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Immunoglobulin Isotypes (GAM) for the EXENT Analyser:

The Immunoglobulin Isotypes (GAM) for the EXENT Analyser is a MALDI-TOF mass spectrometry immunoassay that is used in conjunction with the Binding Site Optilite IgG, IgA and IgM assays for the semi-quantitative in vitro measurement of monoclonal IgG, IgA, and IgM as a reflex test in serum for patients with a result suggestive of the presence of monoclonal immunoglobulins by serum protein electrophoresis (gel or capillary zone electrophoresis), or with an abnormal serum free light chain concentration and free light chain ratio result.

The assay is intended for use as an aid in the evaluation of monoclonal gammopathy of undetermined significance (MGUS); and as an aid in the diagnosis of smouldering multiple myeloma (SMM), multiple myeloma (MM), Waldenström's macroglobulinaemia, and AL amyloidosis.

Assay results should be used in conjunction with other laboratory and clinical findings.

EXENT Analyser:

The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays. The device is designed for professional in vitro diagnostic use only and it is not a device for self-testing.

The system consisting of the EXENT® Analyser and the EXENT® assays are intended for the in vitro measurements of analytes in human body fluids. It is designed to provide automation and integration of all the analytical steps (including liquid handling and MALDI-ToF mass spectrometry). The EXENT Analyser is designed to be used solely in combination with EXENT assays to measure a variety of analytes depending on the reagents. The device is designed for professional use only and it is not a device for self-testing.

The EXENT Analyser combines automated immunoassay with readout by MALDI-ToF mass spectrometry. It is a modular analyser, and the major components are described in Table 3 and illustrated schematically in Figure 1.

The EXENT-iP500 component is an automated liquid handler that prepares human body fluids using the EXENT assay specific reagents. The samples are prepared using magnetic beads that are coated with isotype-specific antibodies. Any unbound material is washed away during the sample preparation process. The EXENT-iP500 also manages the transfer of the prepared patient sample to the MALDI plate.

The EXENT-iX500 component is a MALDI-ToF mass spectrometer. Signals are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios. The EXENT-iX500 is used to read samples prepared by the EXENT-iP500.

The EXENT-iQ software integrates sample preparation and MALDI-ToF mass spectrometry and is used for data storage and processing. It is the primary user interface used by the user to review and release results.

N/A

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In-vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG. IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BN II and BN ProSpec® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The N Antiserum to Human IgG reagent containing animal serum, produced by immunization of rabbits with highly purified human immunoglobulin (< 3.5 g/L). The reagent is a ready-to-use liquid containing preservatives. There are two product variants available. One variant (REF OSAS11) contains 1 x 2 mL vial / box, and the other variant (REF OSAS19) contains 1 x 5 mL vial / box. Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the result is evaluated by comparison with a standard of known concentration.

The provided text describes a special 510(k) premarket notification for a modified device, "N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)". The sole modification is the addition of a High Dose Hook (HDH) effect claim for IgG in cerebrospinal fluid (CSF) samples.

Here's a breakdown of the requested information based on the provided document:

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

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

• Sample Size: The study used a "CSF high sample pool." The exact number of individual patient samples contributing to this pool (if multiple were pooled) is not specified. However, the study involved a dilution scheme with twelve (12) individual dilution levels, including the neat sample.
• Data Provenance: Not explicitly stated. The manufacturer is Siemens Healthcare Diagnostics Products GmbH, located in Marburg, Germany, which suggests the study was likely conducted in Germany or a similar geographic region. It is implicitly a prospective study designed to evaluate the HDH effect for the modified device.

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 section is not applicable as the device is an in-vitro diagnostic reagent for quantitative determination, not an imaging or interpretive device that would typically require expert ground truth establishment in the described manner. The "ground truth" for this type of test is the quantitatively measured concentration of IgG in a sample, established through laboratory methods and comparison to known standards.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in interpretive studies (e.g., radiologists reviewing images). For a quantitative in-vitro diagnostic test, the "ground truth" is determined by the analytical method itself against known standards.

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

This is not applicable. The device is an in-vitro diagnostic reagent, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was performed.

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

This refers to the performance of the analytical system (N Antisera reagent on BN II System) without human intervention in the measurement process. The HDH study performed is a standalone performance evaluation of the reagent/instrument system. The acceptance criteria and performance data in the table above demonstrate this standalone performance.

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

For this in-vitro diagnostic device, the "ground truth" for the High Dose Hook study was established by creating known dilutions of a high-concentration CSF sample, which were then measured by the device. The reported concentrations for these dilutions serve as the reference. The ultimate analytical ground truth for the quantitative measurement itself is tied to international standards like ERM-DA470k/IFCC (as stated in the "Traceability/Standardization" section).

8. The sample size for the training set

This document does not describe the development or training of a machine learning model, so there is no training set in the typical sense. The "training" for such a diagnostic test involves method development, optimization, and validation using various samples and controls, but these are not referred to as a "training set" for an algorithm.

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

As there is no training set for an algorithm, this question is not applicable.

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System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The device consists of two reagents: R1 buffer (Tris buffer pH 7.2, polyethylene glycol 6000) and R2 (goat anti-IgG antiserum). The reagents contain sodium azide as preservative.

When a sample is mixed with R1 buffer and R2 antiserum solution, human IqG reacts specifically with anti-human IgG antibodies to yield insoluble aggregates. Immune complexes formed in solution scatter light in proportion to their size, shape, and concentration. Turbidimeters then measure the reduction of incidence light due to reflection, absorption, or scatter. The decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is a result of complexes formed during the antigen-antibody reaction.

The Beckman Coulter Immunoglobulin G (IgG) reagent for quantitative determination of IgG immunoglobulins in human serum, plasma, and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers, device K221114, underwent various non-clinical (bench) studies to demonstrate substantial equivalence to its predicate device (K162208).

Here is a summary of the acceptance criteria and reported device performance based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes for the test set and data provenance:

• Method Comparison:
  • Serum: 147 samples
  • CSF: 114 samples
  • Data Provenance: Not explicitly stated regarding country of origin or whether retrospective/prospective. The studies were conducted "using patient correlation studies", suggesting human patient samples were used.
• Linearity/Reportable Range: Each dilution was assayed in quadruplicate on a DxC 500 AU analyzer. High and low pools were prepared and inter-diluted. Number of distinct patient samples used for pooling is not specified.
• Sensitivity (LOB, LOD, LOQ):
  • LOB: 72 blank replicates per reagent lot (4 blank native serum samples 'analyte-depleted' run n=6 for 3 days).
  • LOD and LOQ: 500 replicates per reagent lot for each application (10 low-level samples for IgG run 10-fold for 5 days).
• Precision:
  • 20-day study: Not explicitly stated as a number of distinct samples, but samples were tested over 20 days.
  • 5-day study: Not explicitly stated as a number of distinct samples, but samples were tested over 5 days.
• Interference: All test samples were assayed n=5 at two analyte levels. The number of distinct samples for each interferent type is not specified.
• Reference Interval: "Transference approach" used to validate the original IgG serum reference interval. The specific number of samples for the transference study is not detailed.

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) test for quantitative measurement of immunoglobulins. The "ground truth" in this context is the analytically measured concentration of IgG in samples, determined by laboratory methods. Therefore, expert interpretation or consensus as seen in imaging or clinical diagnosis is not directly applicable. The "ground truth" is established by the analytical method itself, calibrated against known standards, and verified through method comparison with predicate devices and established guidelines.

4. Adjudication method for the test set:

Not applicable in the context of quantitative IVD testing. Analytical results are directly compared to predefined acceptance criteria based on industry guidelines (e.g., CLSI).

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 in vitro diagnostic device, not an AI-assisted diagnostic imaging or clinical decision support tool that involves human readers.

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

The device is an analytical reagent system used on automated analyzers. Its performance is inherently "standalone" in the sense that the instrument and reagent determine the quantitative result without human subjective interpretation of the primary measurement. Human involvement lies in sample preparation, loading, and result interpretation, but not in the analytical measurement itself. The studies described are assessing the performance of this standalone analytical system.

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

The ground truth used for performance evaluation is based on analytical measurements against established standards and comparison to a legally marketed predicate device. For example:

• Method Comparison: Comparison against the predicate device (Beckman Coulter IgG Reagent on DxC 700 AU analyzer) to demonstrate similar quantitative results.
• Linearity/Sensitivity/Precision: Determined by assessing the device's ability to accurately and reproducibly measure known concentrations or concentrations derived from highly characterized samples.
• Reference Interval: Validation of an existing reference interval for the predicate device, implying that the ground truth for this is derived from previously established clinical studies.

8. The sample size for the training set:

Not applicable. This device is a diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development of the reagent and its methods would involve extensive research and development, but this is distinct from "training data" for an AI model.

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

Not applicable, as there is no "training set" in the context of this IVD device.

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This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgA 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.

Human IqA liquid reagent kit for use on SPAPLUS® comprises the following reagents:

Antiserum: Monospecific goat anti IgA supplied in stabilised liquid form. lt contains 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine as preservatives.

Calibrator and Controls: These consist of pooled human serum and are supplied in stabilised liquid form. The concentration of IgA given on the quality control certificate has been obtained by comparison with European Reference Material ERM-DA470k. They contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives.

Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The provided document describes the "Human IgA liquid reagent kit for use on SPAPLUS" by The Binding Site Group Ltd. This device is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin, or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyzer. The submission is a special 510(k) for a modification to an existing device (K103824), specifically a change in the source of the detection antibody from sheep to goat.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present acceptance criteria in a dedicated table format with corresponding reported device performance for all aspects. Instead, acceptance criteria are described within the context of each study and then a conclusion about meeting those criteria is stated. I will extract and present this information in a table format where possible.

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

• Precision Studies:
  • Repeatability and Within Laboratory: 4 different samples, 80 data points for each level (total 320 data points).
  • Between Instrument: 4 different samples, 24 data points for each level (total 96 data points).
  • Between Lot: 4 different samples, 24 data points for each level (total 96 data points).
• Linearity Study: A high pool (8.19g/L) and a low pool (0.12 g/L) were used to create a dilution series. Each diluted sample was tested in 3 replicates.
• Accelerated Stability: 6 replicates of controls, internal reference, and 3 different samples were tested.
• Limit of Quantitation (LoQ) Validation: 4 samples were tested using two reagent lots.
• Method Comparison with Predicate Device: 102 serum samples and 42 plasma samples (total 144 samples).
• Expected Values/Reference Range Transfer: 20 samples from "apparently healthy US donors".

Data Provenance:

• For the Expected Values/Reference Range Transfer study, samples were from "apparently healthy US donors".
• For other studies, the country of origin or whether the data was retrospective or prospective is not explicitly stated. The studies were carried out by The Binding Site Group Ltd., which is based in the UK, so it's likely testing was conducted there unless otherwise specified.

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

This product is an in vitro diagnostic (IVD) reagent kit for quantitative Immunoglobulin A (IgA) determination. The "ground truth" in this context refers to the accurate measurement of IgA concentration. The document mentions traceability to European Reference Material ERM-DA470k/IFCC for calibration. This implies that the standard itself serves as the "ground truth" reference, rather than independent expert consensus on clinical interpretation. There are no mentions of experts establishing ground truth in the sense of clinical diagnosis or image interpretation.

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

Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation by multiple human readers (e.g., in radiology studies) to resolve discrepancies and establish a consensus "ground truth." Since this device is a quantitative IVD assay and its performance is validated against analytical standards, reference materials, and comparative measurements, such adjudication methods are not applicable and therefore not used.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use AI assistance to improve their diagnostic accuracy. This device is a standalone quantitative laboratory test kit, not an AI or imaging diagnostic aid, so an MRMC study is not applicable.

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

Yes, the performance studies described are for the standalone device (reagent kit on the SPAPLUS analyzer) without human-in-the-loop performance influencing the measurement part of the device's function. The analytical performance, stability, and comparison studies evaluate the kit's ability to accurately measure IgA concentrations. The device's output is a quantitative value, not an interpretation of data that requires human feedback for performance assessment.

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

The ground truth for this quantitative assay is primarily based on:

• Reference Materials: Calibration traceability to ERM-DA470k/IFCC. This is the international standard for immunoglobulin measurements.
• Reference Methods: The predicate device itself (K103824) serves as a comparative "ground truth" for method comparison studies, demonstrating substantial equivalence.
• Defined Concentrations: For linearity and precision studies, samples with known or precisely diluted concentrations are used.
• Clinical Reference Intervals: The ability to transfer established reference intervals (based on a healthy population) is also part of the "ground truth" for clinical usability.

8. The sample size for the training set

This document describes a special 510(k) submission for a modification to an existing device, which mostly involves re-validation studies to ensure the modification (change in antibody source from sheep to goat) does not alter performance compared to the cleared predicate. It does not describe the development of a novel algorithm or AI model that requires a distinct "training set." The studies performed are validation studies, not training. Therefore, a "training set" in the context of machine learning is not applicable here.

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

As there is no "training set" in the machine learning sense for this device submission, this question is not applicable. The device's underlying principles (immunoturbidimetry) are well-established, and its performance is validated against analytical standards rather than learned from a dataset.

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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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System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The device consists of two reagents: R1 buffer (Tris buffer pH 7.2, polyethylene glycol 6000) and R2 (goat anti-IgG antiserum). The reagents contain sodium azide as preservative.

When a sample is mixed with R1 buffer and R2 antiserum solution, human IgG reacts specifically with anti-human IgG antibodies to yield insoluble aggregates. Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters then measure the reduction of incidence light due to reflection, absorption or scatter. In the AU procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction.

The provided text describes a 510(k) premarket notification for a medical device called "IgG Regulation Number: 21 CFR 866.5510" (Trade/Device Name: IgG). This device is a system reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma, and cerebrospinal fluid on Beckman Coulter AU analyzers. The document details the comparison testing performed to demonstrate substantial equivalence to a predicate device.

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

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

The document doesn't explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds. Instead, it compares the performance of the candidate device (IgG Reagent on DxC 700 AU Beckman Coulter Analyzers) to the predicate device (Olympus IgG Reagent (K073490) on AU400/400ᵉ/480, AU600/640/640ᵉ/680, and AU2700/5400/AU5800 Beckman Coulter Analyzers). The acceptance criterion is essentially that the candidate device's performance is "substantially equivalent" to the predicate, meaning it should perform at least as well as the predicate for key metrics.

Here's a table summarizing the comparison, with the predicate's performance serving as the de-facto acceptance criteria for equivalence:

The study proving the device meets the acceptance criteria:

The study conducted is a comparative performance study between the candidate device and its predicate.

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

The document mentions "Comparison testing" was conducted, including "Method Comparison, Linearity, Sensitivity, Reference Interval, Interference, In use (On board) & Calibrator Stability, Precision, Prozone, Auto-dilution." However, it does not specify the sample sizes used for each of these tests.

Regarding data provenance: The document does not specify the country of origin of the data. It does not explicitly state whether the data was retrospective or prospective. Given the context of a 510(k) submission for an in vitro diagnostic device, the data would typically be generated in a controlled manner, likely through prospective experimental studies, to demonstrate performance characteristics.

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

This information is not applicable and not provided in the document. This device is an in-vitro diagnostic (IVD) for quantitative measurement of immunoglobulins. The "ground truth" for such devices is established through reference methods, calibrated materials, or highly accurate laboratory techniques, rather than expert consensus (e.g., radiological reads). The device measures a biomarker quantitatively, so the "truth" is the actual concentration of IgG, determined by a highly accurate measurement system.

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

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image reading) where multiple human readers might disagree, requiring a third or fourth reader to resolve discrepancies. For a quantitative IVD, the measurement itself is the "output," and its accuracy is assessed against a reference method or known concentration standards, not by human adjudication of its output.

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

This information is not applicable and not provided. An MRMC study is typically performed for AI or computer-aided detection/diagnosis (CAD) systems that assist human readers (e.g., radiologists interpreting images). This device is a lab assay system, not an AI system assisting human interpretation.

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

Yes, the performance data presented (Precision, Sensitivity, Interference, Analytical Range, Stability) for the "Candidate Device: IgG Reagent" are inherent performance characteristics of the assay system itself, irrespective of human intervention in the interpretation of the result. The device quantitatively determines IgG levels. The study assesses the accuracy, precision, and other analytical performance parameters of the device's measurement capability in a standalone fashion.

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

The "ground truth" for this type of quantitative in-vitro diagnostic device would be established by:

• Reference materials/standards with known concentrations: Calibrators and controls with certified IgG concentrations are used to verify the accuracy and linearity of the measurement.
• Reference methods: Highly accurate and precise laboratory methods (e.g., isotope dilution mass spectrometry for some analytes, or established validated methods) that serve as the gold standard for measuring the analyte.
• Sample spiking: Adding known quantities of the analyte to samples to assess recovery.

While the document doesn't explicitly state the specific ground truth methods for each test, the standard practice for IVDs involves these types of analytical validation studies.

8. The sample size for the training set

This information is not applicable and not provided. This device is a chemical reagent and an assay system, not a machine learning or AI model that requires a "training set" in the computational sense. The device's performance is based on chemical reactions and optical detection, not learned patterns from data.

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

This information is not applicable for the same reasons as #8. No "training set" in the AI/ML context exists for this type of device.

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