(148 days)
for the quantitative determination of Nacetylprocainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).
automated fluorescence polarization immunoassays (FPIA).
The provided 510(k) summary for the Abbott AxSYM N-Acetylprocainamide assay details a comparative study against a predicate device, the TDx/TDxFLx N-Acetylprocainamide assay. This document focuses on demonstrating substantial equivalence rather than establishing acceptance criteria against a clinical ground truth or in a standalone clinical performance study as commonly seen with diagnostic imaging or AI devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance (AxSYM N-Acetylprocainamide vs. TDx/TDxFLx N-Acetylprocainamide) |
|---|---|
| Slope close to 1 | 1.05 |
| Y-Intercept close to 0 | -0.1 |
| High Correlation Coefficient | 0.993 |
| Low Standard Error of Y estimate | 0.081 |
Note: The 510(k) summary does not explicitly state pre-defined acceptance criteria for these metrics (e.g., "Slope must be between 0.95 and 1.05"). However, the reported values are presented to demonstrate a strong correlation and therefore substantial equivalence. For immunoassays like this, values very close to 1 for slope, 0 for intercept, and high correlation (e.g., >0.95) are generally considered indicative of good agreement between assays measuring the same analyte.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 205
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given it's a comparative study for a medical device submitted in 1996, it's highly likely to be prospective data collected specifically for the purpose of demonstrating equivalence, possibly from patient samples obtained from a hospital or clinical lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This study compares the performance of a new device against a predicate device (TDx/TDxFLx N-Acetylprocainamide assay), not against a "ground truth" established by experts in the typical sense of clinical interpretation (e.g., radiologists reviewing images). The predicate device's results serve as the reference.
4. Adjudication Method for the Test Set:
Not applicable. There was no expert adjudication involved in establishing an independent ground truth. The comparison is directly between the quantitative results of two different automated assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a study involving human readers interpreting cases. It's a quantitative comparison of two automated fluorescence polarization immunoassays.
6. Standalone Performance (Algorithm Only without Human-in-the-loop performance):
Yes, this is essentially a standalone performance study. The AxSYM N-Acetylprocainamide assay itself is an automated system that provides quantitative results without human interpretation of raw data. Its performance is evaluated by comparing its output directly to that of another automated system.
7. Type of Ground Truth Used:
The "ground truth" in this context is the results obtained from the predicate device, the TDx/TDxFLx N-Acetylprocainamide assay. This is a comparative "ground truth" rather than an absolute, independent, or expert-adjudicated ground truth.
8. Sample Size for the Training Set:
Not explicitly stated. For an immunoassay like this, there isn't typically a "training set" in the machine learning sense. Instead, the assay involves "calibration" using Abbott calibrators. The document mentions:
- "The AxSYM N-Acetylprocainamide standard calibrators and controls are to be used with the AxSYM N-Acetylprocainamide reagents."
- "The calibrators and controls are prepared gravimetrically using purified material obtained from commercial sources."
These calibrators are used to establish the standard curve against which unknown samples are measured. The number of samples used for initial calibration curve development or verification is not provided.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, there isn't a "training set" with an associated ground truth in the machine learning sense. For the calibration process:
- Calibrators and controls are prepared gravimetrically: This means their concentrations are determined by weight, using highly purified reference materials. This is a fundamental metrological principle for establishing quantitative standards.
- Verified using protocols involving multiple instrument testing: This implies internal validation to ensure the calibrators and controls perform as expected across different AxSYM instruments and potentially against reference methods. This process aims to ensure the accuracy of the calibrator values.
§ 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.