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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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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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