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The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoasay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, Sm/RNP, Scl70, Jo1, ribosome and centromere. (*Antibodies to dsDNA, Sm, Sm/RNP, SSA, SSB, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).

Clinical utility: The results of the FIDIS™ CONNECTIVE 10* are to be used in conjunction with the clinical findings and the other laboratory tests to aid in the diagnosis of connective diseases (systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis and CREST syndrome).

FIDIS™ CONNECTIVE 10* kit uses serum only, and is to be run on the FIDIS™ Instrument and MLX-BOOSTER™ Software.

FIDIS™ CONNECTIVE 10* kit may be used with the CARIS™ system (diluting and dispensing device).

This test is for in vitro diagnostic use.

The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescentbased microparticles immunoasay using flow cytometry. The test system is used to simultaneously detect the presence of 10 autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDa and 52 kDa), SSB, Sm, Sm/RNP, Scl70, Jo1, ribosome and centromere. The kit includes a 96 wells microplate, vials of color-coded microsphere beads coupled with antigens and internal standard beads, sample dilution buffer, calibrator, positive control, negative control, anti-human IgG coupled to phycoerythrin, washing buffer, reconstitution buffer, package insert, microplate assay configuration worksheet, and microplate sealing films. The test is run on the FIDIS™ Instrument and MLX-BOOSTER™ Software, and may be used with the CARIS™ system (diluting and dispensing device).

The Biomedical Diagnostics S.A. (bmd) FIDIS™ CONNECTIVE 10* assay is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay that uses flow cytometry to detect 10 autoantibody specificities. The device's performance was established through analytical performance studies and comparison studies against a predicate device (K053653 FIDIS™ CONNECTIVE 10* system) and manual assay preparation steps.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria mainly for precision and outlines performance through agreement studies.

Precision Acceptance Criteria and Reported Performance

Comparison Study with Predicate Device (K053653 FIDIS™ CONNECTIVE 10)*

The acceptance criteria for the comparison study are implicitly that the agreement (Positive Percent Agreement, Negative Percent Agreement, and Overall Agreement) should demonstrate substantial equivalence to the predicate device. While specific percentage targets are not explicitly stated as "acceptance criteria" in the table format, the observed agreement percentages with 95% LCLs are reported and deemed sufficient for substantial equivalence.

Comparison Study: Manual vs. Automated (CARIS™) Assay Preparation

Similar to the predicate comparison, the acceptance criteria here are also implicit that agreement between manual and automated methods shows substantial equivalence.

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

• Precision Study Test Set:

  • Within-run: 6 samples (5 for Jo1) tested 10 times in the same run.
  • Between-run: 6 samples (5 for Jo1) tested 3 times per run, across 6 runs.
  • The document does not specify the country of origin or whether the data was retrospective or prospective for the precision study samples.

• Comparison Study with Predicate Device Test Set:

  • Sample Size: 264 samples.
  • Composition: 194 samples positive for one or more parameters, and 70 negative samples (including some with potential biological interferences).
  • Data Provenance: The document states "obtained from routine laboratory" for interfering substances study (part of analytical performance) and implies a similar source for the comparison study, but the specific country of origin or retrospective/prospective nature isn't explicitly stated. However, given the manufacturer is based in France, it's plausible the samples originated from Europe.

• Comparison Study with Automated (CARIS™) system Test Set:

  • Sample Size: 264 samples.
  • Composition: 194 samples positive for one or more parameters, and 70 negative samples (including some with potential biological interferences).
  • Data Provenance: Same as above.

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

The document does not mention the use of human experts to establish ground truth for the test sets. Instead, the "ground truth" for the comparison studies is defined by the results obtained from the predicate device (K053653 FIDIS™ CONNECTIVE 10 system)* or the manual assay preparation steps of the modified device. For the analytical performance (e.g., precision, interfering substances), the "truth" is based on the inherent characteristics of the spiked or characterized samples.

4. Adjudication Method for the Test Set

This type of in-vitro diagnostic device study typically doesn't involve human adjudication in the traditional sense (e.g., for imaging studies). For the comparison studies, discrepancies were handled as follows:

• "All equivocal samples with predicate and modified CONNECTIVE 10* assays are considered negative for the comparison and the evaluation studies."
• For individual specificities, the number of equivocal results is noted (e.g., "There were 3 equivocal results with the assay. For purposes of calculation, these results were considered as negative."). This method effectively converts equivocal results into negative results for agreement calculations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test system, not an AI-assisted diagnostic tool that human readers would interact with in the context of interpretation. The comparison is between different versions or methods of the assay itself, or against a predicate device.

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

The device itself is a standalone in-vitro diagnostic test system. The performance studies evaluate the device's analytical characteristics and its agreement with a predicate device or different operational modes (manual vs. automated sample preparation). There isn't an "algorithm" in the sense of a standalone AI intended to perform diagnostic interpretation; rather, it's a test system that provides semi-quantitative results. The system operates without human interpretive intervention beyond running the assay and reading the numerical output.

7. The Type of Ground Truth Used

The ground truth for the comparison studies was:

• The results generated by the predicate device (K053653 FIDIS™ CONNECTIVE 10 system)* when comparing the modified device to the predicate.
• The results generated by the manual assay preparation steps when comparing the automated (CARIS™) assay preparation to manual preparation.

For the analytical precision and interfering substances studies, the ground truth was based on the known characteristics of the samples (e.g., characterized positive/negative samples, spiked samples, or samples with known interferences). There is no mention of pathology, expert consensus, or outcomes data being directly used as ground truth for these performance evaluations.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning or algorithm development. The studies performed are for performance evaluation and comparison studies for a medical device. Therefore, no training set size is reported in the provided text.

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

As no training set is indicated, this question is not applicable. The device's operational characteristics and comparisons are the focus of performance evaluation, not machine learning model training.

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The FIDIS™ CONNECTIVE 10* kit is a semi-quantitative homogeneous fluorescent based microparticles immunoassay using flow cytometry readings. It is designed for the simultaneous detection of autoantibody specificities: double stranded DNA (dsDNA), SSA (60 kDA and 52 kDA), SSB, Sm. Sm/RNP, Scl-70, Jo-1 ribosome and centromere in human serum. (* Antibodies to dsDNA, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1, ribosome and centromere can be reported using this assay).

The test system is used to screen serum samples and detect the presence of antinuclear antibodies associated with connective diseases systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease (MCTD), scleroderma, dermatomyositis, and CREST syndrome, in conjunction with clinical findings and other laboratory tests.

The assay kits consist of:

• a mixture of color-coded microspheres sensitized respectively by dsDNA, SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1, Ribosomes and Centromeres.
• a ready to use anti-human IgG coupled to phycoerythrin,
• a ready to use calibrator titered for each specificity,
• a positive control IgG to be diluted.
• a negative control to be diluted,
• a 10X concentrated PBS-Tween.
  Rk: Calibrators, positive and negative controls are diluted human sera.

The FIDIS™ System is a fully integrated and automated system for immunodiagnostic testing.
FIDIS™ System comprised of FIDIS flow cytometer, XYP platform for automatic sampling into the analyser, the analyzer itself, a SD pump, some assay products and a MLX-BOOSTER software.

The FIDIS™ CONNECTIVE 10 kit resembles traditional EIA, but allows simultaneous detection and identification of several antibodies in a single well.

• 1. Diluted patient sera and multiplexed bead suspension are thoroughly mixed in the 96 well microtiter plate. Antigen specific antibodies in the patient sera, if present, bind to the immobilised antigen on one or more of the bead sets. Any unbound material is removed by performing a wash step.
• 2. Phycoerythrin-conjugated goat anti-human IgG is added to the plate and a further incubation performed. The conjugated anti-human igG binds to the antigen specific antibodies immobilised on the microsphere surface to form an antigen/antibody complex.
• 3. The bead suspension is then analysed by the FIDIS™ Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER).

The FIDIS™ Instrument is able to distinguish the specific color-code of each microsphere types and it could associate the microsphere type with the individual tested antigen.
The FIDIS™ Instrument can quantify the fluorescence of the antibody captured by each microsphere. Measurement of the fluorescent signal from the final reaction complex allows the quantification of the presence or absence of autoantibodies.

Here's a summary of the acceptance criteria and the study details for the FIDIS™ CONNECTIVE 10 device, based on the provided text:

Premarket Notification 510(k) Summary for FIDIS™ CONNECTIVE 10 (K053653)

The document primarily focuses on establishing substantial equivalence to predicate devices, rather than defining specific numerical acceptance criteria for performance metrics like sensitivity and specificity. The acceptance criteria appear to be implicit in demonstrating comparability to the predicate devices across various sample types.

1. Table of Acceptance Criteria and Reported Device Performance

• Results from a comparison study analyzing positive, equivocal, and negative sera.
• Results from samples of apparently healthy subjects (normal population).
• Results from samples with potential biological cross-reactivity. |
  | Accuracy | Not explicitly stated as a separate numerical criterion | Implied through substantial equivalence to predicate device results, which are presumed to be accurate. The device allows for the detection of 10 autoantibody specificities (dsDNA, SSA 60kDa, SSA 52kDa, SSB, Sm, Sm/RNP, Scl70, Jo-1, Ribosomes, and Centromeres) and its measurements are directly calculated in biological units using specific data software. |
  | Precision/Reproducibility | Not explicitly stated as a separate numerical criterion | Not explicitly detailed in the provided summary. |
  | Clinical Utility | Ability to screen serum samples and detect the presence of anti-nuclear antibodies associated with connective diseases (SLE, Sjogren's syndrome, MCTD, Scleroderma, Dermatomyositis, CREST syndrome) | The device is designed for this intended use and is presented as being able to screen serum samples and detect these autoantibodies. Its use is in conjunction with clinical findings and other laboratory tests. |

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

The exact sample sizes for the test set (comparison study, healthy subjects, cross-reactivity samples) are not specified in this summary document.
The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) test for autoantibody detection, not an imaging device requiring human reader interpretation in the same way.

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

The device is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is an automated system for immunodiagnostic testing. The "standalone" performance is inherent to its function as an IVD device, where the instrument performs the detection and quantification. The summary describes the assay steps culminating in analysis by the FIDIS™ Instrument which calculates results using specific software. Therefore, the reported performance is a standalone (algorithm/instrument only) performance.

7. The Type of Ground Truth Used

The ground truth for the comparison studies is implicitly based on the results obtained from legally marketed predicate devices. The summary states the comparison included "positive, equivocal and negative sera" and "samples from apparently healthy subject (normal population)" and "samples with potential biological cross reactivity." This suggests that the ground truth for these samples was likely established through existing clinical diagnoses and reference methods (including the predicate devices themselves) based on a combination of clinical findings, other laboratory tests, and potentially expert consensus on patient status.

8. The Sample Size for the Training Set

The document does not provide information on a separate "training set" or its sample size. For IVD devices, the characterization of reagents and assay parameters during development might be analogous to "training," but the summary does not detail this.

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

Since no separate training set is explicitly mentioned, there is no information on how its ground truth was established.

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