(89 days)
The Amedica Drug Screen Methamphetamine Test is a immunochromatographic assay for the rapid detection of methamphetamine in human urine at a cutoff concentration of 1000 ng/ml. This assay has not been evaluated at point-of-care locations and is intended for use by healthcare professionals. This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.
Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The test cutoff is 1000 ng/ml.
Here's an analysis of the provided text regarding the Amedica Drug Screen Methamphetamine Test, structured to address your specific points:
Acceptance Criteria and Study Details for Amedica Drug Screen Methamphetamine Test
The information provided is from a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing de novo performance criteria against a predefined set of acceptance values. Therefore, the "acceptance criteria" for this device are implicitly tied to demonstrating performance comparable to the predicate device and achieving a high level of agreement with a confirmatory method (GC/MS).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| High agreement with GC/MS (confirmatory method) | "> 94% agreement with GC/MS results" |
| Usability by professionals at clinical sites | "demonstrated that Amedica Biotech Drug Screen Methamphetamine Test can be use by professionals to obtain a visual, qualitative detection of drugs of abuse." |
| Substantial equivalence to predicate device | "comparison with Rapid Diagnostics methamphetamine test demonstrated that Amedica Biotech Drug Screen Methamphetamine Test is substantially equivalent to the predicate kit." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The text mentions a "correlation study using blind-labeled clinical specimens" and a "clinical site study." However, the specific number of samples (sample size) for these test sets is not explicitly stated in the provided document.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not specified. The use of "clinical specimens" implies a real-world context, but whether they were collected specifically for this study (prospective) or were pre-existing (retrospective) is not detailed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The document implies that the ground truth for the correlation study was established by Gas Chromatography/Mass Spectrometry (GC/MS) results. GC/MS is an analytical chemistry technique, not a human expert. Therefore, the concept of "number of experts" is not directly applicable in this context.
- For the "clinical site study," human professionals (implied to be healthcare professionals working in certified laboratories) used the device. However, their role was to use the device, not to establish a separate ground truth against which the device was compared. The ground truth for this validation would still likely refer back to objective analytical methods or the predicate device's performance.
- Qualifications of Experts: Not applicable, as GC/MS is an instrumental method. For the clinical site study, the "professionals" were working in "two certified laboratories," implying they were qualified given the laboratory accreditation.
4. Adjudication Method for the Test Set
- None specified. The "correlation study" used GC/MS as the reference standard, which is an objective analytical method. There's no mention of multiple human readers or an adjudication process for the GC/MS results themselves or for the visual test results from the Amedica device to establish a consensus ground truth. The agreement was likely a direct comparison of the device's qualitative result (positive/negative) against the quantitative GC/MS result relative to the 1000 ng/ml cutoff.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly mentioned or clearly conducted. The focus was on the device's performance against GC/MS and its substantial equivalence to a predicate device. While a "clinical site study" was performed, it describes the device being "use by professionals" rather than a formal MRMC study comparing human readers with and without AI assistance to measure an effect size.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in essence, the "correlation study" is a standalone evaluation of the device's analytical performance. The "Amedica Drug Screen Methamphetamine Test" is a lateral flow immunoassay that provides a visual qualitative result. While a human physically interprets the lines on the strip, the device itself is a "standalone" diagnostic rather than an AI algorithm that augments human interpretation. The reported agreement of "> 94% agreement with GC/MS results" directly reflects this standalone performance.
7. Type of Ground Truth Used
- Expert Consensus: No.
- Pathology: No (this is for drug detection, not tissue pathology).
- Outcomes Data: No.
- Other: The primary ground truth for evaluating the device's accuracy was Gas Chromatography/Mass Spectrometry (GC/MS), which is a highly specific and sensitive analytical method considered the gold standard for drug confirmation.
8. Sample Size for the Training Set
- Not applicable / Not specified. This device is a competitive immunoassay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" in this context would refer to the development and optimization of the immunoassay reagents and manufacturing process, which doesn't typically involve a distinct data "training set" like AI models do.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As mentioned above, there isn't a "training set" in the machine learning sense for this type of device. The immunoassay's specificity and sensitivity are inherent in its chemical design and production, not learned from a dataset.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).