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The Immunalysis Opiates ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Opiates in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISAL™ ORAL FLUID COLLECTION DEVICE ONLY using a cutoff of 40 ng/mL of Morphine. This in vitro diagnostic device is intended for clinical laboratory use only.

The Immunalysis Opiates ELISA Kit for Oral Fluids provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method. Clinical and Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Immunalysis Opiates ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Opiates in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISAL™ ORAL FLUID COLLECTION DEVICE ONLY using a cutoff of 40 ng/mL of Morphine.

The provided text is related to an FDA 510(k) clearance for an in vitro diagnostic device and does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a study proving device performance. The document is an approval letter, not a study report or clinical trial summary.

Here's what can be extracted and what cannot:

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

• Cannot be provided from the given text. The document is an FDA clearance letter, which confirms substantial equivalence to a predicate device. It does not contain an acceptance criteria table or specific performance metrics from a study. It only states the intended use and cutoff for detection.

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

• Cannot be provided from the given text. The document does not describe the test set size or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Cannot be provided from the given text. This information would typically be found in a study report, which is not included here. This device involves chemical analysis, so "experts" would likely refer to analytical chemists or toxicologists, but no details are given.

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

• Cannot be provided from the given text. Adjudication methods are not discussed.

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 and cannot be provided from the given text. This is an in vitro diagnostic device for chemical analysis (ELISA for opiates in oral fluids). MRMC studies are typically for imaging analysis with human readers (e.g., radiologists, pathologists). This device does not involve "human readers" in the sense of image interpretation or AI assistance for such interpretation.

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

• Cannot be definitively answered with full detail, but some inference can be made. The device is an "ELISA test system" for "qualitative detection." This implies a largely automated or semi-automated laboratory process where the "algorithm" is the biochemical reaction and detection method. The output is a "preliminary analytical test result." The document states it's "intended for clinical laboratory use only" and that "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result," with GC-MS being preferred. This indicates that while the ELISA provides a standalone result, it's considered preliminary and requires human expertise in a lab setting, possibly with confirmatory testing, rather than a human-in-the-loop "performance" scenario as might apply to AI in medical imaging.

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

• Inferred based on the context of the device: For an opiate detection test, the ground truth would typically be established by a highly accurate and specific analytical method, such as Gas Chromatography/Mass Spectrometry (GC-MS). The document explicitly states, "Gas chromatography/mass spectrometry (GS-MS) is the preferred confirmatory method," strongly suggesting this would be the ground truth for evaluating the ELISA's accuracy.

8. The sample size for the training set

• Cannot be provided from the given text. This information is not present.

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

• Cannot be provided from the given text. As with the test set, it would likely involve a gold-standard analytical method like GC-MS, but no details are given in this document.

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