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The evidence® Barbiturate assay has been designed for use only on the evidence® analyser for qualitative detection of barbiturates, in urine using a cutoff of 200 ng/ml. Qualitative results obtained can be utilized in the diagnosis and treatment of barbiturate use or overdose. This assay provides only a preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS. The Barbiturate Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. The evidence®Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone and phenobarbital. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

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This document is a 510(k) clearance letter from the FDA for a medical device called "evidence® Barbiturate Assay" and "evidence® Drugs of Abuse Calibrators." It does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for an AI/device performance study.

The letter states that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means it met the regulatory requirements for clearance based on its similarity to existing devices, not necessarily through novel performance studies against specific acceptance criteria.

Therefore, most of the information you've requested regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in this document.

Here's what can be extracted based on the provided text, and where your requested information is not applicable (N/A):

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): N/A (Not specified in this regulatory clearance letter.)
• Data Provenance: N/A (Not specified. This document only confirms regulatory clearance based on substantial equivalence.)

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

• Number of Experts: N/A (Not relevant for this type of regulatory clearance document.)
• Qualifications of Experts: N/A

4. Adjudication method for the test set:

• Adjudication Method: N/A (Not relevant for this type of regulatory clearance document.)

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:

• MRMC Study: No (This device is an in-vitro diagnostic assay and calibrator, not an AI system assisting human readers. An MRMC study is not applicable.)
• Effect Size: N/A

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

• Standalone Performance: N/A (This is a laboratory assay, not an AI algorithm. Its performance would be evaluated as a diagnostic test, not an algorithm's standalone performance.)

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

• Type of Ground Truth: N/A (For an in-vitro diagnostic, the "ground truth" for method validation typically involves using reference methods (like GC/MS as mentioned in the indications) or known sample concentrations for analytical performance characterization, rather than expert consensus on images or outcomes data. However, the specific validation data is not included in this clearance letter.)

8. The sample size for the training set:

• Sample Size (Training Set): N/A (Not specified as this is not an AI/machine learning device requiring a traditional training set.)

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

• Ground Truth for Training Set: N/A (Not applicable, as this is not an AI/machine learning device.)

Additional Information from the text:

• Device Name: evidence® Barbiturate Assay and evidence® Drugs of Abuse Calibrators
• Intended Use of Barbiturate Assay: Qualitative detection of barbiturates in urine using a cutoff of 200 ng/ml.
• Purpose of Barbiturate Assay: Used in the diagnosis and treatment of barbiturate use or overdose.
• Confirmation Method: Preliminary analytical test result which should be confirmed by a more specific method, such as GC/MS.
• User Qualification: Must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
• Calibrators: Liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, and phenobarbital, across 9 levels, for calibration of the evidence® system.

In summary, this document is a regulatory approval letter based on "substantial equivalence" to existing devices, and therefore does not detail performance studies with pre-defined acceptance criteria as one would expect for a novel device or AI system requiring independent performance validation.

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