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The Zeus Scientfic, Inc. PR-3 ELISA test system is intended for the semi-quantitative detection of IgGclass antibody to proteinase-3 in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of antibodies to PR-3. Elevated antibody levels to PR-3 may be associated with autoimmune disorders such as Wegener's Granulamotosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.

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Disclaimer: The provided document is a 510(k) clearance letter from the FDA dated December 17, 1998, for the Zeus Scientific, Inc. Aptus (Automated) Application for the PR-3 ELISA Test System. It does not contain detailed acceptance criteria, study results, or information typically found in a clinical study report. Therefore, I cannot fully answer all aspects of your request based solely on this document.

However, I can extract information related to the device, its intended use, and limitations of the document itself concerning your request.

This document is an FDA 510(k) clearance letter dated December 17, 1998, for the Zeus Scientific, Inc. Aptus (Automated) Application for the PR-3 ELISA Test System. It indicates that the FDA found the device "substantially equivalent" to legally marketed predicate devices. This letter confirms the device's classification and permits it to be marketed.

Based on the provided document, I cannot fulfill all parts of your request as it lacks the detailed study information, acceptance criteria, and performance data typically found in a clinical study report or the 510(k) submission itself.

Here's what can be inferred or stated based only on the provided FDA clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided FDA clearance letter. A 510(k) clearance letter summarizes the FDA's decision but does not typically include the detailed acceptance criteria or the full performance data from the studies submitted by the manufacturer. These details would be contained within the original 510(k) submission.

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

This information is not available in the provided FDA clearance letter.

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

This information is not available in the provided FDA clearance letter.

4. Adjudication Method for the Test Set:

This information is not available in the provided FDA clearance letter.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

This information is not available in the provided FDA clearance letter. Given that the device is an ELISA test system for detecting antibodies, it is highly unlikely that an MRMC study (typically for image interpretation by human readers) would have been performed. This device is an in vitro diagnostic (IVD) assay.

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

The device is an "Aptus (Automated) Application for the PR-3 ELISA Test System." This indicates it's an automated or semi-automated immunoassay. Performance studies for such devices typically evaluate the assay's analytical and clinical performance standalone (i.e., the device's output itself, not human interpretation of that output). However, the details of these studies are not available in the provided FDA clearance letter.

7. The Type of Ground Truth Used:

This information is not available in the provided FDA clearance letter. For an IVD like an ELISA, ground truth is typically established by:

• Confirmed clinical diagnosis by a physician.
• Results from a predicate or gold standard reference assay.
• Pathology (if applicable to the disease state, but less direct for antibody detection).
• Patient outcomes over time.

8. The Sample Size for the Training Set:

This information is not available in the provided FDA clearance letter. ELISA assays typically do not have "training sets" in the same way machine learning algorithms do. Instead, they undergo method development, optimization, and validation using various sample cohorts.

9. How the Ground Truth for the Training Set was Established:

This information is not available in the provided FDA clearance letter. As mentioned, the concept of a "training set" ground truth is less directly applicable to a traditional ELISA assay compared to AI/ML devices.

Device Specific Information from the Document:

• Device Name: Aptus (Automated) Application for the PR-3 ELISA Test System
• Manufacturer: Zeus Scientific, Inc.
• Regulatory Class: II
• Product Code: MOB
• Indications for Use: The Zeus Scientific, Inc. PR-3 ELISA test system is intended for the semi-quantitative detection of IgG class antibody to proteinase-3 (PR-3) in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of antibodies to PR-3. Elevated antibody levels to PR-3 may be associated with autoimmune disorders such as Wegener's Granulomatosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.

To obtain the detailed information regarding acceptance criteria, study design, sample sizes, and ground truth establishment, one would need to consult the original 510(k) submission (K984315) itself, which is typically available through FDA's public databases or directly from the manufacturer.

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The assay is to be 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 Wegener's granulomatosis. FOR IN VITRO DIAGNOSTIC USE.

The PR-3 ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of antibodies to Proteinase-3 in human sera. The PR-3 ELISA test is an enzyme linked immunosorbent assay to detect IgG, IgM, and IgA antibodies to Proteinase-3. Purified PR-3 is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG, M, A is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

Acceptance Criteria and Device Performance for PR-3 ELISA Test Kit

This document describes the acceptance criteria and a detailed study supporting the performance of the PR-3 ELISA test kit for the detection and semi-quantitation of antibodies to Proteinase-3 in human sera.

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PR-3 ELISA test kit are derived from its stated intended use as an aid in the diagnosis of Wegener's granulomatosis and its substantial equivalence to IFA (Indirect Immunofluorescence Assay). The study primarily focuses on demonstrating the analytical performance (sensitivity, specificity, precision, linearity, and cross-reactivity) of the device.

II. Sample Size and Data Provenance for the Test Set

• Sample Size for Sensitivity and Specificity (relative to IFA):

  • Patient with Wegener's granulomatosis/microscopic polyangiitis (IFA Positive): 54 sera
  • Normals and other patients (IFA Negative): 181 sera
  • Total: 235 sera

• Sample Size for Sensitivity and Specificity (relative to Alternate ELISA):

  • Total: 235 sera (same group as for IFA comparison)

• Sample Size for Clinical Sensitivity and Specificity:

  • Wegener's granulomatosis: 40 sera
  • Microscopic polyangiitis: 40 sera
  • Other autoimmune sera: 21 sera (containing antibodies to Ro, La, Sm, RNP, Jo-1, Scl-70, dsDNA)
  • Normals: 155 sera
  • Total: 256 sera

• Sample Size for Precision: 9 different sera, each tested 10 times on 3 different assays (total 270 measurements).

• Sample Size for Linearity: 5 positive sera, serially diluted twofold.

• Sample Size for Cross-reactivity: 21 sera containing antibodies to potentially cross-reactive antigens (Ro, La, Sm, RNP, Jo-1, Scl-70, dsDNA).

• Data Provenance: The document does not explicitly state the country of origin. The data appears to be retrospective, as patient sera were "from patients diagnosed with" specific conditions, implying collection prior to the study.

III. Number of Experts and Qualifications for Ground Truth

• The document does not mention the number of experts used or their specific qualifications (e.g., radiologist with 10 years of experience).
• The ground truth for IFA results (used as a comparator for relative sensitivity/specificity) is implicitly established by the performance of the IFA assay itself, which is a predicate device.
• The ground truth for patient diagnoses (Wegener's granulomatosis, microscopic polyangiitis) and the presence of other autoimmune conditions/antibodies are stated as prior diagnoses, but the process of establishing these diagnoses by experts is not detailed within this document.

IV. Adjudication Method for the Test Set

• No explicit adjudication method is described for the test set. The study relies on pre-existing diagnoses and comparator assay results (IFA, alternate ELISA) as the ground truth.

V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This study evaluates an in vitro diagnostic (IVD) device, which typically assesses the analytical and clinical performance of the assay itself rather than the improvement of human reader performance with AI assistance. The device is a laboratory test, not an AI interpretation tool for human readers.

VI. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The entire study analyzes the performance of the PR-3 ELISA kit (the algorithm/device) in isolation, without human intervention in the interpretation of the raw assay data (though human technical skill is involved in performing the assay). The reported sensitivities, specificities, precision, and linearity are all measures of the device's standalone performance.

VII. Type of Ground Truth Used

• Comparator Assay Results: For relative sensitivity and specificity, the ground truth was established by the results of the Indirect Immunofluorescence Assay (IFA) for ANCA and an alternate legally marketed ELISA device.
• Clinical Diagnosis: For clinical sensitivity and specificity, the ground truth was based on patient diagnoses of Wegener's granulomatosis and microscopic polyangiitis, as well as the presence of other autoimmune conditions/antibodies (e.g., Ro, La, Sm, RNP, Jo-1, Scl-70, dsDNA) and serological status of normals.

VIII. Sample Size for the Training Set

• The document does not specify a training set sample size. As this is a traditional ELISA assay and not a machine learning or AI algorithm in the modern sense, the concept of a "training set" for model development as typically understood in AI/ML is not directly applicable. The device's parameters (e.g., cutoff values) would have been established during earlier development and validation phases, but these details are not provided here.

IX. How Ground Truth for the Training Set Was Established

• Given that this is a conventional immunoassay, the concept of a distinct "training set" with ground truth in the AI/ML context isn't relevant. The "ground truth" for establishing assay parameters (like cutoff values) would typically involve internal studies using well-characterized clinical samples and comparison against reference methods (like IFA) to optimize performance, but the specifics of this process are not described in this summary.

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