(297 days)
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.
For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
Here's a breakdown of the acceptance criteria and study details for the Acetaminophen L3K® Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Serum Method Comparison | Strong correlation (e.g., correlation coefficient approaching 1), and a regression equation demonstrating close agreement with the predicate method (slope near 1, intercept near 0). | Correlation Coefficient: 0.9999 (between Acetaminophen L3K® Assay and a similar acetaminophen method) |
| Deming Regression Equation: This method = 1.060 (reference method) + 4.6 µmol/L | ||
| Confidence Interval: 95% | ||
| Scatter around regression line: 8.9 | ||
| Plasma Method Comparison | Strong correlation (e.g., correlation coefficient approaching 1), and a regression equation demonstrating close agreement between serum and plasma measurements of the new device (slope near 1, intercept near 0). | Correlation Coefficient: 0.9999 (between serum and plasma measurements of Acetaminophen L3K® Assay) |
| Linear Regression Equation: This method (plasma) = 0.999 [This method (serum)] -2.2 µmol/L |
Note: The acceptance criteria are "implied" because the document states "Testing results demonstrate that the Acetaminophen L3K® Assay is equivalent to the predicate device" and focuses on the high correlation coefficients and favorable regression results as proof of this equivalence, rather than explicitly listing numerical thresholds for acceptance. The core of the acceptance criteria for a 510(k) often revolves around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance
- Serum Test Set Sample Size: 100 samples
- Plasma Test Set Sample Size: 25 samples
- Data Provenance: Not explicitly stated regarding the country of origin. The submission is from Genzyme Diagnostics P.E.I. Inc. in Canada, so it's likely the data originated there or in a region where they conducted their studies. The data is retrospective as it involves comparing the new device's measurements against an existing "reference method" (presumably the predicate device or a clinical laboratory's established method).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the given document. For an in vitro diagnostic (IVD) like this, "ground truth" would typically be established by comparing the device's results to a recognized reference method or a method already validated for clinical use, rather than expert consensus on individual cases. The "reference method" is the de facto "ground truth" here.
4. Adjudication Method for the Test Set
- This information is not applicable for this type of IVD performance study. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or clinical trials where human interpretation or endpoint determination requires consensus among multiple experts. For a quantitative assay, the comparison is directly numerical against a reference method.
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
- No, this was not done. The Acetaminophen L3K® Assay is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, this was a standalone performance study. The Acetaminophen L3K® Assay is a laboratory assay that produces quantitative results directly. Its performance was evaluated purely on its analytical capabilities (accuracy, correlation) when measuring acetaminophen in samples, without any human-in-the-loop interpretation beyond standard laboratory procedures and result reporting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was established by a "similar acetaminophen method" referred to as the "reference method" in the serum comparison and the "This method (serum)" in the plasma comparison. This implies an existing, validated laboratory method. For IVDs, this is often a widely accepted and validated analytical method or the predicate device itself.
8. The sample size for the training set
- This information is not provided as this is not an AI/ML device that requires a distinct "training set" in the conventional sense. The studies described are validation (test) studies to demonstrate performance. The "training" for such an assay would be its initial development and optimization, which isn't typically detailed in a 510(k) summary for a chemical assay.
9. How the ground truth for the training set was established
- This information is not applicable as there is no mention of a "training set" in the context of an AI/ML device. For the development of the assay, standard analytical chemistry principles, method development, and optimization techniques would have been employed to ensure accuracy, but this is distinct from establishing ground truth for machine learning.
§ 862.3030 Acetaminophen test system.
(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.