(141 days)
A rapid, competetitke binding immunoassay for qualitative determination of tetrahydrocannabinol (THC) metabolites in Urine.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "OneStep Marijuana (THC) Card Test." It does not contain a detailed study report with acceptance criteria and performance data. Therefore, I cannot provide accurate information for most of the requested points.
However, based on the limited information in the document, here's what can be inferred or stated about the device and its clearance:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The 510(k) letter is a notice of substantial equivalence, not a detailed performance study report. It indicates that the FDA has reviewed the manufacturer's submission which would have contained this data, but the data itself is not presented 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided 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:
This is irrelevant for this device. The "OneStep Marijuana (THC) Card Test" is described as a "rapid, competitive binding immunoassay for qualitative determination of tetrahydrocannabinol (THC) metabolites in urine." This is a diagnostic test kit, not an AI-powered image analysis or diagnostic tool that would involve "human readers" or AI assistance in that context. Therefore, an MRMC study and AI improvement effect size are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is an immunoassay card test, which inherently has a "human-in-the-loop" component (someone applying the sample and interpreting the result). The concept of a "standalone algorithm" is not applicable to this type of device. The performance data submitted to the FDA would have evaluated the device's ability to detect THC metabolites, which is its standalone function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a drug test like this, the ground truth would typically be established by confirmatory laboratory methods (e.g., Gas Chromatography-Mass Spectrometry (GC-MS)) performed on the same urine samples. This information is not explicitly stated in the provided document but is the standard for such devices.
8. The sample size for the training set:
This information is not available in the provided document. While the manufacturer would have used a training set during development, the 510(k) letter does not detail this.
9. How the ground truth for the training set was established:
This information is not available in the provided document. Similar to the test set, it would likely involve confirmatory laboratory methods.
In summary, the provided document is an FDA 510(k) clearance letter and not a detailed study report. Therefore, most of the specific information requested about acceptance criteria, sample sizes, expert qualifications, and study methodologies is not present within this document. The letter confirms the device's substantial equivalence to a predicate device based on data submitted by the manufacturer, but it does not present that data.
§ 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).