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N Latex B2-Microglobulin Reagent is an in vitro diagnostic reagent for the quantiative determination of human B2-microglobulin in serum by means of particle-enhanced nephelometry. Measurement of B2 -microblobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

The N Latex Microglobulin Reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of B2-microglobulin in serum. Polystyrene latex particles coated with specific antibodies to human B2-microglobulin are agglutinated when mixed with samples containing B2-microglobulin. The intensity of the resulting scattered light measured by the nephelometer is dependent upon the B2microglobulin content of the sample which is determined by reference to standards of known concentrations.

This is a 510(k) summary for a medical device, specifically an in-vitro diagnostic reagent (N Latex B2-Microglobulin Reagent). The requested information primarily pertains to studies for AI/ML-based medical devices or diagnostic imaging devices, which have different evaluation criteria than an in-vitro diagnostic reagent.

Therefore, many of the requested fields (such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," etc.) are not applicable in their typical sense for this type of submission.

However, I can extract the relevant performance characteristics as outlined in the provided text, which function as the "acceptance criteria" and "reported device performance" for this in-vitro diagnostic.

Here's the information extracted from the provided text, adapted to the closest applicable categories:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Method Comparison (Accuracy): 84 serum samples.
• Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Sample Size for Precision Studies:
  • Intra-assay: 20 replicates for each of three concentrations.
  • Inter-assay: 8 replicates for each of three concentrations.
  • Provenance for precision: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This is not applicable for an in-vitro diagnostic reagent. The "ground truth" for method comparison is the result from a legally marketed predicate device (Abbott IMx B2 Microglobulin) or a commercially available enzyme immunoassay.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for an in-vitro diagnostic reagent.

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

• Not applicable. This is not an AI/ML device or an imaging device with human readers.

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

• This device is a standalone diagnostic reagent – its performance is evaluated directly through chemical assays, not through an algorithm requiring human interaction for interpretation in the same way an AI/ML imaging device would. The performance metrics listed (assay range, precision, method comparison) represent its standalone analytical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the method comparison (accuracy) study, the "ground truth" was established by comparison with a commercially available enzyme immunoassay. The goal was to show strong correlation, slope, and intercept relative to this established method.

8. The sample size for the training set

• Not applicable in the context of an AI/ML training set. For an in-vitro diagnostic, "training" involves calibrating the instrument and establishing the standard curve using known concentrations of the analyte. The document states the sensitivity "depends on the B2-microglobulin concentration of the standard," implying a set of standards are used for calibration, but a specific "training set sample size" as an AI term is not relevant.

9. How the ground truth for the training set was established

• Not applicable as an AI/ML training set. For this device, the "standards of known concentrations" (mentioned in the device description and assay range/sensitivity sections) are used to calibrate the nephelometer. The ground truth for these standards would be established through highly controlled laboratory methods, typically gravimetric or spectrophotometric, using purified B2-microglobulin.

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