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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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