(271 days)
EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 100.
EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 250.
EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangitis (MPA) in conjunction with other laboratory and clinical findings. EliA IgG method on the instrument Phadia 100.
EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangitis (MPA) in conjunction with other laboratory and clinical findings. EliA IgG method on the instrument Phadia 250.
EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to alpha3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 100.
EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to alpha3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 250.
EliA ANCA/GBM Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 100 using the EliA IgG method.
EliA ANCA/GBM Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 250 using the EliA IgG method.
The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.
The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ß-D-Galactoside as substrate.
The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.
The Phadia US, Inc. EliA™ PR3s, EliA™ MPOs, and EliA™ GBM immunoassays are intended for the semi-quantitative measurement of IgG antibodies to PR3, MPO, and alpha3 chain of collagen IV, respectively. These tests aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA), microscopic polyangitis (MPA), and Goodpasture syndrome when used in conjunction with other laboratory and clinical findings. The EliA ANCA/GBM Positive Controls are for monitoring the performance of these immunoassays.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) for the new devices (EliA PR3s, EliA MPOs, EliA GBM). Instead, it focuses on demonstrating "laboratory equivalence" to predicate devices.
The study indicates:
- Results obtained within a comparison study between new and predicate device.
- Results obtained for clinically defined sera.
- Results obtained for samples from apparently healthy subjects (normal population).
The overarching conclusion is: "In summary, all available data support that the new devices are substantially equivalent to the predicate devices."
Without explicit quantitative criteria, a table like the one requested cannot be fully populated. However, if we infer "equivalence" as the acceptance criterion, the reported performance is that this equivalence was supported by the comparison studies.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a data set including results obtained within a comparison study between new and predicate device, results obtained for clinically defined sera, and results obtained for samples from apparently healthy subjects (normal population)."
- Test Set Sample Size: The document does not specify the exact sample sizes used for the comparison study, clinically defined sera, or healthy subjects.
- Data Provenance: The document does not specify the country of origin for the data. It also does not explicitly state if the data was retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic, it is highly probable that the "clinically defined sera" and "samples from apparently healthy subjects" would be retrospective collections, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document describes the devices as "intended for the in vitro semi-quantitative measurement of IgG antibodies... to aid in the clinical diagnosis... in conjunction with other laboratory and clinical findings." The "clinically defined sera" implies that the cases likely had their diagnosis confirmed by clinical experts.
- Number of Experts: The document does not specify the number of experts used to establish the ground truth for the clinically defined sera.
- Qualifications of Experts: The document does not specify the qualifications of these experts. However, for "clinically defined" cases, it would typically involve physicians specializing in the relevant diseases (e.g., rheumatologists, nephrologists) who use a combination of clinical symptoms, imaging, and other laboratory tests for diagnosis.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the devices are immunoassays, which are laboratory tests that produce a quantitative or semi-quantitative result. They are not image-based AI tools interpreted by human readers, so an MRMC comparative effectiveness study involving human readers is not applicable to this type of device.
6. Standalone (Algorithm Only) Performance
- Was a standalone study done? Yes, the described "comparison study between new and predicate device," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects" represent the standalone performance of the immunoassay system. The device itself (the immunoassay) produces the semi-quantitative measurement of antibodies. There is no human-in-the-loop component for interpreting the direct output of these specific diagnostic tests, although a clinician then uses these results in conjunction with other findings for diagnosis.
7. Type of Ground Truth Used
The ground truth for the clinical cases appears to be "clinically defined diagnoses." The document specifically mentions "clinically defined sera," implying that patients were diagnosed with GPA, MPA, or Goodpasture syndrome based on established clinical criteria, which would likely include a combination of clinical symptoms, other laboratory tests, and potentially biopsy results (e.g., pathology for kidney biopsies in Goodpasture syndrome). For the "healthy subjects," the ground truth is the absence of these diseases.
8. Sample Size for the Training Set
The document does not provide information on a specific "training set" sample size. For an immunoassay, the "training" analogous to machine learning often involves assay development, optimization, and establishment of referent ranges and cut-offs. The sample sets described ("comparison study," "clinically defined sera," "healthy subjects") are typically used for validation or verification of performance, not explicitly for "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is described in the context of machine learning, the establishment of its ground truth is not applicable. For the performance studies, as mentioned in point 7, the ground truth was based on clinically defined diagnoses.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).