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The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin 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 does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the Emit® 2000 Digoxin Assay, and it primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and study details. The only relevant information gathered from the text is:

• Device Name: Emit® 2000 Digoxin Assay
• Intended Use: Quantitative analysis of digoxin in human serum or plasma. Used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy.
• Nature of comparison: The modified assay is similar to the predicate device with minor differences in the packaging (smaller fill volume, different shaped reagent bottles, barcode label compatible with OLYMPUS® AU analyzers). The manufacturer 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." This suggests performance characteristics are assumed to be a match to the predicate, rather than independently proven, for the purpose of this 510(k).

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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.

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).

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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.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

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