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The EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma (K3-EDTA, Li+heparin, Na+-citrate). It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.

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This FDA 510(k) clearance letter pertains to an In Vitro Diagnostic (IVD) device, specifically an ELISA test for autoantibodies. The provided text does not contain the kind of information typically associated with the development and validation of an AI/ML-based medical device, which would usually include details about:

• Algorithms and machine learning models
• Training and test datasets (sizes, provenance, ground truth establishment)
• Expert review processes (number of experts, qualifications, adjudication)
• MRMC studies or standalone AI performance metrics

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details based on the provided text.

The document describes the regulatory clearance for the EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit, which is a laboratory assay.

Here's what can be extracted from the document:

• Device Name: EUROIMMUN Anti-BP230-CF ELISA (IgG)
• Regulation Number: 21 CFR 866.5660
• Regulation Name: Multiple autoantibodies immunological test system
• Regulatory Class: Class II
• Product Code: OEG
• Indications for Use: The test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.

To answer the detailed questions about acceptance criteria and study data for an AI/ML device, a different type of regulatory submission document (e.g., a summary of safety and effectiveness data or a clinical study report) would be required.

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The Anti-tissue Transglutaminase ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Lit-heparin, Na+citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

The Anti-tissue Transglutaminase ELISA (IgG) test kit is intended for the qualitative determination of IgC class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Li+-citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease), in conjunction with other laboratory and clinical findings.

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This document is a 510(k) clearance letter from the FDA for an In Vitro Diagnostic (IVD) device, specifically an ELISA test for anti-tissue transglutaminase antibodies. These types of regulatory documents typically do not contain the detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would be found in a clinical trial report or a submission summary.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This determination of substantial equivalence relies on the manufacturer providing adequate data, but the letter itself does not present that data in a public-facing way.

Therefore, I cannot extract the requested information from the provided text. The document is an FDA clearance letter and not a detailed clinical study report.

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The EUROIMMUN IFA Granulocyte Mosaic EUROPattern is intended as an indirect immunofluorescence test for the qualitative or semi-quantitative determination of immunoglobulin class IgG anti-neutrophil cytoplasmic antibodies (ANCA) in human serum. It is used as an aid in the diagnosis of ANCA associated vasculitides, in conjunction with other laboratory and clinical findings. The EUROIMMUN IFA Granulocyte Mosaic EUROPattern test kit is intended for use with the EUROPattern microscope and software system. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

The EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern is intended as an indirect immunofluorescence test for the qualitative or semi-quantitation of immunoglobulin class IgG anti-neutrophil cytoplasmic antibodies (ANCA) and the qualitative determination of IgG anti-MPO, and, if included, anti-GBM antibodies in human serum. It is used as an aid in the diagnosis of ANCA associated vasculitides, in conjunction with other laboratory and clinical findings. The EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern test kit is intended for use with the EUROPattern microscope and software system. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

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The provided text is a 510(k) premarket notification decision letter from the FDA. It does not contain information about the acceptance criteria and study details for the device's performance. The letter primarily focuses on the regulatory determination of substantial equivalence and general device regulations.

Therefore, I cannot provide the requested table and study details based on the given input.

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The EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern test kit is intended for the qualitative and semiquantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is a sensitive method, used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

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This is an FDA 510(k) clearance letter for a medical device. It does not contain the detailed study information needed to answer the questions about acceptance criteria, device performance, and study design. The letter confirms that the device, "EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern," has been found substantially equivalent to a predicate device for aiding in the diagnosis of systemic lupus erythematosus (SLE).

To answer your questions, I would need access to the full 510(k) submission, which would include the performance studies and acceptance criteria agreed upon with the FDA. This information is typically not publicly available in the clearance letter itself.

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The EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern test kit is intended for the quantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

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The provided text is a U.S. FDA 510(k) clearance letter for the EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern test kit. This document primarily focuses on regulatory approval and indications for use, stating that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does NOT contain the detailed information about acceptance criteria or the specific study that proves the device meets those criteria, as typically found in a clinical study report or a more comprehensive submission document.

Therefore, I cannot provide the requested information from the provided text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or details about training sets.
3. Information about experts, ground truth establishment, or adjudication methods.
4. Details about MRMC studies, effect sizes, or standalone algorithm performance.

To provide the requested information, you would typically need to refer to the device's 510(k) summary, the full 510(k) submission, or relevant clinical study publications, which are not included in this document.

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The Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) kit is a Western blot assay intended for the qualitative determination of IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K+-EDTA, Li+-heparin, Na+-citrate) samples that have been found positive or equivocal/borderline using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for Borrelia burgdorferi antibodies. Results can be read manually or automated utilizing EUROLineScan. This test is used as an aid in the diagnosis of infections with Borrelia burgdorferi and the associated diseases, in conjunction with other laboratory and clinical findings.

The Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) kit is a Western blot assay intended for the qualitative determination of IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K+-EDTA, Li+-heparin, Na+-citrate) samples that have been found positive or equivocal/borderline using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for Borrelia burgdorferi antibodies. Results can be read manually or automated utilizing EUROLineScan.

This is an FDA 510(k) clearance letter for the "Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)" device, which is an in vitro diagnostic (IVD) test. IVDs are not typically "AI" devices as understood in the context of machine learning algorithms for image analysis or other complex data interpretation. Therefore, many of the requested fields related to AI-specific studies (e.g., sample size for test set split, MRMC study, training set details) are not applicable to this type of device.

However, I can extract information related to its analytical performance, which is a form of "acceptance criteria" and "device performance" for IVDs.

Device Name: Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

Indications for Use: The kit is a Western blot assay for qualitative determination of IgM class antibodies against Borrelia burgdorferi in human serum and plasma samples. It is intended for samples that have tested positive or equivocal/borderline by EIA or IFA for Borrelia burgdorferi antibodies. It is used as an aid in the diagnosis of Borrelia burgdorferi infections in conjunction with other laboratory and clinical findings.

Given the nature of an IVD, the "acceptance criteria" generally refer to established performance benchmarks (e.g., sensitivity, specificity, agreement with a reference method) that demonstrate the device is safe and effective for its intended use. The "study" would be the clinical performance evaluation or method comparison study.

Since the provided document is a 510(k) clearance letter, it typically summarizes the decision but does not include the full study report. However, based on the context of IVD submissions, I can infer the type of data that would have been presented for acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

For an IVD like this, acceptance criteria would typically involve demonstrating substantial equivalence to a predicate device or meeting certain performance specifications like sensitivity and specificity against a "gold standard" or well-characterized samples. The exact numerical acceptance criteria are not in this document, but I can describe the type of performance metrics expected.

Note: The specific numerical values for PPA, NPA, and Overall Agreement would be found in the detailed study report submitted with the 510(k), which is not part of this clearance letter. The clearance letter only states that the device was found "substantially equivalent" to predicate devices based on the submitted performance data.

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

• Sample Size for Test Set: Not explicitly stated in the clearance letter. IVD studies typically involve hundreds to over a thousand samples for clinical performance.
• Data Provenance: Not explicitly stated. For a US FDA submission, data often includes samples from diverse geographic regions within the US, and sometimes international samples if relevant to the intended use population. It's highly likely to be retrospective (using archived, characterized samples) but could include prospective samples as well.

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

• Number of Experts/Qualifications: This concept of "number of experts" for ground truth is generally not applicable in the same way for an IVD diagnostic kit that measures antibodies. The "ground truth" for such a device is established by:
  • Clinical Diagnosis: Patient's diagnosis by a physician based on clinical symptoms, history, and other laboratory tests.
  • Reference Tests: Results from established, FDA-cleared/approved predicate devices or a panel of standard reference tests (e.g., PCR, culture, or a combination of multiple serological tests).
  • Well-Characterized Sample Panels: Samples from patient cohorts definitively diagnosed as positive or negative for the condition being tested, confirmed by multiple methods.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable in the traditional sense for an IVD like this. The "ground truth" is determined by the methods described in point 3, not by expert consensus on image interpretation. If there were discrepancies between the new device and the reference method, these would be investigated, but not typically "adjudicated" by experts in the sense of image review.

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) kit for antibody detection, not an AI-powered diagnostic imaging device or an AI human-in-the-loop system. The device itself performs the detection (manually or with an automated reader, EUROLineScan), and the result is interpreted. There are no human "readers" whose performance is being improved by "AI assistance" in the context of this device.

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

• Yes, this is essentially a standalone device. The device itself (the Western blot assay) generates a result (presence/absence of specific IgM bands), which can be read manually or automatically by EUROLineScan. This is the "algorithm only" performance for the assay itself. The performance provided in the 510(k) submission would represent the standalone performance of the test. While a human might manually interpret the bands, the core performance metrics are about the assay's ability to correctly identify antibodies, not a human's ability to interpret an image aided by AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: Most likely a combination of:
  • Clinical Diagnosis: Based on physician assessment, patient history, and clinical presentation of Lyme disease.
  • Reference Laboratory Testing: Results from established, often predicate, serological assays (e.g., EIA/IFA followed by another Western Blot) and potentially other confirmatory tests (though less common for Borrelia serology).
  • Well-characterized Patient Samples/Panels: Samples obtained from individuals with confirmed Lyme disease and healthy controls, often with long-standing clinical diagnoses and/or multiple confirmatory tests.

8. The Sample Size for the Training Set

• Not Applicable in the context of machine learning algorithms. For an IVD kit like this, there isn't a "training set" in the sense of data used to train a machine learning model. The device performance characteristics are established through analytical validation and clinical performance studies on distinct panels of samples.

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

• Not Applicable. See point 8. The "ground truth" for validating the device's performance (the "test set" in ML terms) would be established as described in point 7. For the development of the assay itself (e.g., selecting antigens, optimizing reagents), manufacturers use internal development panels, but these are not referred to as "training sets" with "ground truth" in the machine learning sense for regulatory submissions of IVDs.

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The EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) kit is a Western blot assay intended for the qualitative determination of IgG class antibodies against Borrelia burgdorferi in human serum and plasma (K+-EDTA, Li+-heparin, Na+-citrate) samples that have been found positive or equivocal/borderline using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for Borrelia burgdorferi antibodies. Results can be read manually or automated utilizing EUROLineScan. This test is used as an aid in the diagnosis of infections with B. burgdorferi and the associated diseases, in conjunction with other laboratory and clinical findings.

The EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) kit is a Western blot assay. Results can be read manually or automated utilizing EUROLineScan.

This FDA 510(k) clearance letter and Indications for Use document do not contain the detailed information necessary to fully describe the acceptance criteria and the study that proves the device meets those criteria, as typically found in a clinical study report or a detailed 510(k) summary. The document focuses on the regulatory clearance and general intended use of the device.

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

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

This information is not available in the provided document. A 510(k) summary would typically include a detailed comparison to a predicate device, showing performance metrics like sensitivity and specificity. The document only states that the device is "substantially equivalent" to legally marketed predicate devices.

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

• Sample Size for Test Set: This information is not available in the provided document.
• Data Provenance: This information is not available in the provided document.

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

This information is not available in the provided document.

4. Adjudication method for the test set:

This information is not available in the provided document.

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

• The device description states: "Results can be read manually or automated utilizing EUROLineScan." This indicates that there's an automated interpretation component. However, the document does not provide any information about an MRMC study or the effect size of human readers improving with AI assistance. This type of study is more common for diagnostic imaging AI devices, whereas this device is a Western blot assay.

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

• The statement "Results can be read manually or automated utilizing EUROLineScan" suggests that the automated utilization of EUROLineScan implies an algorithmic interpretation. However, the document does not provide specific performance data for the algorithm in a standalone manner or comparisons to human-in-the-loop performance.

7. The type of ground truth used:

This information is not explicitly stated in the provided document. For a diagnostic test like this, the ground truth would typically be established by a combination of clinical diagnosis, other laboratory tests (e.g., culture, PCR, or a consensus of multiple reference tests), follow-up on disease progression, or expert clinical judgment.

8. The sample size for the training set:

This information is not available in the provided document.

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

This information is not available in the provided document.

Summary of missing information:

The provided documents (FDA 510(k) clearance letter and Indications for Use) serve as regulatory approval but do not contain the detailed study results, acceptance criteria, or specifics of how the device's performance was evaluated against a ground truth dataset, which would typically be found in a more comprehensive technical report or the 510(k) summary document that would have been submitted to the FDA.

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The EUROIMMUN Anti-West Nile Virus ELISA (IgM) is intended for the qualitative detection of IgM antibodies to West Nile virus in human serum and plasma (K+EDTA, Li+-heparin). This test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningitis/encephalitis, in conjunction with other laboratory and clinical findings. Positive results must be confirmed by the plaque reduction test (PRNT) or by using the current CDC guidelines for diagnosis of this disease.

The assay characteristics have not been established for testing cord blood, neonates, prenatal screening, and general population screening of patients without symptoms of meningoencephalitis. This assay is not FDA cleared or approved for testing blood or plasma donors.

Warning: Cross-reactivity with IgM to Dengue virus, Malarialanti-Plasmodium falciparum and Parvovirus B19 has been observed with the EUROIMMUN Anti-West Nile Virus ELISA (IgM). Reactive results must be reported with a caution statement regarding possible IgM cross-reactivity with other flaviviruses.

Patient serum or plasma samples are diluted 1:101 in sample buffer and incubated for 10 minutes at room temperature to allow IgG/RF separation. 100 ul of each diluted patient sample and pre-diluted controls and calibrator are added to the antigen coated microtiter wells and incubated for 60 minutes at +37°C. After incubation the microtiter well strips are washed 3 times with wash buffer to remove unbound antibodies and 100 ul of the anti-human IgM enzyme conjugate reagent is added to each microtiter well. After an additional 30 minutes incubation at room temperature, the microtiter wells are again washed 3 times with wash buffer to remove any unbound enzyme conjugate and 100 ul of the chromogen substrate is added. The strips are incubated for 15 minutes at room temperature and 100 ul stop solution is added. The microtiter placed in an ELISA reader and read at a wavelength of 450 nm and a reference wavelength of between 620 nm and 650 nm within 30 minutes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EUROIMMUN Anti-West Nile Virus ELISA (IgM):

Note: This document describes an in vitro diagnostic (IVD) device, not a typical AI/ML device. Therefore, the concepts of "test set," "training set," "experts to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study" do not directly apply in the same way they would to an AI-powered image analysis or diagnostic tool. Instead, the performance is evaluated against a predicate device and/or a reference standard like PRNT (Plaque Reduction Neutralization Test), and clinical studies involve comparisons of the device's results with these established methods.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device, being a diagnostic test, are generally based on sensitivity and specificity relative to a reference standard or a predicate device. The document explicitly states the ranges for these measures.

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The EUROIMMUN Anti-West Nile Virus ELISA (IgG) is intended for the qualitative detection of IgG antibodies to West Nile virus in human serum and plasma (K+EDTA, Li+-heparin). This test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningitis encephalitis, in conjunction with other laboratory and clinical findings. Positive results must be confirmed by the plaque reduction test (PRNT) or by using the current CDC guidelines for diagnosis of this disease.

The assay characteristics have not been established for testing cord blood, neonates, prenatal screening, and general population screening of patients without symptoms of meningoencephalitis. This assay is not FDA cleared or approved for testing blood or plasma donors.

Warning: Cross-reactivity with IgG to Dengue, Chikungunya, Zika and Tick-borne Encephalitis (TBE) viruses has been observed with the EUROIMMUN Anti-West Nile Virus ELISA (IgG). Reactive results must be reported with a caution statement regarding possible IgG cross-reactivity with other flaviviruses.

Patient samples are diluted 1:101 in sample buffer, 100 ul of each diluted patient sample and pre-diluted controls and the calibrator are added to the antigen coated microtiter wells and incubated for 60 minutes at +37°C. After incubation the microtiter well strips are washed 3 times with wash buffer to remove unbound antibodies and 100 ul of the anti-human IgG enzyme conjugate reagent is added to each microtiter well. After an additional 30-minutes incubation at room temperature, the microtiter wells are again washed 3 times with wash buffer to remove any unbound enzyme conjugate and 100 ul of the chromogen substrate is added. The strips are incubated for 15 minutes at room temperature and 100 ul stop solution is added. The microtiter plates are placed in an ELISA reader and read at a wavelength of 450 nm and a reference wavelength of between 620 nm and 650 nm within 30 minutes.

The provided text describes the EUROIMMUN Anti-West Nile Virus ELISA (IgG) device, which is an in vitro diagnostic immunoassay. Therefore, the questions related to AI/MRMC studies, human-in-the-loop performance, and expert ground truth are not applicable in the context of this device. The acceptance criteria and study data are presented for the assay's analytical and clinical performance.

Here's the breakdown of the information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EUROIMMUN Anti-West Nile Virus ELISA (IgG) are primarily based on its analytical performance (repeatability, reproducibility, specificity) and clinical performance (sensitivity and specificity compared to a predicate device and PRNT).

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

The "test set" here refers to the clinical samples used for performance validation against a predicate device and ground truth (PRNT).

• Clinical Study I (Predicate Comparison and PRNT Confirmation):
  • Sample Size: 152 samples for predicate comparison. Of these, 45 were presumptive positives by the predicate, and 27 of these were further tested by PRNT.
  • Data Provenance: Prospective collection from hospitals and clinics across the US in 2015.
• Clinical Study II (Predicate Comparison):
  • Sample Size: 401 serum samples.
  • Data Provenance: Prospective collection from a clinical laboratory in the midwest (US).
• Clinical Study III (PRNT Comparison):
  • Sample Size: 295 serum samples.
  • Data Provenance: Retrospective collection in cooperation with the Robert Koch Institute (RKI), Berlin, Germany, including 200 samples from major outbreaks of West Nile fever in South Africa in 1974 and 1984.
• Analytical Specificity/Cross-Reactivity Study:
  • Sample Size: 910 serologically characterized seropositive specimens.
  • Data Provenance: Not explicitly stated, but implies diverse sources given the range of conditions.
• Assay Cut-off Determination:
  • Sample Size: 18 sera from clinically characterized positive WNV patients and 150 sera from normal healthy blood donors.
  • Data Provenance: Implied clinical and healthy populations, source not specified.
• Expected Values (US Studies):
  • Sample Size: 553 samples.
  • Data Provenance: Prospectively collected from US population.
• Matrix Comparison:
  • Sample Size: 20 paired samples (serum, EDTA plasma, Li-heparin plasma), created by spiking 5 different sets of normal blood donor samples with 5 different positive serum samples.
  • Data Provenance: Normal blood donors (source not specified), spiked with serum samples (source not specified if human/animal).

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

• This is an in vitro diagnostic (IVD) device, not an AI/imaging device requiring expert reads for ground truth in the same way.
• The ground truth for the clinical studies was established by Plaque Reduction Neutralization Test (PRNT), which is considered the gold standard for serological confirmation of West Nile Virus infection.
• For the comparison studies, a legally marketed predicate device (Focus Diagnostics West Nile Virus IgG DxSelect™ (K031953)) also served as a comparative "ground truth" or reference, as is common in 510(k) submissions for substantial equivalence.
• The document does not mention the use of human experts or their qualifications for establishing the ground truth for data used in the clinical studies. The ground truth relies on established laboratory tests (PRNT) or comparison to an already FDA-cleared device.

4. Adjudication Method for the Test Set

• No explicit "adjudication method" in the sense of multiple human readers resolving discrepancies is mentioned for this IVD device.
• For Clinical Study I, it states: "Average of three results for each clinical specimen tested at three sites was considered to calculate the positive percent and negative percent agreement between the EUROIMMUN Anti-West Nile Virus ELISA (IgG) vs the predicate assay." This indicates internal averaging/calculation, not expert adjudication.
• The ground truth for discordant results was resolved by PRNT where applicable (e.g., of the 45 presumptive positives by predicate in Study I, 27 were sent for PRNT).

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 (ELISA) device, not an AI or imaging device that uses human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is an automated ELISA assay. Its "standalone performance" is what is described in the analytical and clinical studies. There is no human-in-the-loop component in the interpretation of the assay results, other than a lab technician running the test and reporting the quantitative ratio/index, which then falls into predefined qualitative categories (negative, borderline, positive).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The types of ground truth used were primarily:

• Reference Laboratory Assay: Plaque Reduction Neutralization Test (PRNT) is considered the gold standard for confirming West Nile Virus infection. (Used in Clinical Study I and III).
• Predicate Device Comparison: The Focus Diagnostics West Nile Virus IgG DxSelect™ (K031953), an already legally marketed device, served as a reference standard for comparison in Clinical Study I and II to demonstrate substantial equivalence.
• Serological Characterization: For the cross-reactivity study, specimens were "serologically characterized," implying prior established diagnostic results for the various pathogens.
• Clinically Characterized Patients: For the initial assay cut-off determination, samples were from "clinically characterized positive West Nile virus patients" and "normal healthy blood donors," suggesting a clinical diagnosis or healthy status served as the ground truth for defining the cut-off.

8. The Sample Size for the Training Set

• This is an IVD kit, not a machine learning model, so there isn't a "training set" in the typical AI sense.
• However, the assay cut-off determination can be seen as analogous to a model's calibration or training phase. For this, 18 sera from clinically characterized WNV positive patients and 150 sera from normal healthy blood donors were used to determine the optimal OD cut-off and borderline range.

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

• As noted above, for the assay cut-off determination (analogous to training/calibration):
  • The "positive" ground truth was established by using "clinically characterized positive West Nile virus patients." Further details about how these patients were characterized (e.g., by PRNT, by symptoms, by other diagnostics) are not provided in this document but are assumed to be based on an established clinical diagnosis of WNV infection.
  • The "negative" ground truth was established by using "normal healthy blood donors from a non-endemic region." These individuals are assumed to be free of WNV infection based on their health status and origin from a non-endemic area.

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The EUROIMMUN Lyme ELISA (IgG/IgM) test kit is intended for the qualitative determination of IgC and/or IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K++EDTA, Li+-heparin) from symptomatic patients or people suspected of B. burgdorferi infection. It is used as an aid in the disease, in conjunction with other laboratory and clinical findings. All positive and borderline results should be supplemented by a second step testing method such as Western blot.

Not Found

This FDA 510(k) clearance letter for the EUROIMMUN Lyme ELISA (IgG/IgM) device provides an "Indications for Use" statement but does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This means the FDA found the device to be similar enough to a pre-existing legally marketed device that it does not require a new Premarket Approval (PMA) application, which would necessitate extensive clinical trial data submission and review.

Therefore, I cannot provide the requested information based on this document. A 510(k) clearance typically relies on demonstrating substantial equivalence, and the detailed performance studies and acceptance criteria are usually summarized in the 510(k) submission itself, not fully articulated in the clearance letter.

To answer your questions, I would need access to the full 510(k) submission document (K142038) or a dedicated performance study report for the EUROIMMUN Lyme ELISA (IgG/IgM).

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