(126 days)
for the quantitative determination of procainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).
automated fluorescence polarization immunoassays (FPIA).
This 510(k) summary (K955444) for the Abbott AxSYM Procainamide assay describes a comparison study against a predicate device, the TDx/TDxFLx Procainamide assay, to demonstrate substantial equivalence. It does not contain information typically found in studies for AI-powered diagnostic devices with "acceptance criteria" in the sense of accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" here are implicitly related to the statistical similarity between the new device and the predicate.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Slope | Close to 1.0 | 0.98 |
| Y-Intercept | Close to 0.0 | 0.1 |
| Correlation Coefficient | Close to 1.0 (e.g., >0.95 or >0.98) | 0.989 |
| Standard Error of the Y estimate | Low (specific threshold not stated, but 0.056 is reported) | 0.056 |
Note: The "acceptance criteria" are implied by the goal of demonstrating substantial equivalence to the predicate device. For a correlation study, slopes close to 1, intercepts close to 0, and high correlation coefficients are generally desired to show agreement between two methods.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 205
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It only mentions "human serum or plasma."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) summary. The "ground truth" for this device is the measurement provided by the predicate TDx/TDxFLx Procainamide assay. There were no human experts evaluating images or making diagnoses that required ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison of analytical measurements between two automated systems, not a diagnostic task requiring human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This is a comparison of two automated laboratory assays, not a diagnostic imaging device where human readers would interpret results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The study compares the performance of the AxSYM Procainamide assay (the algorithm/device) directly against the TDx/TDxFLx Procainamide assay (another algorithm/device) without human intervention in the measurement process. It's a standalone comparison of the two automated systems.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measurement obtained from the predicate device, the TDx/TDxFLx Procainamide assay. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices when a recognized predicate exists.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This is a traditional immunoassay validation. The AxSYM Procainamide assay itself was developed and calibrated, but the document does not detail specific training sample sizes for an algorithm. It mentions:
- "The AxSYM Procainamide standard calibrators and controls are to be used with the AxSYM Procainamide reagents."
- "Calibrators and controls are prepared gravimetrically using purified material obtained from commercial sources."
- "The calibrators and controls are verified using protocols involving multiple instrument testing."
These suggest internal validation and calibration processes, not a "training set" for predictive modeling.
9. How the Ground Truth for the Training Set Was Established
Not applicable for this type of device and study. The calibrators and controls for the AxSYM system are described as "prepared gravimetrically using purified material obtained from commercial sources" and "verified using protocols involving multiple instrument testing." This refers to the analytical accuracy of the calibrators themselves, which is different from establishing ground truth for a diagnostic algorithm's training data.
§ 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.