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The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Epstein-Barr Early Antigen (EBV-EA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to the early antigen complex of the Epstein-Barr Virus in human serum. The test detects IgG antibodies to both the diffuse (D) and restricted (R) components of the EBV early antigen complex. The EBV-EA IFA Test Kit should be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen (EBNA), and heterophile antibody) as an aid in the diagnosis of infectious mononucleosis (IM).

The Epstein-Barr Virus Early Antigen (EBV-EA) IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to EBV-EA in human serum.

Here's an analysis of the acceptance criteria and study details for the Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Epstein-Barr Virus Early Antigen (EBV-EA) IgG Antibody, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds for sensitivity and specificity in the provided text. Instead, the study reports the device's performance relative to a commercially available predicate EBV-EA IFA. The implication is that comparable performance to the predicate device would be a key acceptance criterion.

Table 1: Relative Sensitivity and Specificity of the Stellar EBV-EA IFA Kit Relative to Alternate IFA

Note on Acceptance Criteria: The document explicitly states: "Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease." This highlights that the acceptance criteria are based on agreement with a predicate device, not on direct clinical truth or diagnostic accuracy.

Study Details

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

• Test Set Sample Size for Relative Sensitivity and Specificity: 75 samples (43 positive, 32 negative by the alternate IFA).
• Test Set Sample Size for Titer Agreement: 25 positive sera.
• Test Set Sample Size for Reproducibility: 180 (3 positive sera with various titers, 1 negative sera, each assayed 5 times on 3 different assays at 3 different sites).
• Test Set Sample Size for Specificity (Cross-reactivity): At least 9 samples (CMV+, VZV+, HSV 1&2+, HHV 6+, HHV 8+; note multiple HSV 1&2+ and HHV 6+ samples are listed).
• Data Provenance: The samples were selected from frozen retrospective sera tested at a commercial clinical laboratory. The document doesn't explicitly state the country of origin, but given the applicant's address (Columbia, MD 21046, USA), it's highly probable the data is from the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for the primary relative sensitivity and specificity study was established by the results of a commercially available EBV-EA IFA (the "Alternate IFA"). There is no mention of human experts directly establishing the ground truth for this comparison.

For the categorization of sera by serological status (Acute, Seropositive, Seronegative), the criteria were based on ELISA results for VCA IgM/IgG and EBNA. Again, this points to laboratory assay results, not human expert consensus, as the ground truth.

4. Adjudication method for the test set

No adjudication method involving multiple human readers is mentioned. The ground truth was determined by the results of established laboratory assays (the Alternate IFA and various EBV ELISAs).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. This device is a diagnostic assay (IFA), not an AI-assisted interpretation tool for human readers.

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

Yes, the performance data presented is for the standalone device (the Stellar EBV-EA IFA kit). The "human-in-the-loop" equivalent for an IFA assay would typically be a lab technician reading the fluorescence under a microscope. The study design tests the performance of the kit itself in producing results compared to other similar kits.

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

The ground truth used was primarily the results from a commercially available predicate EBV-EA IFA kit or other serological assays (VCA IgG/IgM ELISA, EBNA ELISA, heterophile antibody assay), rather than expert consensus, pathology, or outcomes data. The study explicitly states there was no attempt to correlate assay results with disease presence or absence.

8. The sample size for the training set

The document does not provide information on a specific training set or its size. As this is a traditional in-vitro diagnostic (IVD) kit based on an established IFA methodology, it's unlikely to have a "training set" in the machine learning sense. The assay development would involve optimizing reagents and protocols during its design phase, but not typically a labeled dataset for algorithm training.

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

Since no training set for an algorithm is mentioned, the method for establishing its ground truth is not applicable/not provided.

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The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for IgG Antinuclear Antibody (ANA) HEp2 is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antinuclear antibodies in human serum. Detection of ANA in humans can be used as an aid in the diagnosis of autoimmune connective tissue diseases.

The ANA IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to ANA antigens in human serum.

Here's a breakdown of the acceptance criteria and the study details for the Stellar Bio Systems' Indirect Fluorescence Assay for Anti-Nuclear Antibodies (ANA) IgG Antibody, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device's performance was evaluated relative to a commercially available ANA IFA kit. The acceptance criteria are implicitly defined by the reported performance metrics, which demonstrate the device's ability to provide comparable results to an existing device.

Study Details

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

• Test Set Sample Size: 199 sera (100 from patients diagnosed with SLE, 99 from normals).
• Data Provenance: The samples were "frozen retrospective sera." The "99 sera were from normals with various ages, gender, and geographical areas." This suggests the data is retrospective and likely from mixed geographical origins, though specific countries are not mentioned.

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 summary. The study used a "commercially available ANA IFA" as the comparator (or "alternate IFA") to establish "relative" truth, but it does not specify how the initial diagnosis of SLE or the determination of "normals" was made, nor the involvement of experts in establishing the reference standard.

4. Adjudication method for the test set:

• This information is not provided. The comparison was made against an "Alternate IFA," but the specifics of how discrepancies between the new device and the alternate were handled (if at all) are not detailed.

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:

• A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, and the device is not an AI-assisted device. It is a laboratory assay (Indirect Fluorescence Assay) for detecting antibodies.

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

• This device is an in-vitro diagnostic assay, not an algorithm or software. Its performance is inherent to the chemical and biological reactions involved in the test. Therefore, the concept of "standalone (algorithm only)" is not applicable. The reported performance is the standalone performance of the assay itself.

7. The type of ground truth used:

• The "ground truth" for this study was relative to another commercially available ANA IFA. The summary explicitly states: "Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease."
• For the SLE patients, their diagnosis (described as "patients diagnosed with SLE") served as an initial categorization, but the comparator IFA was the reference standard against which the new device was measured for "relative" performance.

8. The sample size for the training set:

• This information is not applicable/provided. This device is a manual laboratory assay, not a machine learning model that requires a "training set" in the computational sense. The described evaluations are performance studies.

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

• This information is not applicable as there is no training set in the context of this type of device.

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The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for Anti-native DNA (nDNA) IgG Antibody is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antibody to nDNA in human serum. Detection of nDNA IgG antibody in humans can be used as an aid in the diagnosis of systemic lupus erythematosus (SLE).

The nDNA IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to nDNA antigen in human serum.

The provided document describes the performance characteristics of the "Indirect Fluorescence Assay for Anti-native DNA (nDNA) IgG Antibody" device.

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

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

The document doesn't explicitly state "acceptance criteria" in a separate section. However, the "Performance Characteristics" section provides data comparing the new device against an "Alternate IFA" (a commercially available nDNA IFA), implying these comparative metrics serve as the basis for acceptance. The performance is reported in terms of relative sensitivity, relative specificity, and relative agreement.

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

• Sample Size for Test Set: 149 sera for relative sensitivity/specificity/agreement. 20 positive sera for titer agreement. 4 sera (3 positive, 1 negative) evaluated for reproducibility, with serial dilutions and multiple assays resulting in 36 data points.
• Data Provenance: "The samples were frozen retrospective relative to a commonly treated population of patients diagnosed with SLE." The sera were "gender, and geographical areas," implying a diverse, though unspecified, geographical origin. It's explicitly stated that there was not an attempt to correlate the assay's results with disease presence or absence, and "No judgment can be made on the comparison assay's accuracy to predict disease." This means the study is a comparison to a predicate, not a clinical diagnostic performance study against a true disease gold standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not applicable. The "ground truth" for the test set was established by the "Alternate IFA" (a commercially available nDNA IFA), not by human experts. The study directly compares the new device's results to the predicate device's results.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable, as the "ground truth" was derived from a predicate device's results, not human interpretation 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:

• Not applicable. This is an in vitro diagnostic (IVD) device for laboratory testing, not an AI-assisted diagnostic imaging or interpretation tool for human readers. There are no human readers or AI involved in the interpretation of results as per the described device operation.

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 device itself. The device (IFA for nDNA IgG antibody) is an in vitro diagnostic test. Its performance is measured based on its direct output (positive/negative, titer) in comparison to a predicate device. There is no human-in-the-loop component described for its operation or interpretation.

7. The type of ground truth used:

• Reference standard/Predicate device result: The "ground truth" for this study was the results obtained from a "commercially available nDNA IFA" (the Alternate IFA). The study explicitly states, "Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease."

8. The sample size for the training set:

• Not applicable. This is a traditional IVD device, not a machine learning or AI algorithm that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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