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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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OMNIgene. GUT Dx is intended for the non-invasive collection of human fecal samples and the stabilization of DNA from the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene GUT Dx.

The OMNIgene . GUT Dx device consists of a collection tube with a tube top and pusher cap with a screw seal, along with a spatula or spoon for transferring fecal specimen into the collection tube. The tube contains 2 mL of the stabilizing liquid and a stainless-steel mixing ball. These components are intended to stabilize bacterial DNA in human fecal specimens. notably to preserve the relative abundances of bacterial organisms, for potential downstream analysis of the fecal microbiome. The collection device is designed for storage of fecal specimens at room temperature (20-26°C/68-79°F) for up to 30 days.

Here's a breakdown of the acceptance criteria and the studies conducted to prove the OMNIgene.GUT Dx device meets these criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through several analytical studies focusing on DNA yield, microbial community neutrality (preservation of relative abundances), and stability at room temperature, as well as reproducibility.

Table of Acceptance Criteria and Reported Device Performance

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

Oragene®●Dx family of collection devices offers reliable collection, transportation and long-term ambient temperature storage of human DNA from saliva. Oragene®●Dx devices are a noninvasive alternative for collecting high quality and quantity DNA for use with prescription and over-thecounter (direct-to-consumer) diagnostic testing applications.

Oragene®●Dx devices consist of a collection tube with a funnel lid attached (containing a stabilizing liquid). Saliva is delivered directly by spitting into the collection tube or may be transferred into the Oragene®●Dx container using a sponge. Saliva collection can take place at home, in a laboratory setting, physician's office, 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. A small cap is provided to close the tube for transport and storage (funnel with lid is removed and discarded). 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. Samples can be shipped at ambient temperature to the laboratory for processing. Oragene® •Dx samples are stable at room temperature for up to 12 months. Device and sample integrity are preserved during typical ambient transport and storage conditions.

Oragene®●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 Oragene®●Dx for their specific indications for use.

Using DNA obtained from an Oragene®●Dx sample, laboratory testing is performed on genotyping systems or platforms in a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory. The resulting genetic information may be used to generate a personalized health report related to detected mutations and may be used by medical and health practitioners as an aid in patient management.

The document describes the Oragene®•Dx saliva collection device and its performance characteristics to support its intended use for in vitro diagnostic testing of human DNA.

Here's the breakdown of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Oragene®•Dx device are largely demonstrated by referencing prior 510(k) clearances (K110701, K141410, K152556) and its compatibility with already FDA-cleared test systems. The performance characteristics focus on the stability and suitability of the collected DNA for downstream diagnostic applications.

• 30 months at room temperature
• 12 months at -20±5°C and 6±4°C (for device models OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675, which have the same physical and chemical components as previously cleared devices). |
  | Post-collection Sample Stability | Supported by studies in K110701 and K152556 (specifically for OGD-500, and inferred for the proposed device due to identical physical/chemical components), claiming:
• 12 months at room temperature, -20±5°C or 6±4°C
• 3 months at 50±5°C
  Studies evaluated DNA yield, DNA concentration, A260/A280 ratio, and microbial content. |
  | Sample Volume Tolerance | Demonstrated by previous studies (K110701) where underfilling (by 25% or 50% of target) or overfilling (by 50% of target) did not impact downstream performance, despite affecting DNA yield. Collected samples ranged from 0.58 mL to 3.64 mL of saliva. Further confirmed with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). |
  | Interfering Substances (Endogenous) | Successfully demonstrated with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). No observable effect on performance. |
  | Interfering Substances (Exogenous) | Successfully demonstrated with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). No observable effect on performance. |
  | Over-the-Counter (Direct-to-Consumer) Use | Previously evaluated with 23andMe PGS (K141410, DEN140044) using OGD-500.001. A user comprehension study using standard Oragene®•Dx devices (K192920) in a simulated over-the-counter setting was completed. This usability study evaluated user comprehension and compliance with Instructions for Use (IFU), specifically:
• Correct sample collection (physical parameters: volume, compliance, DNA concentration, call rate).
• User comprehension of IFU (through demographics, ease of use, collection, and shipping instructions survey).
  The study results met acceptance criteria, demonstrating successful use in a direct-to-consumer setting. |

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

• Test Set Sample Size: The document does not explicitly state a specific numerical sample size for the user comprehension study conducted for the K192920 submission. It mentions "Potential users enrolled in usability studies." For other performance aspects (Reproducibility, Stability, Volume Tolerance, Interfering Substances), the document largely references previous 510(k) clearances and compatibility with existing FDA-cleared test systems, implying the sample sizes from those original studies were deemed sufficient.
• Data Provenance: The document does not specify the country of origin for the data for any of the studies mentioned. The submitter is DNA Genotek Inc., located in Ottawa, Ontario, Canada.
• Retrospective/Prospective: The user comprehension study for over-the-counter use appears to be prospective, as it involved "Potential users enrolled in usability studies collected saliva samples at home." The referenced studies for stability and other analytical performance characteristics were likely prospective as well, as they involved specific testing protocols to establish performance claims.

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

• The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of clinical adjudication.
• For the user comprehension study, the "ground truth" was established by objective measures such as successful collection of saliva, compliance with instructions, DNA concentration, and PCR call rate, as well as subjective user comprehension surveys. This process does not typically involve expert consensus on the "truth" of a clinical condition.
• The overall "truth" for the device's function as a DNA collection device is its ability to yield high-quality DNA suitable for downstream diagnostic testing, as demonstrated by compatibility with FDA-cleared molecular diagnostic platforms.

4. Adjudication Method for the Test Set

• Not applicable in the context of this device's performance claims. The studies focus on analytical performance (DNA yield, stability, compatibility) and user comprehension/compliance, rather than diagnostic accuracy requiring adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• Not applicable. This device is a saliva collection kit, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant to its evaluation.

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

• Not applicable. This device is a physical collection kit, not an algorithm. Its performance is inherent to the physical and chemical properties of the kit and the stabilization solution, as well as user compliance with instructions.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The "ground truth" for the performance of the Oragene®•Dx device is primarily based on analytical performance metrics (DNA yield, DNA concentration, purity ratios (A260/A280), microbial content, PCR call rates) and functional compatibility with established FDA-cleared molecular diagnostic test systems.
• For the Over-the-Counter use, the "ground truth" includes user compliance with instructions and successful sample collection based on objective parameters (volume, DNA quality) and user comprehension through surveys.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical collection kit, not a machine learning model that requires a training set. The performance is based on established chemical and physical principles and validated through testing.

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

• Not applicable, as there is no training set for this type of device.

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Oragene Dx devices are intended for use in the non-invasive collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene Dx container or may be transferred into the Oragene Dx container using a sponge. Saliva samples collected using Oragene Dx are stabilized and can be transported and/or stored long term at ambient conditions.

The Oragene-Dx family of products offers reliable collection, transportation and long-term room temperature storage of human DNA from saliva. Oragene Dx is a non-invasive alternative for collecting high quality and quantity DNA for use in molecular diagnostic applications. Oragene-Dx is a device family available in multiple device formats or models.

Oragene-Dx device formats OGD-510, OGD-600, OGD-610 and OGD-675, have the same collection principle and intended use as the FDA cleared Oragene-Dx formats (K110701). All Oragene-Dx formats consist of a collection tube, a DNA stabilizing liquid and optional sponges for assisted collection. In addition, Oragene·Dx device formats are made from the same physical and chemical materials. Oragene Dx formats differ in the amount of DNA stabilizing liquid in the tube and in the difference in the amount of saliva to be collected. The ratio of final sample to stabilizing liquid volume remains the same.

Saliva collection can take place at home, in a laboratory setting, physician's office, or in the field by untrained (naïve) or professional users. Saliva samples are collected into the device directly by spitting or by using the provided sponges. 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). Oragene-Dx Samples can be immediately processed, transported or stored for future use. Samples can be shipped at ambient temperature to the laboratory for processing.

Oragene-Dx device pre-collection shelf life is 24 months at room temperature from the date of manufacture. Post collection, Oragene Dx samples are stable at room temperature for up to 12 months. Oragene Dx device performance and sample integrity are maintained during typical ambient transport and storage conditions.

This document (K152556) describes a 510(k) premarket notification for the Oragene®Dx OGD-510, Oragene®Dx OGD-600, Oragene®Dx OGD-610, and Oragene®Dx OGD-675 devices. These devices are intended for the non-invasive collection of saliva samples, from which human DNA can be isolated, stabilized, and used in FDA-cleared molecular diagnostic applications. The submission references studies performed for the predicate device (Oragene®Dx OGD-500, K110701) to support the substantial equivalence of the new devices.

1. Table of acceptance criteria and reported device performance:

Since the document bases its claims on substantial equivalence to a predicate device (K110701) and applicable studies mentioned in that predicate, specific numerical acceptance criteria for the new devices are not explicitly stated in a tabular format within this document. Instead, the document states that the performance of the new devices is "the same as predicate" or that "both OGD-510 and OGD-500 samples met acceptance criteria for DNA concentration, total DNA yield, A260/A280 ratio and performance on the eSensor Warfarin Sensitivity Saliva Test."

The key performance characteristics and their reported outcomes, primarily referencing the predicate K110701, are summarized below:

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

The document refers to studies in the predicate K110701 for most performance characteristics. For the new comparison study performed for OGD-510 vs. OGD-500, the sample size is not explicitly mentioned. The data provenance is implied to be from Canada, as the submitter, DNA Genotek Inc., is located in Ottawa, Ontario, Canada. The studies are retrospective references to the predicate device or a new comparison study.

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

This information is not explicitly provided in the document. The ground truth for comparative performance (genotyping) would likely be established by the "bidirectional sequencing" method, but details on the experts involved in interpreting this or verifying the ground truth for other studies (e.g., stability) are not given.

4. Adjudication method for the test set:

Not applicable or provided for this type of device and performance testing. The "ground truth" for genotyping involved comparison to bidirectional sequencing.

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 sample collection and stabilization device, not an AI-assisted diagnostic tool requiring human reader interpretation.

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

Not applicable. This is a physical device for sample collection, not an algorithm. The "performance" refers to the ability to collect and preserve DNA for downstream molecular diagnostic applications. The comparison studies against the eSensor® Warfarin Sensitivity Saliva Test (K110786) are standalone evaluations of the collected sample's compatibility with a molecular diagnostic test.

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

For the analytical performance (genotyping agreement), the ground truth was established by bidirectional sequencing. For other performance characteristics like stability and reproducibility, the ground truth would be based on established laboratory methods and controls to demonstrate the integrity and functionality of the DNA.

8. The sample size for the training set:

Not applicable. This device is a physical sample collection device, not an algorithm that requires a training set.

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

Not applicable. No training set is involved for this type of device.

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ORAcollect Dx is intended for use in the non-invasive collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva sample sultured using ORAcollect+Dx are stabilized and can be transported and/or stored long term at anbient can adions.

The ORAcollect-Dx family of collection devices offers reliable collection, transportation and long-term ambient temperature storage of human DNA from saliva. ORAcollect-Dx is a non-invasive alternative for collecting high quality and quantity human DNA and is suitable for use in molecular diagnostic 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. After receiving instruction from a professional, 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.

Using the provided instructions for use, the integrated sponge on the device to collect a saliva sample from the mouth. After saliva is collected, the cap is removed from the tube, inverted to place the sponge into the collection tube with the stabilizing liquid, and re-capped with the sponge remaining inside the tube. 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. Samples can be shipped at ambient temperature to the laboratory for processing.

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.

The provided text describes the performance criteria and studies for the ORAcollect•Dx OCD-100 and ORAcollect•Dx OCD-100A saliva collection devices. The studies aim to demonstrate that the device collects high-quality human DNA suitable for FDA-cleared molecular diagnostic applications, specifically using the eSensor Warfarin Sensitivity Saliva Test.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

General Acceptance Criteria for DNA Endpoints (unless otherwise specified per study):

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

The studies described are primarily performance evaluation studies for the device itself, rather than testing a specific clinical application on patient data. Therefore, the "test set" here refers to the samples collected specifically for these performance evaluations.

• Reproducibility/Precision:
  • Sample-to-sample, Lot-to-Lot, day-to-day and operator-to-operator: 10 donors, each collecting 9 saliva samples (total 90 samples). Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but the study design suggests prospective collection for the purpose of the evaluation.
  • Multi-centre reproducibility: 30 donors, each collecting multiple saliva samples from 3 sites. Data provenance is not explicitly stated, but the study design suggests prospective collection.
• Post-collection Sample Stability: 30 donors provided samples (total 120 DNA samples analyzed, subset of 10 donors tested on eSensor assay). Data provenance is not explicitly stated, but likely prospective.
• User Study (Sampling Variability):
  • Effect of incorrect collection methods: 10 donors, multiple samples each.
  • Effect of collection from incorrect site: 10 donors, multiple samples each.
    Data provenance not explicitly stated, likely prospective.
• Dry Mouth Study: 13 donors. Data provenance not explicitly stated, likely prospective and with specific selection criteria for dry mouth.
• Human Factors: Naive donors (number not specified, but multiple donors implied). Data provenance not explicitly stated, likely prospective.
• Interfering Substances (Endogenous): Donors provided 4 ORAcollect•Dx samples each (number of donors not specified). Data provenance not explicitly stated, likely prospective.
• Interfering Substances (Exogenous): Donors provided 3 samples each for 5 test groups (number of donors not specified, but implied multiple). Data provenance not explicitly stated, likely prospective.
• Matrix Comparison (OCD-100A vs OCD-100): 45 donors, 1 sample each using OCD-100A format and samples collected by the same donors using OCD-100 format. Data provenance not explicitly stated, likely prospective.
• Method Comparison (Overall Analytical Performance): "100% of samples" (total number not specified, but refers to overall performance data generated across various studies).

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

The ground truth for genotyping in these studies was established by bidirectional sequencing. This is an objective laboratory method and does not typically involve human "experts" in the same way, for example, a radiologist would establish ground truth for image interpretation. Therefore, the concepts of "number of experts" and "qualifications of experts" are not directly applicable in this context. The "expert judgment" lies in the robust establishment and validation of the bidirectional sequencing method itself.

4. Adjudication Method for the Test Set

Not applicable. The ground truth (bidirectional sequencing) is an objective laboratory result. Discrepancies would typically lead to re-sequencing or investigation of laboratory error, rather than adjudication between human experts. "First-pass" and "final-pass" results are mentioned for the eSensor Warfarin Sensitivity Saliva Test, indicating that initial results might be re-evaluated or re-tested if they don't meet criteria, but this is an evaluation of the device performance against the objective ground truth, not an adjudication of human interpretation.

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 saliva collection kit, not an AI-powered diagnostic tool for human interpretation. The studies evaluate the device's ability to collect and preserve DNA for subsequent molecular diagnostics, not its impact on human reader performance.

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

This refers to the performance of the ORAcollect•Dx device itself, which is a standalone collection device. The performance evaluation includes the collection, stabilization, and suitability of the DNA for use in a downstream molecular diagnostic application (the eSensor Warfarin Sensitivity Saliva Test). The device's performance is assessed "algorithm only" in the sense that its output (DNA) is objectively measured and then fed into another diagnostic algorithm (the eSensor test).

7. The Type of Ground Truth Used

The primary ground truth used for validating the accuracy of genotyping results from DNA collected by ORAcollect•Dx (when tested with the eSensor Warfarin Sensitivity Saliva Test) was bidirectional sequencing.

For other endpoints:

• DNA concentration, total DNA yield, A260/A280 ratio were measured using standard laboratory equipment and protocols, with established acceptance criteria.
• Microbial content was assessed against baseline measurements.
• Human Factors study involved task observation and post-collection surveys.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development for this device. The studies described are performance validation studies. The device itself (ORAcollect•Dx) is a physical collection kit, not an algorithm that requires a training set. The downstream eSensor Warfarin Sensitivity Saliva Test would have its own training and validation sets as part of its development, but those are not detailed here.

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

Not applicable, as a "training set" in the context of an algorithm is not described for this device. If the downstream eSensor Warfarin Sensitivity Saliva Test had a training set, its ground truth would likely have been established by methods such as bidirectional sequencing, pathology confirmation, or other clinical gold standards relevant to warfarin sensitivity genotyping.

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Oragene®●Dx OGD-500.001 is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for over-the-counter use with FDA cleared, approved, or legally marketed exempt DNA carrier screening genotyping tests. Saliva samples collected using Oragene®Dx OGD-500.001 are stabilized and can be transported and/or stored long term at ambient conditions.

Oragene Dx family of collection devices offers reliable collection, transportation and longterm ambient temperature storage of human DNA from saliva. Oragene Dx OGD-500.001 is a noninvasive alternative for collecting high quality and quantity DNA and is suitable for use in over-thecounter molecular genotyping applications. Oragene-Dx OGD-500.001 consists of a collection tube with a funnel lid attached (containing a stabilizing liquid). Saliva is delivered directly by spitting into the collection tube. Saliva collection can take place at home, in a laboratory setting, physician's office, 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. A small cap is provided to close the tube for transport and storage (funnel with lid is removed and discarded). 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. Samples can be shipped at ambient temperature to the laboratory for processing. Oragene-Dx samples are stable at room temperature for up to 12 months. Device and sample integrity are preserved during typical ambient transport and storage conditions.

The document describes the Oragene® Dx OGD-500.001 device, a saliva collection kit, and its performance characteristics for substantial equivalence to a predicate device (Oragene® Dx OGD-500).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a single table with numerical targets, but rather are inferred from the performance characteristics studies conducted and the claims made. The summary demonstrates that the device performs equivalently or acceptably based on these studies.

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

• Reproducibility/Precision: Specific sample size not provided in this document, but referred to co-submission DEN140044 for the 23andMe PGS Carrier Screening Test.
• Interfering Substances (Endogenous): 10 individuals for saliva samples.
• Interfering Substances (Exogenous): 5 individuals at 3 time points (baseline, 0 min, 30 min) for each substance; smoking tested in a separate study (sample size not specified for smoking or overall study).
• Consumer User Study: 302 individuals completed the survey and provided a saliva sample. The majority (96.3%) were naïve users.

Data Provenance (Retrospective or Prospective / Country of Origin):

• The studies regarding pre-collection shelf-life and post-collection sample stability and sample volume tolerance refer back to information established in the predicate device's 510(k) (K110701). This suggests a mix of potentially existing data from the predicate and current validation for the proposed device where applicable.
• The reproducibility, interfering substances, and consumer user study were performed in conjunction with the 23andMe PGS Carrier Screening Test (co-submission DEN140044). The study design (e.g., collecting samples before/after substances) indicates these were prospective studies. The country of origin for the data is not explicitly stated, but 23andMe is a US-based company, which might imply data from the US market. The submitter is DNA Genotek Inc., located in Canada.

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

This type of device (a sample collection kit) does not typically involve expert review for "ground truth" in the same way an imaging or diagnostic algorithm would. The ground truth in these studies is the actual measured performance of the device in yielding DNA, maintaining DNA quality, and ensuring accurate genotyping by a downstream FDA-cleared test. The "experts" would be the laboratory personnel and analytical methods used for DNA extraction, quantification, and genotyping, verifying aspects like DNA yield, purity, and concordance with known genetic markers. No specific number or qualifications of "experts" are provided as a distinct category for establishing ground truth, as the ground truth is based on laboratory measurements and analytical results.

4. Adjudication Method for the Test Set

Not applicable for a sample collection device. Adjudication methods like "2+1" (two readers agree, third resolves) are typically used in clinical imaging or diagnostic studies where subjective interpretation is involved. Here, the outcomes are objective laboratory measurements (DNA concentration, genotype concordance).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is not relevant for this device. This type of study compares the performance of multiple human readers on multiple cases, often with and without AI assistance, to measure the effect of AI on human reader performance. The Oragene Dx OGD-500.001 is a sample collection device, not an AI diagnostic tool that assists human readers.

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

Yes, in a sense, the performance of the device itself (collecting and stabilizing DNA) is assessed in a standalone manner. The studies evaluate the device's ability to provide suitable DNA for downstream testing, independently of human interpretation of that DNA. The "algorithm" here is the collection and stabilization process, and its output (stabilized DNA) is directly measured and assessed against objective criteria (DNA yield, purity, genotyping concordance).

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily objective laboratory measurements and genotyping concordance.

• DNA Yield and Purity: Measured directly using laboratory techniques (e.g., spectrophotometry for A260/A280 ratio, fluorometry for DNA concentration).
• Genotyping Concordance: Comparison of genotypes obtained from samples collected with the device against reference genotypes (e.g., from unadulterated samples for interference studies, or known genetic profiles if applicable), using an FDA-cleared genotyping test (23andMe PGS Carrier Screening Test). This is a form of outcome data as it assesses the device's ability to enable correct biological outcomes (accurate genotyping).
• Microbial Content: Laboratory assay for the presence of microbes.

8. The Sample Size for the Training Set

No training set is mentioned or applicable for this type of device. Training sets are typically used for machine learning or AI models, which is not the function of this saliva collection device. The device itself is a physical product, and its performance is characterized through validation studies, not by training an algorithm.

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

Not applicable, as there is no training set for this device.

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Oragene-Dx is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene-Dx container or may be transferred into the Oragene·Dx container using a sponge. Saliva samples collected using Oragene·Dx are stabilized and can be transported and/or stored long term at ambient conditions.

The Oragene·Dx family of products offers reliable collection, transportation and long-term room temperature storage of human DNA from saliva. Oragene Dx is a non-invasive alternative for collecting high quality and quantity DNA for use in molecular diagnostic applications. All formats consist of a collection tube, stabilizing liquid and optional sponges for assisted collection. After saliva is collected, the stabilizing liquid is mixed with the sample. Saliva can be delivered directly by spitting or using provided sponges to transfer saliva into the device.

Here's a breakdown of the acceptance criteria and study information for the Oragene·Dx device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Oragene·Dx device are not explicitly stated as distinct pass/fail thresholds in the provided document. However, the performance characteristics and the successful outcome of the studies (e.g., 100% correct calls after re-testing in most cases) imply that these reported values met the internal and FDA requirements for substantial equivalence. The key performance metrics evaluated were:

• DNA Yield (µg): Quantity of DNA extracted.
• DNA Concentration (ng/µL): Concentration of DNA in the extracted sample.
• A260/A280 Ratio: Indicator of DNA purity (ratio of absorbance at 260 nm to 280 nm). A value around 1.7 to 2.0 typically indicates pure DNA.
• % Correct Calls on downstream molecular diagnostic application: The ability of the extracted DNA to produce accurate results in the eSensor® Warfarin Sensitivity Saliva Test.
• Stability: Ability to maintain DNA quality and quantity over time and under various storage/transport conditions.
• Tolerance to interfering substances: Ability to perform correctly despite the presence of common interfering substances.

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

• Performance Characteristics (Initial):
  • OGD-500: 450 samples from 245 unique donors.
  • OXD-525 & OYD-500: Subset of 45 donors.
  • OGD-575: Subset of 43 donors.
• Sample Volume Tolerance Study: 240 samples using OGD-500.
• Reproducibility Study: 3 samples from each of 10 donors (total 30 samples collected, tested in triplicate by 4 operators, leading to 354-360 data points for yield/concentration, and 87-90 samples per SNP per operator for eSensor test).
• Post-Collection Sample Stability: 30 donors, each collecting four saliva samples for each of the 3 specified Oragene Dx formats (total 360 samples initially). A sub-population of 564 DNA samples across all time-points were tested on the eSensor® Warfarin Sensitivity Saliva Test.
• Interfering Substances Study: Samples from donors with known genotypes (exact number not specified beyond "samples").

Data Provenance: The document does not explicitly state the country of origin for the donors or samples. The study appears to be prospective in nature, as samples were "collected" for the purpose of the studies described (e.g., "samples were collected using OGD-500," "30 donors each self-collect four saliva samples").

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

• The document does not specify the number of experts or their qualifications for establishing the ground truth of the genetic information (e.g., Warfarin Sensitivity SNPs) used with the eSensor® Warfarin Sensitivity Saliva Test. The "known genotypes" mentioned in the interfering substances study imply that the ground truth for the genetic markers was pre-established for the donors. The "Correct Calls" refer to the agreement with these known genotypes.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method for discrepancies in the eSensor® Warfarin Sensitivity Saliva Test results. Instead, it mentions "re-testing" for initial no-calls. For instance, in the reproducibility study, "46 first-run no-calls were due to two runs... invalidated due to DNA Contamination Monitor (DCM) failures," and "The other first-pass no calls were low signal... positive control failure... and contradictory score." These suggest technical reasons for initial non-results, which were then resolved by re-testing. One incorrect call was "due to operator error resolved upon investigation," implying an internal review process rather than an independent expert adjudication of the initial assay result.

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

• No, an MRMC comparative effectiveness study was not explicitly done in the context of human readers improving with AI vs. without AI assistance. This device is a sample collection kit, not an AI diagnostic tool that assists human readers.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done in the sense that the extracted DNA from the Oragene·Dx device was tested directly on the eSensor® Warfarin Sensitivity Saliva Test, and the results (correct calls, incorrect calls, no-calls) were reported for the device's output. The performance of the Oragene·Dx device in preparing samples suitable for subsequent molecular diagnostic testing is evaluated objectively based on the accuracy of the eSensor test. This is considered "standalone" for the sample collection device's function as its "output" (DNA) is assessed by a subsequent analytical device without human interpretation of its own performance.

7. Type of Ground Truth Used

• The ground truth used for evaluating the performance of the extracted DNA on the eSensor® Warfarin Sensitivity Saliva Test was known genotypes for the relevant SNPs (2C92, 2C93, VKORC1). This implies that the genetic information of the donors was determined by a reliable, presumably validated, method prior to the study.

8. Sample Size for the Training Set

• The document describes performance evaluation studies but does not mention a training set as this is a sample collection device, not a machine learning algorithm that requires training. The studies described are validation studies for the device's performance characteristics.

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

• As there is no mention of a training set or machine learning algorithm, this question is not applicable. The "ground truth" (known genotypes) for the performance evaluation was established beforehand for the test samples through undisclosed methods.

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