(19 days)
The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of quinidine overdose or in monitoring levels of quinidine 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.
This document does not contain the detailed information necessary to fully answer all aspects of your request. The provided text is a 510(k) summary for a medical device, which primarily focuses on establishing substantial equivalence to a predicate device rather than providing a comprehensive study report with acceptance criteria and detailed performance data.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. A 510(k) summary typically references that performance characteristics are similar to the predicate device but does not usually include a table of specific acceptance criteria and the detailed results of a new study against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document. The summary states "The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device," implying that new, extensive clinical studies for this specific modification were not deemed necessary for substantial equivalence.
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 information is not present in the provided document. The device is an in vitro diagnostic for quantitative analysis of quinidine. The "ground truth" for such devices is typically established through a reference measurement method or certified calibrators, not through human expert consensus in the same way an imaging device might use a radiologist.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document. As a quantitative immunoassay, adjudication by human experts in the described manner is not applicable.
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
This is not applicable to this device. The Emit® 2000 Quinidine Assay is an automated in vitro diagnostic immunoassay for quantitative analysis, not an AI-assisted diagnostic imaging or human-read system. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly detailed in the document as a "standalone study." However, the device itself is a standalone quantitative assay. It functions as an algorithm (the immunoassay process) providing a numerical result, without requiring human interpretation of complex patterns, thus not fitting the typical "algorithm only without human-in-the-loop performance" in the context of imaging or AI. Performance characteristics for such an assay would typically include precision, accuracy, linearity, and interference studies. The summary implies these are "the same... performance characteristics" as the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a quantitative diagnostic assay like this is typically established by comparing results to a reference method (e.g., GC-MS, LC-MS/MS) or by using certified reference materials/calibrators with known concentrations. The document does not specify the exact method used for the original predicate device or for validating this modified version.
8. The sample size for the training set
This is not applicable and not present in the document. This device is an immunoassay, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a system would involve optimizing assay reagents and conditions, which is part of its manufacturing and design, not typically reported as a "training set" size in a 510(k) summary.
9. How the ground truth for the training set was established
This is not applicable and not present for the reasons stated in point 8.
Summary of Device and Study (as far as discernible from the document):
- Device Name: Emit® 2000 Quinidine Assay
- Intended Use: Quantitative analysis of quinidine in human serum or plasma for diagnosis/treatment of overdose or monitoring therapy.
- Device Description: Homogeneous enzyme immunoassay. The modification described in this 510(k) pertains to minor packaging differences (smaller fill volume, different shaped bottles, barcode label) and compatibility with specific OLYMPUS® analyzers, while the assay chemistry and performance are stated to be "the same" as the predicate.
- Study: This 510(k) filing primarily relies on demonstrating substantial equivalence to a predicate device (the original Emit® 2000 Quinidine Assay). No detailed new performance study data for this specific packaging modification is provided in the summary. The assertion is 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." Therefore, the "study" for this 510(k) seems to be a demonstration that the changes do not affect the established performance characteristics.
§ 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.