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The MESACUP TEST MPO is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-myeloperoxidase (MPO) antibodies in human serum. The MESACUP TEST MPO is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as microscopic polyarteritis and crescentic glomerulonephritis.

The MESACUP Test MPO 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 myeloperoxidase antigen. Incubation allows the anti-MPO 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 MPO bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-MPO antibodies. Optical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two callbrators to measure the amount of anti-MPO antibody in patient samples.

Acceptance Criteria and Device Performance Study

The MESACUP Test MPO is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative detection of IgG anti-MPO antibodies in human serum to aid in the diagnosis of certain systemic vasculitides. The device's performance was compared to a legally marketed predicate device, the Bindazyme Human Anti MPO Enzyme Immunoassay Kit (K981030).

1. Table of Acceptance Criteria and Reported Device Performance

The public summary does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it focuses on demonstrating equivalence to the predicate device. The primary performance metrics reported are clinical specificity and sensitivity.

Note: The acceptance criteria are "implied" based on the phrasing "Performance indicates that MESACUP Test MPO and the Bindazyme Human Anti MPO Enzyme Immunoassay are equivalent" and the direct comparison of performance metrics.

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

• Test Set Sample Size:
  • Healthy Donor Serum Population: The specific number is not provided, but the document mentions "a healthy donor serum population."
  • Vasculitis Population: The specific number is not provided, but the document mentions "a vasculitis population."
• Data Provenance: The studies were described as "In-house studies." This typically suggests that the studies were conducted by the manufacturer or a contracted research organization. There is no information regarding the country of origin or whether the data was retrospective or prospective.

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

This type of information is generally not applicable to an ELISA device performance study for antibody detection. The "ground truth" for ELISAs is typically established by the clinical diagnosis of the patient from whom the serum sample was taken (e.g., diagnosed with a vasculitis, or considered healthy). The diagnostic status of the patients (e.g., healthy vs. vasculitis) would have been determined by medical professionals (e.g., physicians, specialists) involved in their care, but these individuals are not functioning as "experts" establishing a ground truth for the device's output in the way a radiologist would interpret an image.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretations, such as image analysis, where multiple readers provide their opinion and discrepancies need to be resolved. This is not applicable to an objective laboratory test like an ELISA, where the result is a numerical optical density reading that is then interpreted against cutoff values.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for diagnostic devices that involve human interpretation of results (e.g., imaging devices) to assess reader performance with and without AI assistance. This document describes an in vitro diagnostic (IVD) device that yields a quantitative result, not one where human readers perform a diagnostic interpretation based on the device's direct output in a way that could be "assisted" by AI.

6. Standalone (Algorithm Only) Performance

Yes, the study primarily describes the standalone performance of the MESACUP Test MPO. As an ELISA kit, it is effectively an "algorithm only" device in a laboratory setting, producing a result based on chemical reactions and optical density measurements, without requiring human "in-the-loop" interpretation beyond performing the assay and reading the result. The performance metrics (sensitivity, specificity, relative agreement) directly reflect this standalone performance.

7. Type of Ground Truth Used

The ground truth for the test samples was based on the clinical status of the patients:

• "Healthy donor serum population": These samples represent individuals without the target condition, providing the ground truth for specificity.
• "Vasculitis population": These samples presumably represent individuals clinically diagnosed with vasculitis, providing the ground truth for sensitivity.

Therefore, the ground truth is based on clinical diagnosis/patient case status, not pathology reports (though pathology may contribute to clinical diagnosis) or expert consensus on the device's output.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" or its sample size. For an ELISA device, the development process typically involves optimizing reagents and protocols, and establishing cutoff values, rather than training an algorithm in the way machine learning models are trained. The samples mentioned (healthy donor and vasculitis populations) are used for "in-house studies" to assess performance and likely to establish or validate cutoff values, which could be considered part of the development/validation process.

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

As noted above, the concept of a "training set" in the context of an ELISA kit is different from that of an AI algorithm. If the "in-house studies" that defined the cutoff values are considered part of a "training" or optimization phase, the ground truth would have been established by the clinical status of the patients (healthy vs. vasculitis diagnosis), similar to the test set. However, the document does not explicitly detail a separate training phase with distinct ground truth methods.

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This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides.

This is an enzyme immunoassay for the detection of antibodies to myeloperoxidase (MPO) in human serum.

Here's an analysis of the provided information regarding the Immuno Concepts RELISA® MPO-ANCA Test System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the FDA's "substantial equivalence" determination, meaning the new device's performance should be comparable to the legally marketed predicate device. While explicit numerical acceptance criteria aren't listed, the study demonstrates performance relative to the predicate device.

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

• Sample Size: A total of 818 samples were used for the test set. Breakdown:
  • 208 samples submitted to clinical laboratories for ANCA, MPO, and PR3 testing (without specific diagnoses).
  • 7 samples from patients with a diagnosis of Churg-Strauss syndrome.
  • 18 patients with a diagnosis of vasculitis.
  • 25 patients with a diagnosis of Wegener's granulomatosis.
  • 261 samples from male blood donors.
  • 239 samples from female blood donors.
• Data Provenance: The document does not explicitly state the country of origin for all samples. However, the predicate device is manufactured in Birmingham, England, UK. The source of the 208 clinical samples is general ("clinical laboratories"), suggesting a broader geographic origin, potentially US. The studies are retrospective, as the samples were "submitted to clinical laboratories" or from patients with existing diagnoses, and then tested in parallel.

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

The concept of "ground truth" as typically established by expert consensus (e.g., radiologists interpreting images) isn't directly applicable here in the same way. For this immunoassay, the "ground truth" for the test set is established by the performance of the predicate device, the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit. The predicate device itself has been legally marketed and its performance implicitly accepted.

The document indicates that for the "false positive" samples identified by the new device, further investigation involved immunofluorescence (P-ANCA pattern). This suggests a second-level diagnostic assessment, but it's not described as an "expert panel" establishing the initial ground truth for the entire sample set.

Therefore, the number and qualifications of experts for establishing ground truth for the entire test set are not explicitly stated as it relies on the predicate device's results.

4. Adjudication Method for the Test Set

The primary "adjudication method" for the test set is direct comparison to the predicate device. Both the Immuno Concepts RELISA® MPO-ANCA Test System and the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit were run in parallel on all 818 samples. Discrepancies were then noted.

For the 38 "false positive" samples (where the new device was positive and the predicate was negative), additional immunofluorescence testing was performed. However, this was for analysis of discrepancies rather than a primary adjudication method for establishing the initial ground truth.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers interpreting cases and comparing their performance with and without AI assistance. The described study is a direct comparison of a new immunoassay device (Immuno Concepts RELISA® MPO-ANCA) against a legally marketed predicate immunoassay device (Bindazyme™ Anti-MPO Enzyme Immunoassay Kit). It does not involve human readers interpreting "cases" in the typical sense of imaging or clinical diagnostics.

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

Yes, a standalone performance study was done. The Immuno Concepts RELISA® MPO-ANCA Test System was run independently on all samples, and its results were then compared to the results of the predicate device, which also ran independently. There was no human interpretation or interaction with the device's output influencing the reported performance metrics (sensitivity, specificity, agreement). The device's output for each sample was a positive or negative result.

7. Type of Ground Truth Used

The primary "ground truth" used for this study is the results obtained from the legally marketed predicate device (Bindazyme™ Anti-MPO Enzyme Immunoassay Kit). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices where a new device is compared against an established, validated method. For discrepant results, some additional immunofluorescence testing was used as a secondary method of investigation.

8. Sample Size for the Training Set

The document does not provide information on a training set. This type of 510(k) submission focuses on the performance of a final, manufactured device. If the Immuno Concepts RELISA® MPO-ANCA Test System involved machine learning or an "algorithm" in a development phase, details of its training set would typically be described during its initial development, not necessarily in this specific regulatory submission which focuses on the final product's comparison to a predicate. It's likely that this immunoassay kit does not involve a machine learning algorithm in the sense of needing a "training set" for model development; rather, it's a biochemical assay for which performance characteristics are established via testing.

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

As no training set is described (see point 8), this information is not applicable or provided in the document.

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