(37 days)
The Bionike AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
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This is a 510(k) clearance letter for a device from 1997, and as such, it does not contain the detailed information about acceptance criteria and study design that would be present in a modern regulatory submission for AI/ML devices. The letter primarily confirms substantial equivalence to a predicate device.
Therefore, many of the requested details cannot be extracted from the provided text. However, based on the information available, here's what can be provided and what cannot:
1. A table of acceptance criteria and the reported device performance
The provided document (a 510(k) clearance letter) does not contain a table of acceptance criteria or specific reported device performance metrics. It states that the device is a "rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL." The clearance letter confirms the device's substantial equivalence to a predicate device, implying that its performance is considered acceptable relative to that predicate. For detailed performance, one would typically need to refer to the original 510(k) submission, which is not provided here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
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)
This information is not available in the provided document. For drug screening tests like this, the "ground truth" would typically be established by a reference method such as GC/MS rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document. This type of adjudication is more relevant for subjective interpretations (e.g., image reading) rather than a qualitative chemical assay.
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
A Multi-Reader Multi-Case (MRMC) study is not applicable to this device. This device is an in vitro diagnostic test (a chemical assay) and does not involve human readers interpreting AI outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a standalone diagnostic test. It's a "rapid immunochromatographic competitive assay." This means it provides a result directly from a sample without an "algorithm" in the modern AI sense or a human-in-the-loop interpretation of AI output. Its performance would inherently be "standalone."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a cannabinoid screen, as indicated by the statement "The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS," would be GC/MS (Gas Chromatography-Mass Spectrometry). GC/MS is the gold standard for confirming drug presence and concentration in toxicology.
8. The sample size for the training set
This information is not available in the provided document. For a traditional immunochromatographic assay, there isn't a "training set" in the sense of machine learning. The development involves analytical studies to establish performance characteristics, which would use samples, but not for "training" an AI model.
9. How the ground truth for the training set was established
Not applicable as there is no "training set" in the AI/ML sense for this type of device. The accuracy of such a device is established through comparison with a reference method, typically GC/MS, for both development and validation.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).