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This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum. This test system is to be used as an aid in the diagnosis of systemic lupus erythematosus.

This is an indirect fluorescent antibody test for screening and semiquantitative detection of IgG anti-nDNA antibody in human serum.

Immuno Concepts IgG Anti-nDNA Fluorescent Test System - Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The study compares the Immuno Concepts IgG Anti-nDNA Fluorescent Test System to a legally marketed predicate device, "Crithidia lucilliae DS DNA Kit (Diagnostic Use)" (K930987). The acceptance criteria are implicitly derived from the reported statistics based on this comparison.

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

• Sample Size: 223 samples
  • 121 samples submitted to clinical laboratories for anti-nDNA testing.
  • 100 blood donors.
  • 2 WHO standards known to contain anti-nDNA antibodies.
• Data Provenance: Not explicitly stated, but based on the context of samples submitted to clinical laboratories and blood donors, it is likely retrospective clinical samples. The country of origin is not specified.

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

• Number of Experts: Not applicable. The ground truth for comparative effectiveness was established by the predicate device's results, not by independent experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study is a direct comparison to a predicate device, where the predicate device's results serve as the reference. There is no mention of an adjudication process by human readers for the primary comparison.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described. This study directly compared the performance of the new device to a predicate device, rather than assessing human reader performance with and without AI assistance.

6. Standalone Performance Study

• Standalone Performance: Yes, a standalone performance study was done in the sense that the device's diagnostic performance metrics (sensitivity, specificity, etc.) were calculated based on its output compared to a reference standard (the predicate device). The algorithm's output was directly compared to the predicate's output for all 223 samples.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used for the primary comparative effectiveness study was the results obtained from the legally marketed predicate device ("Crithidia lucilliae DS DNA Kit (Diagnostic Use)"). Additionally, two WHO standards known to contain anti-nDNA antibodies were used as positive controls, and samples submitted to clinical laboratories and blood donors provided a range of reactivity.

8. Sample Size for the Training Set

• Sample Size for Training: Not applicable. This device is an indirect fluorescent antibody test kit, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The device's performance is inherently based on its physical and chemical components and their interaction, which are generally developed through R&D and quality control, rather than machine learning training.

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

• Ground Truth for Training Set: Not applicable, as explained in point 8. The "training" for this type of test involves developing and optimizing the reagents and assay procedure, ensuring consistency and reliability through standard laboratory practices and quality control, not by processing a "training set" with established ground truth labels for an algorithm.

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This is an enzyme immunoassay test system for the detection of antibodies to Proteinase 3 (PR3) in human serum. This test system is to be used as an aid in the detection of antibodies associated with Wegener's granulomatosis and other vasculitides.

This is an enzyme immunoassay for the detection of antibodies to Proteinase 3 (PR3) in human serum.

The Immuno Concepts RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3 was evaluated for substantial equivalence to the Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit. The study involved a comparison of both devices using a diverse set of human serum samples.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria values for relative sensitivity, specificity, and overall agreement. However, the study aims to demonstrate substantial equivalence to the predicate device. The reported performance metrics based on the comparison serve as the de facto demonstration of equivalence.

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

• Test Set Sample Size: 756 samples (206 samples submitted for ANCA, MPO, PR3 testing, 7 Churg-Strauss syndrome, 18 vasculitis, 25 Wegener's granulomatosis, 261 male blood donors, 239 female blood donors).
• Data Provenance: The origin of the samples (e.g., country) is not explicitly stated. The samples were from patients with specific diagnoses, those submitted for ANCA testing, and blood donors, indicating a mix of clinical and presumably healthy populations. The data appears to be retrospective, collected from existing clinical and donor samples.

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

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. The comparison is made against a legally marketed predicate device, implying the predicate device's results are used as the reference, rather than independent expert adjudication.

However, for the 8 "false positive" samples identified by the new device, additional immunofluorescence patterns (P-ANCA, C-ANCA) were noted, and patient diagnoses (Wegener's granulomatosis, Churg-Strauss syndrome) were considered. This suggests some level of clinical context or expert review for specific discordant cases, but a formal "ground truth establishment" process by experts is not detailed.

4. Adjudication Method for the Test Set:

No formal adjudication method (e.g., 2+1, 3+1) for the test set is described. The study primarily compares the performance of the new device against the predicate device. For discordant results, especially "false positives" of the new device, immunofluorescence patterns and patient diagnoses were used to provide further context, suggesting a form of retrospective review rather than pre-defined adjudication.

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

No MRMC comparative effectiveness study was performed or described. This study focuses on the performance of an in vitro diagnostic test system, not on human readers' interpretive skills with or without AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was conducted. The Immuno Concepts RELISA® PR3-ANCA Test System was tested independently on the 756 samples, and its results were then compared to those of the predicate device. The performance metrics (relative sensitivity, specificity, overall agreement) reflect the standalone performance of the new device in relation to the predicate.

7. Type of Ground Truth Used:

The "ground truth" for this study is established by the results of the predicate device, the Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit. In cases of disagreement, additional clinical information such as immunofluorescence patterns and patient diagnoses were considered to analyze potential "false" results, implying a form of expert or clinical consensus interpretation for discordant cases.

8. Sample Size for the Training Set:

The document describes a comparison study against a predicate device and does not mention a separate training set. This suggests that the device being studied (Immunoconcepts RELISA PR3-ANCA) was likely developed using its own internal development/training data, which is not disclosed in this 510(k) submission. The samples described in the study are explicitly designated for the comparison or test phase.

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

As no training set is discussed in this document, the method for establishing its ground truth is not provided.

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This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides.

This is an enzyme immunoassay for the detection of antibodies to myeloperoxidase (MPO) in human serum.

Here's an analysis of the provided information regarding the Immuno Concepts RELISA® MPO-ANCA Test System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the FDA's "substantial equivalence" determination, meaning the new device's performance should be comparable to the legally marketed predicate device. While explicit numerical acceptance criteria aren't listed, the study demonstrates performance relative to the predicate device.

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

• Sample Size: A total of 818 samples were used for the test set. Breakdown:
  • 208 samples submitted to clinical laboratories for ANCA, MPO, and PR3 testing (without specific diagnoses).
  • 7 samples from patients with a diagnosis of Churg-Strauss syndrome.
  • 18 patients with a diagnosis of vasculitis.
  • 25 patients with a diagnosis of Wegener's granulomatosis.
  • 261 samples from male blood donors.
  • 239 samples from female blood donors.
• Data Provenance: The document does not explicitly state the country of origin for all samples. However, the predicate device is manufactured in Birmingham, England, UK. The source of the 208 clinical samples is general ("clinical laboratories"), suggesting a broader geographic origin, potentially US. The studies are retrospective, as the samples were "submitted to clinical laboratories" or from patients with existing diagnoses, and then tested in parallel.

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

The concept of "ground truth" as typically established by expert consensus (e.g., radiologists interpreting images) isn't directly applicable here in the same way. For this immunoassay, the "ground truth" for the test set is established by the performance of the predicate device, the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit. The predicate device itself has been legally marketed and its performance implicitly accepted.

The document indicates that for the "false positive" samples identified by the new device, further investigation involved immunofluorescence (P-ANCA pattern). This suggests a second-level diagnostic assessment, but it's not described as an "expert panel" establishing the initial ground truth for the entire sample set.

Therefore, the number and qualifications of experts for establishing ground truth for the entire test set are not explicitly stated as it relies on the predicate device's results.

4. Adjudication Method for the Test Set

The primary "adjudication method" for the test set is direct comparison to the predicate device. Both the Immuno Concepts RELISA® MPO-ANCA Test System and the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit were run in parallel on all 818 samples. Discrepancies were then noted.

For the 38 "false positive" samples (where the new device was positive and the predicate was negative), additional immunofluorescence testing was performed. However, this was for analysis of discrepancies rather than a primary adjudication method for establishing the initial ground truth.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers interpreting cases and comparing their performance with and without AI assistance. The described study is a direct comparison of a new immunoassay device (Immuno Concepts RELISA® MPO-ANCA) against a legally marketed predicate immunoassay device (Bindazyme™ Anti-MPO Enzyme Immunoassay Kit). It does not involve human readers interpreting "cases" in the typical sense of imaging or clinical diagnostics.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The Immuno Concepts RELISA® MPO-ANCA Test System was run independently on all samples, and its results were then compared to the results of the predicate device, which also ran independently. There was no human interpretation or interaction with the device's output influencing the reported performance metrics (sensitivity, specificity, agreement). The device's output for each sample was a positive or negative result.

7. Type of Ground Truth Used

The primary "ground truth" used for this study is the results obtained from the legally marketed predicate device (Bindazyme™ Anti-MPO Enzyme Immunoassay Kit). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices where a new device is compared against an established, validated method. For discrepant results, some additional immunofluorescence testing was used as a secondary method of investigation.

8. Sample Size for the Training Set

The document does not provide information on a training set. This type of 510(k) submission focuses on the performance of a final, manufactured device. If the Immuno Concepts RELISA® MPO-ANCA Test System involved machine learning or an "algorithm" in a development phase, details of its training set would typically be described during its initial development, not necessarily in this specific regulatory submission which focuses on the final product's comparison to a predicate. It's likely that this immunoassay kit does not involve a machine learning algorithm in the sense of needing a "training set" for model development; rather, it's a biochemical assay for which performance characteristics are established via testing.

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

As no training set is described (see point 8), this information is not applicable or provided in the document.

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This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

This is an enzyme immunoassay for the detection of antinuclear antibodies in human serum.

This document describes the RELISA® ANA Screening Test System, an enzyme immunoassay for the detection of antinuclear antibodies in human serum, intended as an aid in detecting antibodies associated with systemic rheumatic disease.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion appears to be "overall agreement" with a reference method. The initial comparison to the predicate device set the stage, but a "referee method" (Immuno Concepts HEp-2000® ANA-Ro Test System using indirect fluorescent antibody technique) was ultimately used to clarify "false positive" and "false negative" results.

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

• Sample Size:
  • Initial Comparison (with Predicate device): 214 (Positive) + 46 (Predicate Negative/Test Positive) + 12 (Predicate Positive/Test Borderline) + 105 (Predicate Negative/Test Borderline) + 8 (Predicate Positive/Test Negative) + 787 (Negative) = 1172 samples.
  • Revised Comparison (with Referee Method): The number of samples re-evaluated for the "referee method" was 79 "false positive" (from the initial comparison) and 4 "false negative" samples. The table provided for the revised comparison then summarizes the results for the entire cohort of 1172 samples based on the referee method's classification for the previously discrepant cases.
• Data Provenance: Not explicitly stated, but given context of the submission, it is assumed to be retrospective clinical samples. No country of origin is mentioned.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The ground truth for the referee method involved use of the "indirect fluorescent antibody technique" and observation of "clearly discernible ANA patterns." This strongly implies interpretation by trained laboratory professionals, likely medical technologists or clinical immunologists with expertise in ANA testing. Specific qualifications (e.g., years of experience, board certification) are not provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: The document describes a specific process for adjudication of discrepant results: "The large number of 'false positive' samples seen with the Immuno Concepts test was troubling, so we tested all of these sera for antinuclear antibodies using Immuno Concepts HEp-2000® ANA-Ro Test System (K944096 & K972145)." This indicates a targeted re-evaluation of initially discrepant samples using a more definitive "referee method" (indirect fluorescent antibody technique), where the results of this referee method were then considered the "true" classification. This is a form of discrepancy resolution with a gold standard.

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

• There is no indication of an MRMC comparative effectiveness study being performed. The study focuses on comparing the new device against a predicate device and a "referee method," not on human reader performance with or without AI assistance.

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

• Yes, a standalone performance study was conducted. The RELISA® ANA Screening Test System is an enzyme immunoassay, and its performance was evaluated directly against other laboratory tests (the predicate device and the indirect fluorescent antibody technique) without explicit human intervention in the interpretation of the RELISA results for the purpose of the study. The results are from the device itself.

7. The Type of Ground Truth Used:

• The initial comparison used the predicate device's results as a reference.
• The refined comparison, which led to the final performance metrics, used the indirect fluorescent antibody technique (IFA) performed with the Immuno Concepts HEp-2000® ANA-Ro Test System as the "referee method" or gold standard for establishing ground truth, especially for discrepant samples. IFA is generally considered a highly sensitive and specific method for ANA detection and pattern recognition, often serving as a reference method in clinical immunology.

8. The Sample Size for the Training Set:

• The document does not explicitly mention a separate training set or its sample size. This type of submission for an in vitro diagnostic (IVD) device typically focuses on clinical validation (test set) for regulatory approval rather than machine learning model training.

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

• As no training set is explicitly described, there is no information provided on how its ground truth might have been established.

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This is an indirect immunoenzyme antibody test for the semi-quantitative detection of antinuclear antibodies in human serum, with specific identification of autoantibodies to the SS-A/Ro antigen. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases.

This is an indirect immunoenzyme antibody test for the semi-quantitative detection of antinuclear antibody in human serum. The transfected HEP-2 cell line allows for the identification of anti-SS-A/Ro antibodies because of the unique staining pattern that these antibodies show on this cell line.

The provided text describes a 510(k) submission for the HEp-2000® Colorzyme® ANA-Ro Test System, which is an indirect immunoenzyme antibody test. The document focuses on demonstrating substantial equivalence to a predicate device (RELISA® SS-A/SS-B Antibody Test System, K955603) rather than defining explicit acceptance criteria with numerical thresholds. However, we can infer some criteria from the performance descriptions.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Normal Samples: 500 healthy blood donors (242 females, 258 males). Provenance: Not explicitly stated, likely clinical lab setting. Retrospective or Prospective: Not explicitly stated, but "were tested in parallel" suggests a batch analysis, which could be either.
• Sera from Patients with Only Ro/SS-A Antibodies: 46 patients with SLE or Sjögren's Syndrome. Provenance: Not explicitly stated, likely clinical lab setting. Retrospective or Prospective: Not explicitly stated.
• Sera from Patients with Autoantibodies other than SS-A/Ro: 230 patients with a variety of rheumatic and non-rheumatic diseases. Provenance: Not explicitly stated, likely clinical lab setting. Retrospective or Prospective: Not explicitly stated.
• Reproducibility Titer: 10 samples (CDC controls and characterized in-house sera). Provenance: CDC controls and in-house laboratory. Retrospective or Prospective: Not explicitly stated, likely retrospective for established controls.
• Confirmation SS-A/Ro Antibodies: 349 patients with known positive ANA tests (from a large rheumatology reference laboratory). Provenance: Clinical rheumatology reference laboratory. Retrospective or Prospective: Not explicitly stated, but "known positive ANA tests" suggests retrospective selection.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the "number of experts" used to establish ground truth in the context of interpretation of the device results (e.g., reading patterns). However, the ground truth for the presence of specific antibodies (SS-A/Ro) was established by ELISA testing and Western immunoblotting, which are established laboratory methodologies. The interpretation of these confirmatory tests would be performed by trained laboratory personnel, but no specific number or qualifications of "experts" are provided beyond implied laboratory competence.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) for the test set results interpreted by the device is mentioned. The assessment often involved comparing the device's staining patterns to those on non-transfected HEp-2 cells, with discrepancies resolved by ELISA and Western immunoblotting (which serve as the ultimate ground truth).

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

No MRMC comparative effectiveness study involving human readers with and without AI assistance was reported. This device is an in vitro diagnostic test system that produces a staining pattern for visual interpretation, not an AI model providing automated interpretations or assistance. The comparison is between two different laboratory substrates.

6. Standalone (Algorithm Only) Performance Study

This is an in vitro diagnostic test kit that produces a visual result (staining pattern) to be interpreted by a human. It does not employ an AI algorithm in the standalone sense. The results are visual patterns on cells.

7. Type of Ground Truth Used

The ground truth used was primarily a combination of:

• Confirmatory Laboratory Tests: ELISA testing and Western immunoblotting for the presence of specific autoantibodies (e.g., anti-SS-A/Ro).
• Clinical Diagnoses: Patients were selected based on diagnoses like SLE or Sjögren's Syndrome, and "known history of rheumatic diseases" for normal samples.
• Established Reference Materials: CDC controls and well-characterized in-house sera were used for reproducibility.

8. Sample Size for the Training Set

The document describes studies for validating the device's performance, but it does not mention a "training set" in the context of an AI/machine learning model. The HEp-2000® cell line itself is "transfected" to overexpress the SS-A/Ro antigen, but this is a biological modification, not an algorithmic training process with a data set.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" for an AI algorithm, this question is not applicable to the described device. The "ground truth" equivalent for the development of the HEp-2000® cell line would be the biological understanding of how the transfected cells respond to SS-A/Ro antibodies compared to non-transfected cells, which is based on established scientific principles in immunology and cell biology.

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This test system is for in vitro diagnostic use for the detection of antinuclear antibodies in human serum, with specific identification of autoantibodies to the SS-A/Ro antigen. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease. The results from this assay can be used as an aid in the diagnosis of autoimune diseases.

This is an indirect fluorescent antibody test for the semi-quantitative detection of antinuclear antibody in human serum. The transfected HEP-2 cell line allows for the identification of anti-SS-A/Ro antibodies because of the unique staining pattern that these antibodies show on this cell line.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the HEp-2000® Fluorescent ANA-Ro Test System:

Acceptance Criteria and Device Performance Study

The provided text describes a submission for a new device, the HEp-2000® Fluorescent ANA-Ro Test System, seeking substantial equivalence to a legally marketed device (RELISA® SS-A/SS-B Antibody Test System, K955603). The study focuses on demonstrating the unique ability of the HEp-2000® cell line to specifically identify anti-SS-A/Ro antibodies and confirming the presence of SS-A/Ro antibodies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the comparisons to existing HEp-2 cells and ELISA testing, specifically highlighting the ability to identify SS-A/Ro antibodies distinctly.

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

The "test set" in this context refers to the samples used to demonstrate the device's performance against the described criteria, likely corresponding to a validation or clinical study set.

• Sample Sizes:
  • Normal Samples: 500 healthy blood donors (242 females, 258 males).
  • Sera from Patients with Only Ro/SS-A Antibodies: 46 patients with SLE or Sjögren's Syndrome.
  • Sera from Patients with Autoantibodies Other Than SS-A/Ro: 230 patients with a variety of rheumatic and non-rheumatic diseases.
  • Titer Reproducibility: 10 samples (CDC controls and in-house sera).
  • Confirmation of SS-A/Ro Antibodies: 349 patients with known positive ANA tests (from a large rheumatology reference laboratory).
  • Total SS-A/Ro containing sera examined across studies: 429 sera.
• Data Provenance: The document does not explicitly state the country of origin. The mention of "CDC controls" (Centers for Disease Control and Prevention) suggests a US origin or at least use of US-standardized materials. Given the FDA submission, it's highly likely the studies were conducted in or accepted by the US regulatory framework. The data is retrospective, as it involves analyzing existing sera.

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

The document does not explicitly state the number or qualifications of experts used for establishing ground truth, such as interpreting the HEp-2 or HEp-2000 staining patterns. It implies that these interpretations were done by qualified laboratory personnel following established protocols for fluorescent antibody tests. However, the ground truth for the presence of SS-A/Ro antibodies was established through objective methods.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus) for the interpretation of fluorescent patterns. The interpretation appears to be based on standard laboratory practice, with discrepancies or confirmations being resolved by "ELISA testing and by Western immunoblotting." This suggests a hierarchical approach rather than a consensus among multiple human readers for pattern interpretation.

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

No, a MRMC comparative effectiveness study was not explicitly described. The study compares the performance of the new device (HEp-2000®) against an older method (non-transfected HEp-2 cells) and a predicate ELISA device, but it doesn't involve multiple human readers interpreting cases with and without AI assistance to measure reader improvement. The "device" in this context is primarily an improved assay, not an AI-powered interpretation tool for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done. The entire submission describes the performance of the "HEp-2000® Fluorescent ANA-Ro Test System" (the algorithm/device) on its own, independent of human interpretation improvements (as it's a diagnostic test providing a result rather than an interpretative aid). The results presented are the direct output of the test system, compared to ground truth methods.

7. Type of Ground Truth Used

The ground truth for the presence or absence of SS-A/Ro antibodies was established by objective, highly specific laboratory methods:

• ELISA testing (Predicate Device): RELISA® SS-A/SS-B Antibody Test System (K955603)
• Western immunoblotting

For the patterns observed on HEp-2 and HEp-2000 cells, the ground truth is established by the accepted morphological characteristics of these patterns, which implicitly relies on expert consensus in the field for what constitutes a "speckled pattern" or "typical SS-A/Ro staining." However, when a discrepancy arose or confirmation was needed, the more objective ELISA and Western blot results trumped the pattern interpretation for confirming SS-A/Ro antibody presence.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. The entire dataset described appears to be used for validation and demonstration of performance. This is typical for a 510(k) submission for an in-vitro diagnostic assay improvement, where the "training" (development) of the cell line happened prior to these validation studies.

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

Since a separate "training set" is not detailed, the method for establishing ground truth for any underlying development of the HEp-2000® cell line is not described in this document. It can be inferred that the development of the transfected cell line was guided by scientific understanding of SS-A/Ro autoantigen expression and its visual manifestation in IF (Immunofluorescence) assays, likely confirmed by similar biochemical and immune-assay methods as used in the validation steps (e.g., ELISA, Western Blot, molecular characterization of the transfection).

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This is an in vitro diagnostic test system for thedetection and Semi-quantitation of tagsesses oblic cytoplasmic antibodies in human serum This test system is to be used as an aid in the detection of antibodies associated with autoimmune vasculitis, Wegener's granulomatosis, microscopic polyarteritis, and idiopathic crescentic glomerulonephritis.

This is an indirect fluorescent antibody test for the semi-quantitative detection of antineutrophil cytoplasmic antibody in human serum

Here's a breakdown of the acceptance criteria and study details based on the provided text, using the requested formatting:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria, but it establishes substantial equivalence by comparing the subject device's performance to a predicate device. The final reported performance after integrating a referee method is presented as the basis for this equivalence. Therefore, the "acceptance criteria" can be inferred from the reported performance that led to the FDA's substantial equivalence determination.

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

The study was conducted using retrospective serum samples.

• Normal Blood Donors: 497 samples (247 males, 250 females). Data provenance is not explicitly stated but implies collection from a general donor population.
• Previously ANCA-Positive Samples: 383 samples. Data provenance: Reference laboratories in the USA, the United Kingdom, and Australia.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It mentions "in-house IFA assays" from reference laboratories in the USA, UK, and Australia for the previously positive samples, and the use of "referee method" (ELISA kits for MPO and PR3 antibodies) for discrepant and positive samples.

4. Adjudication Method for the Test Set

The adjudication method involved a "referee method" using ELISA kits for MPO and PR3 antibodies for samples that were:

• Positive by either the subject device or predicate device in the normal blood donor group.
• Discrepant between the subject device and the predicate device in the ANCA-positive sample group.

This can be considered a tertiary adjudication where an independent, more specific test is used to resolve discrepancies and confirm positivity/negativity. It's not a consensus method among human readers, but a higher-tier diagnostic test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable as the device is an in vitro diagnostic test system (indirect fluorescent antibody test) for detecting antibodies in human serum, not an AI-based imaging or diagnostic aid for human readers. No human interpretation improvement with AI is mentioned or relevant to this type of device.

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

Yes, the study describes the standalone performance of the Immuno Concepts ANCA Test System directly compared to the NOVA Lite™ ANCA predicate device. This is a "device only" performance assessment where the output is directly read and compared.

7. The Type of Ground Truth Used

The ground truth was established using:

• A "referee method" based on specific antibody detection: ELISA kits for MPO (myeloperoxidase) and PR3 (proteinase 3) antibodies were used to confirm specific ANCA types in initially positive or discrepant samples. The results from these specific ELISA tests were used to reclassify samples as true positive or true negative for the final analysis.
• For the "previously determined to be positive for ANCA" samples, reference laboratory IFA assay results served as an initial ground truth, which was then further adjudicated by the ELISA referee method.

8. The Sample Size for the Training Set

The document does not mention a training set as this is an in vitro diagnostic kit, not an AI/machine learning algorithm that requires training. The provided data represents a validation/verification study.

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

As no training set is mentioned or applicable, this question is not relevant to the provided document.

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This test system is for in vitro diagnostic use for the detection of antineutrophil cytoplasmic antibody in human serum. This test system is to be used as an aid in the detection of antibodies associated with autoimmune vasculitis, Wegener's granulomatosis, microscopic polyarteritis, and idiopathic crescentic glomerulonephritis.

This is an indirect fluorescent antibody test for the semi-quantitative detection of antineutrophil cytoplasmic antibody in human serum

This document describes the Immuno Concepts Antineutrophil Cytoplasmic Antibody (ANCA) Test System with Ethanol Fixed Human Neutrophils. The study aims to demonstrate substantial equivalence to a legally marketed predicate device, the NOVA Lite™ ANCA test system (K961340).

Here's an analysis of the provided information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to a predicate device and the desired performance metrics for an ANCA test system. While explicit pass/fail criteria are not stated as numerical cut-offs, the goal is to show the new device performs comparably or better than the predicate, especially when a more definitive "reference method" (ELISA for MPO/PR3 antibodies) is considered.

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

• Test Set 1 (Normal Blood Donors): 497 serum samples. Retrospective. Provenance not explicitly stated, but implies general population.
• Test Set 2 (Previously Determined ANCA Positive): 383 serum samples. Retrospective. Provenance: Reference laboratories in the USA, the United Kingdom, and Australia.
• Test Set 3 (Patients with Known Vasculitides): 102 samples. Retrospective. Provenance: Not explicitly stated, but implies clinical settings where vasculitis diagnoses are made.

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

The document does not explicitly state the number of experts or their qualifications for establishing the initial ANCA positivity for the "Previously Determined ANCA Positive" samples. However, it mentions samples were obtained from "reference laboratories," implying that these labs, with their inherent expertise, had already categorized the ANCA status using "in-house IFA assays."

For the "Patients with Known Vasculitides" set, the ground truth was "clinically characterized vasculitides," which would involve diagnosis by medical specialists (e.g., rheumatologists, nephrologists) based on clinical presentation, laboratory findings, and potentially biopsy results. The number and specific qualifications of these clinicians are not provided.

4. Adjudication Method for the Test Set

• Discrepant Samples in Normal Blood Donor Set: For initial discrepancies between the subject device and predicate device, a "referee method" was used: ELISA for MPO and PR3 antibodies and Immuno Concepts HEp-2 ANA Test System for ANA.
• Discrepant Samples in Previously Determined ANCA Positive Set: For discrepancies between the subject device and predicate device, the "referee method" was ELISA for MPO and PR3 antibodies.

This indicates a form of adjudication where a third, more specific test (ELISA/ANA) was used to resolve disagreements or clarify the true status of samples, thereby refining the "ground truth" for those specific samples.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The study compares the performance of the device and a predicate device (and a reference method) on a set of samples. It does not evaluate the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this was a standalone study. The device, an indirect fluorescent antibody test system, is evaluated for its ability to detect ANCA antibodies. It's an assay performed in a laboratory, and the results are interpreted directly from the test system's output (fluorescence patterns and intensity). There is no "human-in-the-loop" AI component described; the device is the diagnostic tool being assessed.

7. Type of Ground Truth Used

Multiple types of "ground truth" were used and evolved:

• Initial Classification:
  • Normal Blood Donors: Implied negative status based on donor population.
  • Previously Determined ANCA Positive: "In-house IFA assays" from reference laboratories.
  • Patients with Known Vasculitides: "Clinically characterized vasculitides" (clinical diagnosis).
• Refined Ground Truth / Reference Method: For discrepant samples, ELISA for Myeloperoxidase (MPO) and Proteinase 3 (PR3) antibodies, and Immuno Concepts HEp-2 ANA Test System for Antinuclear Antibodies (ANA) were used as a more definitive "reference method" to establish the true ANCA status. The final performance metrics are presented against this refined reference method.

8. Sample Size for the Training Set

The document does not provide any information about a "training set." This type of 510(k) submission, typical for in vitro diagnostic (IVD) devices that are not based on machine learning or AI algorithms, focuses on analytical and clinical performance studies for device validation rather than algorithm training.

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

Since no training set is discussed, the method for establishing its ground truth is not applicable.

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This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases.

This is an enzyme immunoassay for the detection of antibodies to extractable nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum.

Here's an analysis of the provided text to extract the requested information about device acceptance criteria and the supporting study:

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

Based on the provided text, the acceptance criteria are not explicitly stated as distinct criteria, but rather are inferred from the performance metrics (sensitivity, specificity, and overall agreement) presented to demonstrate substantial equivalence to a predicate device. The performance is reported in relation to the predicate device.

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

• Test set sample size:
  • The table indicates the total number of samples tested by referring to the "Immuno Concepts RELISA® Multiparameter ENA Screening Test" as the reference method.
  • Total samples = 126 (Positive) + 9 (Positive) + 5 (Positive) + 0 (Borderline) + 2 (Borderline) + 4 (Borderline) + 1 (Negative) + 2 (Negative) + 394 (Negative) = 543 samples
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/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 text. The "ground truth" or reference method for comparison is the "Immuno Concepts RELISA® Multiparameter ENA Screening Assay (K935129)," which is another diagnostic test, not expert opinion.

4. Adjudication method for the test set

• This information is not applicable/provided. The "ground truth" was established by a predicate diagnostic device, not by human experts requiring adjudication.

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 is not an MRMC study. The device is an in vitro diagnostic test (enzyme immunoassay) for detecting antibodies, not an AI system for image interpretation or diagnosis by human readers. Therefore, this question is not relevant to the provided study description.

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

• Yes, this study is inherently a standalone performance evaluation of the RELISA® ENA Single Well Screen Antibody Test System. It compares the device's results directly against a predicate diagnostic device without human interpretation as part of the primary measurement.

7. The type of ground truth used

• The "ground truth" (or reference standard in this context) used was the Immuno Concepts RELISA® Multiparameter ENA Screening Assay (K935129). This is a previously cleared, legally marketed diagnostic device.

8. The sample size for the training set

• The text does not provide information on a training set. This study describes a performance comparison of a final device against a predicate, which aligns with verification/validation testing rather than a description of the model development phase.

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

• As there's no mention of a training set, this information is not applicable/provided.

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This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

This is an enzyme immunoassay for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

The provided text describes a RELISA® Sm/RNP Antibody Test System which is an enzyme immunoassay for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. Instead, the study aims to demonstrate substantial equivalence to a predicate device (RELISA® ENA Antibody Screening Tests System, K935129) by showing high relative sensitivity, relative specificity, and overall agreement. Based on the reported results, it appears the acceptance criteria were implicitly 100% for all these metrics compared to the predicate.

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

• Sample Size (Sm Autoantigen):

  • Positive: 32
  • Borderline: 4
  • Negative: 102
  • Total: 138 samples

• Sample Size (RNP Autoantigen):

  • Positive: 40
  • Borderline: 5
  • Negative: 93
  • Total: 138 samples

• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective). It is simply referred to as "human serum" used in direct comparison with the predicate device.

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

Not applicable. The "ground truth" for this study was established using a predicate device, not human experts.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication as the comparison was made against a predicate device.

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 study does not involve AI assistance or human readers in the context of an MRMC study. It's a direct comparison of a new immunoassay device against an existing immunoassay device.

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

Yes, in a sense. The study evaluated the standalone performance of the new device (Immuno Concepts RELISA® Sm/RNP) by directly comparing its results to the standalone performance of the predicate device (Immuno Concepts RELISA® Screening Assay). There is no human interpretion involved in the comparison, only the output of the immunoassay devices.

7. The Type of Ground Truth Used

The ground truth used was the results obtained from a legally marketed predicate device (Immuno Concepts RELISA® Screening Assay, K935129). This is a form of reference method comparison, where the established performance of the predicate serves as the gold standard for evaluating the new device.

8. The Sample Size for the Training Set

Not applicable. This type of immunoassay device development and validation typically does not involve a "training set" in the machine learning sense. The device is chemical/biological in nature, and its parameters are established through laboratory optimization and validation, not through learning from a labeled dataset.

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

Not applicable, as there is no "training set" in the context of this device and study design.

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