically designed to evaluate the performance of the control.

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

This information is not provided in the summary. For a quality control material, the "ground truth" for the test set is inherent in the design and manufacturing of the control itself. The control is engineered to have specific normal and mutated Factor II and Factor V DNA sequences. The method used to validate the presence of these mutations in the control during its manufacturing is stated as "Bi-directional sequencing," which is a highly accurate method for determining DNA sequences.

4. Adjudication Method for the Test Set

This information is not explicitly stated. However, for a quality control material designed to yield a specific and known genotype, the assessment of "correct genotype" is typically a direct comparison to the expected result. Discrepancies would likely be investigated, as was the case for the single indeterminate result attributed to "operator error."

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the AI's effect on human performance is being evaluated. The HemosIL FII & FV DNA Control is a quality control material, not a direct diagnostic device that requires human interpretation in the same way.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

This study primarily evaluates the standalone performance of the quality control material when processed by the Xpert HemosIL FII & FV Assay on the GeneXpert Dx System. The "algorithm" here is the assay system itself identifying the genotype of the control. The studies demonstrate the assay's consistent ability to correctly identify the known genotype of the control, thus, evaluating the performance of the control in conjunction with the automated assay. There is no external "human-in-the-loop" interpretation step being evaluated here for the control's performance.

7. The Type of Ground Truth Used

The ground truth for the HemosIL FII & FV DNA Control is based on the engineered composition of the control material itself, which contains specific, known normal and mutated Factor II and Factor V DNA sequences. This composition was validated using bi-directional sequencing during the control's manufacturing.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The HemosIL FII & FV DNA Control is a quality control material, not an AI/algorithm that requires a "training set" in the conventional machine learning sense. The Xpert HemosIL FII & FV genotyping assay, which uses this control, would have its own development and validation data, but that is separate from the control product itself.

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

This information is not applicable/not provided as the device is a quality control material and not an AI/algorithm requiring a training set.

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INTROL™ CF Panel I Control is intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic FibrosisTransmembrane Regulator (CFTR) gene mutations and variants. This product is intended to be extracted and analyzed routinely with each CFTR assay run. The INTROL™ CF Panel I Control is designed to monitor the detection of 38 CFTR mutations associated with cystic fibrosis, including the 23 mutations recommended for testing by American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). The INTROL™ CF Panel I Control also monitors 3 polymorphisms (1506V, I507V, F508C) and the 5/7/9T variants.

Modified INTROL™ CF Panel I Control consists of synthetic (recombinant) CFTR DNA suspended in a matrix of carrier DNA of non-human species, preservatives, dye, and stabilizers. CFTR DNA is stabilized in the matrix and released when processed through common extraction methods as if it were a whole blood specimen. INTROL™ CF Panel I Control was modified to contain additional wild type CFTR DNA required for primer annealing of some CFTR detection assays.

The provided document is a 510(k) Summary for a Quality Control Material for Cystic Fibrosis Nucleic Acid Assays, not a medical device in the typical sense of providing diagnostic feedback based on patient data. Therefore, many of the requested criteria related to device performance on patient data, such as sensitivity, specificity, MRMC studies, or ground truth established by experts/pathology/outcomes data, are not applicable in this context.

This document describes a modification to an existing quality control product (INTROL™ CF Panel I Control) and asserts its substantial equivalence to the predicate device (K060070). The acceptance criteria for such a product would primarily revolve around its ability to perform consistently and as intended when used with diagnostic assays.

Here's an analysis based on the provided text, addressing the applicable criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Verification and validation testing performed as needed according to risk analysis showed that modified INTROL™ CF Panel I Control performed as well or better than INTROL™ CF Panel I Control (K060070). Test methods were the same as those used for 510(k) submission of the predicate."

• Sample Size: The specific sample sizes for the "verification and validation testing" are not provided in this 510(k) summary.
• Data Provenance: Not explicitly stated. Given that MMQCI is a US-based company, the testing was likely conducted in the US, but this is not confirmed. The document does not specify if the data was retrospective or prospective, though performance testing of a quality control would typically be prospective for new runs.

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

This question is not applicable. For a quality control material, there isn't a "ground truth" established by experts in the context of diagnostic interpretation. The "ground truth" for the control material itself is its known genetic composition (synthetic CFTR DNA with specific mutations/polymorphisms), which is validated during manufacturing and characterization.

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

Not applicable. Adjudication methods are typically used for interpreting results from diagnostic devices based on patient samples, often involving multiple human readers or expert panels. This is a quality control material, not a diagnostic device.

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 a quality control material, not an AI-powered diagnostic device, and therefore MRMC studies with human readers are irrelevant.

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

Not Applicable. This is a physical quality control material for laboratory assays, not an algorithm.

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

The "ground truth" for the INTROL™ CF Panel I Control is the known, manufactured genetic composition of the synthetic (recombinant) CFTR DNA it contains, including the specific 38 mutations, polymorphisms, and variants it is designed to monitor. This is intrinsic to the product design rather than being derived from external data sources like expert consensus or patient outcomes.

8. The sample size for the training set

Not applicable. This product is a quality control material, not a machine learning algorithm that requires a training set.

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

Not applicable. This product is a quality control material, not a machine learning algorithm that requires a training set.

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The GentriSure™ Human Genomic DNA Reference Control (HGDRC) is an independent. external run control that is intended for use in assessing the performance of diagnostic assays that detect cytochrome p450 2D6 (CYP2D6) genetic polymorphisms. This control is not intended to be used as a substitute for controls provided with licensed test kits. GentriSure HGDRC can be used for assay validation, staff training and proficiency testing, and as a quality control in routine in vitro diagnostic testing.

Not Found

The provided text is an FDA 510(k) clearance letter for the "GentriSure ™ Human Genomic DNA Reference Control". It describes the intended use of the device and confirms its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study designs (MRMC, standalone).

Therefore, I cannot provide the requested information based on the given text. The document is primarily an administrative letter granting market clearance, not a summary of the technical study data.

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INTROL™ CF Panel I Control is intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations and variants. This product is intended to be extracted and analyzed routinely with each CFTR assay run.

The INTROL™ CF Panel I Control is designed to monitor the detection of 38 CFTR mutations associated with cystic fibrosis, including the 23 mutations recommended for testing by American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). The INTROLTM CF Panel I Control also monitors 3 polymorphisms (1506V, 1507V, F508C) and the 5/7/9T variants.

INTROL™ CF Panel I Control consists of synthetic CFTR DNA suspended in a matrix of synthetic DNA targets, carrier DNA of a non-human species, preservatives, dye, and stabilizers. The synthetic DNA contains all 27 CFTR gene exons plus intronic borders, and contains specific mutations and polymorphisms which are divided among 5 bottles (bottles a, b, c, d, and e). The 5 bottles exist in two versions: Version G106ac includes bottles (a), (b), and (c), while Version G106de includes bottles (a), (b), (d), and (e). The specific mutations present in each bottle are listed below in Table 1; all other CFTR sequence is wild type. CFTR mutations that are not listed cannot be detected in the INTROL™ CF Panel I Control.

Control sequences include the mutations, wild type alleles, and polymorphisms recommended for testing by the American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). CFTR mutations that are not listed cannot be detected in the INTROL™ CF Panel I Control.

CFTR DNA is stabilized in the matrix and released when processed through common extraction methods as if it were a whole blood specimen. Following extraction, the released DNA can be used in common amplification based molecular assays techniques. Because INTROL™ CF Panel I Control is designed to mimic the whole blood sample, the resulting copy number of the artificial CFTR segment, after extraction, will be similar to that found in a processed human whole blood sample (v/v).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: In the external site evaluations, samples from 11 different manufacturing lots were tested. The total number of "Calls" (presumably individual tests for specific mutations) was 1133. It's not explicitly stated how many unique samples or cases were used for the test set, but rather the number of lots, runs, and calls.
• Data Provenance: The data was generated through external site evaluations (clinical laboratory study performed at external sites) involving 10 external sites, 8 of which were clinical laboratories representing intended users. The origin country is not specified, but the context of "FDA-cleared" suggests the study was conducted within the United States or under FDA guidelines. The study appears to be prospective as it involves evaluations of the manufactured control materials at various external sites.

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

The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists, pathologists) is not directly applicable here.

• For the test set validation (external site evaluations), FDA-cleared CFTR mutation detection methods and bidirectional sequencing were used to determine if the mutations were correctly detected. The "ground truth" for the content of the control material (which mutations and polymorphisms it contains) was established during the manufacturing process by Maine Molecular Quality Controls, Inc. (MMQCI) before product release.
• The control material itself contains predefined synthetic DNA with specific mutations and wild-type sequences (Table 1). The 'truth' of what the control contains is intrinsic to its design and manufacturing.
• The "experts" involved are those within MMQCI responsible for designing and manufacturing the synthetic DNA, and those performing the bidirectional sequencing, which is a highly accurate molecular technique for confirming DNA sequences. Their specific qualifications are not detailed beyond "experts."

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used when multiple human readers or algorithms provide potentially discordant interpretations, which then need to be resolved. This is not directly applicable to this device.

• The "adjudication" for the performance study (external site evaluations) essentially involved checking if the CFTR assays correctly identified the mutations known to be present in the control material.
• The control materials have a pre-defined composition (Table 1) and are validated internally by FDA-cleared CFTR mutation detection methods and bidirectional sequencing before release. The process is a comparison against this known-good standard. Any discrepancy from the expected result would be a failure. There is no mention of a human review or adjudication of conflicting interpretations from different tests, but rather a direct comparison to the expected truth (the known composition of the control).

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done.
• This device is a quality control material, not an AI-powered diagnostic device, so the concept of "human readers improve with AI vs. without AI assistance" is not relevant here. The studies focused on the analytical performance and stability of the control material itself within various CFTR assays.

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

• A standalone performance evaluation was done, but it pertains to the performance of the various CFTR mutation detection assays (which are algorithms or protocols, but not "AI") when using the INTROL™ CF Panel I Control.
• The "Performance Characteristics" section details how the control material performed when tested by these various FDA-cleared and other amplification methods without direct human intervention in the interpretation of the control result itself. The control material is expected to produce a specific, interpretable result (detection of known mutations), and this was assessed at 10 external sites using different methods. The "100% correct calls" across these methods serve as the standalone analytical performance.

7. The Type of Ground Truth Used

• The ground truth used is primarily synthetic DNA with a precisely known sequence and mutation composition (defined at manufacturing) for the control material, validated by bidirectional sequencing and comparison to FDA-cleared CFTR mutation detection methods.
• This is a form of "known composition" or "reference standard" ground truth, rather than expert consensus, pathology, or outcomes data, which are typically found in clinical diagnostic studies.

8. The Sample Size for the Training Set

• Not applicable. This device is a quality control material and does not involve a "training set" in the context of machine learning or AI models. Its intended use is to monitor the performance of other diagnostic assays, not to be a diagnostic algorithm itself.

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

• Not applicable, as there is no training set. The intrinsic "truth" of the control material is its precisely engineered synthetic DNA sequence designed to contain specific CFTR mutations and polymorphisms. This content is verified during manufacturing using established molecular biology techniques (sequencing and cleared CFTR assays).

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