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1. The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose.
2. The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose.

The ONTRAK TESTSTIK Assays for Barbiturates and Benzodiazepines are in vitro diagnostic tests intended for professional use for the qualitative detection of drug in urine at or above a cutoff of 200 ng/mL. The ONTRAK TESTSTIK Assays are based on the principle of microparticle capture inhibition. These tests rely on the competition between the specific drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane test chamber. When an ONTRAK TESTSTIK is immersed in the urine sample, some of the sample is absorbed into the TESTSTIK sample pad. The absorbed sample travels through a reagent strip contained in the device by capillary action. In the reagent strip, the sample rehydrates and mobilizes antibody-coated blue microparticles. The microparticle-urine suspension continues to migrate through the reagent strip and comes in contact with the immobilized drug conjugate. In the absence of drug in the urine, the antibody-coated microparticles bind to the drug conjugate and a blue band is formed at the result window ("negative" sign). When drug is present in the specimen, it binds to the antibody-coated particles, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. Therefore, a positive sample causes the membrane to remain white ("positive" sign). An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are embedded in the reagent membrane, bind to the antigen on the blue microparticles.

Here's an analysis of the provided text regarding the ONTRAK TESTSTIK Assays, structured according to your requested information.

Please note that the provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full, highly detailed clinical study report. Therefore, some of your requested details might not be explicitly stated or fully elaborated in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of numerical thresholds for a standalone device in this 510(k) summary. Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. The acceptance criteria for the new devices seem to be implied as achieving "greater than 95% confidence at 150% cutoff" for precision and demonstrating similar accuracy to the predicate devices when compared to GC/MS.

¹Note: The predicate for Barbiturates claims "> 99% confidence at 200% of cutoff" and for Benzodiazepines "> 99% confidence at 200% of cutoff". The new device reports "> 95% confidence at 150% cutoff". While visually different, the document concludes "the performance of these devices are essentially equivalent to other legally marketed devices of a similar kind," suggesting this difference was deemed acceptable for substantial equivalence.

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

• Sample Size for Test Set:
  • Barbiturates: 50 positive samples were tested based on the comparison to GC/MS for both the new ONTRAK TESTSTIK and the predicate ONTRAK device. The number of negative samples is not explicitly mentioned in the tabulated accuracy data for positive samples.
  • Benzodiazepines: 50 positive samples were tested based on the comparison to GC/MS for both the new ONTRAK TESTSTIK and the predicate ONTRAK device. The number of negative samples is not explicitly mentioned in the tabulated accuracy data for positive samples.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), not by human experts for interpretive tasks.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by GC/MS, which is an objective chemical analysis method, not requiring human adjudication in the context described.

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 an in vitro diagnostic test for qualitative drug detection in urine, not an AI-assisted diagnostic tool that requires human interpretation or an MRMC study.

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

Yes, a standalone performance assessment was done for both devices. The output of the ONTRAK TESTSTIK Assays (formation of a blue band or lack thereof) is interpreted directly without human-in-the-loop assistance beyond visual inspection of the result window. The accuracy data presented (comparison to GC/MS) reflects this standalone performance.

7. The Type of Ground Truth Used

The ground truth used for performance comparison was Gas Chromatography/Mass Spectrometry (GC/MS). The document states, "Accuracy: Positive Samples... GC/MS." This is a highly accurate analytical chemistry technique often considered the gold standard for drug detection and quantification in biological samples.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its size. As a chemical assay, these devices are not based on machine learning or AI that typically requires separate training, validation, and test datasets in the same way. The development and optimization of such assays involve reagent selection, concentration optimization, and stability testing, but these are not referred to as "training" in the AI sense.

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

Not applicable, as a "training set" in the context of AI/machine learning is not described for these chemical assays. The underlying principles of the assay (antibody-antigen binding) are based on established biochemistry.

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