(24 days)
The Emit® 2000 N-Acetylprocainamide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of N-Acetylprocainamide in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of N-Acetylprocainamide overdose or in monitoring levels of N-Acetylprocainamide to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
The provided text is a 510(k) summary for the Emit® 2000 N-Acetylprocainamide Assay, a diagnostic device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a new, novel device might. The core of this submission is that the modified device is similar to an already approved predicate device, with minor packaging differences.
Therefore, the typical structure for reporting acceptance criteria and a study proving their achievement is not directly applicable in this context. The document emphasizes that the "modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." This implies that the performance characteristics (e.g., accuracy, precision, linearity) are expected to be the same as the predicate device, and the demonstration of substantial equivalence serves as the "proof."
However, I can extract information related to what would be considered "performance" in such a context, even if the detailed study results aren't explicitly provided in this summary.
Here's an attempt to answer your questions based on the provided text, acknowledging its limitations:
Acceptance Criteria and Study for Emit® 2000 N-Acetylprocainamide Assay
Based on the provided 510(k) summary (K011620), the primary "acceptance criteria" for the modified Emit® 2000 N-Acetylprocainamide Assay relate to its substantial equivalence to an existing predicate device. The underlying assumption is that the predicate device's performance already meets established clinical and analytical requirements. The study here essentially demonstrates that the minor changes (packaging, bottle size, barcode) do not negatively impact the assay's performance characteristics.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a modified device emphasizing substantial equivalence due to minor packaging changes, explicit quantitative acceptance criteria for primary diagnostic metrics (e.g., sensitivity, specificity, accuracy) are not detailed in this summary for the modified device. Instead, the "performance" demonstrated is that the re-packaged device maintains the "same assay performance characteristics" as the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. Minor differences in packaging (smaller fill volume, wedge-shaped bottles, barcode). |
| Compatibility with specified OLYMPUS® analyzers | The modified reagent bottles are compatible with OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers. |
| (Presumed Analytical Performance: Sensitivity, Specificity, etc.) | (Implicitly, these are assumed to be identical to the predicate device and meet acceptable analytical standards. Specific data not provided in summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary does not provide specific details about the sample size, type (e.g., patient samples vs. spiked controls), or provenance of a test set used to explicitly re-evaluate performance characteristics for this modified device. The declaration of "same assay performance characteristics" suggests that validation was performed, but the specifics are not included in this high-level summary. Given the nature of a chemical assay, it would typically involve prospective testing with controlled samples or clinical specimens.
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. For an in vitro diagnostic assay like this (measuring N-Acetylprocainamide levels), "ground truth" is established through highly accurate reference methods or clinical outcomes, not typically by expert consensus of imaging or pathology. The determination of N-Acetylprocainamide levels is an objective measurement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human adjudication of results in the conventional sense (e.g., for image interpretation). Analytical measurements are typically verified against established standards or validated reference methods.
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 automated immunoassay, not a device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This is a standalone algorithm/device. The Emit® 2000 N-Acetylprocainamide Assay is an automated immunoassay system (reagents used on OLYMPUS® analyzers) that quantitatively measures N-Acetylprocainamide. Its performance is entirely determined by the chemical reaction and instrument measurement, without human interpretive input affecting the fundamental result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an in vitro diagnostic test measuring a specific analyte, "ground truth" (or analytical true value) is typically established by:
- Reference Methods: Highly accurate and precise analytical methods (e.g., GC-MS, HPLC) that are considered the gold standard.
- Certified Reference Materials: Solutions with known, certified concentrations of the analyte.
- Interlaboratory Comparisons: Though less about "ground truth" and more about comparative performance.
While not explicitly stated in the summary, given it's an assay for N-Acetylprocainamide, the ground truth would have been established using one or a combination of these analytical approaches.
8. The sample size for the training set
Not applicable. This is a chemical immunoassay, not a machine learning or AI-based device that typically requires a "training set" in the computational sense. The "training" of the assay system itself comes from its chemical design and optimization steps during development, and calibration against known standards.
9. How the ground truth for the training set was established
Not applicable, as there isn't a "training set" in the machine learning sense. The assay's analytical performance (linearity, precision, accuracy) is calibrated and validated using reference materials or samples with known, analytically determined concentrations (as described in point 7).
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.