(52 days)
The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma and urine on the Dimension® System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
The Dimension® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® 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) premarket notification for the Dimension® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (DF22), asserting its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving its performance against those criteria as would be found in a clinical trial report.
However, based on the information provided, we can infer some aspects and highlight the lack of others. The core of the submission is to demonstrate substantial equivalence to existing devices.
Here's an attempt to answer your questions based on the provided text, noting where information is explicitly not available in the provided document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a table with specific thresholds for performance metrics (e.g., accuracy, precision, limits of detection) that the new device needed to meet. Instead, it relies on demonstrating comparative performance to predicate devices to establish substantial equivalence.
The table below summarizes the comparative features and stated performance that are used to assert equivalence, rather than a direct acceptance criteria table.
| Feature / Performance Aspect | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma, and urine for diagnosis and treatment of alcohol intoxication and poisoning (similar to predicates). | The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma and urine on the Dimension® System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning. |
| Sample Type | Plasma, serum, and urine (similar to predicates). | Plasma, serum, and urine. |
| Measuring Range | Within a clinically acceptable range, comparable to or improving upon predicates (Predicates: 0-300 mg/dL and 10-600 mg/dL). | 3-300 mg/dL |
| Sample Size | Practical and efficient (Predicates: 3 µL and 4 µL). | 9 µL |
| Measurement Principle | Enzymatic reaction using alcohol dehydrogenase (ADH) and NAD (similar to predicates). | Bichromatic rate, based on an enzymatic reaction. |
| Substantial Equivalence | Performance comparable to Dimension® ALC Flex® (K904302) and Syva® Emit® II Plus Ethyl Alcohol Assay (K010960). | "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." (Specific data not provided in this summary). |
Note on "Acceptance Criteria": For an in-vitro diagnostic device like this, acceptance criteria would typically involve specific assay characteristics such as:
- Analytical Sensitivity: Limit of Detection (LoD), Limit of Quantitation (LoQ).
- Analytical Specificity: Interference studies, cross-reactivity.
- Precision: Repeatability (within-run) and Reproducibility (between-run, between-lot, between-instrument).
- Accuracy: Method comparison studies against a reference method or legally marketed device, often assessed by regression analysis and bias.
- Linearity/Measuring Range.
- Stability.
This 510(k) summary only states that "Comparative testing demonstrated substantial equivalent performance," implying these types of studies were conducted and met predetermined criteria, but the specific criteria and results are not detailed in the provided text.
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 for Test Set: Not specified in the provided text. The document states "Comparative testing described in the protocol included in this submission," but no details about the number of samples or subjects are given.
- Data Provenance: Not specified. There is no information about the country of origin of the data or whether the study was retrospective or prospective.
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 type of device (clinical chemistry reagent cartridge for ethyl alcohol measurement) typically establishes "ground truth" through:
- Reference methods: Highly accurate and precise laboratory methods (e.g., Gas Chromatography-Mass Spectrometry, enzymatic methods traceable to certified reference materials).
- Legally marketed predicate devices: The new device's results are compared to the results obtained from established, cleared devices.
No human experts are typically involved in establishing "ground truth" for the quantitative measurement of ethanol in this context. The "ground truth" refers to the true concentration of ethyl alcohol, which is determined by analytical methods, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among human readers/experts, typically in imaging or clinical assessment where subjective interpretation is involved. Since this device provides a quantitative measurement of alcohol, there is no human interpretation or adjudication process for its primary function.
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 an in-vitro diagnostic (IVD) device for quantitative measurement, not an AI-assisted diagnostic tool for human interpretation.
- There are no "human readers" interpreting results in the way an MRMC study would evaluate, nor is there any AI component described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, this device operates as a "standalone" algorithm/system for quantitative measurement. The Dimension® ETOH Flex® Reagent Cartridge is designed to be used on the Dade Behring Dimension® Clinical Chemistry System, which performs the measurement automatically. The output is a numerical concentration of ethyl alcohol. Human involvement is in operating the instrument and interpreting the numerical result in a clinical context, but not in the analytical measurement itself. The "comparative testing" mentioned would have evaluated this standalone performance against predicate devices.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of IVD device, the "ground truth" for establishing its analytical performance (accuracy, precision, linearity) would typically be:
- Comparisons to legally marketed predicate devices: The Dimension® ALC Flex® reagent cartridge (K904302) and Syva® Emit® II Plus Ethyl Alcohol Assay (K010960).
- Reference methods: Gold standard analytical methods for measuring ethyl alcohol, if used for calibration or method validation (though not explicitly stated in this summary, it's a standard practice).
It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable in the context of this device. This device is a reagent cartridge for a clinical chemistry analyzer, based on an enzymatic reaction. It is not an AI/machine learning model that requires a "training set" of data in the typical sense. The 'training' for such a system would involve validating the chemical reaction, reagent stability, and instrument calibration, which doesn't use a data-driven training set like AI models.
9. How the ground truth for the training set was established
Not applicable. As explained in point 8, there is no "training set" for this type of IVD 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.