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The Platelia™ Toxo IgM kit is an in-vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasma gondii in human serum or plasma (EDTA, Heparin, Citrate)

Note:

• Patient testing with the Platelia™ Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
• The Platelia™ Toxo IgM assay is presumptive for the detection of anti-Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection.
• The performance of the Platelia™ Toxo IgM assay has not been established for neonate testing.
• The Platelia™ Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening.

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The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information required to answer all parts of your request comprehensively. The document confirms the device's substantial equivalence to a predicate device and states its intended use, but it does not detail the specific performance study, acceptance criteria, or the methodology of ground truth establishment.

However, based on the information that is present, here's what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the given document. The document is a clearance letter, not a summary of the performance study itself.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided.

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 information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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 test kit for qualitative detection of antibodies, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study with human readers assisting AI or vice-versa would not be applicable in this context. The document does not mention any AI component.

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

The device is an "in-vitro diagnostic test kit" designed for qualitative detection of antibodies. This implies that the 'device' itself performs the detection without further human interpretation beyond reading the results. Therefore, yes, its performance would inherently be 'standalone' in the context of it being a laboratory assay. However, the study details proving this standalone performance are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. For an antibody detection kit like this, ground truth would typically be established by a combination of a highly sensitive and specific reference method (e.g., Western blot, PCR, or a highly validated serological test with known clinical correlation) and/or clinical diagnosis confirmed by patient outcomes or other established diagnostic criteria for Toxoplasma gondii infection.

8. The sample size for the training set

This information is not provided. For an IVD kit, the term "training set" is less common than for AI models; instead, manufacturers might refer to data used during assay development and optimization.

9. How the ground truth for the training set was established

This information is not provided.

Summary of available information:

• Device Name: Bio-Rad Platelia™ Toxo IgM
• Indication For Use: Qualitative detection of anti-Toxoplasma gondii IgM in human serum or plasma. Presumptive for acute, recent or reactivated Toxoplasma gondii infection. Must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
• Limitations: Not established for neonate testing. Not cleared/approved for blood/plasma donor screening.
• Regulatory Class: II
• Product Code: LGD
• Nature of Device: In-vitro diagnostic test kit (laboratory assay).

To get the detailed information you requested, you would need to consult the full 510(k) submission summary or the actual study reports submitted to the FDA, which are not part of this clearance letter.

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