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quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic test for use with automated instrumentation in the quantitative determination of human rheumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of theumatoid arthritis.

Device Description

Biokit's quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic product for use with automated instrumentation in the quantitative determination of human theumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of Rheumatoid Arthritis.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the quantex RF plus device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Method Comparison/Correlation	Substantial equivalence in performance to the predicate device, implying strong correlation between the new device and the predicate device across different automated instrumentation with extended analysis range (0-200 IU/mL). (Implied: High correlation coefficient (r))	Monarch: r = 0.992 (with n=152 samples) Hitachi: r = 0.995 (with n=175 samples) Cobas Mira: r = 0.990 (with n=261 samples)
Precision (Within Run CV)	Within run coefficient of variation (CVs) < 3% for various rheumatoid factor levels (as per package insert claims, which the study supports).	Within run CVs of < 3% for three serum samples with different levels of rheumatoid factors over multiple runs on a Monarch. (The text states the study "support[s] package insert claims," implying the criteria were met.)
Precision (Between Run CV)	Between run coefficient of variation (CVs) < 5% for various rheumatoid factor levels (as per package insert claims, which the study supports).	Between run CVs of < 5% for three serum samples with different levels of rheumatoid factors over multiple runs on a Monarch. (The text states the study "support[s] package insert claims," implying the criteria were met.)
Analysis Range	Capability to operate within an extended analysis range of 0-200 IU/mL (compared to the predicate's 0-100 IU/mL). (This is a design modification, the performance data implicitly supports the accuracy within this new range by demonstrating strong correlation with the predicate which previously only covered up to 100 IU/mL, and an overall statement of "substantially equivalent in performance".)	The new quantex RF plus has an analysis range extended from 0-100 IU/mL to 0-200 IU/mL. The method comparison studies (listed above) were conducted with this new range in mind, showing strong correlation.
Intended Use	Maintaining the same intended use as the predicate device: in vitro diagnostic for quantitative determination of human rheumatoid factors in serum by turbidimetric immunoassay, as an aid in diagnosis of Rheumatoid Arthritis.	"Substantially equivalent in performance, intended use, safety and effectiveness to the predicate device." The stated intended use is identical to the predicate: "quantitative determination of human rheumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of Rheumatoid Arthritis."
Safety and Effectiveness	Substantial equivalence in safety and effectiveness to the predicate device.	"Substantially equivalent in performance, intended use, safety and effectiveness to the predicate device as supported by the performance data and labeling."

2. Sample Sizes Used for the Test Set and Data Provenance

Method Comparison Studies (Test Set):
- Monarch: N = 152 samples
- Hitachi: N = 175 samples
- Cobas Mira: N = 261 samples
Precision Study (Test Set):
- Three serum samples with different levels of rheumatoid factors. (Specific N not provided beyond "three serum samples").
Data Provenance: The document does not explicitly state the country of origin. It is a submission to the US FDA. The studies were likely internal validation studies conducted by Instrumentation Laboratory Company. The data provenance is retrospective, as it describes the results of already completed method comparison and precision studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. For an in vitro diagnostic device measuring an analyte (rheumatoid factor), the "ground truth" is typically established by comparing the device's results against a well-characterized reference method or against the predicate device itself, rather than expert interpretation of images or clinical findings. The "experts" in this context would likely be skilled laboratory technicians or specialists performing the reference assays, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not applicable/not provided in the context of this type of IVD performance study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation of medical images or clinical cases by multiple readers. For an assay comparing quantitative measurements, the comparison is statistical against a reference or predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools that assist human readers in interpreting complex data (e.g., radiology images). The quantex RF plus is an in vitro diagnostic test that quantitatively measures an analyte directly.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (method comparison correlations, precision CVs) represents the standalone performance of the quantex RF plus device itself, operating as an automated in vitro diagnostic test. There is no human-in-the-loop performance component described; the device yields a quantitative result.

7. The Type of Ground Truth Used

The ground truth used for the method comparison studies was the measurements obtained from the predicate device (quantex RF plus with the original 0-100 IU/mL range), run on different automated instruments (Monarch, Hitachi, Cobas Mira). The new device's extended range performance is validated by its correlation with the established predicate. For the precision study, the "ground truth" for each sample's RF level was its own repeated measurement, used to calculate the variation.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable for a turbidimetric immunoassay like quantex RF plus. This device is not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its performance is based on chemical and optical principles, factory calibration, and performance characteristics established through validation studies.

9. How the Ground Truth for the Training Set Was Established

As stated above, the concept of a "training set" and associated "ground truth" establishment in the AI/ML context is not applicable to this device. For traditional IVDs, the "calibration" or optimization would be based on reference materials and established assay principles, rather than a data-driven training process.

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