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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

The study was conducted using retrospective serum samples.

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

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

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

7. The Type of Ground Truth Used

The ground truth was established using:

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

8. The Sample Size for the Training Set

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

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

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

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

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

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

Here's an analysis of the provided information:

1. Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

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

7. Type of Ground Truth Used

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

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

8. Sample Size for the Training Set

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

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

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

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