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AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.

This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

AESKUSLIDES ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.

This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in coniunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

Slides coated with human neutrophil granulocytes for autoantibody detection are fixated by two different methods: ethanol (EtOH) fixation or formalin fixation. Ethanol fixation allows cell components to move through the cells after the fixation process. Formalin fixation causes cellular components to cross-link (a movement of cellular components is abrogated and the patterns are distinct). By processing serum on both Ethanol and Formalin-fixed slides, the user can confirm if the pattern is C-, P-, or A-ANCA, according to the table below.

This document outlines the acceptance criteria and supporting studies for the AESKUSLIDES® ANCA Ethanol and AESKUSLIDES® ANCA Formalin devices, which are indirect immunofluorescence assays for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance studies with corresponding acceptance criteria and results. Below is a summary of these:

Note on Borderline Samples: Several studies (e.g., Within-Lab Precision, Between-Lab Precision, Accelerated Stability, In Use Stability) explicitly mention the handling of "borderline" samples (very low positive samples that can be evaluated as negative). For certain calculations, results are presented both including and excluding these samples, with justification for lower agreement when included. This indicates a robust statistical approach for handling results near the decision threshold.

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

Total Clinical Samples: 630 clinical samples were used for the Clinical Evaluation and Method Comparison studies.

Provenance:

• 510 clinical samples were sourced from 10 BioBanks in the US (BioChain, BioReclamationIVT, Bioserve, ConversantBio, Cureline, DiscoveryLifeSciences, iSpecimen, Precision for Medicine, ProMedDx, and Vitrologic). These samples were selected based on diagnosis to reflect important conditions for the study.
• 120 serum samples were sourced from a German University Hospital to complement rare but important diagnoses (70 Wegener's Granulomatosis, 25 MPA, 25 Churg-Strauss Syndrome).
• Retrospective/Prospective: The document does not explicitly state whether the studies were retrospective or prospective. However, the nature of acquiring samples from biobanks and the use of de-identified diagnoses strongly suggests a retrospective data collection approach for the main clinical sample set.
• Healthy Donor Samples: An additional panel of 150 sera from healthy donors was used for the Expected Values/Reference Range study: 100 from Germany and 50 from the US.

The document states that the diagnosis criteria of the samples were in agreement with diagnostic standards used in the U.S and Germany (e.g., ACR criteria), and that the US sample set was selected to contain different ethnic groups to reflect the US population. All samples were checked for purity, volume, and contaminations and deemed suitable for the study.

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

The ground truth for the clinical sample set was established based on the "diagnosis criteria of the different samples [that] have been made in agreement with diagnostic standards used in the U.S and Germany." A written statement from different serum suppliers is available on request. This implies that the initial diagnosis (ground truth) was established by medical professionals (e.g., clinicians) at the originating institutions (biobanks, university hospital) based on clinical and laboratory findings, prior to their inclusion in this study. The document does not specify the number or specific qualifications of these initial diagnosing experts.

For the subsequent "reading" or "evaluation" of slides within the various performance studies (e.g., Within-Lab, Between-Lab, Method Comparison, Stability studies), two independent readers/experts were consistently used. The qualifications of these readers are generally referred to as "trained personnel" or "trained operator." For instance, the intended use statement explicitly says "All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel." and "The device is for use by a trained operator in a clinical laboratory setting." Specific details on years of experience or board certification (e.g., "radiologist with 10 years of experience") are not provided for these internal study readers.

4. Adjudication Method for the Test Set

For the "reading" or "evaluation" of slides in the various performance studies:

• The studies consistently involved two independent readers.
• The results of these two readers were often calculated and presented separately as well as combined.
• There is no explicit mention of an "adjudication" process (e.g., a 2+1 or 3+1 method) where a third, senior expert would resolve discrepancies between the two initial readers to establish a final ground truth for the study. Instead, the analysis focuses on the agreement between the readers and their agreement with either the expected reference values (for analytical studies) or comparison methods (for clinical studies). The concept of "User Confirmation" (Method B) implies that human oversight is always required for the automated results, but not necessarily a formal adjudication of discordant human reads.

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

Yes, a multi-reader, multi-case (MRMC) comparative effectiveness study was done. This is evident in the "Method Comparison of Method A, B, and C and clinical study" section (pages 85-96). This study compared:

• Method C (Manual): Manual processing and manual reading by two independent readers.
• Method B (Reader Confirmation): Automated processing/imaging by HELIOS, with manual reading of digital images by two independent readers.
• Method A (HELIOS): Automated processing/imaging by HELIOS, with automated positive/negative classification by the HELIOS Vasculitis Pattern Plus software.

The study was conducted at three different study sites (two US, one German) using the entire 630-sample set, with two independent readers at each site for manual and reader confirmation methods.

Effect Size (AI vs. Human-in-the-Loop):
The document does not present the effect size in terms of how much human readers improve with AI vs. without AI assistance. Instead, it compares the performance (agreements and diagnostic sensitivities/specificities) between:

1. Human reading of traditionally processed slides (Method C).
2. Human reading of AI-processed images (Method B).
3. AI-only classification (Method A).

The statement that "All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel" (intended use) and the acceptance criteria for Method A (lower agreement accepted for automated-only results, e.g., >70% compared to >90% for human reads) consistently emphasize that the AI is an aid that requires human confirmation. The data implicitly supports that humans (Methods B and C) perform better than the standalone AI (Method A) in certain aspects (higher agreement percentages, higher diagnostic performance metrics for Human vs HELIOS in Formalin especially). For example, in ANCA Formalin, Method C vs A pattern agreement was only 69.7% while C vs B was 82.1-87.5%, highlighting the current limitations of standalone AI pattern recognition and the value of human reading (even with automated imaging).

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

Yes, standalone performance of the algorithm (HELIOS Vasculitis Pattern Plus software, referred to as Method A) was evaluated.

• Method A processed slides automatically, acquired images, and performed automated reading/interpretation.
• Its performance was compared against manual reading (Method C) and human reading of automated images (Method B) in the "Method Comparison of Method A, B, and C" study.
• As noted in point 5, the acceptance criteria for Method A were lower (e.g., ≥ 70% agreement) compared to the human-in-the-loop methods (≥ 90%). The results show that Method A generally achieved these lower thresholds but performed less ideally for pattern recognition.

7. The Type of Ground Truth Used

The ground truth used several types throughout the studies:

• Clinical Diagnosis (Outcomes Data / Expert Consensus): For the diagnostic sensitivity and specificity calculations (Method comparison against predicate, and Method A, B, C comparison), the ground truth for patient samples was their established "diagnosis" (e.g., ANCA-associated vasculitis (AAV), other diseases like SLE, RA, etc.). This diagnosis was made in agreement with US and German diagnostic standards (e.g., ACR criteria), implying a form of expert consensus based on clinical and laboratory findings.
• Expected Results/Reference Values (Expert Consensus): For analytical performance studies (e.g., Precision, Stability, Carry Over, Time Extension, Interfering Substances), ground truth was often defined as "expected results" or "expected values" for specific samples (e.g., positive/negative status, specific pattern, fluorescence intensity). These expected values were likely established by experienced operators / experts during the initial characterization of the control and study samples. The repeated use of "correctly found" implies agreement with a pre-established reference.
• Negative Healthy Donor Panel: For the "Expected Values/Reference Range" study, healthy donor samples confirmed to be negative for ANCA were used to establish a reference range, implicitly serving as a negative ground truth.

There is no mention of pathology or direct biopsy results as ground truth, which is typical for diagnoses like vasculitis given the nature of ANCA testing.

8. The Sample Size for the Training Set

The document does not provide a specific sample size for the "training set" of the HELIOS AUTOMATED IFA SYSTEM. The provided information focuses on the validation of the device, particularly the performance evaluation of the final device using various test sets. The software's pattern recognition uses "SVM (Support Vector Machine) technology," which implies a machine learning approach. However, details on the dataset used to train this SVM model are not disclosed in this document.

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

Similarly, since the training set details are not provided, the method for establishing its ground truth is also not explicitly described. For machine learning models like SVMs used in pattern recognition, the training data would typically be images with associated labels (ground truth) that are a result of expert annotation or consensus. Given the context of manual reading by "trained personnel" and the need for "confirmation by trained personnel," it is highly probable that the ground truth for any training set would have been established by multiple expert pathologists or laboratory professionals specializing in indirect immunofluorescence interpretation, likely through a consensus or adjudication process. However, this is an inference based on industry practice and the provided context, not a direct statement in the document.

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AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunassay employs synthetic, deemicated gliadin-derived pertides for the combined seniqualitative detation of 194 and 195 and 195 and 195 and its deamical desirical d Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diac disease (gluter-sensitive enteropatiy) and should be used in conjunction with ather serological tests and clinical findings.

AESKULISA DGP-G is an in-vitro diagnostic device This salid phase enzyme immuncessay employs synthetic, deamicated gliadin-derived peptides for the semiquantitative and qualitative detection of IgG antibodies against deamidded Gliadin-specific peptides (DGP) in human serum. The assy is an aid in the diegnosis of celies disease (gluter-sensitive enteropedly) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA DGP-A is an in-vitro diagnostic device. This solid phase enzyme immunossay employs synthetic, deamidated gliadin-derived peptides for the semiqualitative and qualitative detection of 1gA antibodies against deaminded Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of cellac disease (gluter-sensitive enteropathy) and should be used in corjunction with other serological tests and clinical findings.

Not Found

I am sorry, but the provided document does not contain the detailed study information required to fill out the table and answer your questions. The text includes an FDA 510(k) clearance letter for the AESKULISA DGP-A, AESKULISA DGP-G, and AESKULISA DGP-Check devices, which are in-vitro diagnostic devices for celiac disease.

While it states the indications for use and classification, it does not provide:

• Details of any specific study (e.g., design, methodology, results) that proves the device meets acceptance criteria.
• Acceptance criteria themselves, or reported device performance metrics like sensitivity, specificity, accuracy, etc.
• Information on sample sizes for test or training sets, data provenance, ground truth establishment, expert involvement, or any multi-reader multi-case studies.

Therefore, I cannot fulfill your request based on the given information.

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AESKULISA PR3 is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the semiquantitative and qualitative detection of antibodies against proteinase 3 in human serum.

The assay is an aid in the diagnosis of Wegener's granulomatosis and should be used in conjunction with other serological tests and clinical findings.

solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes

This document is a 510(k) clearance letter for the AESKULISA PR3 device, an in-vitro diagnostic (IVD) test. As such, it does not contain the detailed study information typically found in a clinical study report for other types of medical devices, especially those involving AI or imaging.

Here's an analysis based on the provided text, highlighting why most of your requested points cannot be directly answered:

The document confirms that the AESKULISA PR3 is a solid phase enzyme immunoassay for detecting antibodies against proteinase 3 in human serum, intended as an aid in diagnosing Wegener's granulomatosis. The clearance is based on substantial equivalence to predicate devices. This type of clearance generally relies on demonstrating that the new device performs comparably to a legally marketed predicate device, rather than requiring extensive de novo clinical studies to establish diagnostic performance against a ground truth in a clinical setting.

Therefore, many of the specific questions about acceptance criteria, study design, expert involvement, and AI performance are not applicable to this type of regulatory document for an IVD kit cleared via the 510(k) pathway.

However, based on the nature of IVD devices evaluated for substantial equivalence, we can infer some aspects and explicitly state where information is missing.

Overview of Device and Clearance Type:

• Device Name: AESKULISA PR3
• Device Type: In Vitro Diagnostic (IVD) - Solid phase enzyme immunoassay
• Indications For Use: Semiquantitative and qualitative detection of antibodies against proteinase 3 in human serum, as an aid in the diagnosis of Wegener's granulomatosis (to be used with other serological tests and clinical findings).
• Regulatory Pathway: 510(k) Premarket Notification, cleared based on Substantial Equivalence. This means the device's performance was compared to an existing, legally marketed predicate device, not necessarily proven against a gold standard in a large-scale clinical trial as if it were a novel therapeutic or diagnostic imaging AI.

Analysis of Requested Information:

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

   • Acceptance Criteria: Not explicitly stated in this clearance letter. For IVDs, acceptance criteria for substantial equivalence typically involve demonstrating comparable analytical performance (e.g., sensitivity, specificity, precision, accuracy, linearity, interfering substances) to a predicate device.
   • Reported Device Performance: Not detailed in this clearance letter. The FDA's decision of substantial equivalence implies that the manufacturer submitted data demonstrating comparable performance to their chosen predicate device. This data would usually be found in the 510(k) submission itself, not the clearance letter.

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

   • Sample Size (Test Set): Not specified in the clearance letter. For IVD submissions, test sets are typically patient samples used to evaluate analytical and clinical performance against the predicate.
   • Data Provenance: Not specified in the clearance letter. For IVDs, samples might come from various sources (e.g., commercial banks, clinical laboratories, prospective collections), often representing the intended use population.

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):

   • Not Applicable in this context. For an IVD, "ground truth" (or clinical truth) is typically established by a combination of clinical diagnosis, other laboratory tests, and/or reference methods, not by a panel of expert human readers evaluating the device's output. The device itself is a diagnostic test, providing a result (antibody detection) that contributes to the overall clinical diagnosis.

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

   • Not Applicable. Adjudication methods like '2+1' or '3+1' are typical for studies where human readers interpret medical images or complex clinical data and their interpretations need to be reconciled to form a ground truth or a consensus reading. This process is not relevant for an automated immunoassay kit.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This is an IVD kit, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.

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

   • Yes, in essence. The AESKULISA PR3 device itself is a "standalone" laboratory test in that it performs the assay and produces a result (qualitative or semiquantitative antibody level) based on the sample. There is no "human-in-the-loop" performance of the algorithm itself, as it's a chemical immunoassay, not an AI algorithm. Human involvement would be in running the test, interpreting the results for clinical context, and making a diagnosis.

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

   • Inferable, but not explicitly stated. For IVDs diagnosing conditions like Wegener's granulomatosis, the "ground truth" for clinical performance evaluation would generally be a well-established clinical diagnosis (often based on a combination of clinical symptoms, other laboratory tests, imaging, and sometimes biopsy/pathology). The device's results are then compared against this clinical diagnosis to determine its sensitivity and specificity in diagnosing the condition.

8. The sample size for the training set:

   • Not Applicable/Not Specified. For an immunoassay, there isn't a "training set" in the machine learning sense. The assay is developed and optimized during its R&D phase, often using characterized samples, but this is different from an AI model's training set.

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

   • Not Applicable/Not Specified. As above, the concept of a "training set" with established ground truth is not relevant for this type of IVD device.

Summary of What's Available vs. What's Not:

• Available: Device name, regulatory class, product code, indications for use, regulatory pathway (510(k) substantial equivalence).
• Not Available (and largely not applicable for this device type/clearance letter): Detailed acceptance criteria, specific performance metrics, sample sizes, data provenance details, expert qualifications, adjudication methods, MRMC studies, specific ground truth methodologies, or training set information. These details would be contained within the original 510(k) submission, which is not provided here.

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AESKULISA MPO is a solid phase enzyme immunoassay employing purified native myeloperoxidase (MPO) from human peripheral blood polymorphonuclear cells for the semiquantitative and qualitative detection of antibodies against MPO in human serum.

The assay is an aid in the diagnosis of autoimmune systemic vasculitis such as microscopic polyangiitis, and glomerulonephritis and should be used in conjunction with other laboratory and clinical findings.

AESKULISA MPO is a solid phase enzyme immunoassay.

The provided text is a letter from the FDA regarding the 510(k) premarket notification for the AESKULISA MPO device. While it states that the device is substantially equivalent to legally marketed predicate devices and mentions its intended use, it does not contain the detailed study results, acceptance criteria, or other specific information requested in the prompt for proving the device meets acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily focuses on the regulatory approval process and the "Indications for Use" for the AESKULISA MPO device. It does not include the technical details of the performance study that would be necessary to address your specific questions about acceptance criteria and study data.

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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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AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT).

The assay is a tool in the diagnosis of certain systemic theumatic diseases and should be used in conjunction with other serological tests and clinical findings.

AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic antigens.

I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request regarding the acceptance criteria and the study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "AESKULISA ANA-HEp2," and while it states the device has been found substantially equivalent to a predicate device, it does not include the specific study details you are asking for.

Here's a breakdown of what I can and cannot provide based on the given text:

Information I CAN extract:

• Device Name: AESKULISA ANA-Hep2
• Indication for Use: A solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. It collectively detects total ANAs against dsDNA, histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1, and centromeric antigens, along with sera positive for HEp2 immunofluorescence test (IFT). It's a tool in the diagnosis of certain systemic rheumatic diseases and should be used with other serological tests and clinical findings.
• Regulatory Information: Class II device, Product Code LKJ.

Information NOT present in the provided text:

• A table of acceptance criteria and the reported device performance: This document does not detail specific acceptance criteria or the performance metrics (e.g., sensitivity, specificity, accuracy) from the study.
• Sample sizes used for the test set and data provenance: The document does not mention the sample size of any test set or the origin of the data.
• Number of experts used to establish the ground truth for the test set and their qualifications: There is no mention of experts or ground truth establishment.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Effect size of human readers improving with AI vs. without AI assistance: Not applicable as this is not an AI-assisted device based on the description.
• Standalone (algorithm only) performance: Not applicable as this is an immunoassay, not an algorithm.
• Type of ground truth used: Not specified.
• Sample size for the training set: There is no mention of a training set as this is an immunoassay, not a machine learning model.
• How the ground truth for the training set was established: Not applicable.

Therefore, I cannot fulfill your request for the specific study details as they are not contained within the provided FDA 510(k) clearance letter. This type of information would typically be found in the 510(k) submission summary or the actual study report, neither of which is present here.

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The AESKULISA Glia-A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of IgA antibodies against Gliadin in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjuction with other serological tests and clinical findings.

The AESKULISA Glia-G is a solid phase enzyme immunoassay for the semiquantitative and qualitative detection of IgG antibodies against Gliadin in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjuction with other serological tests and clinical findings.

solid phase enzyme immunoassay

The provided text appears to be an FDA 510(k) clearance letter for the AESKULISA® Glia A and AESKULISA® Glia G devices, which are solid phase enzyme immunoassays for detecting IgA and IgG antibodies against Gliadin.

Unfortunately, the provided document does not contain the acceptance criteria or the study details that prove the device meets these criteria.

FDA 510(k) clearance letters primarily focus on confirming the device's substantial equivalence to a legally marketed predicate device. They typically do not include the detailed performance data, acceptance criteria, or study methodologies that were submitted by the manufacturer to support their claims.

Therefore, I cannot provide the requested information based on the document provided. To answer your questions, I would need access to the actual 510(k) submission, specifically the sections detailing the analytical and clinical performance studies, including:

• Acceptance Criteria: What performance metrics (e.g., sensitivity, specificity, accuracy, precision) were targeted as acceptable for the device.
• Reported Device Performance: The results of the studies showing how the device actually performed against these criteria.
• Study Design: Details on sample size, data provenance, ground truth establishment, expert qualifications, and adjudication methods.
• MRMC or Standalone Studies: Information on the type of performance evaluation conducted.

Without this specific information from the actual submission, I cannot complete the table or answer the detailed questions about the study design.

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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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AESKULISA ENA 6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and purified native human snRNP/Sm, Sm and SS-A 60 kDa.

The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.

solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and purified native human snRNP/Sm, Sm and SS-A 60 kDa.

This document, a 510(k) premarket notification, does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria in the format requested.

The provided text is an FDA clearance letter for a device named "AESKULISA ENA6 S". It confirms that the device is substantially equivalent to legally marketed predicate devices. While it mentions the "Indications For Use" for the device, it does not include the specific study design, performance metrics, or acceptance criteria that would typically be found in a detailed study report or clinical trial summary.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, you would need to refer to the full 510(k) submission document or related study reports, which are not included here.

Here's a breakdown of why each point cannot be addressed with the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The letter only states the device is "substantially equivalent."
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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 device is an in-vitro diagnostic immunoassay, not an AI-based imaging device with human readers. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As above, this is an immunoassay, not an algorithm, so this concept is not applicable.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned. Immunoassays typically don't have "training sets" in the AI sense; instead, they have validation studies.
9. How the ground truth for the training set was established: Not mentioned, and as above, the concept of a "training set" with ground truth in this context is generally not applicable.

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