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The & PR-3 IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative detection and semi-quantitation of antibodies against the Proteinase-3 antigen in serum as an aid in the diagnosis of Wegeners granulomatosis. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.

The & PR-3 IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Proteinase-3 in human serum.

Here's a breakdown of the acceptance criteria and the study details for the Columbia Bioscience, Inc. & PR-3 IgG ELISA Kit based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are implied by the results presented in the performance studies, showing that the device achieved these values. Explicit pre-defined acceptance thresholds are not directly stated in the summary, but the reported performance serves as the basis for substantial equivalence.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Note on Acceptance Criteria: For diagnostic kits like ELISA, typical acceptance criteria for sensitivity and specificity are often high (e.g., >90% or >95%), and for precision, Coefficient of Variation (CV%) values are expected to be low (e.g., <20% for positive samples, although negative samples can have higher CV% due to values close to zero). The provided document doesn't explicitly state the pre-defined acceptance criteria but presents the achieved performance as a demonstration of suitability.

Study Details

This submission describes standalone performance studies for the & PR-3 IgG ELISA Kit. It does not appear to involve a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it explicitly mention human readers or AI assistance. The device is an in-vitro diagnostic (IVD) kit for antibody detection.

2. Sample Size and Data Provenance

• Test Set (Relative Sensitivity and Specificity):

  • Sample Size: 256 frozen retrospective sera.
  • Data Provenance: Not explicitly stated, but the mention of "frozen retrospective sera" suggests samples collected from various sources over time. No country of origin is specified.
  • Retrospective/Prospective: Retrospective.

• Test Set (Clinical Sensitivity and Specificity):

  • Sample Size: 256 frozen retrospective, characterized sera.
  • Data Provenance: Not explicitly stated.
  • Retrospective/Prospective: Retrospective.

• Test Set (Precision):

  • Sample Size: Six sera (four positive, two negative) assayed ten times each in three different runs. This represents 180 individual tests per site (6 samples * 10 reps * 3 runs).
  • Data Provenance: Not specified.
  • Retrospective/Prospective: Prospective (lab-based testing of selected sera).

• Test Set (Correlation of Manual and MAGO Plus Results):

  • Sample Size: 90 serum samples.
  • Data Provenance: Not specified.
  • Retrospective/Prospective: Not specified, but likely prospective testing on a set of existing samples.

• Test Set (MAGO Plus Precision):

  • Sample Size: Six sera assayed ten times each in three different runs. This represents 180 individual tests.
  • Data Provenance: Not specified.
  • Retrospective/Prospective: Prospective (lab-based testing of selected sera).

3. Number of Experts and Qualifications for Ground Truth

• Relative Sensitivity and Specificity: The "ground truth" for this section was another commercially available ELISA for anti-PR-3 antibodies. No human experts were involved in establishing this "ground truth" as it compares one test kit against another.
• Clinical Sensitivity and Specificity: The "ground truth" was established by "characterized sera" which were classified into "Normals," "Wegener's Granulomatosis," and "Microscopic Polyangiitis" patient groups. The summary does not specify the number of experts, their qualifications, or the method by which these characterizations were made. It's likely these were clinically diagnosed and confirmed cases based on established medical criteria, but details are absent.

4. Adjudication Method for the Test Set

Not applicable. The concept of adjudication by human experts typically applies to image interpretation or clinical diagnosis scenarios where multiple experts review and reconcile differences. For this ELISA kit, the "ground truth" was either another commercial ELISA kit or pre-characterized patient groups.

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

No, an MRMC comparative effectiveness study was not conducted. This refers to comparing human reader performance with and without AI assistance, which is not relevant to this IVD (ELISA) kit.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone study was performed. The entire performance evaluation focuses on the performance of the & PR-3 IgG ELISA Kit itself, either manually or in conjunction with the MAGO Plus automated EIA processor. There is no human-in-the-loop component being evaluated in the reported performance metrics.

7. Type of Ground Truth Used

• Relative Sensitivity and Specificity: The ground truth was based on the results of a "similar assay" (another commercially available ELISA).
• Clinical Sensitivity and Specificity: The ground truth was based on "characterized sera" representing patient groups (Normals, Wegener's Granulomatosis, Microscopic Polyangiitis). This implies a form of clinical diagnosis/classification rather than direct pathology or outcome data, although pathology would likely be part of the diagnosis for these conditions.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI model development. This ELISA kit is a biochemical assay, not a machine learning algorithm. The samples described are for performance validation (test set).

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set described for an algorithm.

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