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The MESACUP TEST PR-3 is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-proteinase III (PR-3) antibodies in human serum. The MESACUP TEST PR-3 is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as Wegener's granulomatosis.

The MESACUP Test PR-3 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with proteinase III antigen. Incubation allows the anti-PR-3 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG immunoglobulins, labeled with horseradish peroxidase (HRP), are added forming complexes with the PR-3 bound antibodies. Following another washing step, The bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate, The intensity of the color generated is proportional to the serum concentration of anti-PR-3 antibodies, Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-PR-3 antibody in patient samples.

The provided text describes the MESACUP Test PR-3, an ELISA device for detecting IgG anti-proteinase III (PR-3) antibodies. The information focuses on its substantial equivalence to a predicate device and its intended use, rather than explicit acceptance criteria with pre-defined thresholds. However, we can infer performance metrics and the study details based on the provided summary.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria (e.g., "Sensitivity must be >= 90%") are not stated, we can infer the implicit acceptance criterion was "performance equivalent to the predicate device."

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

• Test Set Sample Size: Not explicitly stated. The document mentions "a healthy donor serum population" and "a vasculitis population," but no numbers are provided for either group.
• Data Provenance: "In-house studies." The country of origin is not specified, but the applicant's address is in Des Plaines, IL, USA. The studies are retrospective as they are testing existing samples to determine performance characteristics.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. The ground truth appears to be based on the clinical diagnosis (healthy vs. vasculitis) and other diagnostic methods (IIF ANCA positive results, cANCA positive IIF patterns), but who made these determinations is not specified.

4. Adjudication Method for the Test Set

• No adjudication method is mentioned for establishing the ground truth. The text implies a pre-existing classification of samples (e.g., "healthy donor serum population," "vasculitis population," "IIF ANCA positive results," "cANCA positive IIF patterns").

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 device is an In Vitro Diagnostic (IVD) assay, not an AI-powered diagnostic imaging device that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• Yes, this is an ELISA (Enzyme-Linked Immunosorbent Assay), which is a standalone laboratory test. Its performance is measured directly without human interpretation of its output in the same way an imaging algorithm's output would be interpreted. The "algorithm" here refers to the biochemical process of the assay itself, and its result (optical density) is read spectrophotometrically.

7. The Type of Ground Truth Used

• The ground truth appears to be a combination of:
  • Clinical diagnosis: Healthy individuals vs. patients with vasculitis (specifically Wegener's granulomatosis).
  • Reference laboratory tests: Immunofluorescence (IIF) ANCA positive results and cANCA positive IIF patterns.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set." This type of IVD typically undergoes development and optimization, but the term "training set" is more commonly associated with machine learning algorithms. The performance data presented is likely from a validation or test set.

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

• As no "training set" is explicitly mentioned for this IVD, the method for establishing its ground truth is not detailed. For typical IVD development, calibration and controls are used, and the assay design itself is based on known biochemical interactions.

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This is an enzyme immunoassay test system for the detection of antibodies to Proteinase 3 (PR3) in human serum. This test system is to be used as an aid in the detection of antibodies associated with Wegener's granulomatosis and other vasculitides.

This is an enzyme immunoassay for the detection of antibodies to Proteinase 3 (PR3) in human serum.

The Immuno Concepts RELISA® PR3-ANCA Test System for Antibodies to Proteinase 3 was evaluated for substantial equivalence to the Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit. The study involved a comparison of both devices using a diverse set of human serum samples.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state pre-defined acceptance criteria values for relative sensitivity, specificity, and overall agreement. However, the study aims to demonstrate substantial equivalence to the predicate device. The reported performance metrics based on the comparison serve as the de facto demonstration of equivalence.

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

• Test Set Sample Size: 756 samples (206 samples submitted for ANCA, MPO, PR3 testing, 7 Churg-Strauss syndrome, 18 vasculitis, 25 Wegener's granulomatosis, 261 male blood donors, 239 female blood donors).
• Data Provenance: The origin of the samples (e.g., country) is not explicitly stated. The samples were from patients with specific diagnoses, those submitted for ANCA testing, and blood donors, indicating a mix of clinical and presumably healthy populations. The data appears to be retrospective, collected from existing clinical and donor samples.

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

The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set. The comparison is made against a legally marketed predicate device, implying the predicate device's results are used as the reference, rather than independent expert adjudication.

However, for the 8 "false positive" samples identified by the new device, additional immunofluorescence patterns (P-ANCA, C-ANCA) were noted, and patient diagnoses (Wegener's granulomatosis, Churg-Strauss syndrome) were considered. This suggests some level of clinical context or expert review for specific discordant cases, but a formal "ground truth establishment" process by experts is not detailed.

4. Adjudication Method for the Test Set:

No formal adjudication method (e.g., 2+1, 3+1) for the test set is described. The study primarily compares the performance of the new device against the predicate device. For discordant results, especially "false positives" of the new device, immunofluorescence patterns and patient diagnoses were used to provide further context, suggesting a form of retrospective review rather than pre-defined adjudication.

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

No MRMC comparative effectiveness study was performed or described. This study focuses on the performance of an in vitro diagnostic test system, not on human readers' interpretive skills with or without AI assistance.

6. Standalone Performance:

Yes, a standalone performance study was conducted. The Immuno Concepts RELISA® PR3-ANCA Test System was tested independently on the 756 samples, and its results were then compared to those of the predicate device. The performance metrics (relative sensitivity, specificity, overall agreement) reflect the standalone performance of the new device in relation to the predicate.

7. Type of Ground Truth Used:

The "ground truth" for this study is established by the results of the predicate device, the Bindazyme™ Anti-PR3 Enzyme Immunoassay Kit. In cases of disagreement, additional clinical information such as immunofluorescence patterns and patient diagnoses were considered to analyze potential "false" results, implying a form of expert or clinical consensus interpretation for discordant cases.

8. Sample Size for the Training Set:

The document describes a comparison study against a predicate device and does not mention a separate training set. This suggests that the device being studied (Immunoconcepts RELISA PR3-ANCA) was likely developed using its own internal development/training data, which is not disclosed in this 510(k) submission. The samples described in the study are explicitly designated for the comparison or test phase.

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

As no training set is discussed in this document, the method for establishing its ground truth is not provided.

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