(350 days)
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EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the the EliA IgG method on the instruments Phadia 100 and Phadia 250.
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EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the the EliA IgM method on the instruments Phadia 100 and Phadia 250.
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EliA B2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to B2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) a as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgG uses the the EliA IgG method on the instruments Phadia 100 and Phadia 250.
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EliA B2-Glycoprotein I IgM is intended for the in vitto semi-quantitative measurement of IgM antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgM uses the the EliA IgM method on the instruments Phadia 100 and Phadia 250.
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EliA APS Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and B2-Glycoprotein I with Phadia 100 using the EliA IgG or IgM method.
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EliA APS Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and ß2-Glycoprotein I with Phadia 250 using the EliA IgG or IgM 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-Methylumbellifery I-BD-Galactoside as substrate. The conjugate for the EliA IgM method is mouse anti-human IgM beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate. The total IgG and IgM calibration is based on a set of six WHO-standardized IgG and IgM Calibrators, respectively, 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 provided text is a 510(k) summary for in-vitro diagnostic devices (EliA Immunoassays) and a separate 510(k) notification for a medical device (PANPAC HSG Catheter Set).
The request asks for information regarding acceptance criteria and a study proving a device meets these criteria. However, for the EliA Immunoassays, the document focuses on establishing substantial equivalence to predicate devices rather than defining specific acceptance criteria for performance and then proving the device meets them through a detailed study.
Therefore, the following information can be extracted for the EliA Immunoassays, but it's important to note the nature of the submission (510(k) for IVDs) means the "acceptance criteria" discussed are largely related to analytical performance demonstrating equivalence to predicates, not clinical efficacy or diagnostic accuracy against a definitive gold standard in the same way a new AI-powered diagnostic might be evaluated.
Here's an attempt to answer the questions based on the provided text for the EliA Immunoassays:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of predetermined acceptance criteria with corresponding reported device performance values in the format usually seen for novel device approvals. Instead, it makes a general statement about laboratory equivalence based on comparison studies. The emphasis is on "substantial equivalence" to predicate devices.
The reported device performance, in this context, is that all available data support that the new devices are substantially equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "The comparability of predicate device and new device is supported by a data set including:
- 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)."
However, specific sample sizes for these comparison studies are not provided in this summary.
Data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable or provided for this 510(k) submission. For in-vitro diagnostic devices like these immunoassays, ground truth for "clinically defined sera" would typically come from a clinical diagnosis of antiphospholipid syndrome (APS) or related thrombotic disorders, which involves a constellation of clinical findings and laboratory tests, not solely expert interpretation of an image or single test. The document does not detail how the clinical status of the "clinically defined sera" was established or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable or provided for this type of in-vitro diagnostic test. Adjudication methods are typically relevant for studies involving human interpretation of data, such as images, where multiple readers might offer differing opinions.
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 is not applicable or provided. The device is an immunoassay for semi-quantitative measurement of antibodies, not an AI-powered diagnostic interpreted by human readers. Therefore, an MRMC study and
the concept of human readers improving with AI assistance are irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device operates in a standalone manner as an "in vitro semi-quantitative measurement" system. The instruments (Phadia 100 and Phadia 250) are "fully automated immunoassay analyzers, which include software for evaluation of test results." The results are generated directly by the instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for the studies mentioned ("clinically defined sera" and "samples from apparently healthy subjects") would be a combination of clinical diagnosis for patients with APS or thrombotic disorders, and the absence of disease for healthy subjects. The document does not specify the exact diagnostic criteria or the methods used to determine these clinical statuses.
8. The sample size for the training set
The document does not specify a training set sample size. For a traditional immunoassay device like this, the concept of a "training set" in the context of machine learning (AI) is not directly applicable. The device's performance is established through analytical validation and comparison with predicate devices, rather than an AI model training process.
9. How the ground truth for the training set was established
As there is no mention of an AI training set, this question is not applicable. For the development and validation of the immunoassays, the "ground truth" for calibrators would be established through a set of six WHO-standardized IgG and IgM Calibrators, derived from human serum, as mentioned in the "General Description of the New Devices." These calibrators define the assay's measurement scale.
Summary Limitations:
The provided 510(k) summary is for traditional in-vitro diagnostic immunoassays, not an AI-powered device. Therefore, many of the questions asked, particularly those related to expert adjudication, MRMC studies, and AI-specific training/test sets, are not applicable to the content of this document. The document focuses on demonstrating substantial equivalence to existing predicate devices based on analytical performance and comparability studies, rather than a de novo clinical validation against specific diagnostic accuracy criteria.
§ 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).