(57 days)
The Array® Systems Rheumatoid Factor (RFME) reagent, when used in conjunction with the Beckman Array System and Beckman Calibrator 5 Plus, is intended for quantitative determination of human rheumatoid factor by rate nephelometry.
The Array Systems Rheumatoid Factor (RFupe) Reagent is designed for optimal performance on Beckman's Array® Systems. It is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum samples.
Here's an analysis of the provided text to extract the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a pass/fail format. Instead, it presents performance data (method comparison, stability, imprecision) and states that this data "supports a finding of substantial equivalence" to the predicate device. For the purpose of this response, I infer the implicit acceptance criteria from the context of demonstrating substantial equivalence, meaning the performance of the new device is comparable to the predicate.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Method Comparison: Array RFMPE Reagent results should be comparable to IMMAGE System RF Reagent results. | Details of the method comparison study are missing due to OCR errors. However, the text states: "Equivalence is demonstrated through method comparison... experiments that results obtained from the Array RFMPE Reagent to the IMMAGE System RF Reagent." This implies the results were favorably comparable. |
| Stability: Reagent should maintain performance over its stated shelf-life (24 months at 2-8°C). | Details of the stability study are missing due to OCR errors. The text mentions "Stability Study Results" and lists "SHELF-LIFE OF 24 MONTHS (STORED AT 2-8°C)" under similarities to the predicate. This implies the stability study confirmed the 24-month shelf-life. |
| Imprecision (Repeatability & Reproducibility): The device should demonstrate acceptable levels of imprecision. | Within-Run Imprecision: |
- Level 1 (30.2 IU/mL): S.D. 1.07 IU/mL, %C.V. 3.56
- Level 2 (313 IU/mL): S.D. 8.71 IU/mL, %C.V. 2.78
- Level 3 (564 IU/mL): S.D. 15.2 IU/mL, %C.V. 2.69
Total Imprecision: - Level 1 (30.2 IU/mL): S.D. 1.56 IU/mL, %C.V. 5.16
- Level 2 (313 IU/mL): S.D. 10.4 IU/mL, %C.V. 3.32
- Level 3 (564 IU/mL): S.D. 17.9 IU/mL, %C.V. 3.17 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For Imprecision, the sample size (N) for each level (within-run and total) was 160.
- The sample size for the Method Comparison and Stability studies is not explicitly stated in the provided text due to OCR errors in the table.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to this type of device (an in-vitro diagnostic reagent for quantitative determination using nephelometry). The "ground truth" for such devices is typically established through reference methods and calibrated standards, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable for this type of device. Adjudication methods (like 2+1) are common in studies involving human interpretation (e.g., imaging devices) where experts might disagree.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. The device in question is a reagent for an automated laboratory system, not an AI-assisted interpretation tool for human readers.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance data presented (method comparison, stability, imprecision) represents the standalone performance of the Array® Systems Rheumatoid Factor (RFMPE) Reagent when used with the Beckman Array System. The device itself is an automated assay, so its performance is inherently "standalone" in this context; there is no human interpretation step being assisted or evaluated.
7. The Type of Ground Truth Used
The ground truth for this type of quantitative diagnostic assay would typically be established through:
- Reference materials/calibrators: The device uses "Beckman Calibrator 5 Plus," which would be crucial for establishing the quantitative accuracy.
- Comparison to a predicate device: The method comparison study directly compares the new device's results to the IMMAGE™ Immunochemistry System Rheumatoid Factor (RF) Reagent (K963048), which itself would have been validated against established reference methods. While not explicitly stated as the ground truth, the predicate serves as the comparative standard against which equivalence is demonstrated.
8. The Sample Size for the Training Set
This information is not applicable to this device. This device is a chemical reagent kit with an associated automated analyzer, not a machine learning or AI algorithm that requires a training set in the typical sense. The "training" for such a system would involve optimizing the reagent formulation and instrument parameters, but not through a labeled data training set as understood in AI development.
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 an AI/ML algorithm development. The development and optimization of the reagent and system would rely on physicochemical principles, established analytical chemistry methods, and performance testing against known concentrations of rheumatoid factor, often using certified reference materials.
§ 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).