(412 days)
Amphetamines II (AMPII) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1000 ng/mL when calibrated with d-methamphetamine. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS).
Amphetamines II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional iudgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Amphetamines II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample, the absorbance increases.
When a urine sample contains the drug in question, this drug competes with the conjugate-bound drug derivative for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited.
The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
The provided text describes the 510(k) summary for the Amphetamines II Assay, Hitachi 917. However, it does not contain the specific details required to answer all parts of your request, particularly regarding detailed study results, acceptance criteria tables with performance, sample sizes for test sets with data provenance, number and qualifications of experts, adjudication methods, MRMC studies, or training set information.
The document primarily focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, as required for 510(k) clearance. Clinical performance data, when present in such documents, often provides high-level summaries rather than granular details.
Here's a breakdown of what information can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as a table with numerical targets. The document focuses on demonstrating "substantial equivalence" to predicate devices and adherence to the intended use. The various cutoff concentrations (300, 500, 1000 ng/mL) could be considered implicit 'targets' for detection.
- Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) are presented in a formal table with acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Not provided. The document describes the assay but does not detail the clinical study design, including the number of samples used for testing, their origin, or whether they were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not provided. For a drug assay like this, the "ground truth" is typically established by a reference method (e.g., GC/MS), not by human experts interpreting results. The document states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. As stated above, ground truth for this type of device is chemical confirmation, not human adjudication.
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:
- Not applicable. This device is a diagnostic assay (chemical kit) and does not involve human readers interpreting images or data alongside an AI. Therefore, an MRMC study and AI assistance improvement are not relevant concepts for this product.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is a standalone analytical test system. Its performance is evaluated on its ability to detect amphetamines and methamphetamines in urine samples. The purpose of the assay is to provide a "preliminary analytical test result," which then requires a confirmatory method like GC/MS. This means the device itself operates without human interpretation of its internal mechanics, but its results are then interpreted by laboratory personnel. However, there are no specific standalone performance metrics (like sensitivity/specificity) for the device itself against a ground truth mentioned in the provided text.
7. The Type of Ground Truth Used:
- Confirmatory chemical method, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
8. The Sample Size for the Training Set:
- Not provided. This information is typically not included in a 510(k) summary for this type of device, as "training sets" are more commonly associated with machine learning algorithms. For chemical assays, the development process involves reagent optimization and validation, rather than a distinct "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
In summary, while the provided 510(k) summary clearly describes the device and its intended use, it lacks the detailed study performance data, sample sizes, and expert ground truth information that would be typical for an AI/software device submission. This is expected, as the Amphetamines II Assay is a chemical diagnostic kit, and its regulatory submission focuses on different aspects of validation compared to, for instance, an AI-powered image analysis system.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).