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Assay:

ZEUS IFA™ ANA HEp-2 Test System is an indirect immunofluorescence assay for the qualitative detection and semiquantitative determination of IgG anti-nuclear antibodies in human serum by manual fluorescence microscopy or with ZEUS dlFine®. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases. All suggested results obtained with ZEUS dIFine® must be confirmed by a trained operator.

Instrument:

ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides. ZEUS dlFine can only be used with FDA cleared or approved ZEUS in vitro diagnostic assays that are indicated for use on this instrument. All suggested results obtained with ZEUS dIFine must be confirmed by a trained operator

ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides.

The provided text is an FDA 510(k) clearance letter for the Zeus IFA ANA HEp-2 Test System and Zeus dIFine. While it states the device is "substantially equivalent" and outlines its indications for use, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and performance data.

The FDA 510(k) summary, often referred to as the 510(k) "Premarket Notification Summary" or "Special 510(k) Notification Summary," would contain the information you are seeking regarding acceptance criteria and performance data. This document is typically publicly available on the FDA's website alongside the 510(k) clearance letter.

Therefore, I cannot provide the requested information based solely on the text you provided. To answer your questions, I would need access to the 510(k) summary document for K201956.

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The ImmuGlo HEp-2 Elite IFA is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of anti-nuclear antibodies (ANA) of the IgG isotype in human serum utilizing standard HEp-2 cells and engineered HEp-2 cells as a substrate. The ImmuGlo HEp-2 Elite IFA is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

The ImmuGlo™ HEp-2 Elite IFA is an indirect immunofluorescence antibody test for the qualitative detection of anti-nuclear antibodies (ANA) of the IgG isotype in human serum utilizing standard HEp-2 cells as a substrate. The HEp-2 Elite sides provided with this kit contain a 1:9 mixture of standard HEp-2 cells and engineered HEp-2 cells with the PSP1 gene knocked out. The engineered HEp-2 cells are able to detect all ANA specificities with the exception of the DF570/AC-2 pattern resulting from autoantibodies associated with PSP2. In DF570 positive reactions standard HEp-2 cells provide a positive reaction while engineered HEp-2 cells do not. The HEp-2 Elite substrate thereby provides additionality to aid in discriminating homogeneous, speckled, and dense fine speckled (DFS70/AC-2) patterns during the screening phase.

The provided text describes the ImmuGlo HEp-2 Elite IFA device, which is an indirect immunofluorescence antibody test for the detection of anti-nuclear antibodies (ANA). It aims to aid in the diagnosis of systemic rheumatic diseases.

Here's an analysis of the acceptance criteria and the study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a dedicated section for all tests. However, performance metrics are provided in the "Non-clinical Tests" and "Precision" sections. Based on the "Repeatability" and "Reproducibility" sections, the acceptance criteria for precision studies are implicitly defined.

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

1. Qualitative Agreement (Pos/Neg) Study (vs. Predicate):

   • Sample Size: 591 samples (298 positive, 293 negative by predicate).
   • Data Provenance: Not explicitly stated, but the "Method Comparison" implies these are clinical samples tested against the predicate device. No details on country of origin or retrospective/prospective collection are provided.

2. Pattern Agreement Study:

   • Sample Size: 243 samples with known ANA patterns.
   • Data Provenance: Not explicitly stated. The samples were "randomized." No details on country of origin or retrospective/prospective collection are provided.

3. Repeatability Study:

   • Sample Size: 8 negative and 17 positive samples. Each sample was tested in 6 replicates in 10 runs (over 5 days), resulting in 60 replicates for each sample. Read by 2 operators, total N = 120 per sample series.
   • Data Provenance: Not specified.

4. Reproducibility Study:

   • Sample Size: 10 positive samples with various patterns and intensities. Each sample was tested in triplicate in 10 runs (2 runs/day for 5 days) at 3 different sites, resulting in 90 replicates per sample.
   • Data Provenance: Not specified, other than "three different sites."

5. Clinical Study (Sensitivity/Specificity):

   • Sample Size: 256 ANA-associated disease samples and 497 autoimmune and infectious disease controls. (Total 753 samples, excluding normal human sera and DFS70 suspected samples for these specific calculations).
   • Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective collection. These are referred to as "sets of clinical samples."

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

• Qualitative Agreement Study: Ground truth was established by comparison to a "Predicate" device. No human experts are explicitly mentioned for ground truth.
• Pattern Agreement Study: Three independent evaluators provided reads. The ground truth for the comparison was established by "Consensus (2/3 Readers)." The qualifications of these evaluators are not specified (e.g., if they are expert medical professionals like radiologists or pathologists, or their years of experience).
• Precision (Repeatability and Reproducibility) Studies: The repeatability study mentions "2 operators." The reproducibility study mentions testing at "three different sites" and implies readers/operators at those sites. However, the qualifications of these operators/readers are not specified.
• Clinical Study (Sensitivity/Specificity): The classification of samples into "ANA-associated autoimmune disease" or "control" implies a clinical diagnosis was used as ground truth, likely established by referring clinicians. However, the exact method of ground truth establishment (e.g., based on clinical criteria, pathology, or expert consensus) and the qualifications of those who established it are not detailed.

4. Adjudication Method for the Test Set

• Qualitative Agreement (Pos/Neg) Study: The comparison is made against a "Predicate" device. No explicit human adjudication method for the ground truth of the samples themselves is stated; the predicate device's results are used as the reference.
• Pattern Agreement Study: The adjudication method for comparing the Elite device against the predicate was based on "Consensus (2/3 Readers)." This means that for a result to be considered consensus, at least two out of the three independent evaluators had to agree.
• Precision (Repeatability and Reproducibility) Studies: For reproducibility, "consensus pattern agreement" was part of the AQL. This indicates an adjudication process was used, likely involving agreement among multiple readers/operators, but the specific number or method isn't detailed beyond the term "consensus."

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

• Yes, a form of MRMC study was done for pattern agreement. The "Pattern Agreement Study" involved 243 samples and 3 independent evaluators (readers) who were blinded to each other's results and the samples. The data was analyzed by comparing the Elite device vs. the Predicate device based on reader consensus (at least 2 of 3 readers).
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: This information is not applicable as the device (ImmuGlo HEp-2 Elite IFA) is a diagnostic kit read by human operators (microscopists/technologists) and is not described as an AI-powered image analysis tool. The study assesses the agreement between patterns identified using the new device and the predicate by human readers, not the effect of AI assistance on human reader performance.

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

• No, the device described is an "indirect immunofluorescence antibody test kit" (IFA). This is a laboratory diagnostic method that requires human-in-the-loop performance for slide preparation, reading under a fluorescence microscope, and interpretation of patterns and titers. There is no mention of an algorithm-only or AI-driven standalone component in the provided text.

7. The Type of Ground Truth Used

• Qualitative Agreement Study: The ground truth for this comparison was the results obtained from the predicate device.
• Pattern Agreement Study: The ground truth for comparison in the pattern study was established by expert consensus among 2 out of 3 independent evaluators.
• Clinical Study (Sensitivity/Specificity): The ground truth was based on a clinical diagnosis of "ANA-associated autoimmune disease" or "control" conditions. This typically reflects real-world clinical outcomes and physician diagnoses, potentially supported by other laboratory and clinical data. There is no mention of pathology or other specific "gold standard" laboratory tests cited as the primary ground truth.

8. The Sample Size for the Training Set

• The document describes performance studies for a diagnostic kit (ImmuGlo HEp-2 Elite IFA). This typically does not involve "training sets" in the context of machine learning or AI models, but rather clinical samples are used for method comparison, precision, and clinical performance evaluation.
• Therefore, a "training set" for an algorithm is not applicable to this device as described. The samples mentioned in the clinical study (753 samples) are test sets for evaluating the performance of the device itself.

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

• As a "training set" in the AI or machine learning sense is not applicable to this device, the method for establishing its ground truth is not relevant here.

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Instrument & Software:

The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

Assay:

AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies (ANA) in human serum by manual microscopy or with HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM instrument must be confirmed by trained personnel.

The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions.

This document is a 510(k) premarket notification for the HELIOS® AUTOMATED IFA SYSTEM and AESKUSLIDES® ANA-HEp-2-Gamma. It describes the device's indications for use and confirms that the FDA has found it substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document primarily focuses on regulatory approval and the device's intended use. Information about the performance study, including acceptance criteria and results, would typically be found in a separate section of the 510(k) submission, such as a "Summary of Safety and Effectiveness" or a "Performance Data" section, which is not included in the provided snippets.

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Instrument: The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides. The Image Navigator can only be used with cleared or approved Immuno Concepts in vitro diagnostic assays that are indicated for use on the microscope. All suggested results generated by the Image Navigator software must be confirmed by trained laboratory personnel.

Assay: This is an indirect fluorescent antibody test for the semi-quantitative detection of IgG antinuclear antibody (ANA) in human serum by manual fluorescent microscopy or with the Image Navigator Fluorescence Semi-Automated Microscope. This test system uses transfected HEp-2000® cells, which allow specific identification of autoantibodies to the SSA/Ro antigen. Autoantibodies to SSA/Ro may show a distinctive staining pattern on the transfected cells. When this pattern is present, it is considered to be confirmatory evidence that anti-SSA/Ro antibodies are present. Absence of this distinctive pattern does not rule out the possible presence of anti-SSA/Ro antibodies. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator semi-automated device and software.

The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides.

The provided document serves as an FDA 510(k) clearance letter for the HEp-2000® Fluorescent ANA/Ro Test System; Image Navigator by Immuno Concepts. While it outlines the device's indications for use and classification, it does not include detailed information regarding acceptance criteria, study design, specific performance metrics, or ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is an administrative clearance, not a scientific study report.

To answer your request, a different type of document, such as a summary of safety and effectiveness (SSED) from the FDA or the original submission's performance data, would be needed.

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Instrument: The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides. The EUROPattern Microscope and Software can only be used with cleared or approved EUROIMMUN in vitro diagnostic assays that are indicated for use on the device. All suggested results obtained with the EUROPattern Microscope and Software must be confirmed by trained personnel.

Assay: The EUROIMMUN IFA 40: HEp-20-10 EUROPattern is an indirect immunofluorescence antibody test for the qualitative or semiquantitative determination of IgG antibodies against antibody (ANA) in human serum with the EUROPattern Microscope and Software automated instrument. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

The EUROPattern Microscope and Software is an automated system consisting of fluorescent microscope and software that acquires, interprets, stores and displays digital indirect immunofluorescence slides.

The provided text is a cover letter from the FDA to EUROIMMUN US INC. regarding the 510(k) premarket notification for their EUROIMMUN IFA 40: HEp-20-10 EUROPattern and EUROPattern Microscope and Software. While it states that FDA has determined the device is substantially equivalent to a predicate device, and outlines the indications for use, it does not contain any information about acceptance criteria, device performance results, specific study details, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table and study details based on the provided document. The document focuses on regulatory approval and compliance rather than technical performance data.

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NOVA Lite® DAPI ANA Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-nuclear antibodies of the IgG isotype in human serum by manual fluorescence microscopy or with the NOVA View Automated Fluorescence Microscope. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases. A trained operator must confirm results when generated with the NOVA View device.

The NOVA Lite DAPI ANA Kit is an indirect immunofluorescence assay for the detection and semiquantitative determination of anti-nuclear antibodies in human serum.
Kit components:

• HEp-2 (human epithelial cell) substrate slides; 12 wells/slide, with desiccant.
• FITC IgG Conjugate with DAPI, containing 0.09% sodium azide; ready to use.
• Positive Control: ANA Titratable Pattern, human serum with antibodies to HEp-2 nuclei in buffer, containing 0.09% sodium azide; pre-diluted, ready to use.
• . Negative Control: IFA System Negative Control, diluted human serum with no ANA present, containing 0.09% sodium azide; pre-diluted, ready to use.
• PBS II (40x) Concentrate, sufficient for making 2000 mL of 1x PBS II.
• Mounting Medium, containing 0.09% sodium azide ●
• Coverslips

The provided document describes the analytical and clinical performance of the NOVA Lite® DAPI ANA Kit, an indirect immunofluorescence assay for detecting anti-nuclear antibodies. The study focuses on demonstrating substantial equivalence to a predicate device and the agreement between manual microscopy, digital image interpretation, and the automated NOVA View system.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Average reactivity grade difference between any runs is within ± one reactivity grade.
• Pattern consistent for 100% of the replicates (considering positive results only). | - First set, Digital Reading: Reactivity grade range was consistent with criterion (e.g., 0-1, 1-2, 2-3, 4).
• Second set, Digital Reading: All grades were within ± one reactivity grade within one run, and average grade was no more than one reactivity grade different between runs.
• Second set, Manual Reading: All grades were within ± one reactivity grade within one run, and average grade was no more than one reactivity grade different between runs.
• All sets, Pattern Consistency: 100% pattern consistency for positive results was reported for digital reading and manual reading across all precision studies. |
  | Conjugate Comparison (DAPI vs. non-DAPI) | - Agreement between the two conjugate sets is > 85%.
• Pattern agreement (for positive samples only) is > 85%.
• Grades are within ± one grade from each other for 90% of the samples. | - Total Agreement: 96.6% (94.3-98.1%)
• Positive Agreement: 98.6% (95.9-99.7%)
• Negative Agreement: 94.3% (90.1-97.1%)
• All grades were within ± one grade from each other (100%).
• Pattern discrepancy was observed in only 3 cases out of 210 positive samples, indicating high pattern agreement. |
  | Lot-to-Lot Comparison | - Average negative agreement > threshold (implied by meeting grade agreement).
• Average positive agreement > threshold (implied by meeting grade agreement).
• Total agreement > threshold (implied by meeting grade agreement).
• All grades (100%) within ± 1 grade from each other for all samples in any pairwise comparison.
• 100% pattern agreement between lots for definitive patterns (considering positive samples only). | - Agreements (Digital Reading): Average negative agreement 91.9-97.4%, average positive agreement 93.0-97.6%, total agreement 92.5-97.5%.
• Agreements (Manual Reading): Average negative agreement 93.8-100%, average positive agreement 95.8-100%, total agreement 95.0-100%.
• Grade Agreement: 100% of grades were within ± 1 grade for all pair-wise comparisons (both digital and manual reading).
• Pattern Agreement: 100% pattern agreement (both digital and manual reading). |
  | Accelerated Stability | Reactivity grades obtained on slides stored at 37 °C for 2 weeks are within ± one grade of those obtained on the control slides (for a preliminary 1-year shelf life). | - All reactivity grades of tested samples from accelerated stability studies were within ± one grade of the control samples for both digital and manual reading across all three lots.
• Pattern consistency also maintained. |
  | Accuracy of Endpoint Titration (Manual vs. Digital) | Endpoints by digital reading are the same or within ± 1 dilution step from that of manual reading for a high percentage of cases (implicitly demonstrating good agreement). | - 100% of cases at Site #1, 60% at Site #2, and 90% at Site #3 were within ± 1 dilution step.
• All remaining cases were within ± 2 dilution steps. |
  | Clinical Sample Agreement (Manual vs. Digital vs. NOVA View) | Agreement between digital image reading and manual reading results > 90% at all three testing sites. | - Reproducibility Cohort (120 samples): Total Agreement between Manual vs Digital was 99.2% (Site 1), 95.8% (Site 2), 96.7% (Site 3).
• Clinical Cohort (463 samples): Total Agreement between Manual vs Digital was 91.4% (Site 1), 92.2% (Site 2), 92.2% (Site 3).
• Grade Agreement (Clinical Cohort): Fluorescence intensity grades determined by digital image reading were within ± one dilution step from manual reading in 96.3% (Site 1), 99.1% (Site 2), and 99.6% (Site 3) of samples.
• Pattern Agreement (Clinical Cohort): Agreement between digital image reading and manual reading was above 90% at all three sites (94.7% Site 1, 91.6% Site 2, 95.7% Site 3). |
  | Clinical Sensitivity & Specificity | Sensitivity and specificity values at each site should have overlapping confidence intervals between NOVA View classification, digital image reading, and manual reading, indicating no significant differences. | - Site 1: Overlap observed (e.g., SLE sensitivity for NV: 80.0%, Manual: 72.0%, Digital: 80.0%; SARD+AIL sensitivity for NV: 69.4%, Manual: 62.9%, Digital: 69.9%; Specificity for NV: 75.3%, Manual: 74.1%, Digital: 72.4%).
• Site 2: Overlap observed (e.g., SLE sensitivity for NV: 72.0%, Manual: 70.7%, Digital: 73.3%; SARD+AIL sensitivity for NV: 62.9%, Manual: 65.6%, Digital: 62.98%; Specificity for NV: 77.0%, Manual: 67.2%, Digital: 75.3%).
• Site 3: Overlap observed (e.g., SLE sensitivity for NV: 82.7%, Manual: 82.7%, Digital: 81.3%; SARD+AIL sensitivity for NV: 72.0%, Manual: 71.0%, Digital: 69.4%; Specificity for NV: 69.0%, Manual: 67.2%, Digital: 71.3%).
• No statistically significant differences were found between the different reading methods. |
  | CDC ANA Reference Sera | All reference sera should produce the expected pattern. Results of NOVA View digital image interpretation should be within ± one reactivity grade from manual interpretation. No discrepancies in pattern interpretation. | - All reference sera produced the expected pattern.
• Digital image interpretation results were within ± one reactivity grade from manual interpretation.
• No discrepancies in pattern interpretation were seen between manual and digital results. |

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

• Precision/Reproducibility Studies:
  • First Set: 13 samples (3 negative, 10 positive), processed in 3 replicates across 10 runs (30 data points per sample).
  • Second Set: 22 samples (20 negative/around cut-off, 2 strong positive), processed in 3 replicates across 10 runs (30 data points per sample).
  • Third Set: Samples tested in triplicates or duplicates across 5 runs (15 or 10 data points per sample).
• Conjugate Comparison: 407 individual human serum samples.
• Method Comparison: 410 samples (400 clinically characterized sera, 10 samples with known ANA patterns).
• Lot-to-Lot Comparison: 40 sera.
• Endpoint Titration Accuracy: 10 ANA positive samples.
• Agreement on Clinical Sample Cohort (Reproducibility): 120 samples at each of 3 sites.
• Clinical Performance (Clinical Sensitivity and Specificity): 463 clinically characterized samples at each of 3 sites.
• CDC ANA Reference Sera: 12 reference sera.

Data Provenance:

• The document implies that the studies were conducted by Inova Diagnostics (Site #1) and two external sites (Site #2 and Site #3). While origin of patients' samples (e.g., country) is not explicitly stated for all cohorts, the studies conducted at "external sites" suggest broader geographic reach for sample collection, and certainly implies varied patient populations.
• The studies were retrospective, using "clinically characterized samples" and "individual serum samples" that were already available.

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

The document consistently states that "A trained operator must confirm results when generated with the NOVA View device" and that "all slides were read by the same operator with manual microscopy" for various studies. For adjudication specifically, the number of experts for initial ground truth establishment isn't broken down for each individual sample, but implies internal validation by "trained operators".

• Precision Studies, Conjugate Comparison, Accelerated Stability, CDC Reference Sera: "The slides were read with NOVA View, and digital images were interpreted by the operator." and "all slides were read by the same operator with manual microscopy." This suggests at least one trained operator for defining ground truth for reading discrepancies.
• Endpoint Titration and Reproducibility/Clinical Performance Studies: "all slides were read by the same operator with manual microscopy." for generating ground truth. These studies were carried out at three different sites (Inova Diagnostics and two external locations), implying that a "trained operator" at each site was responsible for manual readings. The qualifications of these "trained operators" are not further specified beyond "trained operator."

4. Adjudication Method for the Test Set

The primary method for establishing agreement and performance comparison appears to be through comparison with manual microscopy readings by a "trained operator". There is no explicit mention of an adjudication protocol (e.g., 2+1 or 3+1 consensus) for discrepant results between the automated system and manual reading, or between multiple manual readers for the general test sets. The "trained operator" performing the manual reading effectively serves as the reference standard against which the digital and NOVA View results are compared. For the NOVA View results, it states "Digital images were interpreted and confirmed," implying a human review step and potential individual reconciliation.

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

• No explicit MRMC comparative effectiveness study involving AI-assistance performance improvement for human readers is described. The studies primarily focus on the agreement and equivalence between:

  1. Manual reading (human only, traditional method)
  2. Digital image reading (human interpreting images from the automated system)
  3. NOVA View output (raw automated classification)

  The design compares the performance of the automated system and its digital interpretation against the manual method, rather than quantifying how much human readers improve when assisted by the AI in making their initial assessments. The phrasing "A trained operator must confirm results when generated with the NOVA View device" suggests that the human remains in the loop for final confirmation, but the study doesn't isolate the "effect size" of this assistance.

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

Yes, partial standalone performance data is presented as "NOVA View output".
"NOVA View" refers to "raw results obtained with the NOVA View Automated Fluorescence Microscope, such as Light Intensity Units (LIU), positive/negative classification and pattern information." These raw results are then compared against "Digital reading" (human interpretation of NOVA View images) and "Manual reading" (human interpretation of actual slides).

For example, in the "Precision performance" section, NOVA View output (standalone) is compared to digital image reading. In the "Clinical performance" section, NOVA View classification (standalone) is compared to digital image reading and manual reading for sensitivity, specificity, and agreement.

7. The Type of Ground Truth Used

The primary ground truth used for performance validation is expert consensus/manual interpretation by experienced "trained operators" using traditional fluorescence microscopy. This is explicitly stated in multiple sections, for instance: "all slides were read by the same operator with manual microscopy" serving as a reference.

For the clinical performance section, "clinically characterized samples" are used, implying that patient diagnoses (e.g., SLE, SSc, SS, etc.) served as the clinical classification for sensitivity/specificity calculations, but the ANA ground truth itself (positive/negative, pattern, grade) within those clinical cohorts was established by manual interpretation.

The CDC ANA reference sera also represent a form of "known ground truth" based on established reference standards and known antibody specificities.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size of the training set used to develop or train the NOVA View automated system's algorithms. The focus of this 510(k) submission is on the validation of the NOVA Lite® DAPI ANA Kit, which includes its use with the previously cleared NOVA View device (DEN140039). Training data details for NOVA View itself would likely be in its original submission.

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

Since the document does not specify the training set used for the NOVA View algorithm, it also does not describe how its ground truth was established. This information would typically be found in the original submission for the NOVA View device itself (DEN140039).

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The EUROIMMUN IFA 40: HEp-20-10 is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of antibodies against cell nuclei (ANA) in human serum. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

The test system consists of BIOCHIPs coated with HEp-20-10 cells. It includes a fluorescein-labeled goat anti-human IgG, a positive and negative control, salt for PBS, Tween 20, embedding medium, cover glasses and instruction booklet. Reagent trays for the TITERPLANE technique are required but ordered separately.

Here's a breakdown of the acceptance criteria and study information for the EUROIMMUN IFA 40: HEp-20-10 device, based on the provided text:

Acceptance Criteria and Device Performance

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AESKUSLIDES ANA-HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA-HEp-2 Test System is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

Not Found

I am sorry, but the provided text does not contain detailed information about acceptance criteria, study design, or device performance metrics for the AESKUSLIDES ANA-HEp-2. The document is primarily an FDA clearance letter and an "Indications for Use Form," which state the device's purpose and regulatory classification but do not elaborate on the specific studies conducted to demonstrate its performance relative to acceptance criteria.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
• Details on standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information is usually found in the 510(k) summary or the full 510(k) submission, which is not provided in the given text.

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The EUROIMMUN ANA IFA:HEp-20-10 is an indirect fluorescent antibody test for the qualitative or semiquantitative detection of antibodies against cell nuclei (ANA) in human serum and EDTA-plasma. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

Not Found

The provided text does not contain information about acceptance criteria, device performance, or any studies with AI or human readers. The document is a 510(k) clearance letter from the FDA for a device called "EUROIMMUN ANA IFA: Hep-20-10," which is an indirect fluorescent antibody test for detecting antibodies against cell nuclei.

Therefore, I cannot provide the requested information.

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The HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies in human serum. The HEP-ANA Test System is intended for use as an aid in the diagnosis of certain autoimument diseases.

The RhiGene HEP-ANA Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate, similar to the predicate device. Diluted serum samples are incubated on substrate slides coated with HEP-2 (human epithelial) cells. Incubation allows the anti-nuclear antibodies (ANA) present in the samples to react with the antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins, labeled with fluorescein isothiocyanate (FITC), are added forming complexes with the nuclear bound antibodies. Following another washing step, coverslips are mounted and then the slides are examined with a fluorescence microscope. The total incubation time (at room temperature in a moist chamber) of the assay is 40 minutes.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the RhiGene HEP-ANA Test System:

Acceptance Criteria and Device Performance

The core of the acceptance criteria is predicated on the new device, the RhiGene HEP-ANA Test System, demonstrating substantial equivalence to a legally marketed predicate device, the RhiGene Titer-Fluor ANA Test System (K872845). While explicit numerical acceptance targets aren't given in the summary, the study's goal was to show comparable performance.

The "reported device performance" refers to the RhiGene HEP-ANA Test System. It's compared directly to the predicate device, with results indicating equivalence rather than specific performance metrics in isolation.

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a single number.
     • "a healthy donor serum population"
     • "an autoimmune diseases population"
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "In-house studies," implying they were conducted by RhiGene Inc. The samples appear retrospective as they are described as "populations" rather than detailing a prospective enrollment strategy.

2. 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 summary. The ground truth for the healthy and autoimmune populations would have been established through clinical diagnosis, but the involvement of specific experts for validating these diagnoses for the study is not mentioned.

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

   • This information is not provided in the summary.

4. 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 was not performed. This device is an in-vitro diagnostic (IVD) assay, not an AI-powered image analysis tool requiring human reader interpretation. The performance is based on the assay's output as interpreted by laboratory personnel.

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

   • A "standalone" study in the typical AI sense (algorithm only) was not performed as this is a traditional laboratory assay. However, the performance metrics (specificity and sensitivity) are representative of the device's inherent capability, with human involvement primarily in performing the assay and interpreting the fluorescent patterns, not the "algorithm" itself. The comparison is between two similar lab assays.

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

   • For specificity, the ground truth was derived from a "healthy donor serum population." This implies individuals diagnosed as healthy, likely through clinical evaluation or self-reported health.
   • For sensitivity, the ground truth was derived from "an autoimmune diseases population." This implies individuals with a clinical diagnosis of an autoimmune disease.
   • The document implies that the ground truth for these populations was established through standard clinical diagnostic practices, rather than a specific expert consensus for this study.

7. The sample size for the training set:

   • This information is not applicable as this is not a machine learning or AI device that requires a "training set." The device is a chemical/biological assay.

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

   • This information is not applicable as this is not a machine learning or AI device.

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