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510(k) Data Aggregation
(344 days)
OUF
The QMS® Everolimus Assay is intended for the quantitative determination of Everolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.
The QMS® Everolimus Assay consists of separately packaged reagents (R1, R2, and Precipitation Reagent) with the following contents and configurations.
R1 Antibody Reagent:
Here's an analysis of the acceptance criteria and study findings for the Thermo Scientific QMS® Everolimus Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|
| Analytical Sensitivity (LDD) | ≤0.51 ng/mL |
| Functional Sensitivity (LOQ) | 2.0 ng/mL (at 20%CV acceptable inter-assay precision and recovery) |
| Precision (Total run %CV) | ≤10.0% |
| Linearity (Assay range 2-20 ng/mL) | Performs in a linear fashion |
| Method Comparison with LC/MS (Correlation Equation) | y = 1.07x + 0.19 |
| Method Comparison with LC/MS (Correlation Coefficient) | R = 0.97 |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not explicitly state the total number of samples used for the "Method Comparison" study or for other performance tests like precision and linearity. It mentions "Everolimus samples were tested for precision" and "Samples were tested in the QMS® Everolimus Assay and compared to LC/MS."
- Data Provenance: The document does not provide details on the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is an in-vitro diagnostic assay for quantitative determination of a drug in human whole blood. The "ground truth" for method comparison and analytical performance is established by comparison to a reference method (LC/MS) or by known concentrations of the analyte in manufactured samples (e.g., calibrators, controls). It does not involve human expert interpretation of images or clinical data.
4. Adjudication method for the test set
This is not applicable for this type of in-vitro diagnostic device. Analytical studies like method comparison and precision do not typically involve adjudication by experts.
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. This device is an automated in-vitro diagnostic (IVD) assay, not an AI-powered diagnostic tool requiring human interpretation or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is essentially how the device operates. The QMS® Everolimus Assay is an automated clinical chemistry assay that provides quantitative results. Its performance (analytical sensitivity, precision, method comparison) is evaluated in a standalone manner, meaning the assay itself generates the readings, which are then used by clinicians for patient management. There isn't a "human-in-the-loop" for the direct measurement process itself, although clinicians interpret the results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the analytical performance studies appears to be:
- LC/MS (Liquid Chromatography/Mass Spectrometry): For the "Method Comparison" study, LC/MS served as the reference method for determining Everolimus concentrations.
- Known Concentrations: For studies like Analytical Sensitivity (LDD), Functional Sensitivity (LOQ), Precision, and Dilution Recovery, the ground truth would be based on precisely prepared samples with known concentrations of Everolimus (e.g., calibrators, controls, spiked samples).
8. The sample size for the training set
This information is not provided in the summary. For an IVD assay like this, there isn't a traditional "training set" in the sense of machine learning algorithms. Instead, assay development involves extensive testing and optimization using various formulations and spiked samples to establish performance characteristics, rather than a distinct training/test split of clinical data.
9. How the ground truth for the training set was established
As noted above, a distinct "training set" with ground truth in the machine learning sense is not explicitly described or typically applicable for IVD assay development. The "ground truth" during development and optimization would involve using:
- Reference standards: Pure Everolimus used to create calibrators and controls with known concentrations.
- LC/MS analysis: As a highly accurate reference method to verify concentrations in samples during development.
- Spiked samples: Whole blood samples spiked with known amounts of Everolimus to assess recovery and other analytical parameters.
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(388 days)
OUF
The QMS® Everolimus assay is intended for the quantitative determination of everolimus, the active ingredient of Zortress®, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.
The QMS Everolimus Calibrators set is intended for use in calibration of the QMS Everolimus Assay.
The QMS® Everolimus Controls set is intended for use in quality control of the QMS® Everolimus Assay.
The QMS® Everolimus Assay system is a homogeneous assay utilizing particle agglutination technology and competitive binding principles.
The acceptance criteria and study proving device performance are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Sensitivity (LOQ) | Not explicitly stated as a numerical threshold in the provided text. | The QMS Everolimus Assay Functional Sentivity results in a C.V. of 20%. The claimed LOQ is 2.0 ng/mL. |
| Precision | Total run %CV less than or equal to 15.0%. | In the study, the total run %CV was less than or equal to 15.0%. |
| Method Comparison | Not explicitly stated as a numerical threshold (e.g., specific correlation coefficient). | Samples were tested in the Everolimus Assay and compared to LC/MS. The method comparison exhibited correlated well with LC/MS as follows: System 1 = 0.93x + 0.03 R2 = 0.94; System 2 = 1.00x - 0.08 R2 = 0.95. |
| Dilution Recovery (Linearity) | Not explicitly stated as a numerical threshold for recovery or linearity. | Results showed that the assay performs in a linear fashion. |
| On-Board Open Vial Reagent Stability | Reagents are stable for up to 30 days when stored on the analyzer. | Reagents stored on the analyzer are stable for up to 30 days. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the specific number of samples used for each performance test (e.g., Functional Sensitivity, Precision, Method Comparison, Dilution Recovery, Stability). For Method Comparison, it mentions "Samples were tested in the Everolimus Assay and compared to LC/MS."
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
- This information is not provided. The ground truth for comparative studies (e.g., Method Comparison) was established using LC/MS, which is an analytical method rather than relying on human expert consensus.
4. Adjudication Method
- Not applicable as the ground truth for the Method Comparison was LC/MS, an analytical technique, not expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic assay, and its performance is evaluated against reference analytical methods (like LC/MS) or established precision protocols, not against human reader performance.
6. Standalone Performance Study
- Yes, a standalone performance study was done for the algorithm (assay). The performance metrics like Functional Sensitivity, Precision, Method Comparison, Dilution Recovery, and Stability are all assessments of the device's standalone analytical performance.
7. Type of Ground Truth Used
- For the Method Comparison study, the ground truth was LC/MS (Liquid Chromatography/Mass Spectrometry), which is a gold standard analytical method for quantifying Everolimus in biological samples.
8. Sample Size for the Training Set
- This information is not provided. The document describes an assay system, not a machine learning algorithm that requires a separate "training set" in the conventional sense. The "calibration" of the assay refers to establishing a standard curve with known concentrations, but the sample size for developing this calibration is not specified.
9. How the Ground Truth for the Training Set Was Established
- For the assay's calibration (which can be considered analogous to training in a general sense for an analytical device), the QMS® Everolimus Assay's calibrators are "Traceable to calibration based on minimization of bias between the QMS assay and an LCMSMS assay for a specified adult renal transplant sample set." This means the ground truth for these calibrators was established by comparing them to results from an LC/MS/MS assay using a specific set of clinical samples.
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