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The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples using the Optilite analyser.

The Optilite IgM CSF Kit comprises the following reagents:
Latex Reagent: Supplied in stabilised liquid form. Preservatives: 0.025% sodium azide, 0.1% E-amino-n-caproic acid (EACA) and 0.01% benzamidine, 0.05% ProClin.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The provided text describes the 510(k) submission for the Optilite IgM CSF Kit, an in vitro diagnostic device, not an AI/ML-based device. Therefore, the questions related to AI/ML specific criteria, such as expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The acceptance criteria and device performance evaluation for this diagnostic kit are centered on analytical performance characteristics, which are standard for laboratory assays.

Here's a breakdown of the applicable information from the provided text:

1. Table of acceptance criteria and the reported device performance:

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The Optilite Freelite Mx Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

The Optilite Freelite Mx Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

The Optilite Freelite Mx Kappa Free Kit is comprised of the following reagents: Latex Reagent: Sheep anti-Human Kappa (polyclonal monospecific) antibody (F(ab')2 fragment) bound to 200nm polystyrene latex particles. In 0.033M Glycine buffered saline pH8 (containing Sodium Azide (0.033%), Proclin (0.05%), Benzamidine (0.01%) and EACA (0.1%) as preservative plus BSA (0.033%)). Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The Optilite Freelite Mx Lambda Free Kit is comprised of the following reagents: Latex Reagent: Sheep anti-Human Lambda (polyclonal monospecific) Free antibody (F(ab')2 fragment) bound to 200nm polystyrene latex particles. In 0.033M Glycine buffered saline pH8 (containing Sodium Azide (0.033%), Proclin (0.05%), Benzamidine (0.01%) and EACA (0.1%) as preservatives plus BSA (0.1665%)). Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

Note - In Optilite Freelite kits, the latex reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite Kappa Free Mx Reagent or Optilite Lambda Free Mx Reagent.

The provided text describes the performance characteristics of the Optilite Freelite Mx Kappa Free Kit and Optilite Freelite Mx Lambda Free Kit, which are devices for the quantitative measurement of Kappa and Lambda free light chains in serum and urine.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for an in-vitro diagnostic device, the "acceptance criteria" are typically inferred from the performance targets set by the manufacturer and assessed against relevant CLSI (Clinical and Laboratory Standards Institute) guidelines. The reported device performance is directly stated in the tables within the document.

Precision/Reproducibility

Clinical Agreement (2x2 Table with Predicate)

Notes on Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria or pass/fail thresholds for many of these performance metrics. The criteria listed above are inferred based on typical expectations for in-vitro diagnostic devices undergoing 510(k) clearance, often guided by CLSI guidelines. The FDA's substantial equivalence determination implies that the reported performance is acceptable in comparison to the predicate device and the recognized standards.

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

• Precision/Reproducibility:

  • Kappa: Four urine sample pools were tested. The testing involved 21 days with two runs per day using one reagent lot on three analyzers.
  • Lambda: Five urine sample pools were tested. The testing involved 23 days with two runs per day using one reagent lot on three analyzers.
  • Provenance: Not explicitly stated, but likely in-house (Binding Site Group Ltd.) and conducted under controlled laboratory conditions, given it's part of analytical performance testing for an IVD.

• Linearity/Assay Reportable Range:

  • Sample Size: "serially diluted urine samples" were used. The exact number of individual samples or dilutions is not specified.
  • Provenance: Not explicitly stated, but likely in-house.

• Detection Limit:

  • LoB: 60 determinations of blank samples (analyte depleted serum and urine at a low analyte concentration).
  • LoQ: Five independent samples (serum and urine) tested twelve times over five days.
  • Provenance: Not explicitly stated, but likely in-house.

• Analytical Specificity (Interference):

  • Sample Size: "a single urine sample for the Kappa Free assay and the Lambda Free assay". These were prepared with interferents.
  • Provenance: Not explicitly stated, but likely in-house.

• Method Comparison with Predicate Device:

  • Kappa Free: 165 urine samples (including 86 with analyte levels below the reference limit).
  • Lambda Free: 115 urine samples (including 59 with analyte levels below the reference limit).
  • Provenance: Not explicitly stated, but these are patient samples tested against a predicate device. Given the context of a European manufacturer and the lack of specific geographical mention, they could be from various locations or a specific clinic associated with the manufacturer. Retrospective or prospective is not specified, but typically for method comparison, collected samples are used retrospectively.

• Clinical Agreement (2x2 Table with Predicate):

  • Kappa: 166 samples (derived from the 2x2 table: 78+1+8+79 = 166, though the sum of listed cells is 166, the total is given as 166, implying a discrepancy in the row/column totals). The method comparison stated 165, so there might be a rounding or slight difference in sample inclusion for the clinical agreement vs. regression.
  • Lambda: 168 samples (derived from the 2x2 table totals). The method comparison stated 115. This suggests different sample sets or criteria for the 2x2 table analysis compared to the regression analysis, especially given the sample sizes below the reference limit quoted for the method comparison.
  • Provenance: Not explicitly stated, but presumed to be from clinical settings for patient samples. These are likely retrospective samples previously analyzed by the predicate.

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

For an in-vitro diagnostic device like this, "ground truth" and "experts" are typically not established in the same way as for imaging devices requiring expert interpretation.

• Ground Truth: For this device, the "ground truth" is typically the result obtained from a well-established, often reference, method or the predicate device that the new device is being compared against. In this case, the predicate device (Freelite® Human Kappa/Lambda Free Kit for use on the Siemens BN™II) serves as the comparator, from which the "Assay" results are compared.
• Experts and Qualifications: There is no mention of external experts being used for establishing ground truth. The evaluation relies on analytical and clinical performance studies comparing the new device against the predicate or established analytical standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable for this type of in-vitro diagnostic device performance study. Adjudication methods like 2+1 or 3+1 are common in studies where human readers interpret medical images and their interpretations need to be reconciled to establish a ground truth or a consensus opinion. For IVD devices, the "truth" for comparison is usually defined by the results of a reference method or legally marketed 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

Not applicable. MRMC studies, and improvement with AI assistance, are relevant to medical imaging devices where human readers (e.g., radiologists) interpret images. This submission is for an in-vitro diagnostic assay for laboratory measurement of biomarkers, which does not involve human interpretation of complex visual data in the same way.

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

This device is a standalone diagnostic assay (an "algorithm only" if one considers the assay chemistry and instrument processing as the "algorithm"). It performs quantitative measurements without direct human real-time interpretation influencing the numerical result. The human element is in collecting the sample, running the test, and interpreting the numerical result in a clinical context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for comparative studies and assessment of substantial equivalence is primarily established by:

• Predicate Device Results: For method comparison and clinical agreement, the results from the legally marketed predicate device (Freelite® Human Kappa/Lambda Free Kit on the Siemens BN™II) are used as the reference ('ground truth') for comparison.
• CLSI Guidelines: For analytical performance (precision, linearity, detection limits, interference), the "ground truth" is defined by adherence to the methodologies and performance expectations outlined in recognized CLSI guidelines (e.g., EP17-A, EP7-A2, EP6-A, EP5-A2).

8. The Sample Size for the Training Set

This document does not specify a separate "training set" sample size in the context of machine learning. For IVD devices, development involves extensive internal testing and optimization (which can be considered analogous to "training"), but the provided document focuses on the validation studies. The studies described are primarily validation studies against regulatory requirements.

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

Given that this is an IVD kit based on turbidimetry, it doesn't involve a "training set" or "ground truth" in the machine learning sense. The "ground truth" during development (analogous to training) would involve using known concentrations of analytes, reference materials, and established analytical methods to ensure the assay performs as expected.

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