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AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum. This in vitro diagnostic assay is used as an aid for the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. The assay can be processed manually and analyzed at the microscope or processed and analyzed with HELIOS® AUTOMATED IFA SYSTEM. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semiquantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.

Each kit contains (Quantity depends on product variant):

• -Slides, each containing 10 wells coated with Crithidia Luciliae cells
• 4.0 ml vial containing Fluorescein (FITC) labelled Anti-human Antibody lgG conjugate in a solution of BSA, ready for use
• -0.5 ml vial of positive control containing human serum (diluted), ready for Use
• 0.5 ml vial of negative control containing diluted human serum, ready for use -
• -8.0 ml vial of mounting medium containing a solution of glycerol and PBS, ready for use
• 70 ml bottle of sample buffer, containing BSA, PBS and ready for use -
• -100 ml bottle of wash buffer, concentrated buffer 1:10 in distilled water, containing BSA, PBS.

Here's a breakdown of the acceptance criteria and study information for the AESKUSLIDES® nDNA (Crithidia luciliae) device, based on the provided document:

Acceptance Criteria and Device Performance Study for AESKUSLIDES® nDNA (Crithidia luciliae)

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several studies with specific acceptance criteria. Below is a summary for the Between-Lab Precision Study and the Lot-to-Lot Precision Study, as these provide clear, quantitative acceptance criteria and corresponding results. Other studies, like Serum Stability and Carryover, also met their respective criteria (e.g., 100% agreement, no significant deviations).

Between-Lab Precision Study (Excluding Borderline Samples - Method B: Reader Confirmation)

Between-Lab Precision Study (Excluding Borderline Samples - Method C: Manual)

Lot-to-Lot Precision Study (Combined Readers)

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

The primary clinical evaluation and method comparison studies used 776 clinical samples.

• Test Set Size: 776 samples.
• Data Provenance:
  • 746 samples were obtained from 10 US BioBanks (BioChain, BioReclamationIVT, Bioserve, ConversantBio, Cureline, DiscoveryLifeSciences, iSpecimen, Precision for Medicine, ProMedDx, and Vitrologic).
  • 30 serum samples were from a German University Hospital (used to complement rare diagnoses like Vasculitis).
• Retrospective/Prospective: The samples were collected from BioBanks, indicating they are retrospective samples with pre-existing diagnoses.
• Sample Characteristics: The samples were selected to reflect various diagnoses relevant to the study (e.g., 297 SLE, 479 other diseases) and different ethnic groups in the US population (White, Black/Black African, Asian, Hispanic). Serum stability over multiple freeze-thaw cycles and long-term storage was also evaluated and deemed acceptable.

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

The term "ground truth" for the diagnosis of the clinical samples (used in the method comparison studies) was established based on diagnostic standards used in the U.S. and Germany, such as ACR criteria. A written statement from different serum suppliers confirmed this.

For evaluation of the device performance within the studies (e.g., precision studies, clinical study), the ground truth for individual results was typically established by:

• Two independent readers.
• Qualifications of experts: The document consistently refers to "trained personnel" and "trained readers" to perform manual microscopy and confirm automated results. Specific certifications or years of experience (e.g., "Radiologist with 10 years of experience") are not explicitly provided in this document.

4. Adjudication Method for the Test Set

For studies involving human readers:

• Results were analyzed by two independent readers.
• The document implies a consensus-based approach or separate reporting of each reader's results for evaluation, but a formal adjudication method (like "2+1" or "3+1") where a third reader resolves discrepancies is not explicitly stated. For instance, in the Between-Lab and Within-Lab Precision studies, results for two readers were calculated separately and then combined. In cases of discrepancy (e.g., sample S1 in Within-Lab precision for Method B, where Reader 1 found 30 Negatives and Reader 2 found 6 Negatives and 24 Positives), the combined percentage reflects this disagreement rather than a formal adjudication.

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

The document does not explicitly describe a formal MRMC comparative effectiveness study in the sense of comparing human reader performance with and without AI assistance to quantify an "effect size" of improvement.

Instead, it evaluates the agreement between:

• Method C (Manual): Manual processing and manual reading by human readers.
• Method B (Reader Confirmation): Automated processing and automated imaging, followed by manual reading of digital images by human readers.
• Method A (HELIOS): Automated processing, automated imaging, and automated software interpretation (with required human confirmation).

The study compared the performance and agreement between these methods. It highlights that Method A (software-only interpretation) had lower agreement and sensitivity compared to human interpretation (Method B and C), underscoring the need for human confirmation. However, it does not quantify how much human readers improve when using AI as an assistance tool, but rather assesses the standalone performance of the AI component and the human element with and without automated processing.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was done:

• Method A (HELIOS): This method represents the algorithm's standalone performance, where the "HELIOS DNA Pattern Plus Software" performs positive/negative classification.
• Results: For Method A (HELIOS suggestion, excluding borderline samples) in the Between-Lab Precision Study:
  • Positive Agreement: 72.7% (69.1 - 76)% CI (across all sites)
  • Negative Agreement: 90% (84.7 - 93.6)% CI (across all sites)
  • Overall Agreement: 76.5% (73.5 - 79.3)% CI (across all sites)
    The document notes that acceptance criteria for Method A were met for negative and overall agreement, but positive agreement was sometimes below 70% for individual site comparisons, explaining that this was due to out-of-focus images that the software couldn't interpret as positive. This reinforces the requirement for human confirmation.

7. Type of Ground Truth Used (Clinical Samples)

For the 776 clinical samples used in the method comparison studies, the "ground truth" for patient diagnosis (e.g., SLE, other rheumatic diseases, autoimmune liver diseases, infections, leukemia) was established based on diagnostic standards used in the U.S. and Germany (e.g., ACR criteria). This implies a clinical diagnosis based on a combination of clinical findings and existing laboratory tests, rather than a single definitive gold standard like pathology or outcome data.

For validation within the performance studies (e.g., precision, stability), the "expected result" (positive/negative, fluorescence intensity) of specific control or serum samples was pre-defined or derived from manual readings by trained personnel, which can be considered an expert consensus type of ground truth for analytical performance.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size used for training the HELIOS DNA Pattern Plus Software (Method A). It mainly focuses on the performance evaluation of the device in various settings.

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

Since information on the training set sample size is absent, how its ground truth was established is also not specified in this document.

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QUANTA Flash® dsDNA is a chemiluminescent immunoassay for the quantitative determination of IgG anti-double stranded deoxyribonucleic acid (dsDNA) antibodies in human serum. The presence of anti-dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of Systemic Lupus Erythematosus.

QUANTA Flash® dsDNA Calibrators are intended for use with the QUANTA Flash® dsDNA chemiluminescent immunoassay for the determination of IgG anti-dsDNA antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values.

QUANTA Flash® dsDNA Controls are intended for use with the OUANTA Flash® dsDNA chemiluminescent immunoassay for quality control in the determination of IgG anti-dsDNA antibodies in human serum.

QUANTA Flash dsDNA is a chemiluminescent microparticle immunoassay for the quantitative determination of IgG anti-double stranded deoxyribonucleic acid (dsDNA) antibodies in human serum. The QUANTA Flash dsDNA assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash dsDNA assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument.

Synthetic dsDNA is coated onto paramagnetic beads, which are stored in the reagent cartridge in suspension. When the assay cartridge is ready to be used for the first time, the entire cartridge is inverted several times to thoroughly mix the reagents. The sealed reagent tubes are then pierced with the reagent cartridge lid. The reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. A patient serum sample is prediluted 1:10 by the BIO-FLASH with system rinse in a disposable plastic cuvette. Small amounts of the diluted patient serum, the beads, and assay buffer are all combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated antihuman IgG antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(III) coproporphyrin in sodium hydroxide solution) and Trigger 2 (urea-hydrogen peroxide in sodium chloride solution) are added to the cuvette, and the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which is in turn proportional to the amount of anti-dsDNA antibodies bound to the corresponding dsDNA on the beads.

For quantitation, the QUANTA Flash dsDNA assay utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use, with the QUANTA Flash dsDNA Calibrators. The Master Curve is created during manufacturing by using in-house standards that are traceable to the First International Standard Preparation for dsDNA (WHO code: Wo/80). Based on the results obtained with the two Calibrators included in the Calibrator Set (sold separately), an instrument specific Working Curve is created, which is used to calculate international units (U)/mL from the instrument signal (RLU) obtained for each sample.

The QUANTA Flash dsDNA kit contains the following materials:

One (1) QUANTA Flash dsDNA Reagent Cartridge, containing the following reagents for 50 determinations:

• dsDNA antigen coated paramagnetic beads in a suspension. a.
• b. Assay Buffer 3 – buffer containing protein stabilizers and preservatives.
• Tracer IgG 2 Isoluminol labeled anti-human IgG antibodies in buffer, containing protein C. stabilizers and preservative.

The QUANTA Flash dsDNA Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2.

• QUANTA Flash dsDNA Calibrator 1: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives.
• QUANTA Flash dsDNA Calibrator 2: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives.

The QUANTA Flash dsDNA Controls kit contains two vials of Negative Control and two vials of Positive Control.

• QUANTA Flash dsDNA Low Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers and preservatives.
• QUANTA Flash dsDNA High Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers and preservatives.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

This table summarizes key acceptance criteria and the performance of the QUANTA Flash® dsDNA device as reported in the document.

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AESKULISA®dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.

solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum.

This FDA 510(k) clearance letter for the AESKULISA dsDNA G device does not contain the detailed study information needed to fully address your request regarding acceptance criteria and device performance. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

However, based on the information provided, I can infer some points and explicitly state what is not present in this document:

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

This document does not provide a table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision). The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, and while performance data is submitted, it is not typically detailed in the clearance letter itself.

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

This document does not provide any information about the sample size used for the test set, data provenance (country of origin), or whether the study was retrospective or prospective.

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

This document does not provide information on the number or qualifications of experts used to establish ground truth for any test set.

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

This document does not provide any information about an adjudication method for a 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:

The device described, AESKULISA dsDNA G, is an "immunoassay" for the quantitative and qualitative detection of IgG antibodies. This is a laboratory diagnostic test and is not an AI-assisted diagnostic device that would involve human readers or MRMC studies. Therefore, this question is not applicable.

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

The device is a laboratory immunoassay, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable here. Its performance is inherent to the assay's biochemical reactions and detection method.

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

While not explicitly stated in this document, for an immunoassay like AESKULISA dsDNA G, the "ground truth" for the presence or absence of IgG antibodies against dsDNA would typically be established by:

• Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by established criteria (e.g., ACR or SLICC criteria), which often includes a combination of clinical findings, other serological tests, and sometimes biopsy results.
• Reference laboratory methods for dsDNA antibody testing, which might involve other established immunoassays or IFA techniques where the "positive" or "negative" status is determined by expert interpretation and standard cut-offs.

The document only states the assay "is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings." This implies the "ground truth" for SLE diagnosis is complex and multi-faceted, not solely dependent on this one test.

8. The sample size for the training set:

This document does not provide information on the sample size for a training set. As an immunoassay, the concept of a "training set" in the context of machine learning (where this term is often used) doesn't directly apply. However, during the development of an immunoassay, there would be extensive testing on various patient cohorts to establish cut-offs, demonstrate linearity, precision, and agreement with predicate devices. These cohorts would serve a similar purpose to a training set in informing the assay's parameters.

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

This document does not provide information on how any ground truth for a "training set" was established. (See explanation for point 8).

Summary of what can be extracted from the document:

• Device Name: AESKULISA dsDNA G
• Indication for Use: Quantitative and qualitative detection of IgG antibodies against dsDNA in human serum as a tool in the diagnosis of systemic lupus erythematosus (SLE), to be used in conjunction with other serological tests and clinical findings.
• Regulatory Class: Class II
• Product Code: LSW
• Regulation Name: Antinuclear antibody immunological test system (21 CFR 866.5100)
• Type of Device: Solid phase enzyme immunoassay (ELISA) using human recombinant double-stranded DNA (dsDNA).
• Clearance Type: 510(k) substantial equivalence.

To obtain the detailed study information regarding acceptance criteria, performance metrics, sample sizes, and ground truth establishment, one would typically need to consult the full 510(k) submission available from the FDA, or the device's Instructions for Use (IFU) document, which often summarizes the performance characteristics from the validation studies.

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EliA dsDNA is intended for the in vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA dsDNA Immunoassav uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.

EliA ANA Control is intended for laboratory use in monitoring the performance of in vitro measurement of antinuclear antibodies (ANA) with ImmunoCAP 100 or ImmunoCAP 250 using the EliA IgG method.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve. which mav be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test, method specific, and general reagents that are packaged as separate units.

This document describes a 510(k) submission for the EliA™ dsDNA Immunoassay and EliA™ ANA Control. The submission focuses on establishing substantial equivalence to a predicate device rather than presenting a study where a device meets specific acceptance criteria. Therefore, many of the requested categories are not applicable to this type of regulatory submission. The document primarily details the intended use, classification, and comparison to a predicate device.

Here's an analysis based on the provided text:

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

This document does not provide a table of acceptance criteria and reported device performance in the traditional sense of a clinical trial demonstrating a device meets a pre-defined performance threshold. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed through "laboratory equivalence" studies as described below.

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

The document mentions "a comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)". However, specific sample sizes for these test sets are not provided. The data provenance (country of origin, retrospective/prospective) is also not specified.

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

This information is not provided in the document. The "ground truth" here would likely refer to the clinical diagnosis of Systemic Lupus Erythematosus (SLE) for "clinically defined sera". However, details on how these diagnoses were established or by whom are absent.

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

This information is not provided as the document does not describe a process involving adjudication of expert opinions for a 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

An MRMC study is not applicable to this type of in vitro diagnostic device (immunoassay). This is an immunoassay measuring anti-dsDNA antibodies, not an imaging device requiring human interpretation, nor does it incorporate AI.

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

This is an immunoassay, and its performance is inherently "standalone" in the sense that it provides a quantitative measurement. There isn't an "algorithm only" component that would be compared to a human-in-the-loop. The device's performance is its output based on the biological sample.

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

For the "clinically defined sera," the ground truth implicitly stems from a clinical diagnosis of Systemic Lupus Erythematosus (SLE), as the device aids in this diagnosis. For "samples from apparently healthy subjects," the ground truth is their healthy status. However, the exact methodology for establishing these ground truths (e.g., expert consensus based on specific clinical criteria, detailed clinical outcomes) is not explicitly described.

8. The sample size for the training set

This document describes a medical device, not a machine learning model that requires a distinct "training set." Therefore, a separate training set in the AI/ML context is not applicable. The "calibration" of the device is mentioned, which involves a set of six WHO-standardized IgG Calibrators.

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

As there is no "training set" in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's calibration involves "WHO-standardized IgG Calibrators derived from human serum," implying these calibrators have established, known concentrations of IgG.

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The FIDIS™ dsDNA kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against double stranded DNA (dsDNA).

Clincal unlity:

The test system is used on serum samples as an aid in the diagnostic of systemic lupus erythematosus (SLE), in conjunction with clinical findings and other laboratory tests.

The FIDIS™ dsDNA kit is to be used on FIDIS™ Analyser, software and washer.

The assay kits consist of

• a vial of color-coded microspheres coupled with dsDNA
• a ready to use anti-human IgG coupled to phycoerythrin.
• a ready to use calibrator littered for the specificity.
• a positive control lgG 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 invmunodiagnostic lesting

FIDIS™ System comprised of FIDIS flow cylometer. XYP platform for automatic sampling into the analyzer the analyzer itself, a SD pump, some assay products and a software MLX-BOOSTER

The IIIDIS™ dsDNA kit resembles traditional EIA and allows the detection and identification of antibodies against dsDNA

• i . Diluted patient sera and microsphere suspension are thoroughly mixed in the 96 well microtiter plate. dsDNA specific antibodies in the patient sera, if present, bind to the immobilised untigen on the beads. Any unbound material is removed by performing a wash step.

• 2. Phycoerythrin-conjugated goal anti-human IgG is added to the plate and a further antibedies, immentiliand antibodies immobilised on the microsphere surface to form an antigen/antibody complex
• 3. The bead suspension is then analysed by the FIDISTM Instrument and reactions are directly calculated in biological units using specific data software (MLX-BOOSTER)
     The FIDIS™ Instrument is able to distinct the specific code-colored of the microsphere and it could associated the microsphere type with the individual tested antigen. The FIDIS™ Instrument could quantify the finorescente of the antibody captured by
     each microsphere. Measurent of the finorescence of the antibody captured by
     allows the overl allows the quantification of the presence or absence of autoantibudies m

It's a simple (just two steps) and quick (2 x 30 minutes for the two incubations).

The provided document is a 510(k) summary for the FIDIS™ dsDNA kit, a semi-quantitative immunoassay for detecting antibodies directed against double-stranded DNA, used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). This summary focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a novel device. Therefore, much of the requested information, particularly regarding specific numerical acceptance criteria, detailed study results against those criteria, and information about expert consensus, is not explicitly present in the document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a traditional sense. Instead, it relies on demonstrating substantial equivalence to a predicate device (Varelisa dsDNA antibodies by Sweden Diagnostics, GMH). The "performance" is reported in terms of comparability with this predicate device.

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

• Test Set Sample Size: The document mentions "results obtained within a comparison study analysing positive, equivocal and negative sera," and "results obtained for samples from apparently healthy subject (normal population)," and "samples with potential hiological cross reactivity." However, the exact number of samples used in these studies is not specified.
• Data Provenance: Not explicitly stated. The document indicates the device manufacturer (Biomedical Diagnostics S.A.) is located in France, suggesting the studies could have been conducted there or in other European countries. It is not specified if the data is retrospective or prospective.

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

This information is not provided in the document. The method for establishing "ground truth" (e.g., expert diagnosis, clinical outcomes) is also not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC comparative effectiveness study is not mentioned in the document. The focus is on the device's performance as an immunoassay, not on human reader improvement with or without AI assistance.

6. Standalone Performance Study

The FIDIS™ dsDNA kit itself is the "algorithm" in this context (an immunoassay performed by an automated system). The comparability study described is essentially a standalone performance assessment against a predicate.

• "results obtained within a comparison study analysing positive, equivocal and negative scra ."
• "results obtained for samples from apparently healthy subject (normal population)"
• "results obtained for samples from samples with potential hiological cross reactivity"
  While not using the term "standalone study," the various testing methods described are designed to evaluate the device's performance characteristics on its own.

7. Type of Ground Truth Used

The document describes the device as a "detection test of autoantibodies directed against double stranded DNA (dsDNA)" that "can be used to aid in the diagnosis of SLE." This implies that the 'ground truth' for evaluating the test performance would likely be based on:

• Clinical diagnosis of SLE: Established by clinical findings and other laboratory tests, against which the presence/absence of dsDNA antibodies would be evaluated.
• Predicate device results: As the primary comparison is with the "Varelisa dsDNA antibodies" predicate, the results from this established test would serve as a comparative standard.
  The exact methodology for establishing the ground truth is not explicitly detailed (e.g., whether it relied on specific clinical criteria for SLE diagnosis, or primarily on concordance with the predicate).

8. Sample Size for the Training Set

This information is not provided. As a diagnostic kit, the concept of a "training set" in the context of machine learning algorithms may not directly apply. If assay parameters were optimized, the details of that process (including sample sizes) are not given.

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

This information is not provided.

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AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum.

The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum.

The provided text is a 510(k) clearance letter from the FDA for a diagnostic device, AESKULISA dsDNA G. It does not contain information about specific acceptance criteria for performance, details of a study proving the device meets those criteria, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a study report.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory framework. It specifies the product's intended use as a tool for diagnosing systemic lupus erythematosus (SLE) by detecting IgG antibodies against dsDNA.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the other questions based on the provided text. The requested information about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this regulatory document.

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