(59 days)
This in vitro method is intended to quantitatively measure vancomysia, an antibiotic, in human serum or plasma (heparin) using Syva EMIT® Vancomycio Assay on a Technicon Immuno-J system. Messurements of vancomycin are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to easure appropriate therapy.
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Here's an analysis of the provided information, structured to address your specific questions. It's important to note that the document is a Summary of Safety and Effectiveness for a new in vitro diagnostic device (IVD) from 1997, specifically for the Immuno 1 Vancomycin method. This type of document is a pre-market submission to regulatory bodies and typically focuses on demonstrating substantial equivalence to an existing, legally marketed device (the predicate device) rather than presenting a full clinical trial report with detailed study designs as might be expected for an AI/CAD product. Therefore, some of your requested information, especially regarding AI-specific studies, MRMC, and expert adjudication, will not be applicable.
Acceptance Criteria and Study Details for the Vancomycin Method for Bayer Technicon Immuno 1° System
This submission describes the Immuno 1 Vancomycin method, an in vitro diagnostic intended to quantitatively measure vancomycin in human serum or plasma. The study's purpose is to demonstrate substantial equivalence to a predicate device, the Syva EMIT® Vancomycin Assay.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a traditional table format for each performance metric. Instead, it presents performance data for both the Immuno 1 Vancomycin method and the predicate device (Syva EMIT® Vancomycin Assay), implying that the Immuno 1 system's performance is acceptable if it is comparable to the predicate. For Correlation, the acceptance would likely be a strong positive correlation (r close to 1) and a relatively small standard error of the estimate (Syx).
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Immuno 1 Vancomycin (Reported Performance) | Predicate Device (Syva EMIT® Vancomycin, Reported Performance) |
|---|---|---|---|
| Minimum Detectable Conc. | Not explicitly listed for predicate, but a low concentration is desirable. | 0.2 µg/mL | Not Listed |
| Precision (Between-Run) | Comparable or better %CV at different concentration levels to the predicate device. | 8.5 µg/mL: 5.3% | |
| 39.5 µg/mL: 6.6% | |||
| 50.6 µg/mL: 5.3% | 7.2 µg/mL: 10.3% | ||
| 38.7 µg/mL: 5.6% | |||
| 39.5 µg/mL: 6.2% | |||
| Correlation | Strong positive linear correlation (r approaching 1) and small standard error (Syx) compared to the predicate device. | y = 1.032 x - 0.006 | |
| n = 53 | |||
| r = 0.981 | |||
| Syx = 1.779 µg/mL | Not applicable (Immuno 1 correlated against this) |
Observation: For Precision, the Immuno 1 method generally shows comparable or better precision (lower %CVs) than the predicate device at similar concentrations. The correlation coefficient (r = 0.981) indicates a very strong positive linear relationship between the Immuno 1 method and the predicate.
2. Sample Size and Data Provenance:
- Sample Size for Test Set: n = 53 (This is specified for the correlation study).
- Data Provenance: Not explicitly stated. Given it's a submission to the FDA (implied by the date and context of "Summary of Safety and Effectiveness"), the data would likely be from studies conducted by the manufacturer, Bayer Corporation. The geographic origin of the samples (e.g., country) is not mentioned. The data is retrospective in the sense that the performance characteristics were analyzed from collected samples using the device and compared to a predicate, not from a prospective study where patients are enrolled.
3. Number of Experts and Qualifications:
- Not applicable. This study is for an in vitro diagnostic device measuring a chemical compound, not an imaging device requiring expert interpretation or diagnosis from radiologists or other medical specialists. The "ground truth" (or reference method) here is the predicate device's measurement.
4. Adjudication Method:
- Not applicable. See point 3. This type of study does not involve expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This study is for a quantitative chemical assay, not an imaging device or AI-assisted diagnostic requiring human reader input or comparison. It does not involve human readers interpreting cases.
6. Standalone Performance Study:
- Yes, a standalone performance was done for the Immuno 1 Vancomycin method. The "Precision (Between-Run)" data represents the standalone performance of the Immuno 1 system at different control levels. The "Correlation" data also demonstrates the Immuno 1 device's output compared to the predicate, which can be seen as its standalone measurement capabilities when evaluated against a reference.
7. Type of Ground Truth Used:
- The "ground truth" for the correlation study was the Syva EMIT® Vancomycin Assay. The Immuno 1 method's measurements are correlated against values obtained from this predicate device, implying the predicate device serves as the reference or comparative standard. This is typical for demonstrating substantial equivalence for IVDs.
8. Sample Size for Training Set:
- Not applicable. This document describes a traditional in vitro diagnostic device, not an AI or machine learning model that requires a "training set." The device is likely calibrated using known standards, but this is different from an ML training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.