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The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device employing Enzyme Linked Immunosorbent Assay (ELISA) for qualitative screening at 1.0 pg/mg of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass Spectrometry (GC-MS-MS) for the final quantitative reporting of THC-COOH in hair specimens for the purpose of identifying chronic marijuana use. This process is intended exclusively for in-house professional use only. The process has not been evaluated for use with hair specimens other than head. Clinical consideration and professional judgement should be applied to any drug of abuse test result.

The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device employing Enzyme Linked Immunosorbent Assay (ELISA) for qualitative screening at 1.0 pg/mg of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass Spectrometry (GC-MS-MS) for the final quantitative reporting of THC-COOH in hair specimens.

This document is a 510(k) clearance letter for a drug test, not an AI/ML medical device. Therefore, the questions regarding AI/ML device performance, ground truth, expert involvement, and training/test sets are not applicable to the provided text.

The document discusses the substantial equivalence of the "Quest Diagnostics Haircheck-DT (THC)" device to legally marketed predicate devices for screening and quantifying THC-COOH in hair specimens.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or report device performance in a table format. It states that the device is "substantially equivalent" to predicate devices. This implies that its performance is considered acceptable based on comparison to existing, legally marketed tests for the same purpose.

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

Not applicable. This is a 510(k) clearance for a laboratory test, not an AI/ML device requiring a specific test set in the context of algorithm evaluation. The letter refers to the "Indications for Use" which describes what the device does.

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

Not applicable. Ground truth in the context of an AI/ML medical device is not relevant here. The device itself is a test to determine the presence and quantity of THC-COOH.

4. Adjudication method for the test set:

Not applicable.

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 is not an AI-assisted device.

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

Not applicable. This is a laboratory test, not an algorithm.

7. The type of ground truth used:

Not applicable. The "ground truth" for a drug test would be the actual presence/absence and concentration of the substance in the specimen, as determined by a reference method, but this document does not detail the validation studies beyond stating "substantial equivalence."

8. The sample size for the training set:

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable.

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