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Optilite® Freelite Mx Kappa Free Kit:
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 in serum and urine 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); and in serum aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

Optilite® Freelite Mx Lambda Free Kit:
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 in serum and urine 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); and in serum aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.

The provided FDA 510(k) clearance letter and its associated 510(k) Summary pertains to the Optilite Freelite Mx Kappa Free Kit and Optilite Freelite Mx Lambda Free Kit. The submission sought to add a claim for the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) to the intended use statement (in serum).

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list acceptance criteria in terms of pre-defined numerical thresholds for sensitivity, specificity, or positive/negative rates that were required to be met for the MGUS claim. Instead, it describes clinical performance studies designed to demonstrate the utility of the device for MGUS evaluation. The conclusion states that "The studies generated successful results where all pre-defined acceptance criteria were met," implying these criteria were internal to the manufacturer's study design and not explicitly detailed in the public document as numerical targets.

However, we can infer the de facto "reported device performance" based on the results of Study 1 and Study 2.

Inferred Performance/Results:

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

• Study 1 (Evaluation of MGUS and disease controls at single time points):

  • MGUS Test Set: 229 samples from patients with clinically confirmed MGUS.
  • Disease Control Test Set (non-MGUS): 136 samples from patients with polyclonal hypergammaglobulinemia.
  • Provenance: Retrospective study. The country of origin is not explicitly stated, but the submitter (The Binding Site Ltd) is based in the United Kingdom.

• Study 2 (Evaluation of MGUS progression):

  • Total Patients: 49 MGUS patients.
    • Stable MGUS Cohort: 45 patients.
    • Progressive MGUS Cohort: 4 patients (who progressed from MGUS to MM).
  • Total Samples: 185 samples (up to 4 individual draws for stable, up to 6 for progressive).
  • Provenance: Retrospective study. Country of origin not explicitly stated.

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

• The document states that the clinical diagnostic criteria for MGUS and disease controls were "confirmed with each site" and "as practiced clinically."
• For the progressive MGUS study, changes were defined as clinical progression from MGUS to MM.
• No specific number of experts or their qualifications (e.g., "Radiologist with 10 years of experience") are mentioned in the provided text. The ground truth relies on "clinical diagnosis" or "clinical truth," which typically implies the consensus opinion of treating clinicians or established diagnostic criteria within the medical community (e.g., IMWG guidelines for MGUS/MM).

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the clinical ground truth. It relies on "clinical diagnosis" or "clinical truth" established by the sites providing the samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This device is an in vitro diagnostic (IVD) kit for quantitative measurement of biomarkers, not an image-based AI device that would typically involve human readers interpreting images. The closest analog would be a clinical utility study comparing outcomes with and without the FLC test, but that is beyond the scope of a 510(k) for an IVD kit unless explicitly requested for a novel claim.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This is a standalone study. The Optilite Freelite Mx Kappa and Lambda Free Kits are laboratory assays. The "performance data" presented (positive rates, negative rates, tracking of progression) are derived solely from the measurements made by the device (Optilite Analyser) on patient samples, compared against established clinical diagnoses (ground truth). There is no "human-in-the-loop" aspect to the device's direct measurement and result generation. The results are then interpreted by clinicians in conjunction with other findings, but the device's output itself is standalone.

7. Type of Ground Truth Used

• The ground truth used was clinical diagnosis/clinical truth.
  • For Study 1: "clinically confirmed MGUS" and "polyclonal hypergammaglobulinemia confirmed by study testing... with supporting clinical information." The diagnostic criteria for MGUS were stated to align with or be similar to those outlined by the International Myeloma Working Group (IMWG).
  • For Study 2: "clinically determined stable or progressive status" for MGUS patients, with progression defined as conversion from MGUS to Multiple Myeloma (MM) based on clinical diagnosis. FLC results criteria adapted from IMWG guidelines were used for evaluation of the device's performance, but the patient's status (stable/progressive) was the "clinical diagnosis."

8. Sample Size for the Training Set

• The document states, "The devices in this submission have not materially changed since originally cleared under K150658." This implies that the core analytical performance studies (e.g., analytical measuring range, precision, accuracy) were previously established and referenced from prior 510(k) submissions (K173732 and K150658).
• For the new MGUS claim, the performance data presented are for clinical validation on the test sets described in points 1 and 2.
• The document does not describe a distinct "training set" for the clinical claim of MGUS evaluation, nor is it typical for IVD kits to have a "training set" in the machine learning sense for their clinical claims. The performance studies demonstrate the device's ability to measure FLCs in patient populations relevant to MGUS, and these measures are compared against clinical ground truth. The assay itself (reagents, instrument) would have been "trained" (i.e., optimized and validated analytically) during its initial development and previous clearances.

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

• As a "training set" for the clinical claim is not explicitly mentioned or relevant for this type of IVD 510(k), this question is not directly applicable. For the device itself, analytical validation and calibration would have established its operational parameters, but this isn't "ground truth" in the diagnostic performance sense. The clinical ground truth for the test sets was derived from established clinical diagnoses and diagnostic criteria.

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The FLC Kappa kit is intended for the quantification of Kappa free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use only.

The FLC Lambda kit is intended for the quantification of Lambda free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use only.

The FLC Kappa and FLC Lambda test kits are intended for the quantification of free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure utilizing specific antibodies targeting anti-Lambda free light chains.

It is carried out in 8 successive steps:

• Incubation of the previously diluted samples and calibrators, in the wells of the microplate, where specific free light chain antibodies are fixed.
• Washing of the wells to remove elements that have not been fixed by the anti-free light chain antiserum.
• Incubation with an anti- light chain antiserum (Kit specific) conjugated to peroxidase.
• Washing of the wells to remove the excess of antiserum conjugated to peroxidase.
• Incubation with peroxidase substrate.
• Stopping of the enzymatic reaction with an acidic solution.
• Reading of the optical density by absorbance spectrophotometry at 450 nm of the colored product.
• Calculation of the free light chain concentration of the sample using a calibration curve obtained with calibrators that have been analyzed on the same microplate.

The provided document is an FDA 510(k) clearance letter and associated summary for the Sebia FLC Kappa and FLC Lambda kits. These kits are in vitro diagnostic (IVD) devices used for quantifying free light chains in human serum. They are immunoassay-based tests, not AI/ML-driven devices.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device cannot be extracted from this document. The concepts of "test set," "training set," "experts to establish ground truth," "adjudication methods," "MRMC studies," and "standalone performance" are relevant to AI/ML device evaluations, but they do not apply to the traditional IVD assay described here.

The document discusses analytical and clinical studies for the immunoassay, focusing on performance characteristics such as:

• Clinical Study: Evaluates the concordance of FLC Kappa and FLC Lambda kit results with clinical assessment and other tests for monitoring Multiple Myeloma and AL Amyloidosis.
  • Sample size:
    • Multiple Myeloma: 551 follow-up samples from 235 unique subjects.
    • AL-amyloidosis: 190 follow-up samples from 87 unique subjects.
  • Data Provenance: Subjects had "expanded racial and ethnic diversity (Caucasian, African American, Hispanic, Asian)". No specific country of origin is mentioned, but the manufacturer is based in France and the submission is to the US FDA. The studies appear to be retrospective analyses of follow-up samples.
  • Ground Truth: Clinical assessment and other tests based on criteria from the IMWG (International Myeloma Working Group) for Multiple Myeloma and consensus guidelines (Comenzo et al., 2012; Palladini et al., 2012; Kumar et al., 2022 NCCN guidelines) for AL-Amyloidosis.
  • No mention of experts establishing ground truth or adjudication methods in the context of human readers for an AI system, as this is a laboratory assay.
  • No MRMC study, as this is not an image-based or AI-assisted diagnostic.
  • No separate "standalone" algorithm performance because the device itself is the diagnostic assay.
  • No specific training set or how its ground truth was established is mentioned, as this is a traditional laboratory assay, not a machine learning model.
• Stability Studies: Determined shelf-life for the kits and controls.

In summary, this document describes a traditional immunoassay, not an AI/ML device. Thus, the requested AI/ML-specific information is not applicable and not present.

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The Optilite Freelite Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum 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), and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

The Optilite Freelite Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda in serum using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE), and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Optilite Freelite Kappa Free Kit and Optilite Freelite Lambda Free Kit:

Context: This submission is for a modification to a previously cleared device (K150658) to extend its indications for use to "aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS)". The core device technology and its principles (immunoturbidimetry for quantitative measurement of free light chains) remain unchanged. Therefore, the performance data provided specifically addresses the new MGUS claim.

Acceptance Criteria and Reported Device Performance

Device: Optilite® Freelite® Kappa Free Kit and Optilite® Freelite® Lambda Free Kit

Intended Use Extension: Aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS).

Study Details:

1. Sample Sizes and Data Provenance:

• Study 1 (Sensitivity and Specificity):
  • MGUS Samples (Sensitivity): 234 samples from patients with clinically confirmed MGUS.
  • Disease Controls (Specificity): 140 samples from patients with polyclonal hypergammaglobulinemia (non-MGUS).
  • Data Provenance: Retrospective testing of residual samples. The country of origin is not explicitly stated, but the company (The Binding Site Ltd.) is based in the United Kingdom.
• Study 2 (MGUS Progression):
  • Total Samples: 185 samples from 49 MGUS patients (45 stable, 4 progressive). Up to 4 individual sample draws for stable, up to 6 for progressive per patient.
  • Data Provenance: Retrospective testing of residual samples. Country of origin not explicitly stated.

2. Number of Experts and Qualifications for Ground Truth:

• The document states that the clinical diagnostic criteria that clinicians used to establish the "clinical truth" of MGUS positive samples were confirmed with each site.
• The ground truth for non-MGUS samples was based on "clinically confirmed polyclonal hypergammaglobulinemia" and "supporting clinical information."
• For the progression study, "clinically determined stable or progressive status" was the basis.
• The number of experts and their specific qualifications (e.g., radiologist with 10 years of experience) are not explicitly provided in the summary. It generally refers to "clinicians" and "clinical diagnosis."

3. Adjudication Method for the Test Set:

• Not explicitly mentioned. Given that the ground truth relies on "clinical diagnosis" and "clinically confirmed MGUS," it implies that the diagnostic criteria were applied by the treating clinicians at the respective sites prior to the retrospective study. There is no indication of an independent multi-expert adjudication process specifically for this study's test set.

4. MRMC Comparative Effectiveness Study:

• No. This submission is for an in-vitro diagnostic (IVD) device (a laboratory test), not an AI-assisted diagnostic tool that would directly assist human readers in image interpretation. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to measure improvement in human readers with AI assistance is not applicable and was not performed.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):

• Yes. The study evaluates the performance of the device (Optilite Freelite Kappa and Lambda Free Kits on the Optilite Analyser) in measuring FLC levels and deriving the kappa:lambda ratio. The performance metrics (sensitivity, specificity, categorization of stable/progressive) are reported for the device's output itself, compared to the clinical ground truth. This is a standalone performance assessment of the IVD test.

6. Type of Ground Truth Used:

• Clinical Diagnosis / Clinical Findings:
  • For MGUS positive samples: "clinically confirmed MGUS" based on diagnostic criteria, including those outlined by the 'International Myeloma Working Group (IMWG)' consensus.
  • For non-MGUS samples: "polyclonal hypergammaglobulinemia confirmed by study testing (total IgG/lgA/lgM and serum IFE), with supporting clinical information."
  • For stable/progressive MGUS: "clinically determined stable or progressive status" based on patient follow-up and conversion to MM or stable status over time. This includes evaluation criteria based on IMWG guidelines for multiple myeloma regarding FLC changes.

7. Sample Size for the Training Set:

• Not applicable. This submission focuses on the performance of a lab-based immunoassay kit, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The test method is immunoturbidimetry, which relies on chemical reactions and optical detection, not an algorithm that learns from data.

8. How Ground Truth for the Training Set Was Established:

• Not applicable, as there is no "training set" for this type of device. The method is a validated laboratory assay.

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The FLC Kappa kit is intended for the quantification of Kappa free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.

The FLC Lambda kit is intended for the quantification of Lambda free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure. Measurement of free light chains aids in the diagnosis of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.

The FLC Kappa and FLC Lambda test kits are intended for the quantification of free light chains in human serum from adults with an Enzyme-Linked Immunosorbent Assay (ELISA) procedure utilizing specific antibodies targeting anti-Lambda free light chains. It is carried out in 8 successive steps: Incubation of the previously diluted samples and calibrators, in the wells of the microplate, where specific free light chain antibodies are fixed. Washing of the wells to remove elements that have not been fixed by the anti-free light chain antiserum. Incubation with an anti- light chain antiserum (Kit specific) conjugated to peroxidase. Washing of the wells to remove the excess of antiserum conjugated to peroxidase. Incubation with peroxidase substrate. Stopping of the enzymatic reaction with an acidic solution. Reading of the optical density by absorbance spectrophotometry at 450 nm of the colored product. Calculation of the free light chain concentration of the sample using a calibration curve obtained with calibrators that have been analyzed on the same microplate.

Here's a breakdown of the acceptance criteria and study details for the Sebia FLC Kappa and FLC Lambda kits, based on the provided FDA 510(k) summary.

Note: This document describes an in vitro diagnostic (IVD) device, which measures specific analytes (free light chains) in human serum using a laboratory assay (ELISA). The concepts of "AI assistance," "human readers," "radiologist," and "image" are not relevant to this type of device. Therefore, sections pertaining to these concepts (like MRMC studies) are not applicable and will be marked as such. The "ground truth" for an IVD kit is established through various analytical performance studies demonstrating its accuracy and reliability compared to established methods, and clinical studies correlating its results with disease states.

Acceptance Criteria and Device Performance for Sebia FLC Kappa and FLC Lambda Kits

1. Table of Acceptance Criteria & Reported Device Performance

The FDA 510(k) summary does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds. Instead, it details various performance studies and their results, which implicitly form the basis for acceptance. The reported device performance is indicated by the successful execution of these studies and the obtained values meeting recognized clinical laboratory standards (e.g., CLSI guidelines).

General Performance Categories and Key Findings:

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The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple mycloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

Not Found

I'm sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance for an AI/ML medical device.

The document is an FDA 510(k) clearance letter for Diazyme Laboratories Inc.'s Human Kappa Free Light Chain Assay and Human Lambda Free Light Chain Assay. These are in-vitro diagnostic assays (laboratory tests), not AI/ML-based devices. The document primarily discusses:

• The FDA's review and determination of substantial equivalence for these specific assays.
• General regulatory requirements for medical devices (e.g., registration, labeling, good manufacturing practices).
• Indications for use for each assay (quantitative determination of Kappa/Lambda FLC concentrations in serum to aid in diagnosis and monitoring of multiple myeloma).

Therefore, I cannot extract the following information because it is not present in the provided text:

1. A table of acceptance criteria and reported device performance (for an AI/ML device): The document does not describe performance metrics like sensitivity, specificity, AUC, etc., in the context of an AI/ML model for image or other data interpretation.
2. Sample size used for the test set and data provenance: No mention of test sets for an AI/ML model.
3. Number of experts used to establish ground truth and qualifications: This is irrelevant for a chemical assay.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as there is no AI assistance to human readers.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for chemical assays is typically established through reference methods and clinical correlations, not "expert consensus" in the way it's used for AI image analysis.
8. Sample size for the training set: Not applicable for an IVD assay.
9. How ground truth for the training set was established: Not applicable.

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The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple mycloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

Not Found

This document is an FDA 510(k) clearance letter for Diazyme Human Kappa Free Light Chain Assay and Diazyme Human Lambda Free Light Chain Assay. It describes the indications for use of the devices but does not contain any information regarding the acceptance criteria or a study proving the device meets the acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness data, a clinical study report, or a 510(k) summary that details the performance studies and acceptance criteria for these specific diagnostic assays.

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N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma. N Latex FLC kappa and lambda assays are used: • as an aid in the diagnosis and monitoring of multiple myeloma (MM) on the BN Systems and Atellica® CH Analyzer. • as an aid in the diagnosis of immunoglobulin light-chain amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer. • as an aid in the monitoring of immunoglobulin light-chain amyloidosis (AL) on the BN Systems. · as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) on the BN Systems and Atellica® CH Analyzer. Results of FLC measurements should always be interpreted in conjunction with other laboratory and clinical findings.

The N Latex FLC (free light chain) assays are in vitro diagnostic reagents for the quantitative determination of free light chains, type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunoassay determination. Used in conjunction with other clinical and laboratory findings, FLC measurements are used as an aid in the diagnosis and monitoring of multiple myeloma (MM), as an aid in the diagnosis of amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer; as an aid in the monitoring of amyloidosis (AL) on the BN Systems and as an aid in the evaluation of MGUS on the BN Systems. The FLC test systems on the Atellica® CH Analyzer are based upon the principles of particle-enhanced turbidimetry. Polystyrene particles coated with antibodies to human free light chains, type kappa or lambda, respectively, are agglutinated with samples containing FLC. Monitoring the agglutination by measuring the increase in turbidity, a concentration curve is obtained. The actual change in absorbance is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

The provided text describes the acceptance criteria and performance study for the Siemens Healthcare Diagnostics Products GmbH N Latex FLC kappa and N Latex FLC lambda assays when applied to the Atellica® CH Analyzer, specifically for the added indication as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed through a method comparison study between the N Latex FLC kappa and N Latex FLC lambda assays on the Atellica® CH Analyzer (candidate device) and the N Latex FLC kappa and N Latex FLC lambda assays on the BN ProSpec System (predicate device).

Note on MGUS Specific Results: While the overall study meets the acceptance criteria for slope and predicted bias, the separate analysis for MGUS patients only for N Latex FLC lambda shows predicted biases of -15.7% and -16.9% at the lower and upper limit reference intervals respectively, and a slope of 0.841. These specific MGUS-only results for lambda do not meet the stated acceptance criteria of ≤ +/- 10% bias and a slope of 0.9-1.1. However, the document's general conclusion states "Acceptance criteria fulfilled" based on the overall results (Table 7.3.1-2 and 7.3.1-3). The separate MGUS-only table (7.3.1-4 and 7.3.1-5) is presented as a sub-analysis, and the acceptance criteria for this sub-analysis are not explicitly re-stated or modified from the general criteria. The FDA’s acceptance of this submission implies that the overall performance was considered sufficient.

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

• Sample Size (Overall):
  • N Latex FLC kappa: 212 samples
  • N Latex FLC lambda: 202 samples
• Sample Size (MGUS-specific analysis):
  • N Latex FLC kappa: 38 MGUS samples
  • N Latex FLC lambda: 35 MGUS samples
• Data Provenance: The method comparison study was conducted internally at the Siemens Healthcare Diagnostics Products GmbH site in Marburg, Germany. It incorporated "samples derived from MGUS patients." The text for the clinical performance study for MGUS evaluation mentions "121 MGUS samples (89 Non-IgM, 21 IqM and 11 LC MGUS) and 102 polyclonal immunostimulation samples," but it's important to differentiate these from the test set numbers used in the method comparison study (212/202 and 38/35). The specific type (retrospective/prospective) is not explicitly stated for the source of these samples, but the mention of "derived from MGUS patients" suggests pre-existing samples, which would typically be retrospective.

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

This information is not provided in the given text. The device is an in-vitro diagnostic reagent for quantitative determination of free light chains, and the "ground truth" for the method comparison study is established by comparison to a legally marketed predicate device (N Latex FLC assays on the BN ProSpec System).

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is established by a predicate diagnostic device, not by expert consensus or adjudication. The study is a method comparison, not a reader study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic assay, not an imaging AI device that relies on human reader interpretation. The study evaluates the analytical performance of the assay compared to a predicate, not how human readers improve with AI assistance.

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

Yes, in essence. This is a standalone performance study of the diagnostic assay on a new instrument platform (Atellica® CH Analyzer) compared to its performance on a predicate instrument (BN ProSpec System). The "algorithm" here refers to the analytical process of the in-vitro diagnostic test.

7. The Type of Ground Truth Used

The ground truth for the method comparison study is the performance of the predicate device (N Latex FLC kappa and N Latex FLC lambda assays on the BN ProSpec System). This is a comparative study aiming to show equivalence to an already legally marketed and accepted diagnostic method.

8. The Sample Size for the Training Set

This information is not provided in the text. The document describes a study to support a 510(k) submission for a diagnostic assay, which typically involves validation studies rather than "training sets" in the context of machine learning (unless the underlying technology uses machine learning, which is not indicated here). If there was any internal development or calibration process that could be considered "training," the sample size used for that is not disclosed.

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

This information is not applicable/not provided as there is no mention of a "training set" in the context of machine learning. If the question refers to how the "predicate device" performance (which acts as the reference for this study) was originally established, that information is outside the scope of this particular 510(k) submission document. The predicate device itself has been cleared under previous 510(k)s (K171742, K182098, K193047, K201496).

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N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA plasma. N Latex FLC kappa and lambda assays are used:
• as an aid in the diagnosis and monitoring of multiple myeloma (MM) on the BN Systems and Atellica® CH Analyzer.
• as an aid in the diagnosis of immunoglobulin light-chain amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer.
· as an aid in the monitoring of immunoglobulin light-chain amyloidosis (AL) on the BN Systems.
· as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) on the BN Systems.
Results of FLC measurements should always be interpreted in conjunction with other laboratory and clinical findings.

N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTAplasma. N Latex FLC kappa and lambda assays are used as an aid in the diagnosis and monitoring of multiple myeloma (MM) and immunoglobulin light-chain amyloidosis (AL) and as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS). Monitoring of immunoglobulin light-chain amyloidosis (AL) and evaluation of MGUS are cleared for use only on the BN Systems.
The N Latex FLC test systems are based upon the principles of particle-enhanced immunonephelometry. Polystyrene particles coated with monoclonal antibodies to human free light chains, type kappa or lambda, respectively, are agglutinated when mixed with samples containing free light chains. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

This document describes the N Latex FLC kappa and N Latex FLC lambda assays, in vitro diagnostic reagents used for the quantitative determination of free light chains (FLC), type kappa or type lambda, in human serum and EDTA plasma. This submission seeks to add "monitoring of immunoglobulin light-chain amyloidosis (AL) on the BN Systems" to the device's indications for use.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparative studies presented, aiming to demonstrate substantial equivalence to the predicate device and acceptable concordance with clinical status. The reported performance is summarized in the tables below, using Evaluation Mode 2 as favored by Siemens.

Comparison of N Latex FLC versus Freelite (Predicate Device) - Evaluation Mode 2

Concordance of N Latex FLC versus Clinical Status - Evaluation Mode 2

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

The test set for the comparative effectiveness study included data from a multi-center study on immunoglobulin light-chain amyloidosis (AL) patients.

• Sample Size: The N Latex FLC versus Freelite comparison involves a total of 241 observations based on initial and consecutive blood draws. The comparison to clinical status involves 222 observations.
• Data Provenance: The document does not explicitly state the country of origin. The study is retrospective, comparing changes between an initial sample draw and each consecutive blood draw, and then comparing these results to both a predicate device and clinical response.

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

The "clinical response" used as ground truth was "provided by the physician taking into account all available clinical and laboratory information."

• Number of Experts: Not explicitly stated, but it implies individual physicians for each patient.
• Qualifications: "Physician" is the qualification mentioned. No specific experience levels (e.g., years of experience or specialization in oncology/hematology) are provided for these physicians.

4. Adjudication Method for the Test Set

The document mentions that clinical response was "provided by the physician taking into account all available clinical and laboratory information." There is no mention of a formal adjudication panel or process (e.g., 2+1, 3+1). The response evaluation criteria are derived from NCCN Response Criteria for serum M protein/IFE and FLC levels/ratios.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted. This device is an in-vitro diagnostic assay, not an imaging AI device that would typically involve human readers. The comparative effectiveness assessment focuses on the agreement between the new device and a predicate device, and the concordance of both devices with physician-determined clinical status.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies presented are standalone performance assessments of the N Latex FLC kappa and lambda assays. The device itself is an automated assay, and its performance is evaluated directly (algorithm only). The comparison to clinical status is essentially an evaluation of the algorithm's output versus an established clinical truth.

7. Type of Ground Truth Used

The ground truth for the clinical comparison was based on clinical status/physician assessment, which encompasses "all available clinical and laboratory information" including NCCN Response Criteria. This is closer to an "outcomes data" or "expert consensus" type of ground truth in a clinical context.

8. Sample Size for the Training Set

The document does not provide information on the training set size. This submission focuses on performance data for an extended indication for monitoring AL. It refers to previous submissions (K171742, K182098, K193047) for established analytical and clinical studies, implying that the device was already developed and validated. The current submission's study used a distinct set of AL patients for evaluating the new monitoring claim.

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

Not applicable/provided. As this submission is for an extended indication and refers to previous clearances for the device, details on the ground truth establishment for the initial training set (if any for algorithm development) are not included in this document. The focus of the provided text is on demonstrating performance for the new monitoring claim.

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N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma. N Latex FLC kappa and lambda assays are used:
• as an aid in the diagnosis and monitoring of multiple myeloma (MM) on the BN Systems and Atellica® CH Analyzer,
• as an aid in the diagnosis of amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer,
• as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) on the BN Systems.
Results of FLC measurements should always be interpreted in conjunction with other laboratory and clinical findings.

The N Latex FLC (free light chain) assays are in vitro diagnostic reagents for the quantitative determination of free light chains, type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunoassay determination. Used in conjunction with other clinical and laboratory findings, FLC measurements are used as an aid in the diagnosis and monitoring of multiple myeloma (MM), as an aid in the diagnosis of amyloidosis (AL) and on the BN Systems, as an aid in the evaluation of MGUS.
Polystyrene particles coated with antibodies to human free light chains, type kappa or lambda, are agglutinated when mixed with samples containing FLC. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the concordance percentages achieved in various patient cohorts. The document does not explicitly state numerical thresholds as "acceptance criteria" but rather presents the performance results.

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

• MGUS Concordance:
  • Test Set Sample Size: 121 MGUS samples (89 Non-IgM, 21 IgM, 11 LC MGUS)
  • Data Provenance: Not explicitly stated, but the study was described as a "multi-center study," suggesting samples were collected from various clinical sites. It is implied to be retrospective as they are described as "clinically defined samples" and patients with "diagnosed" MGUS or polyclonal immunostimulation.
• LC MGUS Concordance:
  • Test Set Sample Size: 11 LC MGUS samples (subset of the 121 MGUS samples).
  • Data Provenance: Same as above (multi-center, implied retrospective).
• Polyclonal Immunostimulation Concordance:
  • Test Set Sample Size: 102 specimens.
  • Data Provenance: Same as above (multi-center, implied retrospective).
• Evaluation of MGUS Patients (Stable Cohort):
  • Test Set Sample Size: 61 patients.
  • Data Provenance: Not explicitly stated, but patients were "initially diagnosed for MGUS" and "evaluated over different time periods" with "at least 4 sample draws at various time intervals," indicating a prospective or longitudinal study design over time.
• Evaluation of MGUS Patients (Progressive Cohort):
  • Test Set Sample Size: 4 patients.
  • Data Provenance: Same as above (prospective/longitudinal).

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It refers to "clinically defined samples" and "clinical diagnosis," implying that the ground truth was based on a comprehensive clinical assessment, likely by medical professionals (e.g., oncologists, hematologists), but the details are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing the ground truth of the test set (e.g., 2+1, 3+1). The ground truth appears to be based on pre-existing "clinical diagnosis" or "clinically defined samples."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic reagent, which provides quantitative measurements, not an imaging device that human readers interpret. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone performance study was done. The studies described (concordance and evaluation of stable/progressive patients) assessed the performance of the N Latex FLC assays (the "device" or "algorithm" in this context) directly against clinical diagnoses and criteria. The results are reported as the "N Latex FLC κ/λ Ratio Concordance" and "N Latex FLC results," indicating an assessment of the device's output without direct human-in-the-loop interpretation of the assay results during the diagnostic process itself (though human interpretation of the FLC results in conjunction with other clinical findings is part of the intended use).

7. Type of Ground Truth Used

The ground truth used was expert consensus / clinical diagnosis / outcomes data.

• "Clinically defined samples" with diagnoses of MGUS or polyclonal immunostimulation.
• "Clinical diagnosis of MGUS" and "change in clinical diagnosis of MGUS to MM" for the stable and progressive cohorts, respectively. This implies that the ground truth was established by medical professionals using a combination of clinical findings, established diagnostic criteria, and other laboratory results, which could be considered a form of expert consensus or clinical outcomes.

8. Sample Size for the Training Set

The document does not report on a separate training set or its sample size. The performance data provided is for the evaluation of the device, implying the device was already developed. For an in-vitro diagnostic assay like this (which is a reagent test and analytical system), the "training" typically refers to the development and optimization of the assay's chemical and biological components, calibration, and establishment of analytical performance characteristics, rather than machine learning model training on a distinct labeled dataset. The document refers to prior submissions (K171742 and K182098) for "previously documented analytical and clinical studies," which likely covered the initial development and analytical validation.

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

As no explicit "training set" for an AI/ML model is mentioned, this question is not directly applicable. For a traditional diagnostic assay, the "ground truth" during development involves rigorous analytical validation (e.g., using reference materials, spiked samples, and comparison to established methods) and initial clinical studies to define normal ranges and characteristic responses in different disease states. These would have been established through standard laboratory and clinical practices, likely involving certified reference materials, reference methods, and clinical expert assessment of patient samples.

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The CAPI 3 IMMUNOTYPING kit is designed for the qualitative detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS 3 TERA instrument, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPI 3 PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).

The CAPILLARYS 3 TERA instrument performs all procedural sequences automatically to obtain a profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig G). alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively.

The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.

The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.

For In Vitro Diagnostic Use.

The capillary electrophoresis provides complete automation with fast separation and good resolution. This electrokinetic separation technique is carried out in a silica glass tube (i.e., capillary) with internal diameter lower than 100 um filled with a buffer composed of electrolytes.

The CAPILLARYS 3 TERA instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation occurs according to the electrolyte pH and electroosmotic flow. The CAPILLARYS 3 TERA instrument has silica capillaries functioning in parallel allowing 12 simultaneous analyses.

In capillary electrophoresis, abnormal fractions detected in serum or urine protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones, are always suspect of being monoclonal proteins (M-proteins, paraproteins, monoclonal immunoglobulins). With the CAPI 3 IMMUNOTYPING procedure, the immunotyping procedure uses specific antibodies to identify these abnormal fractions.

In immunotyping a sample dilution is prepared and injected at the anodic end of six capillaries. The reference pattern (ELP pattern), which is a complete electrophoretic pattern of the sample's proteins, is obtained by mixing the sample with the ELP solution and injection into the 1st capillary. The antisera patterns are obtained by sample aspiration into the 5 subsequent capillaries. Previously diluted samples are mixed with specific antisera against gamma (Ig G), alpha (lg A), mu (lg M) heavy chains, and free and bound Kappa and Lambda light chains. Protein separation is performed in a high voltage electrical field. The separated proteins are detected using absorbance at 200 nm at the cathodic end of the capillary. After the analysis, the capillaries are immediately washed with a wash solution and filled with buffer which prepares the capillaries for the next analysis.

The immunotyping is performed in four automated steps:

1. Dilution of serum or urine samples with a specific diluent in the pre-dilution well of the reagent cup. This dilution is made according to the sample's immunoglobulin concentration.
2. Mixing diluted serum sample with specific antisera. The antigen - antibody complex is formed rapidly in liquid medium without the need for extra incubation step or removal of the immune complexes.
3. Injection of the prepared samples with simultaneous aspiration into 6 capillaries at the anodic end. Protein separation occurs when a high voltage field is applied to the alkaline buffer. The separated proteins are detected using absorbance at 200 nm at the cathodic end of the capillary.
4. Overlay of the ELP pattern on the antisera patterns (Ig G, Ig A, Ig M, Kappa and Lambda) allows characterization of suspected monoclonal component.

Here's an analysis of the acceptance criteria and study data for the CAPI 3 IMMUNOTYPING device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list predefined quantitative acceptance criteria with specific numerical thresholds for all performance metrics (e.g., repeatability, reproducibility, accuracy). Instead, for qualitative assessments, the acceptance criterion appears to be "concordant results" or "100% agreement." For sensitivity, the acceptance criterion is implicitly shown by the reported detection limits.

• Lambda free: 0.010 g/L (1.0 mg/dL)
• Kappa free: 0.030 g/L (3.0 mg/dL)
• IgG Lambda: 0.004 g/L (0.4 mg/dL)
• Lambda (part of IgG Lambda): 0.004 g/L (0.4 mg/dL) |
  | Sample Stability (2-8 °C) | Results after 1 week storage at 2-8 °C should comply with "acceptance criteria defined by SEBIA." (Specific criteria not detailed in document). | The results obtained complied with the acceptance criteria defined by SEBIA. Conclusion: Urine samples can be stored for 1 week between 2 and 8 °C. |
  | Sample Stability (-70/-80 °C) | Results after 1 month storage at -70/-80 °C should comply with "acceptance criteria defined by SEBIA." (Specific criteria not detailed in document). | The results obtained complied with the acceptance criteria defined by SEBIA. Conclusion: Urine samples can be stored for 1 month between -70 and -80 ℃. |
  | Kit Stability (CAPI 3 IMMUNOTYPING sample diluent) | Stable for 2 years at 2 - 30 °C. (The acceptance criterion is the claimed stability period and conditions). | 2 years at 2 - 30 °C (Reported as claimed stability). |
  | Kit Stability (CAPI 3 IMMUNOTYPING ELP solution) | Stable for 2 years at 2 - 8 °C. (The acceptance criterion is the claimed stability period and conditions). | 2 years at 2 - 8 °C (Reported as claimed stability). |
  | Kit Stability (CAPI 3 IMMUNOTYPING antisera) | Stable for 2 years at 2 - 8 °C. (The acceptance criterion is the claimed stability period and conditions). | 2 years at 2 - 8 °C (Reported as claimed stability). |
  | On-Board Stability (Sample Diluent, ELP, Antisera) | Stable for 2 months on-board the instrument. (The acceptance criterion is the claimed stability period). | 2 months (Reported as claimed stability). |
  | Accuracy/Concordance | 100% agreement between the test technique (CAPI 3 IMMUNOTYPING on CAPILLARYS 3 TERA) and the reference technique (CAPILLARYS IMMUNOTYPING on CAPILLARYS 2) for qualitative results, including presence/absence and type of monoclonal component. | This study demonstrated 100% agreement between the two techniques for all 52 urine samples (8 without, 44 with monoclonal components of various types). This 100% agreement was confirmed for specific monoclonal protein types (IgG Lambda, IgG Kappa, IgG Lambda with Lambda free, IgG Kappa with Kappa free, Lambda free, Kappa free, IgM Kappa with Kappa free, IgA Lambda, IgA Lambda with Lambda free, and without Monoclonal). |

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

• Repeatability: 4 different urine samples with monoclonal proteins (including Bence Jones proteins).
• Reproducibility: 3 different urine samples with monoclonal proteins (including Bence Jones proteins).
• Sensitivity: 3 pathological urine samples, serially diluted in normal urine.
• Sample Stability (2-8 °C): 10 urine samples (normal and pathological).
• Sample Stability (-70/-80 °C): 10 urine samples (normal and pathological).
• Accuracy/Concordance: 52 urine samples (8 without monoclonal component, 44 with monoclonal component including Bence Jones proteins).

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's a 510(k) submission from Sebia (manufacturing in France, submitter in USA), and refers to "urine samples," these are likely clinical samples, but details on their origin are not provided. The phrase "analyzed at the beginning of the study (reference) and after X storage (test)" suggests a prospective element for the stability studies on stored samples.

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

The document states: "All electrophoregrams were evaluated visually for the qualitative results." However, it does not specify the number of experts used for ground truth establishment or their qualifications (e.g., "radiologist with 10 years of experience"). This is a significant omission from the perspective of external validation of the ground truth. It is implied that visual evaluation by trained personnel (likely laboratory professionals or experts in electrophoresis interpretation) was the method, but no further details are provided.

4. Adjudication Method for the Test Set

The document does not detail an adjudication method (such as 2+1 or 3+1 consensus) for the visual evaluation of electrophoregrams. It simply states they were "evaluated visually." This implies a single evaluator, or an internal process where disagreement (if any) was resolved, but the process is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was described. The accuracy/concordance study compares the new device's visual interpretation results to an existing, cleared device's visual interpretation results, which is a comparison of two methods, not an assessment of human readers with and without AI assistance. The device itself is a qualitative detection and characterization system, and the evaluation stated is "electrophoregrams were evaluated visually," indicating human interpretation is still involved in the final result.

6. Standalone Performance Study

The studies described (repeatability, reproducibility, sensitivity, stability, accuracy/concordance) evaluate the performance of the integrated system (CAPI 3 IMMUNOTYPING kit on CAPILLARYS 3 TERA instrument). The "electrophoregrams are evaluated visually" suggests human-in-the-loop performance, rather than a purely standalone algorithm. The device produces a "protein profile for qualitative analysis," which is then visually interpreted. Therefore, a standalone (algorithm only) performance study, in the sense of an AI algorithm making a definitive diagnosis without human oversight, does not appear to have been performed or is not directly applicable to the described use case which involves visual evaluation.

7. Type of Ground Truth Used

The ground truth for the test sets (e.g., for accuracy, repeatability, reproducibility studies) appears to be established by the visual evaluation of electrophoregrams performed by an expert or experts using a "reference technique" or the device itself.

• For the accuracy/concordance study, the "reference technique" (CAPILLARYS IMMUNOTYPING URINE procedure performed with the CAPILLARYS 2 instrument) served as the comparator for establishing ground truth, assuming the predicate device's results are considered the established truth.
• For other studies like repeatability and reproducibility, the "ground truth" seems to implicitly be the correct identification of presence/absence and type of monoclonal protein based on the expected outcome for the known pathological samples, assessed by visual evaluation.
• No mention of pathology, outcomes data, or independent gold standard beyond another electrophoretic method is provided.

8. Sample Size for the Training Set

The document does not mention a "training set" or explicitly describe the development of an algorithm that learns from data. This device is an immunodiagnostic test system based on capillary electrophoresis and specific antisera, producing profiles that are then visually interpreted. It is not presented as an AI/ML-driven device requiring a training set in the conventional sense. The "training" for such a system would typically involve its chemical and mechanical design, calibration, and validation against a standard.

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

As no training set is described for an AI/ML algorithm, this question is not applicable. The assay's "truth" is inherent in its biochemical principle (antigen-antibody reaction, electrophoretic separation) and the expertise of interpreting the resulting electrophoregrams.

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