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The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection.

The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA ampification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome.

Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the illumigene Mycoplasma DNA Amplification Assay may be necessary.

illumigene Mycoplasma is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection.

The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA ampification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome.

This document is a 510(k) premarket notification for the illumigene Mycoplasma DNA Amplification Assay. It primarily focuses on regulatory approval and does not contain detailed study information or acceptance criteria beyond the intended use and performance claims. Therefore, I cannot provide a comprehensive answer to your request based solely on this document.

However, I can extract the following relevant information:

Device Name: illumigene Mycoplasma DNA Amplification Assay
Intended Use: Qualitative in vitro diagnostic test for direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs from patients suspected of having Mycoplasma pneumoniae infection.

To answer your questions completely, a more detailed study report (often called a "Summary of Safety and Effectiveness" or a "Device Description" document submitted with the 510(k)) would be needed. That report would contain the performance data and the specifics of the clinical study.

Given the information provided, here's what can be inferred or directly stated, with limitations:

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

This document does not explicitly state specific acceptance criteria (e.g., minimum sensitivity or specificity targets) or present a table of reported device performance. It only states the intended use of the device.

2. Sample size used for the test set and the data provenance:

This document does not mention the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). These details would typically be found in the clinical study section of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document does not provide information on the number or qualifications of experts used to establish ground truth.

4. Adjudication method for the test set:

This document does not specify any adjudication method for the test set.

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 a DNA amplification assay, which is a laboratory diagnostic test, not an imaging device typically involving human "readers" or AI assistance in interpretation in the same way as radiology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device.

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

Given it's an "illumigene Mycoplasma DNA Amplification Assay," this is inherently a standalone diagnostic test performed in a lab. The results are then interpreted by laboratory personnel and clinicians. It is a standalone algorithm/device in the sense that its performance evaluation would focus on its accuracy in detecting the target DNA, independent of human interpretation of complex images. The "human-in-the-loop" would be the clinician's use of the result in conjunction with other findings.

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

For a DNA amplification assay, the ground truth for measuring performance (sensitivity and specificity) would typically be established by a reference method, often another highly sensitive and specific molecular test (e.g., PCR with sequencing confirmation), or by culture, which is considered definitive for microbial identification. This document does not explicitly state the ground truth method.

8. The sample size for the training set:

This document does not mention a training set sample size. For a device like this, the "training" may refer to internal optimization and validation studies during development, not a formal external training set that would be documented in the same way as a machine learning algorithm's training set.

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

As above, this document does not provide information on how ground truth for any potential "training set" was established.

In summary, this regulatory notification provides minimal technical detail regarding performance studies. A full understanding would require access to the complete 510(k) submission, specifically the sections detailing analytical and clinical performance studies.

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