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The HYDRASHIFT 2/4 isatuximab kit is intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. The HYDRASHIFT 2/4 isatuximab kit is to be used in conjunction with the HYDRAGEL IF kit and the semi-automated HYDRASYS 2 electrophoresis apparatus. The electropherograms are evaluated visually for the presence of specific reactions with the suspect monoclonal proteins. The HYDRASHIFT 2/4 isatuximab kit removes isatuximab IgG kappa interference and enables the visual evaluation of the presence of monoclonal proteins on HYDRAGEL IF kits in patients who have received isatuximab therapy.

For In Vitro Diagnostic use. For Prescription Use Only.

HYDRASYS 2 is a semi-automated multi-parameter system for start-to finish agarose gel electrophoresis: application of samples, migration, drying, staining, destaining and final-stage drying.

Abnormal bands in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones, are always suspected to be monoclonal proteins (M-proteins, paraproteins, monoclonal immunoqlobulins) and therefore, an indication of performing an Immunofixation technique to type and confirm the monoclonal gammopathies.

lsatuximab is a human therapeutic IgG kappa monoclonal antibody and as such, during the clinical monitoring of patients treated with isatuximab, this antibody simulates a band detected by serum protein electrophoresis and immunofixation in the gamma region. It can simulate an endogenous IgG kappa paraprotein.

The HYDRASHIFT isatuximab immunofixation procedure, performed on the HYDRAGEL IF 2/4 gel, is based on the creation of an isatuximab / anti-isatuximab antibody complex and shifting it outside the gammaglobulins zone. With the HYDRASHIFT isatuximab procedure, the isatuximab / anti-isatuximab antibody complex is visualized in alpha-1 zone on IgG and Kappa immunofixation tracks and then the interference is removed from the gamma zone.

The provided text describes the performance data for the HYDRASHIFT 2/4 isatuximab kit, which is intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis, specifically by removing isatuximab IgG kappa interference.

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

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, based on the performance data presented, is 100% concordance in visual evaluation of the presence or absence of monoclonal proteins, particularly after the removal of isatuximab interference.

Study Details Proving Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device performance:
(See table above)

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

• Repeatability Study: 10 different serum samples (2 controls, 8 spiked with monoclonal components). 4 runs per sample within the same gel.
• Reproducibility Study: 8 different serum samples with monoclonal components + Normal Control Serum + Isatuximab Control. Each sample analyzed on 9 runs (1 analysis per gel, over 3 working days) on 3 HYDRASYS 2 instruments with 3 lots of HYDRASHIFT 2/4 isatuximab kit.
• Comparative Studies:
  • Internal Study: 53 serum samples (26 normal, 27 pathological).
  • External Study No. 1: 204 serum samples.
  • External Study No. 2: 203 serum samples. (Note: "The same serum samples were analyzed in both external studies with exception of one sample included in external study 1." suggesting ~204 unique samples across external studies.)

Data Provenance:

• Internal Study: Conducted by Sebia (manufacturer).
• External Studies: Performed in the USA.
• Retrospective/Prospective: Not explicitly stated, but the description of "serum samples" and "analyzed with" suggests they were existing or collected samples, making it likely retrospective for the comparative studies. The repeatability and reproducibility studies appear to be prospective experimental designs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number or qualifications of experts used to establish the ground truth. The results are described as "100% concordant" based on detection and characterization of monoclonal proteins, which implies a pre-established or expert-verified classification for each sample. However, the exact process or personnel involved in this ground truth establishment are not detailed. Given it's an in vitro diagnostic (IVD) device for lab use, the "ground truth" would likely be the result of a reference method interpretation by qualified lab personnel.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method. The outcome measures are presented as "100% concordant results," which suggests a clear, unambiguous read for each test, or that any discrepancies were resolved, though the process for resolution is not described.

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 MRMC study was performed or described. This device is an in vitro diagnostic (IVD) kit for immunofixation electrophoresis, not an AI-assisted diagnostic imaging device for human readers. It automates a lab procedure and provides an electropherogram for visual evaluation. The "visual evaluation" mentioned refers to lab personnel interpreting the results of the gel electrophoresis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, effectively. This device is an IVD kit. Its performance is evaluated on its ability to process serum samples and produce an electropherogram that then is visually evaluated. The "performance data" sections (repeatability, reproducibility, comparative studies) essentially describe the standalone performance of the kit itself in consistently producing the expected analytical result (i.e., shifting the isatuximab band and allowing for accurate detection/characterization of monoclonal proteins). While the final "reading" is visual, the kit's function is mechanistic/chemical, not algorithmic interpretation requiring human oversight in the AI sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth appears to be based on the presence and characterization of monoclonal proteins in serum samples, determined by standard laboratory methods and potentially confirmed by expert consensus in a clinical laboratory setting. For the comparative studies, samples were characterized as "normal" or "abnormal with monoclonal components," implying a reference standard or pre-established truth for each sample type. The "native" samples and "spiked" samples with isatuximab served as a form of ground truth for evaluating the device's ability to differentiate between intrinsic monoclonal proteins and isatuximab interference.

8. The sample size for the training set:
Not applicable/Not specified. This is an in vitro diagnostic (IVD) kit, not a machine learning or AI-based device that typically requires a separate "training set" for model development. The development process for such a kit involves chemical and biochemical optimization rather than data-driven learning.

9. How the ground truth for the training set was established:
As above, not applicable. The device is a wet-lab kit, not an AI algorithm.

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

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

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

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

For In Vitro Diagnostic Use.

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

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

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

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

The immunotyping is performed in four automated steps:

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone Performance Study

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

7. Type of Ground Truth Used

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

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

8. Sample Size for the Training Set

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

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

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

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HYDRASHIFT 2/4 daratumumab kits are to be used in conjunction with the HYDRAGEL IF kits and the semi-automated HYDRASYS 2 electrophoresis apparatus. HYDRASHIFT 2/4 daratumumab with the HYDRAGEL IF kit are intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. The proteins, separated by electrophoresis on alkaline buffered agarose gels, are incubated with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) and lambda (free and bound) light chains, respectively. After removing the non-reacted proteins, the immunoprecipitates are stained with acid violet. The electrophoregrams are evaluated visually for the presence of specific reactions with the suspect monoclonal proteins. The HYDRASHIFT 2/4 daratumumab kits remove the daratumumab Ig G, Kappa interference and enable the visual evaluation of the presence or absence of monoclonal proteins on the HYDRAGEL IF kits in patients who have received daratumumab therapy.

HYDRASYS 2 is a semi-automated multi-parameter system for start-to finish agarose gel electrophoresis: application of samples, migration, incubation, drying, staining, destaining and final-stage drying. Abnormal bands in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones, are always suspected to be monoclonal proteins (M-proteins, paraproteins, monoclonal immunoqlobulins) and therefore, an indication of performing an Immunofixation technique to type and confirm the monoclonal qammopathies. Daratumumab is a human therapeutic Iq G Kappa monoclonal antibody and as such, during the clinical monitoring of patients treated with daratumumab, this antibody simulates a band detected by serum protein electrophoresis and immunofixation in the gamma region. It can simulate an endogenous Ig G Kappa paraprotein. The HYDRASHIFT 2/4 daratumumab test is intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. The kits are to be used in conjunction with the HYDRAGEL IF kits and the semi-automated HYDRASYS 2 electrophoresis apparatus. The proteins, separated bv electrophoresis on alkaline buffered agarose gels, are incubated with individual antisera that are specific against gamma (lg G), alpha (lg A) and mu (lg M) heavy chains, and kappa (free and bound) and lambda (free and bound) light chains, respectively. After removing the non-reacted proteins, the immunoprecipitates are stained with acid violet. The electrophoregrams are evaluated visually for the presence of specific reactions with the suspect monoclonal proteins. The HYDRASHIFT 2/4 daratumumab kits remove the daratumumab lg G, Kappa interference and enable the visual evaluation of the presence or absence of monoclonal proteins on the HYDRAGEL IF kits in patients who have received daratumumab therapy.

The provided FDA 510(k) summary describes the HYDRASHIFT 2/4 daratumumab device, which is an in-vitro diagnostic test. It is a modification of a previously cleared device. The acceptance criteria and study details are primarily focused on demonstrating that the modified device performs equivalently to the predicate device.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the study is a comparison between the modified device (HYDRASHIFT 2/4 daratumumab with anti-daratumumab from Chinese Hamster Ovary cells, referred to as 'Candidate/Modified Device' or 'CHO') and the predicate device (HYDRASHIFT 2/4 daratumumab with anti-daratumumab murine, referred to as 'Predicate Device (K172195)' or 'murine').

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

• Sample Size:
  • Concordance Study: A total of 51 human serum samples were used:
    • 9 negative samples (without monoclonals)
    • 21 daratumumab treated patient samples
    • 21 daratumumab spiked samples
  • Sensitivity and Efficiency Study: 3 serum samples were used:
    • 2 normal serum samples
    • 1 serum with an IgG Kappa monoclonal
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) summary for a modified device, the samples were likely acquired under institutional review board (IRB) approval for research use, but specifics are not provided. The samples referred to as "human serum samples" and "daratumumab treated patient samples" suggest human origin.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The evaluation method described is "electrophoregrams are evaluated visually for the presence of specific reactions." This implies visual interpretation, likely by trained laboratory personnel, but no explicit details are given about expert panels.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1). The evaluation is described as "visual," which suggests individual assessment, potentially followed by internal quality control.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study focused on demonstrating equivalence in performance characteristics between the modified device and its predicate, specifically around its ability to remove daratumumab interference. It did not involve comparing human reader performance with and without AI assistance.

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

This device is not an AI/algorithm-only device. It is an in-vitro diagnostic test kit (reagents) used in conjunction with an electrophoresis apparatus, where the final evaluation is visual and performed by a human. The "device" in this context refers to the HYDRASHIFT 2/4 daratumumab kits, which are reagents for laboratory testing.

7. The Type of Ground Truth Used

The ground truth for the performance studies appears to be based on:

• Known sample characteristics: Using "negative samples," "daratumumab-treated patient samples" (with known treatment status), and "daratumumab spiked samples" with predetermined concentrations.
• Visual evaluation of electrophoregrams: The presence or absence of specific reactions with monoclonal proteins is visually assessed, likely based on established laboratory protocols and the expected behavior of the predicate device.

It's essentially a performance comparison against known sample statuses and the established performance of the predicate device.

8. The Sample Size for the Training Set

This document does not describe a training set. This device is a reagent kit, not a machine learning or AI-based system that typically requires a training set. The performance studies are validation studies for the modified reagent.

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

As there is no training set mentioned or implied for this type of device, this question is not applicable.

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The HYDRASHIFT 2/4 daratumumab test is intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. The kits are to be used in conjunction with the HYDRAGEL IF kits and the semi-automated HYDRASYS 2 electrophoresis apparatus. The proteins, separated by electrophoresis on alkaline buffered agarose gels, are incubated with individual antisera that are specific against gamma (Ig G), alpha (Ig M) heavy chains, and kappa (free and bound) and lambda (free and bound) light chains, respectively. After removing the nonreacted proteins, the immunoprecipitates are stained with acid violet. The electrophoregrams are evaluated visually for the presence of specific reactions with the suspect monoclonal proteins. The HYDRASHIFT 2/4 daratumumab kits remove the daratumumab Ig G, Kappa interference and enable the visual evaluation of the presence of monoclonal proteins on the HYDRAGEL IF kits in patients who have received daratumumab therapy. For In Vitro Diagnostic Prescription Use Only.

The daratumumab Control is designed for quality control of the HYDRASHIFT daratumumab immunofixation procedure performed using the HYDRASYS 2 instrument. The daratumumab Control is designed for laboratory use. It should be used like a human serum. For In Vitro Diagnostic Prescription Use Only.

HYDRASYS 2 is a semi-automated multi-parameter system for start-to finish agarose gel electrophoresis: application of samples, migration, drying, staining, destaining and final-stage drying.

Abnormal bands in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones, are always suspected to be monoclonal proteins (M-proteins, paraproteins, monoclonal immunoglobulins) and therefore, an indication of performing an Immunofixation technique to type and confirm the monoclonal gammopathies.

Daratumumab is a human therapeutic Ig G Kappa monoclonal antibody and as such, during the clinical monitoring of patients treated with daratumumab, this antibody simulates a band detected by serum protein electrophoresis and immunofixation in the gamma region. It can simulate an endogenous Ig G Kappa paraprotein.

Daratumumab CONTROL is a qualitative quality control for the assay.

The HYDRASHIFT daratumumab immunofixation procedure performed on HYDRAGEL IF 2/4 gel is based on the creation of a daratumumab / anti-daratumumab antibody complex and shifting it outside the gammaglobulins zone. With the HYDRASHIFT daratumumab procedure, the daratumumab / anti-daratumumab antibody complex is visualized in alpha-1 zone on Ig G and Kappa immunofixation tracks and then the interference is removed from the gamma zone.

The HYDRASHIFT 2/4 daratumumab device is an immunofixation electrophoresis kit designed to remove daratumumab Ig G, Kappa interference, allowing for the visual evaluation of monoclonal proteins in human serum from patients treated with daratumumab. The study to prove the device meets acceptance criteria involved repeatability, reproducibility, and external comparative studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Repeatability Study: 10 different serum samples (1 normal, 9 with monoclonal components).
• Reproducibility Study: 10 different serum samples (1 normal, 9 with monoclonal components).
• External Comparative Study No. 1: 198 serum samples.
• External Comparative Study No. 2: 172 serum samples (noted that the first 172 samples from study 1 were analyzed on both sites, implying potentially shared samples in part).

The data provenance is from "2 external studies performed in the USA." It is not explicitly stated whether the data was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The evaluation of electrophoregrams is noted as "evaluated visually," implying human interpretation, but specifics about the interpreters are absent.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1, 3+1) for the test set results. The concordance of results is reported without detailing how disagreements, if any, were resolved.

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

No MRMC comparative effectiveness study is reported in the provided text. The studies focus on the technical performance of the device (repeatability, reproducibility, and concordance with existing methods) rather than the improvement of human reader performance with or without AI assistance. The device is a "HYDRASHIFT" kit that removes interference for visual evaluation, not an AI-based interpretation system.

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

No standalone algorithm performance study was done. The device is a diagnostic kit that requires visual evaluation of electrophoregrams by a human. Its purpose is to prepare samples to remove interference for human readability, not to interpret the results automatically.

7. The Type of Ground Truth Used

The ground truth appears to be based on the established clinical characterization of the serum samples (e.g., "normal" or "pathological with monoclonal components"). For normal samples, it's the absence of monoclonal components. For pathological samples, it's the specific type of monoclonal component (e.g., Ig G, L + Ig A, K + Ig M, L). This would typically be confirmed by standard laboratory techniques and expert interpretation of immunofixation electrophoresis. The external comparative studies also use existing methods (HYDRAGEL 4 IF alone) as a comparison baseline.

8. The Sample Size for the Training Set

The document does not mention a "training set" as it is typically understood in the context of machine learning or AI. The studies performed are for device validation, focusing on performance characteristics such as repeatability, reproducibility, and comparison with predicate devices, rather than training a model.

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

Since there is no mention of a training set for an AI/algorithm, there is no information on how its ground truth would have been established. The ground truth for the validation studies (test sets) is based on the known characteristics of the serum samples and comparison with established methods.

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

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

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

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

For In Vitro Diagnostic Use.

The IT / IF Control is designed to qualitative detection and characterization of human monoclonal immunoglobulins (Ig G, Ig A, Ig M, Kappa and Lambda) with the electrophoresis methods :

• Immunotyping performed using capillary electrophoresis on SEBIA CAPILLARYS 2, CAPILLARYS 2 FLEX-PIERCING and CAPILLARYS 3 TERA instruments and on SEBIA MINICAP instrument,

• Immunofixation methods : SEBIA HYDRAGEL IF, HYDRAGEL IF Penta, HYDRAGEL BENCE JONES (Standard mask and Dynamic mask) performed using the HYDRASYS and HYDRASYS 2 instruments and the K20 electrophoresis chamber.

The IT / IF Control is designed for laboratory use. It should be used (with its barcode label for CAPILLARYS and MINICAP procedures) like a human serum sample.

The electrophoretic pattern obtained is specific for each batch of IT / IF control.

For In Vitro Diagnostic Use.

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

In CAPI 3 MMUNUOTYPING kit contains the sample diluent and specific antisera against gamma (Ig G), alpha (Ig A), mu (Ig M) heavy chains, and free and bound Kappa and Lambda light chains. A sample dilution is prepared and injected at the anodic end of six capillaries. The reference pattern (ELP pattern), which is a complete electrophoretic pattern of the sample's proteins, is obtained by mixing the sample with the ELP solution and injection into the 1st capillary. The antisera patterns are obtained by sample aspiration into the 5 subsequent capillaries separation is performed in a high voltage electrical field and detected using absorbance at 200 nm.

The IT / IF control contains three monoclonal proteins which can be used as a qualitative control with the CAPI IMMUNOTYPING kit on the CAPILLARYS 3 TERA instrument.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table. However, the method comparison study provides the performance benchmark against the predicate device.

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

• Sample Size for Method Comparison (Test Set): 115 serum samples (12 normal, 103 pathological).
• Data Provenance: Not explicitly stated as country of origin. The manufacturing information (Sebia, FRANCE) implies the device developer is French, but the source of the samples is not provided. The study is retrospective as it compares results from existing clinical samples.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. The comparison is made against a "predicate device" (CAPILLARYS IMMUNOTYPING procedure), which implies the predicate device's results are considered the reference or "ground truth" for this study. The visual evaluation of electrophoregrams is mentioned, which typically involves trained laboratory personnel or pathologists, but specifics are missing.

4. Adjudication Method

Not explicitly stated. The study reports 100% agreement, suggesting no significant discrepancies arose that would require an adjudication process.

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 explicitly done based on the provided text. The study compares the device's performance to a predicate device, not human readers with and without AI assistance.

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

Yes, the method comparison study appears to be a standalone performance evaluation of the CAPI 3 IMMUNOTYPING procedure (algorithm + instrument system) against the predicate device's procedure. While the "electrophoregrams are evaluated visually," the 100% agreement is attributed to the techniques rather than individual human interpretations.

7. The Type of Ground Truth Used

The ground truth for the method comparison study was established by the results obtained from the predicate device (CAPILLARYS IMMUNOTYPING procedure). This means the predicate device's ability to detect and characterize monoclonal proteins served as the reference standard.

8. The Sample Size for the Training Set

The document does not mention a training set nor does it explicitly describe an AI/machine learning component that would require a distinct training set. The device appears to be a diagnostic instrument based on capillary electrophoresis, not an AI-driven interpretation tool.

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

Since no training set or AI component is described, this information is not applicable.

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The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP and the MINICAP FLEX-PIERCING instruments, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).

The MINICAP and MINICAP FLEX-PIERCING instruments perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa and lambda (free and bound) light chains. respectively.

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

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

For In Vitro Diagnostic Use.

The MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoresis mobility in an alkaline buffer. The separation occurs according to the electrolyte pH and electro-osmotic flow. In capillary electrophoresis abnormal fractions in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones are always suspected of being monoclonal proteins, paraproteins, monoclonal immunoglobulins) and therefore an indication of a gammopathy. The MINICAP FLEX-PIERCING instrument has 2 capillaries functioning in parallel. A sample dilution is prepared and injected simultaneously by aspiration at the anodic end of the 2 capillaries.

The Immunotyping procedure follows the steps in which the sample is mixed with an ELP solution (reference pattern), specific antisera gamma ( IgG), mu (IgM) heavy chains and free/bound Kappa and Lambda light chains.

A high voltage protein separation is then performed and direct detection of the proteins at 200 nm at the cathodic end of the capillary. The capillaries are then washed and prepared for the next analysis. The superimposition of the antisera patterns with the ELP pattern allows for the visualization of the disappearance and /or the decrease of the monoclonal fraction on the antiserum pattern and to indicate a gammopathy.

The provided text describes a Special 510(k) submission for the MINICAP IMMUNOTYPING device, indicating a modification to allow its use with a new instrument, the MINICAP FLEX-PIERCING. The core of the submission aims to demonstrate that this modification does not change the intended use or fundamental scientific technology of the device and that the performance characteristics remain substantially equivalent to the original cleared device.

Unfortunately, the document does not contain a detailed study report with specific performance data that directly proves the device meets acceptance criteria in a quantitative manner as typically expected for medical device studies. Instead, it states that "Completed detailed sets of data are on file at Sebia manufacturing" and discusses the "results of risk analysis employing acceptance criteria" which were met. Therefore, I cannot provide a table of acceptance criteria with reported device performance or information about sample sizes, ground truth establishment, or expert adjudication as these details are not present in the provided text.

However, I can extract the acceptance criteria as stated for the modified device and explain the general approach taken for the special 510(k) submission based on the available information.

Acceptance Criteria and Study for MINICAP IMMUNOTYPING (using MINICAP FLEX-PIERCING)

The Special 510(k) submission focuses on demonstrating that the MINICAP IMMUNOTYPING procedure, when run on the new MINICAP FLEX-PIERCING instrument, maintains performance equivalent to its use on the predicate MINICAP instrument.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific quantitative performance data is not provided in the document to populate such a table. The document states that "Completed detailed sets of data are on file at Sebia manufacturing" and that "The results of risk analysis employing acceptance criteria demonstrate the predetermined performance characteristics were met and the predetermined acceptance criteria were satisfied."

However, the predetermined acceptance criteria for the modified device are explicitly stated as:

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

• Sample Size: Not specified in the provided text. The document only mentions "Completed detailed sets of data are on file at Sebia manufacturing."
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• This information is not provided in the document. The adjudication method for the "electrophoregrams are evaluated visually" is mentioned, implying human interpretation, but details about the experts or their qualifications are absent.

4. Adjudication method for the test set

• The document implies visual evaluation by experts: "The electrophorograms are evaluated visually to detect the presence of specific reactions with suspected monoclonal proteins." However, no specific adjudication method (e.g., 2+1, 3+1) is described for the test set.

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 document describes a device for detecting and characterizing monoclonal proteins using capillary electrophoresis, with visual evaluation of electrophoregrams. It is a modification of an in vitro diagnostic device, not an AI-assisted diagnostic tool for Human Readers. Therefore, an MRMC comparative effectiveness study regarding human readers improving with AI vs without AI assistance is not applicable and not mentioned in this submission.

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

• The device involves instrumental analysis and the 'PHORESIS software' for evaluation, but the final interpretation mentions "electrophoregrams are evaluated visually to detect the presence of specific reactions." This suggests a human-in-the-loop component for qualitative analysis rather than a fully standalone algorithm interpretation. A standalone performance study of the algorithm without human interpretation is not explicitly mentioned or described.

7. The type of ground truth used

• The document describes the device as providing "detection and the characterization of monoclonal proteins (immunotyping) in human serum." The comparison is against the predicate device's performance. The nature of the "ground truth" for the samples used in the underlying studies (e.g., confirmed patient diagnoses, reference lab results, pathology) is not specified.

8. The sample size for the training set

• The document does not detail any "training set." This is a Special 510(k) for an instrument modification to an existing device, focusing on demonstrating substantial equivalence, not a de novo submission for a novel algorithm that would typically involve distinct training and testing sets.

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

• As no training set is mentioned or described, this information is not applicable/provided.

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The Immunofixation Electrophoresis (IFE) Test using Interlab G 26 v2.0 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings.

The Interlab IFE kits 2, 4, and 6 samples per gel, are intended to be used with the automated Interlab G26 v1.0 and v2.0 electrophoresis analyzers in conjunction with the Easy Mask antisera application device.

The Immunofixation Electrophoresis (IFE) Test kit is packaged as a 20 (2 samples/ gel), 40 (4 samples/ gel) or 60 (6 samples/ gel) test kits. The kit contains ready-to-use components: 10 gel plates, 2 buffered sponges, acid violet stain (500 mL), washing solution for applicators (80 mL), washing solution 1 for IFE (80 mL), washing solution 2 for IFE (80 mL), IFE diluent (6 or 12 mL), disposable sample trays 26 (10 pcs) or 39 (10 pcs), blotters A (10 pcs), blotters L (10 pcs), blotters G (10 pcs), and 1 CD Package Insert.

The following components are required for the test but are not supplied in the test kit: destain solution pack (6x100 mL), fixative solution (1.5 mL) and specific antisera Anti-Human-IgG (1 mL), Anti-Human-IgA (1 mL)), Anti-Human-IgM (1 mL), Anti-Human-Kappa (1 mL) and Anti-Human-Lambda (1 mL).

The Automated Interlab G 26 ver. 2 Electrophoresis Analyzer provides automated pipetting of samples from barcode sample tubes in a rack and dilutes the samples into a sample tray for dispensing onto an agarose gel. The protein fraction separation uses the principle of electrophoresis; separation involving electrically charged molecules that orient and migrate at different rates when subjected to an electric field. The migration is performed at a constant temperature, obtained through the use of a Peltier device, on assay specific buffered agarose gel plates. The agarose gel medium provides a support and molecular sieve allowing the different fractions to migrate to points based on individual net charges.

After electrophoresis, the gel is heated to "fix" the focalized proteins, followed by assay specific staining, destaining, washing and drying. All methods utilizing a quantitative assessment are immediately processed using the on-board densitometer. The signal obtained for each specimen result is sent to the personal computer and presented using the Elfolab interpretive software. The Interiab G26 instrument is preprogrammed with all necessary firmware to conduct and manage all phases of the analytical procedures used in Interlab manufactured assays. The instrument works in coniunction with a personal computer using Windows® based software featuring pull down menus and intuitive icons for easy instrument control, selection of analytical methods, and data evaluation.

Instrument design includes: automated application of the samples on the agarose gel; electrophoretic migration; "heat fixing" proteins to the gel; gel staining/ destaining/ drying, densitometric reading of the gel; and data transmission and processing.

The Interlab Easy Mask Antisera Applicator Device is a standalone electronic instrument identical to the peltier contained within the Interlab G26 and is designed to work in conjunction with the Interlab G26. This device allows for accurate and simplified processing of various electrophoretic agarose gel assays that require reagent or antisera overlays. This device allows for easier user processing of the manual steps necessary in antisera type assays (IFE, BJ, Penta) by allowing the user to work unencumbered from mechanical arms and instrument covers.

The Easy Mask provides functions identically to the processing steps used in other agarose gel systems that require the user to perform the manual antisera steps directly on the instrument. Through the use of a Peltier and vacuum pump, the temperature across the surface of the gel remains at a precise and controlled temperature, thus improving assay quality and decreasing time. Instrument is designed to receive the Gel Holder from the Interiab G26 Instrument. The Gel Holder is inserted into a template which places the gel in direct contact with the peliter plate assuring uniform and controlled temperature over the entire surface of the gel. Perfect adhesion of the geltier plate is accomplished using a vacuum pump. Assay specific application masks are placed in the frame, which provide precise application of the antisera or reagents during the incubation phase. After the incubation phase is complete, the frame locks over the gel providing a calibrated heated press to blot away un-bound antisera and reagents. When processing is completed on the Easy Mask, the operator places the Gel Holder back in the parking location on the Interlab G26 for the final steps of the analysis.

Here's a breakdown of the acceptance criteria and the study details for the Immunofixation Electrophoresis Test using Interlab G26 Instrument, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

For this particular device, the "acceptance criteria" are implicitly defined by the demonstration of 100% agreement and reproducibility with a previously cleared predicate device. The performance is reported as concordance. There are no explicit numerical thresholds for sensitivity or specificity stated as acceptance criteria, as this is a qualitative test comparing to a predicate.

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

• Reproducibility (Within-Run): 2 series of 8 samples (1 normal, 7 pathological with monoclonal bands). For each sample, 6 replicates were run. Total replicates = (2 series * 8 samples/series * 6 replicates/sample) = 96.
• Reproducibility (Between-Run): 4 cycles of 3 agarose gel plates used to analyze 18 samples (3 normal, 15 pathological with monoclonal bands). Total runs/gels = (4 cycles * 3 gels/cycle) = 12 gels.
• Inter-Lot Reproducibility: 9 different samples (1 normal, 8 pathological with monoclonal bands) analyzed using 3 different batches of antisera on 9 agarose gel plates.
• Interference (Serum): Not explicitly stated, but implies a sufficient number of spiked and un-spiked samples.
• Interference (Urine): 8 urine samples (7 pathological, 1 normal).
• Method Comparison (Serum): 102 serum samples (10 normal, 92 suspected pathological).
• Method Comparison (Urine): 64 urine samples (56 pathological, 8 negative).

Data Provenance: The document does not explicitly state the country of origin for the patient samples. The studies seem to be retrospective, using existing samples.

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

The ground truth for the test set interpretations (e.g., comparison studies, reproducibility) was established by visual inspection. The document does not specify the number of experts, nor their qualifications (e.g., "radiologist with 10 years of experience"). This type of qualitative visual interpretation is typically done by trained laboratory professionals or experts in immunofixation electrophoresis.

4. Adjudication Method for the Test Set

The document does not detail a formal adjudication method (e.g., 2+1, 3+1). The evaluation was based on visual inspection for agreement and reproducibility. It can be inferred that either a single expert visually inspected and confirmed the results, or multiple experts reviewed, and any discrepancies were resolved, but the process is not explicitly described.

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. The study focused on the performance of the device itself compared to a predicate device, not on the improvement of human reader performance with or without AI assistance. The device is for qualitative diagnostic separation and identification, interpreted visually.

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

Yes, the studies described are essentially standalone performance evaluations of the Interlab G26 v2.0 instrument. The visual inspection "evaluation" is about the clarity and accuracy of the bands produced by the instrument, which is then interpreted by a human. The "standalone" here refers to the instrument's ability to process samples and produce the electrophoretic patterns correctly, rather than an AI or algorithm making a final diagnosis without human input. The output is a visual pattern that a human then interprets.

7. The Type of Ground Truth Used

The ground truth used for the test set appears to be:

• Visual Inspection/Expert Consensus: For reproducibility, precision, and interference, the "ground truth" for what constitutes a correct pattern (monoclonal bands, normal pattern, etc.) is based on established interpretation criteria for immunofixation electrophoresis and is visually confirmed.
• Predicate Device Agreement: For the method comparison studies, the results obtained from the predicate G26 v1 device (which was previously cleared by the FDA) served as the "reference method" or de-facto ground truth for qualitative agreement.

There is no mention of pathology, long-term outcomes data, or other definitive "gold standard" methods used to establish ground truth.

8. The Sample Size for the Training Set

The document does not specify a training set in the context of machine learning or AI. This device submission is for an automated electrophoresis instrument, not an AI/ML algorithm that requires a training set. The "preprogrammed" firmware and software (Elfolab system) manage the analytical procedures and data evaluation, but it's not described as an adaptive learning system that undergoes a "training" phase with data.

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

As no training set (in the AI/ML sense) is described, there's no information on how its ground truth was established.

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The Helena V8 Immunodisplacement Kit is designed for the detection and the characterization of monoclonal proteins (immunoglobulin's IgG, IgA, IgM, kappa (bound) and lambda (bound) light chains), in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit designed for serum protein separation into 6 major fractions in alkaline buffer. The electrophoretograms of separated proteins mixed with individual specific antisera are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. The test results are to be used in conjunction with clinical findings and other laboratory tests.

For In Vitro Diagnostic Use Only.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Not Found

The provided document is an FDA 510(k) clearance letter for the "V8 Immunodisplacement Kit" and does not contain the detailed study information required to fully answer the request. This document primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence to a predicate device.

Therefore, I cannot provide all the requested information. However, I can extract what is available and note what is missing.

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

This information is not available in the provided document. The document states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail specific acceptance criteria or performance metrics from a study.

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

This information is not available in the provided document.

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

This information is not available in the provided document.

4. Adjudication method for the test set

This information is not available in the provided document.

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 available in the provided document. The device described (V8 Immunodisplacement Kit) is for in vitro diagnostic use involving capillary electrophoresis and visual evaluation of electrophoretograms. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting imaging or similar data.

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

This information is not available in the provided document. As mentioned, this device appears to be an in vitro diagnostic kit with visual evaluation by a human.

7. The type of ground truth used

This information is not available in the provided document. For this type of device (detection and characterization of monoclonal proteins), ground truth would likely involve established laboratory methods or clinical diagnoses.

8. The sample size for the training set

This information is not available in the provided document. As this is not an AI/machine learning device, the concept of a "training set" in that context may not apply.

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

This information is not available in the provided document.

Summary of available information from the document:

• Device Name: V8 Immunodisplacement Kit
• Intended Use: Detection and characterization of monoclonal proteins (IgG, IgA, IgM, kappa (bound), and lambda (bound) light chains) in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit.
• Evaluation Method: Electrophoretograms of separated proteins mixed with individual specific antisera are evaluated visually to detect the presence of specific reactions with suspect monoclonal proteins.
• Context of Use: Test results are to be used in conjunction with clinical findings and other laboratory tests.
• Regulatory Status: 510(k) clearance based on substantial equivalence to legally marketed predicate devices.
• Classification: Class II, Product Codes: CFF (Immunoglobulins A, G, M, D, and E immunological test systems).
• Prescription Use: Yes.

To obtain the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, and performance, one would typically need to review the 510(k) submission summary or additional technical documentation provided by Helena Biosciences Europe to the FDA, which is not part of this clearance letter.

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The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings.

The Interlab IFE kits (2, 4, 6 samples per gel), are intended to be used with the automated Interlab G26 electrophoresis analyzer in conjunction with the Easy Mask antisera application device.

Not Found

The provided text is a 510(k) clearance letter from the FDA for an Immunofixation Electrophoresis Test using the Interlab G26 Instrument. It does not contain information about formal acceptance criteria, device performance reports, or details of a study used to prove the device meets acceptance criteria.

The letter primarily:

• Identifies the device and its regulatory classification.
• States that the device has been determined substantially equivalent to legally marketed predicate devices.
• Outlines general regulatory requirements for the manufacturer.
• Provides the "Indications for Use" for the device, which describes its intended purpose but not performance metrics.

Therefore,Based on the provided document, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: The document is an FDA 510(k) clearance letter and does not contain detailed acceptance criteria or performance data. It indicates that the device was found "substantially equivalent" to predicate devices, implying that its performance is comparable, but no specific metrics are given.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available in this document.
6. If a standalone performance study was done: Not available in this document.
7. The type of ground truth used: Not available in this document.
8. The sample size for the training set: Not available in this document.
9. How the ground truth for the training set was established: Not available in this document.

The document only provides:

• Device Name: Immunofixation Electrophoresis Test using Interlab G26 Instrument
• Indications For Use: "The Immunofixation Electrophoresis (IFE) Test using the Interlab G26 instrument is for the qualitative in vitro diagnostic separation and identification of immunoglobulins (IgG, IgA and IgM), and kappa and lambda light chains in human serum and concentrated urine using agarose gel supported on Mylar®. The test is useful as an aid in identifying suspected monoclonal proteins. The test result is to be used in conjunction with clinical and other laboratory findings. The Interlab IFE kits (2, 4, 6 samples per gel), are intended to be used with the automated Interlab G26 electrophoresis analyzer in conjunction with the Easy Mask antisera application device."

Ask a specific question about this device

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

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

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

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

For In Vitro Diagnostic Use.

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

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

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

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

This document is a 510(k) premarket notification approval letter for a medical device called "CAPILLARYS IMMUNOTYPING PN 2100". It establishes substantial equivalence to a predicate device, meaning it doesn't require a new PMA.

Therefore, the document does not contain the level of detail typically found in a clinical study report or a pre-market approval application regarding device performance and acceptance criteria. It primarily focuses on the regulatory approval process based on substantial equivalence.

As a result, I cannot provide the requested information in full detail from the provided text. The information below is what can be inferred or explicitly stated.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state acceptance criteria or provide a table of performance data. An approval based on substantial equivalence implies that the device's performance is comparable to a legally marketed predicate device, but specific metrics are not detailed here.

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

This information is not present in the provided text.

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

This information is not present in the provided text.

4. Adjudication Method for the Test Set:

This information is not present in the provided text.

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 document describes an "Immunological test system" for detecting and characterizing monoclonal proteins, which appears to be a laboratory diagnostic device, not an AI-assisted imaging or diagnostic tool relevant to MRMC studies comparing human readers with and without AI assistance. Therefore, it is highly unlikely such a study was performed or would be applicable to this device type.

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

The device description states "The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins." This indicates that human visual evaluation is part of the process, suggesting it's not a purely standalone algorithm.

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

The document does not specify the type of ground truth used for validation. For an immunotyping system, it would likely involve comparison to established laboratory methods or reference standards, but this is not detailed.

8. The sample size for the training set:

This information is not present in the provided text.

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

This information is not present in the provided text.

Summary of what can be extracted/inferred:

• Device Name: CAPILLARYS IMMUNOTYPING, PN 2100
• Intended Use: Detection and characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS System, for capillary electrophoresis. Used with CAPILLARYS PROTEIN(E) 6 kit.
• Mechanism: Performs automatic procedural sequences to obtain a protein profile. Each sample is mixed with individual antisera specific against Ig G, Ig A, Ig M heavy chains, and kappa and lambda light chains. Proteins are separated in silica capillaries and detected by absorbance at 200 nm.
• Evaluation: Electrophoregrams are evaluated visually to detect specific reactions.
• Regulatory Basis: Substantial equivalence to a legally marketed predicate device. This implies that the performance is considered comparable, but specific metrics are not provided in this regulatory letter itself.
• Human-in-the-loop: Yes, "evaluated visually" indicates human involvement.

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