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INTENDED USE: This is an indirect Fluorescent antibody test for the qualitative and semi-quantitative detection of IgG autoantibodies in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence SemiAutomated Microscope. This test system is to be used as an aid in the detection of anti-mitochondrial (AMA), antiparietal cell (APCA), and anti-smooth muscle (ASMA) autoantibodies associated with Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.

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This FDA 510(k) clearance letter for K180202, the HISTOFLUOR RODENT LKS FLUORESCENT ANTIBODY TEST SYSTEM Image Navigator by Immuno Concepts, provides information about its intended use but does not include a detailed description of the acceptance criteria or a study proving that the device meets those criteria, nor does it provide specifics about the test set, ground truth, or training set parameters.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. The "Indications for Use" section describes what the device is intended for (qualitative and semi-quantitative detection of certain autoantibodies) and how it's to be used (manual fluorescent microscopy or with the Image Navigator® Fluorescence Semi-Automated Microscope, with a trained operator confirming results).

Therefore, based solely on the provided text, I cannot complete the requested table and detailed study information. The details about the performance study, acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies would typically be found in the 510(k) submission document itself, which is a much larger and more technical document than this clearance letter.

Here's what can be inferred or stated from the provided text, along with the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Information that cannot be determined from the provided FDA clearance letter:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be determined from the provided text. The clearance letter does not include details on the study design, sample sizes, or data origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Cannot be determined from the provided text. The letter states that a "trained operator must confirm results generated with the Image Navigator® semi-automated device and software," implying human oversight, but it does not specify the number or qualifications of experts for establishing ground truth during the validation studies.

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

• Cannot be determined from the provided text. No information on adjudication methods is present.

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

• Cannot be determined from the provided text. The letter does not explicitly mention an MRMC study or quantify human performance improvement with AI assistance. It indicates the device can be used with a semi-automated microscope and software, but the impact on human readers is not detailed.

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

• Implied not standalone by "A trained operator must confirm results." The text states, "A trained operator must confirm results generated with the Image Navigator® semi-automated device and software." This indicates that the device is intended for use with human-in-the-loop and not as a fully standalone diagnostic tool for final results. Whether a standalone performance evaluation was conducted internally for algorithm development is not stated.

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

• Cannot be determined from the provided text. While the device aids in detecting autoantibodies associated with specific conditions (Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis) "in conjunction with other laboratory and clinical findings," the specific method for establishing ground truth in the device's validation studies is not described.

8. The sample size for the training set

• Cannot be determined from the provided text. Information about the training set size is not included in this document.

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

• Cannot be determined from the provided text. No details are provided regarding the establishment of ground truth for any training data used for the device's algorithm.

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An indirect immunofluorescent antibody test for the qualitative and semi-quantitative detection of IgA class endomysial autoantibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.

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I'm sorry, but without further textual input, I cannot furnish information about acceptance criteria or supporting studies. The documents you provided appear to be an FDA 510(k) clearance letter and an "Indications For Use" statement for the "NOVA Lite™ Endomysial Antibody Test Kit," but they do not contain details regarding specific performance criteria or the studies conducted to demonstrate those criteria.

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The Wielisa anti-GBM Test Kit is an Enzyme Linked Immunosorbent Assay (ELISA) for the detection and semi-quantitation of IgG antibodies in human serum to GBM (glomerular basement membrane). The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Goodpasture syndrome. FOR IN VITRO DIAGNOSTIC USE.

The Wielisa anti-GBM Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to glomerular basement membrane(GBM) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Goodpasture syndrome. FOR IN VITRO DIAGNOSTIC USE. The wells of the microtiter strips are coated with purified GBM antigen. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating. The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase-labeled antibodies to human IgG binds to the antibodies in the wells in this second incubation. After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the color intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.

The Wieslab AB Ideon Research Park's Wielisa anti-GBM Test Kit is an enzyme-linked immunosorbent assay (ELISA) designed for the detection and semi-quantitation of IgG antibodies to glomerular basement membrane (GBM) in human sera. The assay aims to aid in the diagnosis of Goodpasture syndrome. The device applied for 510(k) clearance (K974169) to the FDA. The submission outlines studies demonstrating the performance characteristics of the device.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the performance is demonstrated through comparison with clinical characterization and existing methods. The implied acceptance is that the device demonstrates high sensitivity and specificity in diagnosing anti-GBM nephritis and distinguishing it from other conditions, as well as showing comparable results to a predicate device and an alternative ELISA.

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

• Clinical Sensitivity and Specificity Study (Table 1):
  • Sample Size: 272 frozen sera.
  • Data Provenance: Retrospective, with clinical characterization. The country of origin is not specified, but the applicant's address is in Sweden.
• Relative Sensitivity and Specificity vs. GBM IFA (Table 2):
  • Sample Size: 68 frozen retrospective sera.
  • Data Provenance: Retrospective. Country of origin not specified.
• Relative Sensitivity and Specificity vs. Alternate ELISA (Table 3):
  • Sample Size: 122 frozen retrospective sera.
  • Data Provenance: Retrospective. Country of origin not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts used or their detailed qualifications (e.g., radiologist with 10 years of experience).

• For Table 1 (Clinical Sensitivity and Specificity), the "clinical characterization" of the sera implies that a clinical diagnosis was used as ground truth. This would typically involve review by clinicians, potentially specialists in nephrology or rheumatology, based on a combination of clinical symptoms, other laboratory tests, and potentially biopsy results. However, the exact number and qualifications are not provided.
• For Table 2 (Relative Sensitivity and Specificity vs. GBM IFA), the Immunofluorescence Assay (IFA) results are used as the comparator, which serves as a form of ground truth or an established benchmark. The interpretation of IFA typically requires experienced laboratory personnel or pathologists.
• For Table 3 (Relative Sensitivity and Specificity vs. Alternate ELISA), another commercial ELISA is used as the comparator, also serving as an established benchmark.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (like 2+1 or 3+1) for resolving discrepancies in diagnostic classifications for the ground truth. It relies on "clinical characterization" or comparison with established methods (IFA, alternate ELISA).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the performance of the in-vitro diagnostic device itself, not on the improvement of human readers with or without AI assistance. The device is a laboratory assay, not a tool for interpretation by human readers in the same way an imaging AI might be.

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

Yes, the studies presented are essentially standalone performance evaluations of the Wielisa anti-GBM Test Kit. This is an immunoassay that produces quantitative results (optical density, then arbitrary units) and then applies defined cut-offs (e.g., <10 units negative, >20 units positive) to classify samples. There is no "human-in-the-loop" interaction in the interpretation of the assay's output as part of the primary device function itself, beyond a clinician interpreting the final numerical result provided by the kit in the context of a patient's overall clinical picture.

7. The Type of Ground Truth Used

• Clinical Sensitivity and Specificity (Table 1): Clinical diagnosis based on "clinical characterization" of the sera. This would likely stem from a combination of patient symptoms, medical history, other diagnostic tests, and potentially pathology (e.g., kidney biopsy for anti-GBM nephritis).
• Relative Sensitivity and Specificity vs. GBM IFA (Table 2): Results from Immunofluorescence Assay (IFA) for GBM antibodies. IFA is considered a standard method for detecting these antibodies.
• Relative Sensitivity and Specificity vs. Alternate ELISA (Table 3): Results from an alternate commercial ELISA for anti-GBM antibodies. This serves as a comparison against another established in-vitro diagnostic approach.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or "validation set" in the context of machine learning. For an ELISA kit, development typically involves optimizing reagents and conditions using various samples, but this is not typically referred to as a "training set" in the same way as in AI/ML. The provided sample sizes (272, 68, 122) appear to be for the performance evaluation/testing of the device with established parameters.

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

Since a "training set" in the AI/ML sense is not explicitly described, neither is the method for establishing its ground truth. However, for the development of such an assay, the "ground truth" used during optimization would typically involve well-characterized patient samples with confirmed diagnoses (e.g., biopsy-proven Goodpasture syndrome, healthy controls, or patients with other well-defined autoimmune diseases).

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The Euro-Diagnostica Immunoscan Anti-GBM Kit is an enzyme immunoassay (EIA) kit for the in vitro diagnostic detection of anti-Glomerular Basement Membrane (GBM) antibodies in human serum. This kit is useful as an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.

enzyme immunoassay (EIA) kit

This document is a 510(k) clearance letter for the Immunoscan Anti-GBM Kit, an in vitro diagnostic device. It does not contain the detailed information required to answer the specific questions about acceptance criteria, study design, and performance metrics typically associated with AI/ML device evaluations. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.

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

1. Acceptance criteria or reported device performance
2. Sample sizes or data provenance for test sets
3. Number or qualifications of experts for ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document is a regulatory approval notice, not a study report or technical specification for the device's performance.

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Ask a specific question about this device