(33 days)
This in vitro method is intended to quantitatively measure n-acetylprocainamide, the pharmacologically active meabolite for procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® N-Acetylprocainamide Assay on a Bayer Immuno-1 system. Measurements of n-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of n-acetylprocainanide to ensure appropriate therapy.
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Acceptance Criteria and Device Performance for N-Acetylprocainamide Assay
The provided document describes the N-Acetylprocainamide (NAPA) assay for the Bayer Immuno 1® System, seeking substantial equivalence to a predicate device (Syva EMIT® N-Acetylprocainamide Assay). The acceptance criteria are implicitly defined by the performance characteristics of the predicate device, against which the new device's performance is compared.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate Device: Syva EMIT® NAPA Assay) | Reported Device Performance (Immuno 1 NAPA Assay) |
|---|---|---|
| Minimum Detectable Concentration | 0.25 µg/mL | 0.11 µg/mL |
| Precision (Total/Between-Run) | 3.9% @ 1.7 µg/mL | |
| 4.5% @ 4.5 µg/mL | ||
| 4.5% @ 10.8 µg/mL | 5.5% @ 1.7 µg/mL | |
| 4.3% @ 4.2 µg/mL | ||
| 6.5% @ 8.7 µg/mL | ||
| Correlation (vs. Predicate) | Implied strong correlation (r close to 1) and agreement (slope near 1, intercept near 0) with predicate. | y = 0.99x - 0.03 |
| r = 0.99 | ||
| Syx = 0.29 µg/mL | ||
| n = 99 |
Interpretation:
- Minimum Detectable Concentration: The Immuno 1 NAPA Assay demonstrated a lower minimum detectable concentration (0.11 µg/mL) compared to the predicate (0.25 µg/mL), indicating potentially better sensitivity.
- Precision: The precision of the Immuno 1 NAPA Assay is comparable to the predicate, with some points slightly higher (e.g., 5.5% vs 3.9% at 1.7 µg/mL, and 6.5% vs 4.5% at 8.7/10.8 µg/mL) and some slightly lower (4.3% vs 4.5% at 4.2/4.5 µg/mL). Given the slight differences, the overall precision is considered acceptable for substantial equivalence.
- Correlation: The Immuno 1 NAPA Assay shows excellent correlation with the predicate device, with an 'r' value of 0.99, a slope (0.99) very close to 1, and an intercept (-0.03) very close to 0. This indicates strong agreement between the two methods over the tested range.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: n = 99 for the correlation study.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it compares an existing predicate device with the new device using presumably collected samples, but this is not definitively stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This study is a method comparison for an in vitro diagnostic assay, not a study involving human interpretation of data by experts. The "ground truth" for the test set is established by the measurements obtained from the predicate device.
4. Adjudication Method for the Test Set
- None. As this is a method comparison study, there is no human adjudication process involved. The performance of the new device is directly compared to the measurements from the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC study was not done. This describes an in vitro diagnostic assay, where the performance is based on quantitative measurements, not human reader interpretation. Therefore, the concept of human reader improvement with or without AI assistance is not applicable.
6. Standalone Performance Study
- Yes, a standalone study was done in the sense that the new device's performance characteristics (Minimum Detectable Concentration, Precision, and Correlation) were evaluated independently. While its correlation was measured against a predicate device, its fundamental performance metrics were assessed for the algorithm/device itself.
7. Type of Ground Truth Used
- The "ground truth" for the test set was the measurements provided by the predicate device (Syva EMIT® N-Acetylprocainamide Assay). The study aimed to demonstrate that the new device's measurements are substantially equivalent to those of the predicate.
8. Sample Size for the Training Set
- Not specified. The document does not provide details about a training set. This type of in vitro diagnostic device typically undergoes method validation rather than machine learning model training specific to a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified. As there is no mention of a traditional "training set" for a machine learning model, the method for establishing ground truth for such a set is not detailed. The performance validation relies on comparing the new assay's output to an established method (the predicate device) on test samples.
§ 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.