(20 days)
The SYNCHRON® Systems Rheumatoid Factor (RF) Reagent, in conjunction with Beckman SYNCHRON Systems is intended for the quantitative determination of rheumatoid factor concentration in human serum or plasma.
A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
The SYNCHRON Systems Rheumatoid Factor (RF) Reagent is designed for optimal performance on Beckman's SYNCHRON® Systems. It is intended for use in the quantitative determination of human rheumatoid factor by rate nephelometry.
Here's an analysis of the provided text regarding the SYNCHRON® Systems Rheumatoid Factor (RF) Reagent, focusing on acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the SYNCHRON® Systems RF Reagent in terms of a pre-defined threshold for performance metrics. Instead, it presents performance data (method comparison, imprecision) and makes a statement of "substantial equivalence" to a predicate device. The performance data implicitly serves as the basis for this claim of equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance (SYNCHRON RF Reagent) |
|---|---|
| Method Comparison (vs. Predicate IMMAGE RF Reagent) | |
| Slope close to 1.0 | 0.982 |
| Intercept close to 0 | -3.43 |
| Correlation coefficient (r) close to 1.0 | 0.953 |
| Imprecision (Within-Run) | |
| Level 1 %CV | 5.6% (Mean: 68.3 IU/mL) |
| Level 2 %CV | 2.3% (Mean: 220.7 IU/mL) |
| Level 3 %CV | 2.2% (Mean: 582.2 IU/mL) |
| Imprecision (Total) | |
| Level 1 %CV | 11.5% (Mean: 68.3 IU/mL) |
| Level 2 %CV | 2.9% (Mean: 220.7 IU/mL) |
| Level 3 %CV | 2.8% (Mean: 582.2 IU/mL) |
| Analytical Range | 20 to 800 IU/mL |
| Shelf-life | 24 months (at 2-8°C) |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison Test Set Sample Size: Not explicitly stated. The table shows a single slope, intercept, and 'r' value derived from a comparison, but the number of individual samples tested for this comparison is not provided.
- Imprecision Test Set Sample Size: For each of the three levels (Level 1, Level 2, Level 3), N=80 individual measurements were performed for both "Within-Run Imprecision" and "Total Imprecision."
- Data Provenance: Not explicitly stated. The document does not specify the country of origin for the samples or if the data was retrospective or prospective. Given the context of a 510(k) submission for a diagnostic device, it's highly probable these were prospective experimental studies conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document. The SYNCHRON® Systems RF Reagent is an in vitro diagnostic device for quantitative determination of rheumatoid factor in human serum or plasma. Its performance is assessed through analytical studies (method comparison, imprecision) against a predicate device or expected analytical characteristics, not by expert interpretation of images or clinical diagnoses. Therefore, there is no "ground truth" established by experts in the context of clinical interpretation, like a radiologist, for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, the device's performance is evaluated analytically, not through a process requiring expert adjudication in the traditional sense (e.g., for diagnostic discrepancies).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No.
- Effect size of how much human readers improve with AI vs. without AI assistance? This is not applicable. The device is a laboratory reagent system for quantitative measurement, not an AI-assisted diagnostic tool that aids human readers (like radiologists or ophthalmologists) in interpreting medical images or clinical cases.
6. Standalone Performance Study
- Was it done? Yes. The "Summary of Performance Data" explicitly presents the standalone performance of the SYNCHRON® Systems RF Reagent through:
- Method Comparison Study: Comparing its results directly against the predicate IMMAGE™ Immunochemistry System RF Reagent.
- Imprecision experiments: Reporting its inherent within-run and total imprecision at different analyte levels.
The data presented are for the algorithm (reagent system) itself, independent of human interpretation.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the reference standard against which the new device's performance is measured. For the method comparison study, the predicate device (IMMAGE™ Immunochemistry System RF Reagent) served as the reference or comparator. For the imprecision studies, the "ground truth" is the true concentration of RF in the control samples, as determined by precise laboratory methods and used to calculate the mean and variability.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a chemical reagent system, not a machine learning or AI model that requires a "training set" in the computational sense. The development of such a system involves chemical formulation, optimization, and extensive analytical validation but not computational training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of machine learning for this type of device. The development and validation of the SYNCHRON® Systems RF Reagent would involve established analytical chemistry principles and quality control processes to ensure the accuracy and reliability of the reagent's performance.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).