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AML HairCheck-DT (Cocaine) is a process that utilizes the IDS One-Step ELISA Cocaine Kit in which head hair samples undergo forensic testing for the qualitative detection of cocaine at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic cocaine use. This process has not been evaluated for use with hair specimens other than head. This process is intended exclusively for in-house professional use only. The process is not intended for sale to anyone.

The AML HairCheck-DT (Cocaine) provides only a preliminary analytical test result. For a quantitative analytical result or for confirmation, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in the selected ion monitoring mode using the deuterated internal standards. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

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This document describes the AML HairCheck-DT (Cocaine), a process utilizing the IDS One-Step ELISA Cocaine Kit for the qualitative detection of cocaine in head hair samples.

Here's an analysis based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard). The primary acceptance criterion mentioned is the qualitative detection of cocaine at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic cocaine use.

The document refers to the process as providing "only a preliminary analytical test result," with "presumptive positives" requiring confirmation using gas chromatograph-mass spectrometer (GC-MS). This implies the device's performance is gauged by its ability to accurately identify these "presumptive positives" within the specified concentration threshold, which are then subject to a confirmatory method.

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

The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

The provided text does not mention the number of experts used to establish the ground truth for the test set or their qualifications. Given the nature of drug testing, the "ground truth" would likely be established through a confirmatory analytical method rather than expert consensus on interpretation of the initial ELISA result.

4. Adjudication Method for the Test Set

The provided text does not describe an adjudication method for the test set. Instead, it clearly states that "presumptive positives are analyzed using a gas chromatograph - mass spectrometer," which serves as the confirmatory method rather than an adjudication process between human readers.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a diagnostic test, not a system that assists human readers in interpreting images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is described as "a process that utilizes the IDS One-Step ELISA Cocaine Kit." This implies a standalone performance as the ELISA kit performs the initial qualitative detection. The phrase "in-house professional use only" suggests human intervention in the execution of the test and interpretation of the preliminary result, but the initial detection itself is an algorithmic (chemical reaction-based) process. The subsequent GC-MS confirmation is also a standalone analytical procedure.

7. Type of Ground Truth Used

The ground truth for this device is based on confirmatory analytical testing using a gas chromatograph - mass spectrometer (GC-MS). The text states: "For a quantitative analytical result or for confirmation, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in the selected ion monitoring mode using the deuterated internal standards." This is a highly accurate and widely accepted method for drug confirmation, making it the de facto gold standard for this type of test.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set.

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

The provided text does not specify how the ground truth for the training set was established. However, it can be inferred that similar to the test set, the ground truth for any training or validation would have been established through robust analytical methods, most likely GC-MS, given its role in confirming presumptive positives.

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