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The Immunalysis Cocaine ELISA Kit for Hair test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of cocaine in head hair samples using a cutoff of 500 pg/mg (0.5 ng/mg) of hair for the purpose of identifying chronic cocaine use. This process has not been evaluated for use with hair specimens other than head. This in vitro diagnostic device is intended for clinical laboratory use only.

The Immunalysis Cocaine ELISA Kit for Hair test system provides only a preliminary analytical test result. For confirmation of the results, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in electron impact mode and using deuterated internal standards. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Immunalysis Cocaine ELISA Kit for Hair test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of cocaine in head hair samples.

The provided text is a 510(k) premarket notification letter from the FDA for the "Immunalysis Cocaine ELISA Kit for Hair." It does not contain a detailed study report with the specific information requested.

Therefore, I cannot provide the complete answer based solely on the provided text. The document refers to the acceptance of a "substantial equivalence" determination but does not include the actual study data, acceptance criteria table, or details about ground truth establishment, expert qualifications, or sample sizes.

However, based on the limited information in the "Indications for Use" section, here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria Mentioned (Implicitly): The "Indications for Use" states a cutoff of 500 pg/mg (0.5 ng/mg) of hair for identifying chronic cocaine use. This cutoff itself acts as an implicit performance characteristic related to the device's ability to differentiate between positive and negative samples.
• Reported Device Performance: NOT PROVIDED. The document does not contain data on sensitivity, specificity, accuracy, or any false positive/negative rates.

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

• NOT PROVIDED.

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

• NOT PROVIDED.

4. Adjudication method for the test set:

• NOT PROVIDED.

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:

• NO. This is an ELISA kit for detecting cocaine, not an AI imaging device. Therefore, an MRMC study with human readers assisting with AI is not applicable.

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

• YES (Implied). ELISA kits are designed to operate in a standalone manner to provide a preliminary analytical test result. The term "algorithm" is not applicable in the same way as with AI, but the kit itself is the "standalone" diagnostic tool.

7. The type of ground truth used:

• Confirmatory Test (Explicitly Mentioned): "For confirmation of the results, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in electron impact mode and using deuterated internal standards." This highly accurate analytical method (GC-MS) serves as the gold standard or ground truth to confirm the preliminary ELISA results.

8. The sample size for the training set:

• NOT PROVIDED.

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

• NOT PROVIDED, but likely similar to the test set. Given that GC-MS is used for confirmation of positive results from the ELISA, it is highly probable that similar confirmatory methods would have been used to establish the ground truth for any samples used in developing or "training" the ELISA kit's performance characteristics.

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