(196 days)
The ESA Plasma Free Metanephrine Analysis Kit is intended for use in clinical laboratories that hold a CLIA certificate to perform tests of high complexity to measure endogenous free levels of the metanephrines (normetanephrine and metanephrine) in plasma using high performance liquid chromatography with electrochemical detection. The analysis of these analytes is used in the differential diagnosis of adult male and female patients with pheochromocytoma. For In Vitro Diagnostic Use Only.
The ESA Free Plasma Motanephrine Analysis Kit consists of reagents for the extraction of metanephrines (normetanephrine and metanephrine) sufficient for 100 plasma samples. Sample clean-up is achieved with ion exchange solid phase extraction. The final extracts are ovaporated to dryness, reconstituted and analyzed via reversed phase ion-pair high performance liquid chromatography and electrochemical detection using the ESA CoulArray® detector. The multichannel electrode system oxidizes the metanepluines and the internal standard, 4-Hydroxy-3-mothoxybenzlamine (HMBA), followed by reduction at a downstream electrode. Total chromatographic run time is approximately 28 minutes per sample. Quantitative data analysis and report generation is performed using ESA CoulArray for Windows Data Station.
The provided document is a 510(k) summary for the ESA Plasma Free Metanephrine Analysis Kit. It describes the device, its intended use, and states that its performance and reliability have been verified. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes (for test or training sets), expert qualifications, ground truth establishment methods, or comparative effectiveness studies.
Therefore, I cannot populate most of the requested fields. The document confirms a "standalone" performance assessment was done, as it verifies the assay's performance.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | - Adequate sensitivity was demonstrated. |
| Not specified in document | - Adequate precision was demonstrated. |
| Not specified in document | - Adequate linearity was demonstrated. |
| Not specified in document | - Adequate recovery was demonstrated. |
| Not specified in document | - Adequate detection limits were demonstrated. |
| Not specified in document | - Immunity from interferences was demonstrated. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the document. The document mentions "plasma samples, augmented plasma samples, standards and controls" were used.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. This is a diagnostic kit; the "ground truth" for its performance would typically be based on established analytical methods and clinical correlations, not necessarily expert image interpretation.
4. Adjudication method for the test set:
- Not applicable/Not specified. This refers to consensus among human readers, which is not relevant for an in vitro diagnostic (IVD) assay performance study described here.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI on human reader performance for tasks like image interpretation, which is not applicable to this IVD kit.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was done. The document explicitly states: "Through the use of plasma samples, augmented plasma samples, standards and controls the performance and reliability of this assay has been verified." This refers to the independent analytical performance of the kit itself.
7. The type of ground truth used:
- The implicit "ground truth" for assessing the kit's performance would be the known concentrations/presence of metanephrines in the standards, controls, and augmented plasma samples, as determined by reference analytical methods or known spiking concentrations. For clinical correlation, it would relate to the differential diagnosis of pheochromocytoma, but the verification described is about the analytical performance of the assay.
8. The sample size for the training set:
- Not applicable/Not specified. This is an IVD kit, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a kit involves its development and calibration using various samples, but these are not referred to as a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable/Not specified for the reasons stated above.
§ 862.1165 Catecholamines (total) test system.
(a)
Identification. A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.