(77 days)
The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
The Dimension Vista® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension Vista® System. The reagents contained in the Dimension Vista® ETOH Flex® reagent cartridge are: Reagent 1 which contains the buffering system and; Reagent 2 which contains alcohol dehydrogenase (ADH), the coenzyme nicotinamide adenine dinucleotide (NAD), buffer, preservatives, and stabilizers.
The provided text describes a 510(k) submission for the Dimension Vista® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge. This document is focused on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics as might be found in an AI/ML device submission.
Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of submission.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the way an AI/ML device study would. Instead, it demonstrates performance by comparing its features and principles to predicate devices and stating that comparative testing demonstrates substantial equivalent performance. Without specific thresholds or numerical acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity), a direct comparison table as requested cannot be fully generated.
However, we can infer "performance" from the comparison to predicate devices, focusing on areas like measuring range, sample type, and principle.
| Feature / Performance Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Dimension Vista® ETOH Flex®) |
|---|---|---|
| Intended Use | Quantitative measurement of ethyl alcohol in human serum, plasma, and urine; diagnosis and treatment of alcohol intoxication and poisoning. | Meets the same intended use. |
| Sample Type | Supports serum, plasma, and urine. (Predicate 1 also supports supernatants from precipitated whole blood) | Supports plasma, serum, and urine. |
| Measuring Range | Expected to be comparable to or encompass the ranges of predicates (0-300 mg/dL for Predicate 1, 10-600 mg/dL for Predicate 2). | 3 - 300 mg/dL |
| Sample Size | Comparable to predicates (3 µL or 4 µL). | 4 µL |
| Measurement Principle | Enzymatic reaction / alcohol dehydrogenase (ADH) enzymatic procedure. | Based on an enzymatic reaction. |
| Substantial Equivalence | Demonstrated equivalent performance through comparative testing. | Conclusion: Substantially equivalent to predicates based on comparative testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance," but does not detail the number of samples or cases used in this testing.
- Data Provenance: Not specified.
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):
Not applicable. This is a chemical assay, and "ground truth" would be established through reference methods or validated laboratory results, not expert consensus in the diagnostic imaging sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As a chemical assay, adjudication methods are not relevant.
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 is a laboratory diagnostic assay, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable in the AI/ML sense. This device is a reagent cartridge for an automated analyzer. Its performance is standalone in that it directly measures ethyl alcohol concentrations. However, this is not an "algorithm-only" performance as traditionally understood for AI/ML devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for a chemical assay like this would typically be established using reference methods or highly accurate analytical techniques for ethyl alcohol concentration. The document does not explicitly state the specific reference method used but implies that the performance was compared to established predicate devices and internal validation protocols.
8. The sample size for the training set:
Not applicable. This is a chemical reagent cartridge, not a machine learning model that undergoes a "training phase" in the conventional sense. Its development relies on chemical and biological principles and optimization, not data-driven training as in AI/ML.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the AI/ML context for this device.
§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.