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The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. Measurement of the different types of light chains aids in the diagnosis of multiple myeloma. Iymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins) and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus in conjunction with other clinical and laboratory findings.

The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. The determination of Lambda light chains is based on the specific turbidimetric reaction, which occurs between a polyclonal antiserum against human Immunoglobulin Lambda light chains and its corresponding antigen under optimal pH conditions and in the presence of polyethylene glycol (PEG). The turbidity of the immune complex is proportional to the concentration of the analyte in the sample.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The primary study conducted was a performance characteristic study for the Lambda light chains assay on the Synchron LX20 System. The goal was to demonstrate substantial equivalence to a predicate device, the Beckman IMMAGE Immunochemistry System Lambda light chain (K964260).

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

• Test Set Sample Size: The document does not explicitly state the total number of patient samples used for the method comparison study. It only mentions that precision studies were conducted on "5 levels (N=80 for each level)," totaling 400 precision test samples. For method comparison, it refers to "acceptable correlation," implying a comparison of results from unknown patient samples run on both devices.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

This type of study (in vitro diagnostic assay verification) does not typically involve human experts establishing "ground truth" in the same way an image analysis or diagnostic AI study would. The ground truth for this assay is the quantitative concentration of Lambda light chains, as determined by the accepted scientific methods and calibration standards.

For the method comparison, the "truth" for the comparison samples would have been the results obtained from the predicate device (Beckman IMMAGE Immunochemistry System Lambda light chain). The predicate device itself (K964260) would have undergone its own validation to establish its accuracy.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic assay comparing quantitative measurements to a predicate device, there is no human adjudication process involved in establishing the "ground truth" for individual test results. The comparison is based on numerical agreement and statistical correlation.

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-assisted diagnostic study or an imaging study involving human readers. It's an in vitro diagnostic assay.

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

Yes, the device performance described (method comparison, precision, AMR) represents the standalone performance of the Lambda light chains assay on the Synchron LX20 System. It measures the analytical capabilities of the assay itself, independent of a human interpretation loop required for diagnostic imaging or similar applications.

7. The Type of Ground Truth Used

The ground truth for the method comparison was established by the results from the legally marketed predicate device (Beckman IMMAGE Immunochemistry System Lambda light chain, K964260). The predicate device's results are considered the established "truth" for the purpose of demonstrating substantial equivalence of the new device.

For the assay's own internal calibration and reference, it is stated that "Both assays are traceable to ERM-DA 470 (European Reference Material) from BCR (EG Community Bureau of Reference), corresponding to RPPHS (Reference Preparation for Protein in Human Serum)." This indicates the use of certified reference materials and established scientific standards to define the quantitative values.

8. The Sample Size for the Training Set

Not applicable in the context of this traditional in vitro diagnostic assay. There isn't a "training set" in the machine learning sense. The assay is developed and validated based on chemical and immunological principles, not by training an algorithm on a dataset. The calibration material used ("calibrator material with assigned Lambda Light chains concentration based on definition of Lambda Light chains as Whole IgG content (MW 150000)") could be considered analogous, but it's not a "training set" in the AI sense.

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

Not applicable for a "training set" in the AI sense. For the calibrator material, its "ground truth" or assigned concentration is established by its traceability to ERM-DA 470 and RPPHS (Reference Preparation for Protein in Human Serum), which are internationally recognized reference materials.

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