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ORAcollect®•Dx is intended for the collection of saliva samples for diagnostic testing of human DNA. Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using ORAcollect®•Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using ORAcollect®•Dx can be transported and/or stored at ambient conditions.

ORAcollect® Dx family of collection devices offers reliable collection, transportation and longterm ambient temperature storage of human DNA from saliva. ORAcollect® • Dx devices are a minimally invasive alternative for collecting high quality and quantity DNA for use with prescription and over-the-counter (direct-to-consumer) diagnostic testing applications.

ORAcollect® • Dx consists of a collection tube containing a stabilizing liquid and a double ended cap with an integrated sponge used to collect a saliva sample. Using provided instructions for use, saliva collection can take place in a laboratory setting, physician's office, at home, or in the field. Untrained (naïve) or professional users can carry out saliva collection.

After saliva is collected, the stabilizing liquid is mixed with the sample. Upon contacting saliva cells, the stabilizing liquid lyses cellular and nuclear membranes to release and stabilize nucleic acids (DNA). Samples can be immediately processed, transported or stored for future use.

ORAcollect-Dx device pre-collection shelf life is 24 months at room temperature (15°C to 25°C) from the date of manufacture. Post collection, ORAcollect·Dx samples are stable at room temperature for up to 60 days. ORAcollect-Dx device and sample integrity are preserved during typical ambient transport and storage conditions.

ORAcollect®●Dx saliva collection devices are suitable for use with prescription and over-the-counter (direct-to-consumer) downstream diagnostic testing applications, systems or platforms. Test or assay manufacturers must validate the use of ORAcollect®●Dx for their specific indications for use. Using DNA obtained from an ORAcollect®•Dx sample, laboratory testing is performed on genotyping systems or platforms in a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory.

The provided text does not contain specific acceptance criteria with numerical thresholds or a detailed study description that directly proves the device meets those criteria in a standard "table of acceptance criteria and reported device performance" format.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Oragene®•Dx) and refers to various performance characteristics and previously evaluated studies (listed by k-number) that support the ORAcollect®•Dx device's performance.

However, based on the information provided, I can infer and summarize relevant details for each requested point:

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

Since explicit numerical acceptance criteria are not presented in the provided text, I will construct a table based on the discussed performance characteristics and the device's demonstrated suitability or equivalence. The "Reported Device Performance" will indicate that the device met the implied performance expectations by referring to the successful outcomes of the mentioned studies or equivalence claims.

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

The document references several previous 510(k) submissions (K152464, K152612, K192858, k21115, K221420) for the detailed studies. However, the exact sample sizes for the test sets in these underlying studies are not explicitly provided in this document.

For the "Over-the-Counter (Direct-to-Consumer) Use" study mentioned:

• Sample Size: "potential users enrolled in usability studies" and "each study sample" refers to participant samples, but no specific number is given.
• Data Provenance: The study involved users collecting samples "at home" and mailing them to a "CLIA certified laboratory" for assessment. This indicates prospective, real-world data collection in a consumer setting. No specific country of origin is mentioned, but DNA Genotek Inc. is based in Ottawa, Ontario, Canada, and the FDA review is for the U.S. market, suggesting a North American context.

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

This information is not provided in the text. The document refers to "genotyping systems or platforms in a CLIA certified laboratory" and comparison to "gold standard bidirectional sequencing" for method comparison, implying established laboratory procedures as the ground truth.

4. Adjudication method for the test set

This information is not provided in the text. Given the nature of the device (saliva collection kit for DNA), adjudication in the context of expert review of images or diagnoses is not directly applicable in the same way as for imaging AI. Instead, the "ground truth" would be established through laboratory analyses.

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

An MRMC comparative effectiveness study is not applicable to this device. This device is a saliva collection kit, not an AI algorithm assisting human readers in diagnostic interpretation.

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

This question is not applicable as the device is a physical collection kit, not an algorithm. Its performance is evaluated on its ability to collect and stabilize DNA for subsequent laboratory testing, not on standalone interpretive capabilities.

7. The type of ground truth used

The ground truth for evaluating the ORAcollect®•Dx device's performance is primarily based on:

• Laboratory-based analytical results: DNA concentration, purity, and successful genotyping after extraction from the collected saliva.
• Comparison to "gold standard" methods: For instance, "gold standard bidirectional sequencing" for genotyping accuracy (as mentioned for method comparison studies in K152612 and K192858).
• Compliance and physical assessment: For the over-the-counter use, ground truth involved assessing compliance to collection instructions, sample volume, and DNA concentration by a CLIA-certified laboratory.

8. The sample size for the training set

The document describes performance evaluation (test-set like activities) rather than the development of an algorithm requiring a "training set." Therefore, information on the "training set" sample size is not applicable/provided.

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

As explained in point 8, the concept of a "training set" for this type of device is not applicable. The ground truth is established through standard laboratory and analytical methods as detailed in point 7 for performance evaluation.

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The AlphaID™ At Home Genetic Health Risk Service uses qualitative genotyping to detect clinically relevant genetic variants associated with alpha-1 antitrypsin deficiency (AATD) in genomic DNA isolated from human saliva collected from individuals ≥ 18 years with ORAcollect Dx OCD-100.014 for the purpose of reporting and interpreting Genetic Health Risks (GHR).

This Service is indicated for reporting 14 genetic variants in the SERPINA1 gene: PIS; PIM procida; PIM malton; PIS iiyama; PIQ0 granite falls; PIQ0 west; PIQ0 bellingham; PIF; PIQ0 mattawa; PIQ0 clayton, and PI*M heerlen. The report describes if a person is at an increased risk of developing either liver disease linked to AATD. The report does not describe a person's overall risk of developing lung and/or liver disease. AATD is more common in persons of European descent.

The AlphaID™ At Home Genetic Health Risk Service (AlphaID At Home) uses qualitative genotyping to detect clinically relevant genetic variants associated with alphal-antitrypsin deficiency (AATD) and provides a report describing if a person is at risk of developing either lung and/or liver disease linked to AATD. This Service is direct-to-consumer and intended for an Over-the Counter (OTC) use.

The AlphaID™ At Home Genetic Health Risk Service is composed by AlphaID™ At Home Saliva Collection kit for human saliva sample collection (ORAcollect®·Dx OCD-100.014), A1AT Genotyping Test for the genetic analysis and detection of genetic variants associated with alpha-1 antitrypsin deficiency (AATD), and AlphaID™ At Home Genetic Health Risk Service website and result portal software to provide the contents and the procedure to order and use the over the counter (OTC) Service.

A consumer's saliva is self-collected using custom version ORAcollect Dx (model OCD-100.014) device manufactured by DNA Genotek, Inc (See K212745) which consists of collection tube containing a stabilizing buffer solution. Once the sample is collected, it is shipped to Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for processing.

Human DNA from the saliva sample is isolated and processed with the A1AT Genotyping Test device (K211115) that provides results on 14 genetic variants in the SERPINA / gene: PIS; PIZ; PIM procida; PIM malton; PIS iiyama; PIO0 granite falls: PIO0 west: PIO0 bellingham: PIF; PIP lowell; PIO0 mattawa; PIQ0 clayton, and PI*M heerlen.

Briefly, genomic DNA extracted from human saliva is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200™ system. Raw fluorescence data is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE to provide allelic variant genotypes, which are subsequently converted into associated alleles, based on current scientific evidence. Additionally, the software application also provides the type of Genetic Health Risk Report associated with the identified alleles, which is subsequently used as the basis for the generation of personalized reports by the AlphaID™ At Home Genetic Health Risk Service website and result portal.

Depending on the specific variant combination detected, the AlphaID™ At Home Genetic Health Risk Service provides the individuals' genetic health risk for developing lung and liver disease linked to AATD. Personalized reports, in an easy-to-understand format are generated for each consumer that provide results of the testing performed.

Here's a breakdown of the acceptance criteria and study information for the AlphaID™ At Home Genetic Health Risk Service, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Increased risk: >80% development.
• Slightly at Increased risk: 20-80% development.
• Not likely at increased risk:

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The POMC/PCSK1/LEPR CDx Panel is a next generation sequencing (NGS)-based in vitro diagnostic test that analyzes genomic DNA isolated from blood or saliva. Specimens used with the test are K-EDTA blood collected using certain indicated K-EDTA blood collection devices and saliva collected using ORAcollect-Dx™ OCD-100 devices. The test detects germline nucleotide substitutions, short insertions and deletions, and copy number variants (CNVs) within the following 3 genes:

• Pro-opiomelanocortin (POMC) .
• Proprotein Convertase Subtilisin/Kexin type 1 (PCSKI) .
• Leptin Receptor (LEPR) .

The test is a companion diagnostic device intended to select adult and pediatric patients 6 years of age and older who have obesity and certain variants in POMC, PCSKI or LEPR genes for treatment with IMCIVREE® (setmelanotide) in accordance with the approved therapeutic product labeling. The POMC/PCSK1/LEPR CDx Panel is a single-site assay performed at PreventionGenetics, LLC (Marshfield, WI).

The POMC/PCSK1/LEPR CDx Panel is a next generation sequencing (NGS) assay for the detection of germline variants in three genes (pro-opiomelanocortin (POMC), leptin receptor (LEPR), and convertase subtilisin/kexin type 1 (PCSK1)). The POMC/PCSK1/LEPR CDx Panel is performed in a single laboratory (PreventionGenetics, LLC in Marshfield, WI).

Acceptance Criteria and Device Performance for POMC/PCSK1/LEPR CDx Panel

The POMC/PCSK1/LEPR CDx Panel is a next-generation sequencing (NGS)-based in vitro diagnostic test for detecting germline variants in POMC, PCSK1, and LEPR genes, intended to select patients for treatment with IMCIVREE (setmelanotide). The acceptance criteria primarily revolve around the analytical performance of the device, focusing on accuracy, precision, and specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a genetic variant detection system), the acceptance criteria are generally established through analytical performance metrics like Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Overall Percent Agreement (OPA) when compared to validated orthogonal methods.

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The Progenika A1AT genotyping kit is a qualitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminent (with xPONENT software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (AIAT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect Dx OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only.

Alpha 1 antitrypsin (A1AT) Genotyping Test utilizes Luminex xMAP technology. Genomic DNA is extracted from DBS, from human EDTA anticoagulated whole blood or from human saliva samples collected as buccal swabs using ORAcollect-Dx OCD-100. Extracted DNA is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200 system. Raw data obtained is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE in order to obtain the final report. The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm converts the allelic variant genotypes into associated alleles, based on the current literature.

The A1AT Genotyping Test Kit is composed of 4 reagent components (A1AT PCR Master Mix, A1AT Beads Master Mix, SAPE, SAPE Dilution Buffer) required to perform all the abovementioned processing steps. The A1AT Genotyping Test ANALYSIS SOFTWARE, instructions for use and other necessary files are uploaded on a Grifols website. Two kit configurations are available: for 48 or 192 tests (different amounts of the same reagent components are provided in each case).

The provided document describes the A1AT Genotyping Test. This 510(k) submission (K211115) is for a modified version of a previously cleared device (K192858), primarily involving a software update. Therefore, much of the performance data refers back to the original submissions (K192858 and K171868).

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • LoD: 20 replicates of nine DNA dilutions for a "Sample Panel" (total of 180 tests per lot, across two lots used).
  • Precision (Lot-to-Lot): Five DNA samples ("Sample Panel") tested in triplicate, with three different reagent lots, by two operators, on six non-consecutive days, alternating between two Luminex instruments (5 samples * 3 replicates * 3 lots * 2 operators * 6 days = 540 tests, plus additional factors for instruments).
  • Accuracy: For the predicate device, 147 samples were used. The document refers to K171868 and K192858 for specific method comparison data for the modified device, so the exact number for the modified device's accuracy testing isn't explicitly stated but would be similar to or larger than the predicate's 147.
• Data Provenance: Not explicitly stated as "country of origin for data" or "retrospective/prospective." However, the applicant is Progenika Biopharma S.A. based in Spain, suggesting the studies likely occurred in Spain or affiliated regions. The nature of the studies (analytical performance) implies laboratory-based testing, which can be seen as a form of controlled prospective data collection for the device's technical performance.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• The document does not mention the use of experts to establish ground truth for the test set for the analytical performance studies described (LoD, Precision). These studies focus on the device's ability to consistently and accurately detect specific genetic variants based on known DNA samples.
• For Accuracy (Method Comparison), the ground truth was established by Bi-directional Sanger sequencing. This is considered a gold standard in genetic sequencing, not typically requiring "experts" to interpret the sequence output, but rather highly skilled laboratory personnel and bioinformaticians.

4. Adjudication Method (Test Set)

• Not applicable as the ground truth for analytical performance studies is typically objective (e.g., known DNA concentrations, Sanger sequencing results). The results are compared directly to these objective standards.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) genetic test, which generates objective results (detection of allelic variants). The performance evaluation focuses on the analytical accuracy and precision of the device itself, rather than human interpretation of complex images or clinical scenarios that would necessitate an MRMC study.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done. The entire "Performance Data" section (H) describes the analytical studies to determine the device's capabilities (LoD, precision, stability, accuracy). These are evaluations of the algorithm and the assay itself, demonstrating its standalone performance from DNA input to reported genotype. The device includes "A1AT Genotyping Test ANALYSIS SOFTWARE" which processes raw data to obtain the final report, indicating its role as a standalone algorithm in the diagnostic process once the PCR and hybridization steps are completed.

7. Type of Ground Truth Used

• For LoD and Precision: Known DNA samples with established genotypes/concentrations were used.
• For Accuracy (Method Comparison): Bi-directional Sanger sequencing was used as the comparator (a gold standard laboratory method) to establish the ground truth for the samples tested.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set. This is a 510(k) submission for a device with a software update (v1.0.8.16 from v1.0.6.1). The software's algorithm for converting allelic variant genotypes into associated alleles is based on current literature. It's possible that the "training" for such an algorithm is not based on a 'training set' in the machine learning sense, but rather on established scientific knowledge and rules coded into the software. If any machine learning components were present, their training data is not disclosed here.

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

• Given that the document refers to the algorithm converting genotypes into alleles "based on the current literature," the ground truth for the "training" (or more accurately, the ruleset development) of the algorithm would be derived from published scientific literature and established genetic associations between allelic variants and their corresponding alleles for the SERPINA1 gene. There is no indication of a specific "training set" of patient samples with prospectively established ground truth for algorithm development in this context.

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The Progenika A1AT genotyping kit is a quantitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminex 200 instrument (with xPONENT software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spot (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect Dx model OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only.

Alpha 1 antitrypsin (A1AT) Genotyping Test utilizes Luminex xMAP technology. Genomic DNA is extracted from DBS or from human EDTA anticoagulated whole blood or from human saliva samples collected as buccal swabs using ORAcollect-Dx model OCD-100. Extracted DNA is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200 system. Raw data obtained is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE in order to obtain the final report. The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm converts the allelic variant genotypes into associated alleles, based on the current literature.

The A1AT Genotyping Test Kit is composed of 4 reagent components (A1AT PCR Master Mix, A1AT Beads Master Mix, SAPE, SAPE Dilution Buffer) required to perform all the above mentioned processing steps, and a CD containing the A1AT Genotyping Test ANALYSIS SOFTWARE and other necessary files. Two kit configurations are available: for 48 or for 192 tests (different amounts of the same reagent components are provided in each case).

Here’s a summary of the acceptance criteria and study details for the A1AT Genotyping Test, as extracted from the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a separate section with specific numerical thresholds for each performance metric. Instead, the study aims to demonstrate "100% concordance" with bi-directional Sanger sequencing for accuracy. The "Performance specifications" section outlines the areas tested, and the "Comparison Data" section reports the accuracy.

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

• Sample Size for Accuracy Test Set: 147 DNA samples.
  • 140 archived left-over clinical genomic DNA samples obtained from human saliva (buccal swabs using ORAcollect Dx model OCD-100).
  • 3 genomic DNA samples extracted from cell lines.
  • 4 synthetic DNA samples.
• Data Provenance: The 140 clinical samples were "archived left-over clinical genomic DNA samples," suggesting a retrospective collection of samples from clinical practice. The country of origin for the clinical samples is not specified in the provided text.

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

Not applicable. The ground truth was established by bi-directional Sanger sequencing, which is a laboratory method, not human expert interpretation.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was based on a laboratory method (bi-directional Sanger sequencing) rather than expert review requiring adjudication.

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 genotyping test, not an image-based AI-assisted diagnostic tool for human readers. It provides direct genetic results.

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

A standalone performance study was done for the device, where its results were compared directly against bi-directional Sanger sequencing (the ground truth). The A1AT Genotyping Test ANALYSIS SOFTWARE algorithm processes raw data to obtain the final report, effectively representing the "algorithm only" performance against the comparator.

7. The Type of Ground Truth Used

The ground truth used for the accuracy study was bi-directional Sanger sequencing.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the device itself in the context of an AI/ML algorithm. This device is a PCR and hybridization-based assay with associated analysis software. The performance data presented refers to the evaluation of this assay. If the "ANALYSIS SOFTWARE" incorporates machine learning, the training set details are not provided. However, given the nature of the device (genotyping test), it is unlikely to involve a dynamic machine learning model in the typical sense that would require a separate, distinct training set in the context of this submission. The software's algorithm converts allelic variants into associated alleles based on existing literature.

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

Not applicable, as a distinct training set (in the context of AI/ML) and its ground truth establishment are not discussed in the provided text. The "analysis software algorithm" is described as converting genotypes into alleles "based on the current literature," implying established scientific knowledge rather than a learned model from a specific training dataset.

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The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and the Vitamin K epoxide reductase C1 (VKORC1) gene promoter polymorphism (-1639G>A) from genomic DNA extracted from human saliva samples collected using the Oragene® Dx and ORAcollect® Dx devices, as an aid in the identification of patients at risk for increased warfarin sensitivity.

The eSensor® XT-8 instrument is an in vitro diagnostic device intended for genotyping multiple mutations or polymorphisms in an amplified DNA sample utilizing electrochemical detection technology.

The kit consists of the eSensor® Warfarin Sensitivity Saliva Test cartridge, the eSensor® Warfarin Sensitivity Saliva Test amplification reagents (including PCR mix and DNA polymerase), the eSensor® Warfarin Sensitivity Saliva Test detection reagents (including exonuclease, probes and hybridization buffer ingredients) and the eSensor® XT-8 System. One eSensor® Warfarin Sensitivity Saliva Test Kit has sufficient materials for 24 tests.

The provided document, a 510(k) summary for the eSensor® Warfarin Sensitivity Saliva Test, details performance data primarily focused on a new specimen collection kit (ORAcollect®·Dx Device) and its impact on the existing device's performance. The study aims to demonstrate that incorporating this new collection kit does not compromise the accuracy or reliability of the Warfarin Sensitivity Saliva Test.

Here's an analysis of the acceptance criteria and study findings:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state 'acceptance criteria' in terms of specific numerical thresholds for accuracy, reproducibility, or call rates. However, the studies consistently aim for 100% agreement with the ground truth (bi-directional sequencing), and 100% correct calls with 0% incorrect calls. The "Method Comparison" section indicates an aspiration for high concordance and call rate.

2. Sample Sizes and Data Provenance

• Reproducibility (Sample-to-Sample, Lot-to-Lot, Day-to-Day, Operator-to-Operator):

  • Test set sample size: 10 donors, with 3 samples each (total 30 samples collected). These were processed by 3 operators, with genotyping data evaluated for each operator for each of the 3 SNPs. This implies 20 tests per SNP per operator (based on the "20" under "Samples Tested" for each SNP for each operator), totaling 60 tests per SNP across all operators, or 120 calls per SNP when considering all samples and operators for the "Summary of Results by Sample and Genotype" table.
  • Data Provenance: Not explicitly stated, but likely prospective and from a controlled lab environment.

• Multi-center Reproducibility:

  • Test set sample size: 30 donors. Multiple saliva samples collected from each.
  • Data Provenance: Saliva samples were collected from 3 sites. Two sites were described as "professional setting" with "supervised collections," and the third site had "unsupervised collections." One sample from each donor was transported to three independent sites for extraction. All eSensor Warfarin Sensitivity Saliva testing was conducted at Site 1. This suggests a prospective data collection design, with samples from multiple (unspecified) locations. No country of origin is mentioned.

• Method Comparison:

  • Test set sample size: 156 saliva samples.
  • Data Provenance: Not explicitly stated, but implies a prospective or retrospectively collected set of human saliva samples. No country of origin is mentioned.

• Interfering Substances (Endogenous):

  • Test set sample size: 14 donors, each providing 4 saliva samples.
  • Data Provenance: Not explicitly stated, but likely prospective, controlled lab study.

• Interfering Substances (Exogenous):

  • Test set sample size: Varied per activity, ranging from 5 to 9 donors per activity group. Each donor provided samples at two time-points (immediate and 30 minutes post-activity).
  • Data Provenance: Not explicitly stated, but likely prospective, controlled lab study.

3. Number of Experts and Qualifications for Ground Truth

The ground truth for all studies was established by bi-directional DNA sequencing. This is a laboratory-based method, not typically requiring "experts" in the sense of clinical specialists. The interpretation of sequencing results is a standard molecular biology technique. No specific number of experts or their qualifications (e.g., geneticists, molecular biologists) are mentioned for establishing the ground truth, as it's assumed to be a direct, objective measurement.

4. Adjudication Method for the Test Set

The studies used bi-directional DNA sequencing as the gold standard, not a human expert adjudication process. The agreement was calculated directly between the device's genotypes and the sequencing results. If there were discrepancies in the initial device results (e.g., initial miscalls or no-calls in the method comparison), retests were performed. For instance, in the method comparison, two miscalls were attributed to "operator error (sample mix-up) occurring during the first XT8 testing" and one remaining no-call to "an operator error at the purification step." This suggests an internal investigation and re-testing process rather than an external adjudication panel.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a diagnostic test for genotyping, not an imaging device or a system requiring human interpretation with or without AI assistance. Therefore, the concept of "readers improving with AI vs. without AI" is not applicable here. The device itself performs the genotyping.

6. Standalone Performance Study

Yes, a standalone performance study was done. All the performance data described (reproducibility across operators/sites, method comparison with sequencing, and interfering substances studies) directly assesses the performance of the eSensor® Warfarin Sensitivity Saliva Test (algorithm/device only, without human-in-the-loop performance influencing the genotyping call itself, though human operators are involved in sample preparation and running the test). The percentage agreement and call rates reflect the direct output of the device compared to the ground truth.

7. Type of Ground Truth Used

The primary ground truth used for all studies was bi-directional DNA sequencing. This is a highly accurate molecular method for determining genetic sequences and polymorphisms (genotypes).

8. Sample Size for the Training Set

The document is a 510(k) summary for a labeling modification (addition of a new specimen collection kit) to an already cleared device. It primarily presents validation data for the continued performance of the device with the new collection kit. It does not mention a "training set" for the eSensor® Warfarin Sensitivity Saliva Test itself, as this device likely relies on established molecular biology principles and probes designed against known genetic targets, rather than machine learning algorithms that require extensive training data. It's a deterministic diagnostic test, not an AI model that learns from data in the way a computer vision algorithm would.

9. How Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" doesn't directly apply in the context of this device. The device's design is based on known genetic sequences and electrochemical detection rather than a machine learning model. The validation studies verify its performance against the established ground truth of bi-directional DNA sequencing.

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