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The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite IgA Kit comprises the following reagents: Antiserum: Goat anti IgA supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 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.

Here's a breakdown of the acceptance criteria and study detailed in the provided document for the Optilite IgA Kit, organized according to your requested information.

It's important to note that this document is a 510(k) summary for a modification to an existing device (Optilite IgA Kit, K103824). Therefore, the study presented here primarily focuses on confirming that the modified device (with a change from sheep to goat antibody) performs comparably to the predicate device (the original cleared kit) and that the performance characteristics detailed in the original submission still hold true. This is not a study to establish initial performance characteristics, but rather to demonstrate equivalence after a modification.

Acceptance Criteria and Device Performance Study for Optilite IgA Kit (K191985)

This study was conducted to demonstrate that the modified Optilite IgA Kit, with a change in the source of the detection antibody from sheep to goat, maintains comparable performance to the predicate device (Optilite IgA Kit, K103824). The acceptance criteria were primarily based on demonstrating no significant change in performance compared to the previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision (Repeatability & Within Laboratory): 5 different samples, N=80 per level (total 400 replicates).
• Precision (Between Instrument): 5 different samples, N=24 per level (total 120 replicates).
• Precision (Between Lot): 5 different samples, N=24 per level (total 120 replicates).
• Linearity: High pool (8.59 g/L) and low pool (0.10 g/L) for dilution series. Each diluted sample tested in 3 replicates.
• Kit Stability (Accelerated): 6 replicates of controls, internal reference, and samples.
• Detection Limit (LoQ): 4 samples tested using 2 reagent lots.
• Method Comparison: 102 serum samples, 42 plasma samples (total 144 samples). The document does not specify county of origin, but it is implied to be for US market. The study appears to be prospective as it's conducted to support a new submission for a modified device.
• Reference Range Transfer: 20 samples from apparently healthy US donors.

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

This type of in-vitro diagnostic device (measuring Immunoglobulin A levels in blood samples) does not typically involve human expert readers or a "ground truth" derived from expert consensus in the same way an imaging AI device would. The "ground truth" for the performance characteristics (precision, linearity, limits, comparison) is derived from:

• Reference materials: Traceability to ERM-DA470k/IFCC for calibration.
• Established analytical methods: Results from the predicate device serve as the comparative "reference."
• Pre-defined specifications: Acceptance criteria for analytical performance established based on regulatory guidelines (e.g., CLSI standards) and the performance of the predicate device.

Therefore, there is no mention of experts establishing ground truth for the test set in the conventional sense of human readers for an AI imaging study.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic analytical performance study. Adjudication by human experts is typically performed in clinical studies involving interpretation of data (e.g., imagery, patient symptoms) where subjective judgment might be involved. Here, the measurements are quantitative and based on instrument readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC study was not done. This is an in-vitro diagnostic device that quantifies an analyte (IgA) in blood samples. MRMC studies are specific to imaging devices and human interpretation. This device does not involve human readers in its direct use or interpretation of results beyond a lab technician operating the instrument and a clinician interpreting the quantitative IgA values.

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

Yes, the analytical performance studies (precision, linearity, detection limits, method comparison) represent the "standalone" performance of the analytical instrument and reagents. The device provides a direct quantitative measurement, so there isn't a human-in-the-loop directly assisting the measurement process itself, only interpreting the final numerical result.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• Quantitative Reference Materials: The calibration is traceable to an international reference material (ERM-DA470k/IFCC).
• Comparative Performance to Predicate Device: The performance of the predicate device (Optilite IgA Kit, K103824) serves as the established "truth" against which the modified device is compared to prove substantial equivalence.
• Analytical Standards: Established methods and guidelines (e.g., CLSI standards) define how analytical accuracy, precision, and other parameters are measured and what constitutes acceptable performance.
• Known Concentrations in Quality Control (QC) Materials: Pooled human sera with known concentrations are used for controls and calibrators, providing a known value against which measurements are assessed.

8. The Sample Size for the Training Set

This document describes a pre-market notification for a modified in-vitro diagnostic device; as such, it does not detail a "training set" in the context of machine learning or AI algorithm development. The "training" for such a system would typically refer to the initial development and optimization of the assay reagents and instrument parameters. The studies presented here are primarily verification and validation studies to demonstrate that the performance of the modified device is equivalent to the predicate. The specifics of the original assay development/optimization (which could be considered analogous to "training") are not provided here, as this is a 510(k) for a modification.

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

Not applicable in the context of this 510(k) for a modified in-vitro diagnostic device. As explained above, there isn't a "training set" in the machine learning sense. The "ground truth" for the development of the original assay would have involved rigorous biochemical and analytical characterization of the antibodies and their reaction with IgA, optimization of assay conditions (e.g., reagent concentrations, incubation times), and calibration against international reference standards.

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The Optilite IgM Kit is intended for the quantitative in vitro measurement of IgM in human serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgM aids in the diagnosis of abnomal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

The Optilite IgM Kit comprises the following reagents: Antiserum: Goat anti IgM supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 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 a 510(k) submission for the Optilite IgM Kit, which is a quantitative in vitro measurement system for IgM in human serum, lithium heparin, or EDTA plasma. The submission is a modification to an existing device (K082129). The core of the submission revolves around demonstrating that the modified device maintains performance comparable to the previously cleared device, rather than proving initial efficacy or diagnostic accuracy.

Based on the provided text, here's an analysis of the acceptance criteria and study proving the device meets them:

Key Takeaway: This 510(k) submission is for a modification to an existing device (change of antibody source and buffer). Therefore, the "acceptance criteria" and "study" are primarily focused on demonstrating that this modification does not negatively impact the performance compared to the original, already cleared device. There is no new clinical effectiveness study to establish diagnostic accuracy against a disease state from scratch.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed as "no change in performance compared to the device cleared in K082129" or meeting specific pre-defined quantitative thresholds (e.g., allowable CV, limits of agreement).

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

• Precision Studies (Repeatability and Within Laboratory):
  • Sample Size: 5 different samples. For each level, N=80 for Repeatability/Within Lab Summary (20 working days * 2 runs/day * 2 reps/run).
  • Data Provenance: Not explicitly stated, but typically internal lab data (e.g., from the manufacturer's R&D or QC labs).
• Precision Studies (Between Instrument):
  • Sample Size: 5 different samples. For each level, N=24 (6 working days * 2 runs/day * 2 reps/run).
  • Data Provenance: Not explicitly stated, typically internal lab data.
• Precision Studies (Between Lot):
  • Sample Size: 5 different samples. For each level, N=24 (6 working days * 2 runs/day * 2 reps/run).
  • Data Provenance: Not explicitly stated, typically internal lab data.
• Linearity Study:
  • Sample Size: Dilution series from a high pool (8.44 g/L) and a low pool (0.17 g/L). Each diluted sample tested in 3 replicates.
  • Data Provenance: Not explicitly stated, typically internal lab data.
• Kit Stability (Accelerated):
  • Sample Size: 6 replicates of controls, internal reference, and samples.
  • Data Provenance: Not explicitly stated, typically internal lab data.
• Detection Limit (LoQ) Study:
  • Sample Size: Four samples.
  • Data Provenance: Not explicitly stated, typically internal lab data.
• Method Comparison with Predicate Device:
  • Sample Size: 120 serum samples and 60 plasma samples (total 180 samples).
  • Data Provenance: Not explicitly stated, but typically clinical samples or commercial samples purchased for the study. Given the medical context, these would be human samples. The study was conducted as per pre-submission meeting Q171503, implying a prospective design for this specific comparative testing.
• Expected Values/Reference Range:
  • Sample Size: 20 samples from apparently healthy US donors.
  • Data Provenance: Prospective collection of samples from US donors.

Overall Data Provenance: The document explicitly mentions "20 samples from apparently healthy US donors" for the reference range study. For other analytical performance studies (precision, linearity, stability, detection limit), the provenance is not specified, but these are typically conducted in-house by the manufacturer (retrospective analysis vs. new data collection is not detailed, but likely new data generation for the modified kit).

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

This device is an in vitro diagnostic (IVD) for quantitative measurement of IgM. The "ground truth" for IVDs of this nature is established by the reference measurement procedure or the assigned/target values of calibrators and controls used in the analytical performance studies, not by clinical expert consensus in the way a diagnostic imaging AI might establish ground truth from radiologists.

• For Analytical Studies (Precision, Linearity, LoD/LoQ, Stability): The ground truth for these samples are their known or reference concentrations, which are determined by highly accurate laboratory methods or traceable standards (e.g., ERM-DA470k/IFCC for IgM). No clinical experts are involved in establishing this type of ground truth.
• For Method Comparison: The "ground truth" in this context is the result obtained from the predicate device (the unmodified K082129 kit), as the goal is to show agreement between the modified and unmodified kit.
• For Reference Range Study: The "ground truth" is the established reference interval for IgM in a healthy population. The study assessed whether the modified kit's results for healthy individuals fell within this known range.

Therefore, the concept of "experts establishing ground truth" as it applies to reader studies for imaging devices does not directly apply here.

4. Adjudication Method for the Test Set

Given that this is an IVD kit for quantitative measurement and not an imaging device requiring human interpretation, there is no mention of an adjudication method among multiple human readers. The analytical performance is evaluated against quantitative measurements, established standards, or the performance of the predicate device.

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

No. MRMC studies are specific to diagnostic performance, typically for imaging devices where multiple readers interpret cases with and without AI assistance. This submission is for an IVD kit that provides a quantitative measurement, not an interpretative diagnosis requiring human readers in the loop. The "comparison" done was a method comparison between the modified kit and the predicate kit.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The "device" here is the Optilite IgM Kit used on the Optilite analyser. Its performance is evaluated analytically (precision, linearity, limits, stability) and comparatively against its predicate. This is a standalone performance assessment of the kit, which automatically provides quantitative results. There is no human interpretative step that the kit is assisting or replacing within its intended use.

7. The Type of Ground Truth Used

• For Analytical Performance (Precision, Linearity, LoD/LoQ, Stability):
  • Traceability: ERM-DA470k/IFCC (a certified reference material for immunoglobulins). This is a highly robust form of ground truth based on international standards.
  • Known Concentrations: Samples and controls with established or assigned target values.
• For Method Comparison:
  • Predicate Device Results: The results from the previously cleared Optilite IgM Kit (K082129) served as the reference for comparison to demonstrate equivalence.
• For Reference Range Study:
  • Established Reference Interval: The pre-determined reference range (0.35 – 2.42 g/L) for IgM in a healthy population served as the ground truth against which results from healthy donors were compared.

There is no pathology confirmation or outcomes data mentioned, as these are typically used for assessing clinical accuracy or impact on patient management, which is beyond the scope of this 510(k) for a modified quantitative IVD.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm. This submission is for an immunoturbidimetric test kit, not an AI-powered diagnostic system. The "training" of such a system would refer to the development and optimization of the reagent formulation and methods, which involves extensive R&D and internal testing, often with many samples. However, the document provided focuses on the validation testing required for regulatory submission.

The section M. Performance Characteristics details the validation experiments for the modified kit. These are the test sets to prove performance, not training sets.

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

As noted above, there is no "training set" in the AI/ML sense described. For the development of the original device and its subsequent modifications, the "ground truth" would be established through:

• Reference materials: Calibrating the assay against international reference standards (e.g., ERM-DA470k/IFCC).
• Internal validation: Testing against well-characterized in-house samples and controls with known concentrations.
• Method optimization: Iteratively adjusting reagent concentrations and reaction parameters to achieve desired analytical performance (sensitivity, specificity, precision, linearity) based on these known samples and reference materials.

The provided document focuses on the verification and validation studies for a pre-defined modified product, demonstrating its performance against regulatory requirements, rather than the developmental phase of the original or modified kit's creation.

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This kit is intended for the quantitative in vitro determination of human IgM in human serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

The SPAPlus IgM Kit comprises the following reagents:

Antiserum: Goat Anti-IgM is supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine.

Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 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 document (K191465 - Human IgM Kit for use on SPAPlus Special 510(k) Submission Summary) describes the analytical and performance characteristics of a quantitative in vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the questions regarding acceptance criteria for AI/ML performance, ground truth establishment by experts, MRMC studies, and training/test set details are not applicable.

This submission is for a modification to an existing device (Human IgM Kit for Use on SPAPlus, K082129), specifically changing the source of the detection antibody from sheep to goat and altering the antibody resting buffer. The primary goal of the studies presented is to demonstrate that these changes do not adversely affect the device's performance compared to the original cleared device and that the new kit is substantially equivalent.

Here's an attempt to answer the questions based on the available information, noting when a question is not applicable to this type of device:

Acceptance Criteria and Device Performance

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

Since this is a chemistry assay device, the "acceptance criteria" are more about demonstrating comparable performance to the predicate device and meeting established analytical performance standards for in vitro diagnostics rather than an AI/ML output metric like accuracy or AUC.

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

• Precision Studies:
  • Repeatability & Within Laboratory: 3 different samples, 80 replicates each (20 working days, 2 runs/day, 2 reps/run).
  • Between Instrument: 3 different samples, 24 replicates each (6 working days, 2 instruments/day, 2 reps/instrument).
  • Between Lot: 3 different samples, 24 replicates each (6 working days, 2 lots/day, 2 reps/lot).
  • Provenance: Not explicitly stated, but likely retrospective lab testing from the manufacturer (The Binding Site Group Ltd. in UK). Dates of testing are implied by "over 20 working days" etc.
• Linearity Study: High and low pools, dilution series, 6 replicates per diluted sample.
  • Provenance: Not explicitly stated, likely retrospective lab testing.
• Stability Studies:
  • Accelerated Stability: 6 replicates of controls, internal reference, and samples.
  • Provenance: Not explicitly stated, likely retrospective lab testing.
• Detection Limit (LoQ) Study: Four samples, two reagent lots.
  • Provenance: Not explicitly stated, likely retrospective lab testing.
• Method Comparison Study: 89 serum samples and 44 plasma samples.
  • Provenance: Performed "in accordance with pre-submission meeting Q171503." Not explicitly stated, but likely retrospective from clinical laboratories or biobanks.
• Reference Range Transfer Study: 20 samples from "apparently healthy US donors."
  • Provenance: Prospective collection from apparently healthy US donors appears to be implied given the mention of "US donors" and the purpose of transferring the reference interval.

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 an in vitro diagnostic device that measures a quantitative analyte (IgM). "Ground truth" for this type of device is established by the analytical measurement itself, traceable to an international reference material (ERM-DA470k/IFCC). Clinical expert consensus is not a method for establishing the "ground truth" concentration of an analyte in a sample for this type of device.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in image interpretation or clinical diagnosis, often when human expert variability is a factor. This submission is for a turbidimetric assay, where the "ground truth" is a quantitative measurement traceable to a reference standard.

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 and does not involve human readers interpreting images or data.

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

Not applicable. This is not an AI/ML device. The "performance" is the analytical performance of the assay itself.

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

The "ground truth" for the quantitative measurement of IgM in this IVD is established by its traceability to a recognized international reference material (ERM-DA470k/IFCC). This standard provides the authoritative value for IgM concentration against which the device's measurements are calibrated and compared.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is a "kit" of reagents and controls used on an analyser.

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

Not applicable (as above, no "training set" in the AI/ML sense). The calibration of the assay (which could be conceptually analogous to "training" a traditional assay) is traceable to ERM-DA470k/IFCC, an international reference material.

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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:

2. Sample size used for the test set and the data provenance:

• Precision Study: 4 sample preparations tested (details on the specific number of aliquots or patient samples composing these preparations are not given). The study design involved 2 runs per day (each in duplicate) over 5 days using 3 analyzers.
• Linearity Study: A serially diluted sample was used. Specific N is not provided.
• Detection Limit (LoQ) Study: The study was based on CLSI EP17-A2. Specific N is not provided.
• Analytical Specificity (Interference) Study: Samples at different IgM concentrations were spiked with interfering substances and tested. Specific N is not provided.
• Method Comparison Study: A total of 239 samples were initially tested, including 219 native CSF samples and 20 patient samples spiked with purified IgM. 155 of these samples were within the measuring range and used for regression analysis.
• Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the samples would be human CSF.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is a quantitative immunodiagnostic assay, not an imaging device requiring expert interpretation for ground truth. The "ground truth" for this device's performance is established by reference methods, international standards (ERM-DA470k/IFCC), and the inherent accuracy and precision of the measurements themselves validated against established statistical methodologies (CLSI guidelines).

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

Not applicable, as this is a quantitative diagnostic assay, not a subjective interpretation task that requires adjudication.

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, as this is not an AI/ML-based device that assists human readers.

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

The device is an automated turbidimetric analyzer (Optilite) performing a quantitative assay. Its performance is inherently "standalone" in the sense that the instrument provides a numerical result without human interpretation being part of the result generation. The performance metrics presented (precision, linearity, detection limit, method comparison) are its standalone performance.

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

The ground truth or reference for this quantitative assay is:

• Traceability: Established through calibration traceable to the ERM-DA470k/IFCC international reference material.
• Method Comparison: Comparison against a legally marketed predicate device (Human IgM CSF Kit for use on SPAPLUS K120750) using patient samples. The predicate device itself serves as a reference point for substantial equivalence.
• Statistical Methodologies: Adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines for evaluating precision, linearity, detection capability, and interference.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device that requires a "training set."

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

Not applicable, as this is not an AI/ML device.

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

The Optilite IgA CSF Kit comprises the following reagents: Latex Reagent, Calibrator and Controls, and Reaction Buffer.

The provided text describes the performance characteristics of the Optilite IgA CSF Kit. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision/Reproducibility: 4 different samples were used. The number of runs (two per day for 5 days) and analysts (two) suggest multiple measurements for each sample. Data provenance is not explicitly stated but is implicitly from an internal laboratory study (prospective).
• Linearity: One serially diluted sample was used. Data provenance is implicitly from an internal laboratory study (prospective).
• Analytical Specificity: A CSF sample close to the medical decision point and an elevated CSF sample were tested. Data provenance is implicitly from an internal laboratory study (prospective).
• Method Comparison: 130 CSF samples (including 40 samples with analyte levels within the reference interval) were used. Data provenance is not explicitly stated, but it's likely from a collection of clinical samples. It is retrospective in nature as these are "samples" analyzed, not patients prospectively enrolled.

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

This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker. The "ground truth" for the test set is established by the reference methods or the true concentration of the analyte, not by expert interpretation in the same way an imaging or pathology device would involve human experts.

• For precision, the ground truth is the true concentration of IgA in the sample, measured repeatedly to assess variation.
• For linearity, the ground truth is the expected concentration based on the serial dilution.
• For traceability, the ground truth is the value assigned by the international reference material (ERM-DA470k/IFCC).
• For method comparison, the ground truth is the measurement obtained from the alternative commercially available assay (predicate device).

Therefore, the concept of "number of experts used" or their "qualifications" for establishing ground truth is not directly applicable in the context of this type of quantitative IVD performance study.

4. Adjudication Method for the Test Set

Not applicable. As a quantitative IVD, the results are numerical values, and adjudication by experts is not a standard practice for assessing performance metrics like precision, linearity, or method correlation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on human performance. The Optilite IgA CSF Kit is a standalone automated quantitative assay, not an AI-assisted interpretation tool.

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

Yes, the performance studies described are intrinsically standalone performance evaluations of the Optilite IgA CSF Kit (the "algorithm/device only" in this context) without human-in-the-loop performance. The device provides a quantitative measurement directly.

7. The Type of Ground Truth Used

• Precision and Linearity: The ground truth is based on the known or reference concentrations of the samples used in the study.
• Traceability: The ground truth is the value assigned by the international reference material (ERM-DA470k/IFCC).
• Method Comparison: The ground truth for comparative purposes is the result obtained from an alternative commercially available assay (predicate device).

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is an in vitro diagnostic kit based on immunoturbidimetry, which is a chemical/biological reaction and measurement system, not a machine learning model that requires a training set. The term "training set" is not applicable here.

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

Not applicable, as there is no "training set" for this type of device.

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The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser.

The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following:

Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.

Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.

The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.

The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.

The Binding Site Optilite C-Reactive Protein Reagent, Calibrator, and Controls have several performance characteristics, and the report details the studies conducted to verify these characteristics against pre-defined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Precision/Reproducibility: 4 sera samples. The provenance is not specified (e.g., country of origin or retrospective/prospective).
• Linearity/Assay Reportable Range: A series of 14 samples. The provenance is not specified.
• Detection Limit: LoB and LoD were based on 4 serum samples, while LoQ was determined from 4 serum samples. The provenance is not specified.
• Analytical Specificity (Interference): Serum samples with CRP concentrations at approximately 9mg/L, 60mg/L, and 150mg/L. The provenance is not specified.
• Method Comparison: 193 serum samples, including 83 normal donors and 110 clinical samples. The provenance is not specified.
• Expected values/Reference range verification: 50 adult donor samples. The provenance is not specified.

All studies appear to be prospective in nature, as they involve testing the device under controlled conditions to determine its performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is an in vitro diagnostic (IVD) assay for measuring C-Reactive Protein concentration. Ground truth is established by the analytical method itself (e.g., precise dilution, reference methods, or spiking with known quantities) rather than expert interpretation of images or clinical data. Therefore, experts in human diagnosis are not directly involved in establishing the ground truth for these analytical performance studies. The studies followed established CLSI guidelines for laboratory assay validation.

4. Adjudication method for the test set:

Not applicable. As described above, the studies focus on analytical performance where ground truth is intrinsically known or established through controlled experimental design and reference methods, not through expert adjudication of results.

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 an IVD device for quantitative measurement of a biomarker (CRP). It does not involve human readers interpreting images or clinical cases, nor does it incorporate AI assistance.

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

Yes, the studies described are standalone performance evaluations of the analytical device (Optilite CRP Reagent, Calibrator, Controls) on the Optilite analyser. The performance metrics (precision, linearity, detection limit, specificity) are inherently algorithm-only or instrument-only performance measures, as the human involvement is in operating the instrument and interpreting the numerical output, not in making a diagnostic interpretation that the instrument assists.

7. The type of ground truth used:

• Precision/Reproducibility: The "ground truth" for precision studies are the known concentrations of the sera samples, which are then measured repeatedly to assess variability.
• Linearity/Assay Reportable Range: The "ground truth" is the known concentration gradient created by mixing high and low concentration pools, or by spiking with pure protein, allowing for comparison with the measured values.
• Detection Limit: The "ground truth" is based on statistical calculations from repeated measurements of blank and low-concentration samples.
• Analytical Specificity: The "ground truth" involves comparing results from samples with known interfering substances added to those without, to assess if the interfering substances impact expected CRP values.
• Method Comparison: The "ground truth" is the result obtained from the legally marketed predicate device (Roche Diagnostics Tina-Quant C-Reactive Protein Gen. 3) when assaying the same samples.
• Traceability: The assay calibration is traceable to the international reference standard ERM-DA474, which serves as the "ground truth" for CRP concentration.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device that requires a distinct training set. The calibration curve is established using known calibrator materials according to standard IVD practices, not a machine learning training process.

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

Not applicable, as there is no machine learning training set. For the instrument's calibration, the Optilite C-Reactive Protein Calibrator is used. This calibrator consists of pooled human serum, and its concentrations are traceable to the international reference standard ERM-DA474. This traceability ensures that the instrument's measurements relate to a globally recognized standard for CRP.

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The Hevylite IgG Kappa kit is a quantitative in vitro assay intended for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum using the Optilite analyser. Measurement of Hevylite IgG Kappa is used alongside Hevylite IgG Lambda to calculate the IgG Lambda ratio. The Hevylite IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

The Hevylite IgG Lambda kit is a quantitative in vitro assay intended for the measurement of IgG heavy chain and Lambda light chain intact immunoglobulin) in serum using Site Optilite analyser. Measurement of Hevylite IgG Lambda is used alongside Hevylite IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

The Hevylite Human IgG Kappa and IgG Lambda Kits contain vials of ready-to-use polyclonal monospecific sheep anti-lgG antisera against combined γ heavy and κ light chain or combined y heavy and À light chain, calibrators (six levels), controls (low and high) and reaction buffer in liquid form. The reagents contain 0.099% sodium azide as preservative.

The provided text describes the performance characteristics of the Optilite Hevylite IgG Kappa Kit and Optilite Hevylite IgG Lambda Kit, which are in vitro diagnostics. It does not describe an AI medical device, but rather a laboratory assay. Therefore, many of the requested points, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and information on experts for ground truth and adjudication methods, are not applicable to this type of device.

However, I can extract and present the relevant information regarding the performance study of this In Vitro Diagnostic (IVD) assay.

Device Information:

• Trade/Device Name: Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
• Regulation Number: 21 CFR 866.5510
• Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system
• Regulatory Class: Class II
• Product Code: PCN, PCO
• Intended Use: Quantitative in vitro assay for the measurement of IgG Kappa (IgG heavy chain and kappa light chain intact immunoglobulin) and IgG Lambda (IgG heavy chain and lambda light chain intact immunoglobulin) in serum. Used alongside each other to calculate the IgG Kappa/IgG Lambda ratio, which can be used when monitoring previously diagnosed IgG multiple myeloma patients in conjunction with other laboratory tests and clinical evaluations.

Study Proving Device Meets Acceptance Criteria:

The study evaluated the analytical and clinical performance of the device by comparing it to a legally marketed predicate device (Hevylite Human IgG Kappa Kit and Hevylite Human IgG Lambda Kit for use on the Siemens BN™II, K132555).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list pre-defined "acceptance criteria" in a table format with pass/fail values. Instead, it presents the results of several performance studies which, taken together, demonstrate the device's suitability for its intended use and its substantial equivalence to the predicate device. The performance is demonstrated through precision, linearity, stability, detection limits, analytical specificity (interference and cross-reactivity), and method comparison studies. Clinical validity is supported by a monitoring response category comparison and data modeling.

Here's a summary of the performance metrics reported:

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

• Precision/Reproducibility: Six serum samples (contents not detailed, likely pooled or commercial controls/spiked samples) tested over 21 days with two runs per day on three different reagent lots on three analyzers.
• Linearity: Serum samples (quantity not explicitly stated, but "serially diluted serum samples") to cover the standard measuring ranges.
• Open-vial stability: Three lots of kits.
• On-board stability: Three lots of kits.
• Detection limit: Analyte depleted samples (60 determinations for LoB), 5 independent samples diluted with analyte depleted serum for LoQ (tested twelve times over five days).
• Analytical specificity (Interference): Three serum samples with different IgG Kappa/Lambda concentrations, spiked with interfering substances.
• Antigen Excess Detection: 8 monoclonal IgG Kappa and 6 monoclonal IgG Lambda samples.
• Method Comparison (with predicate device):
  • IgG Kappa: 284 serum samples (including 135 IgG Kappa paraprotein, 60 IgG Lambda paraprotein, 60 donor samples, and 29 other samples).
  • IgG Lambda: 172 serum samples (including 42 IgG Kappa paraprotein, 59 IgG Lambda paraprotein, 59 donor samples, and 1 AL Amyloidosis sample).
  • IgG Kappa/Lambda Ratio: 143 serum samples (including 39 IgG Kappa paraprotein, 44 IgG Lambda paraprotein, 59 donor samples, and 1 AL Amyloidosis sample).
• Clinical Monitoring Response Category Study: 69 monitoring samples from 10 IgG Kappa patients and 12 IgG Lambda patients. The data provenance is implied to be from patient samples, consistent with clinical monitoring. Country of origin not specified, but typically for submissions to the US FDA, data from well-regulated regions (e.g., US, EU) are accepted. It is a retrospective analysis utilizing existing patient data.
• Data Modelling: Monitoring sample results from the original BNII submission (predicate device's clinical data). The total number of evaluations was 437. This is a retrospective application of new data to existing clinical outcomes.
• Expected values/Reference range: 50 adult donor samples.

Data Provenance: The document does not explicitly state the country of origin for the clinical samples. The studies are based on patient and donor serum samples. The clinical monitoring study and data modeling are retrospective analyses of previously collected patient data.

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

This device is an IVD assay, not an AI image analysis device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image annotation is not directly applicable.

For IVDs, "ground truth" for clinical effectiveness is typically established by:

• Reference Methods: Comparison against an established, validated method (the predicate device in this case, the Siemens BN™II).
• Clinical Diagnosis/Outcomes: In the context of monitoring multiple myeloma, the "ground truth" for patient response categories (CR, VGPR, PR, SD, PD, Relapse from CR) is defined by clinical guidelines (NCCN Guidelines v1.2011) that integrate multiple clinical tests (immunofixation, bone marrow, urine assessments) and patient history, rather than a single expert adjudication on an image. The study compares the calculated HLC ratio response classification from the new device with that from the predicate based on these clinical definitions.

4. Adjudication Method for the Test Set

Not applicable as this is an IVD assay. The performance is assessed against analytical standards and agreement with a predicate device and established clinical guidelines for patient response classification.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable as this is an IVD assay, not an AI-assisted diagnostic tool involving human readers of images.

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

This concept is tailored for AI devices. For this IVD, the "standalone performance" is represented by its analytical performance characteristics (precision, linearity, detection limits, specificity) and its ability to classify patient responses independently using its measured values and interpretation rules, which are then compared to the predicate device's classifications. The device itself (the Optilite analyzer and the kits) provides quantitative measurements.

7. The Type of Ground Truth Used

• Analytical Performance: The ground truth for analytical performance (e.g., true concentration for linearity, known interferences for specificity) would typically be established by highly accurate reference methods or certified reference materials.
• Clinical Monitoring Response: The ground truth for "clinical response categorization" (e.g., Complete Response, Partial Response) is defined by established clinical guidelines (NCCN Guidelines v1.2011) that consider a combination of laboratory tests (including immunofixation, bone marrow, and urine assessments) rather than a single, independent "ground truth" measure. The study aimed to show agreement between the new device's HLC ratio-based classification and the predicate device's HLC ratio-based classification within these established clinical guidelines.

8. The Sample Size for the Training Set

This document describes a pre-market notification (510(k)) for a medical device that is an in vitro diagnostic quantitative assay. It is not an AI/Machine Learning device that requires a "training set" in the conventional sense for model development. The "training" for such an IVD would be the development and optimization of the assay reagents and analytical procedure by the manufacturer. The data described here are for validation and verification, not for training a machine learning model.

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

As noted above, there is no "training set" in the context of machine learning for this type of IVD. The development of the assay's performance characteristics (e.g., reagent formulation, calibration curve fitting) would be based on internal development work and validated against established laboratory practices and reference materials.

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The Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite Rheumatoid Factor Kit comprises the following reagents: Reaction Buffer, Latex Reagent, RF Controls (supplied at 2 levels, Low and High), and RF Calibrator.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them, structured according to your requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Precision/Reproducibility: 5 sample preparations, each tested 84 times (2 runs/day, 2 duplicates/run, over 21 days).
• Linearity/Assay Range: A dilution series comprising a high pool and a low pool, tested in 3 replicates.
• Method Comparison with Predicate Device: 103 samples tested.
• Analytical Sensitivity (LoD/LoB/LoQ):
  • LoB: 60 determinations of a blank sample.
  • LoD: 6 determinations of 4 samples near the lower limit of the reportable range.
• Analytical Specificity: Not explicitly stated, but samples were spiked with interfering substances.

Data Provenance: The document does not explicitly state the country of origin of the samples or whether they were retrospective or prospective. Given the manufacturer is based in the UK and it's a medical device submission, it's plausible the data collection occurred within a regulatory-compliant framework, potentially from a clinical laboratory setting.

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

There is no mention of experts being used to establish ground truth in the context of the analytical performance studies (precision, linearity, specificity, method comparison). This device is an in vitro diagnostic (IVD) for quantitative measurement of Rheumatoid Factor, and its performance is assessed through analytical validation against an established reference standard (WHO 64/2) and comparison with a predicate device. Ground truth, in this context, refers to the known concentration or behavior of the analyte, verified through laboratory methods rather than expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. The studies described are analytical performance validations, which do not involve subjective interpretation or adjudication by experts. The results are quantitative measurements against defined criteria and methods.

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 device is a fully automated in vitro diagnostic (IVD) kit for measuring a biomarker; it does not involve human "readers" or Artificial Intelligence (AI) in its measurement process. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device.

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

Yes, the studies detailed in "1. Analytical performance" and "2. Comparison studies" demonstrate the standalone performance of the Optilite® Rheumatoid Factor Kit without human intervention in the measurement process after the sample is introduced to the analyzer. The device performs the quantitative analysis automatically.

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

The primary ground truth for the quantitative measurement performed by this device is:

• International Reference Preparation: The calibration of the assay is traceable to the International Reference Preparation of Rheumatoid Arthritis Serum WHO 64/2. This standard serves as the "ground truth" for the quantitative accuracy of Rheumatoid Factor levels.
• Predicate Device/Established Methods: For method comparison, an alternative commercially available assay (presumably a legally marketed and validated method) served as a comparative ground truth.

For analytical performance studies (precision, linearity, specificity), the ground truth is either:

• Known concentrations: Samples with known or spiked concentrations of analytes or interferents.
• Blank samples: Samples known to contain no analyte (for Limit of Blank).

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay kit, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of developing the device. The reagents and assay parameters are developed based on biochemical principles and optimized through laboratory testing, not machine learning.

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

Not applicable, as there is no "training set" for this type of device.

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The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Lambda is used alongside Hevylite IgA Kappa to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Not Found

The provided document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, the Optilite Hevylite IgA Kappa Kit and Optilite Hevylite IgA Lambda Kit. It describes the intended use and regulatory classification, but it does not contain information about:

• Acceptance criteria and reported device performance (in the context of a study demonstrating it meets the criteria)
• Sample sizes for test sets, data provenance, training sets, or how ground truth was established for training sets
• Number/qualifications of experts or adjudication methods for ground truth
• MRMC comparative effectiveness studies or standalone algorithm performance

Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.

The document states the Indications for Use of the device, which are:

• The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser.
• The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser.
• Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Kappa/IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations.
• The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

This indicates the device's role in monitoring IgA multiple myeloma patients, but it does not specify performance metrics or the studies used to validate these claims.

Summary of unavailable information from the given text:

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Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Binding Site SPAPLUS for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Hevylite Human IgA Lambda is a quantitative in vitro assay performed on The Binding Site SPAPLUS for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA, along with the device's Indications for Use. It describes a diagnostic device, the Hevylite Human IgA Kappa Kit and Hevylite Human IgA Lambda Kit, which are quantitative in vitro assays performed on the Binding Site SPAPLUS for measuring IgA Kappa and IgA Lambda in serum. These measurements are used to calculate the IgA Kappa/IgA Lambda ratio for monitoring previously diagnosed IgA multiple myeloma patients.

This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies. It primarily focuses on the regulatory aspects of the device's clearance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information is typically found in the accompanying technical documentation, such as the 510(k) summary or detailed clinical study reports, which are not present here.

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