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The illumigene Mycoplasma Direct 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 swabs obtained from patients suspected of having Mycoplasma pneumoniae infection.

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

Results from the illumigene Mycoplasma Direct 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 Direct DNA Amplification Assay may be necessary.

The illumigene Molecular Diagnostic Test System is comprised of the illumigene® Mycoplasma Direct DNA Amplification Assay Test Kit, the illumigene Mycoplasma Direct External Controls Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System.

The illumigene Mycoplasma Direct molecular assay utilizes loop-mediated amplification (LAMP) technology to detect Mycoplasma pneumoniae in throat swab specimens. The illumigene Mycoplasma Direct kit includes illumigene Sample Preparation Apparatus III (SMP PREP II), illumigene Mycoplasma Test Devices, and Heat Treatment Tubes. The throat swab is added directly to the SMP PREP II, which contains assay control buffer. Samples processed through SMP PREP II (sample/control mixture) are heat treated to make target and control DNA available for amplification. The heat-treated sample is added to the illumigene Mvcoplasma Test Device.

The illumipro-10 heats each illumigene Mycoplasma Test Device containing prepared sample and control material, facilitating amplification of target DNA. When M. pneumoniae is present in the specimen, a 208 base pair (bp) sequence of the M. pneumoniae intracellular protease-like gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, S;) and at the assay Run End (Signal final, S;). The illumipro-10 calculates the change in light transmission between Run End and Run Start (S, :S, ) and compares the ratio to a fixed cut-off value for disposition of results.

Fixed cut-off values for the TEST chamber are used to report sample results. TEST chamber Sy:S, ratios less than 82% are reported as 'POSITIVE'; TEST chamber S;.S; ratios greater than or equal to 82% are reported as 'NEGATIVE'. Numerical values are not reported. Fixed cut-off values for the CONTROL chamber are used to determine validity. CONTROL chamber S; S, ratios less than 90% are considered valid and allow for reporting of TEST chamber results (POSITIVE, NEGATIVE). CONTROL chamber S;& ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as 'INVALID'. More stringent cut-off criteria are applied to the CONTROL chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately.

The illumigene Mycoplasma Direct External Control Kit contains a Positive Control reagent for use in routine Quality Control testing; the illumigene Sample Preparation Apparatus III reagent provided with the Mycoplasma Direct Kit serves as the External Negative Control reagents are provided to aid the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors.

The provided text describes the illumigene Mycoplasma Direct DNA Amplification Assay and its performance through analytical and clinical studies. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state "acceptance criteria" in a separate section. However, the approval of the device indicates that the observed performance was acceptable to the FDA for substantial equivalence. For the purpose of this response, I will interpret the reported clinical performance statistics as meeting implied acceptance criteria for substantial equivalence to the predicate device.

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

• Sample Size for Test Set: A total of 458 prospective, de-identified human throat swab specimens were evaluated in the clinical study. Two samples were excluded, resulting in 456 eligible samples for analysis.
• Data Provenance: The clinical studies were conducted in 2015-2016 at independent clinical test sites representing three geographically distinct regions throughout the United States. The data is prospective as specimens were collected under informed consent from symptomatic patients.

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

The text does not specify the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The text describes that the performance of the illumigene Mycoplasma Direct assay was compared to a reference molecular in vitro diagnostic method, the illumigene Mycoplasma DNA Amplification Assay (Meridian Bioscience, Inc., Cincinnati, OH). This indicates that the predicate device serves as the ground truth or "referee" method. There is no mention of a human expert adjudication method for resolving discrepancies beyond further testing for specific samples (e.g., 4/10 samples identified positive by illumigene Mycoplasma after testing with an additional frozen sample).

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 section is not applicable. The device is an in vitro diagnostic (IVD) assay for molecular detection, not an AI or imaging device involving human readers or interpretation of complex data by experts. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The illumigene Mycoplasma Direct DNA Amplification Assay is an automated system where the illumipro-10™ instrument performs the amplification and detection, and then calculates the ratio of light transmission to compare against fixed cut-off values to report results as 'POSITIVE', 'NEGATIVE', or 'INVALID'. The system operates without human interpretation of the primary result (the S_f:S_i ratio). The clinical study data (PPA, NPA, OPA) directly reflects this standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the clinical study was established by comparing the results of the illumigene Mycoplasma Direct assay to those of a reference molecular in vitro diagnostic method, the illumigene Mycoplasma DNA Amplification Assay (Meridian Bioscience, Inc.). This is a laboratory-based molecular assay, acting as the "gold standard" or highly accurate reference.

8. The Sample Size for the Training Set

The text does not explicitly state a separate "training set" sample size. The description of the assay cut-off development mentions "development optimization of characterized positive and negative clinical specimens" and that "amplification reagent concentrations are adjusted during design as needed to ensure illumigene results are aligned with clinical specimen reported results." This implies internal development and optimization using samples, but a distinct, quantified "training set" as understood in machine learning is not detailed. The 456 clinical samples mentioned are for evaluating performance against the predicate, not for training.

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

Given that a specific "training set" is not explicitly defined with sample size, the method for establishing its ground truth is also not explicitly stated. However, considering the nature of the device (a molecular diagnostic assay), it is highly probable that any internal "training" or optimization samples would have their Mycoplasma pneumoniae status confirmed using highly accurate laboratory methods, similar to or including the predicate device, or other established molecular or culture-based techniques. The text mentions "development optimization of characterized positive and negative clinical specimens," implying these internal samples were well-defined for their Mycoplasma pneumoniae status.

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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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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 amplification (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 Molecular Diagnostic Test System is comprised of the illumigene® Mycoplasma DNA Amplification Assay Test Kit, the illumigene® Mycoplasma External Control Kit and the illumipro-10™ Automated Isothermal Amplification and Detection System.

The illumigene Mycoplasma assay utilizes loop-mediated isothermal amplification (LAMP) technology to detect the presence of Mycoplasma pneumoniae in human respiratory specimens (throat and nasopharyngeal swab specimens), Each illumigene Mvcoplasma assay is completed using an illumicene Assay Control Reagent containing Control material, an illumigene Reaction Buffer, an illumigene Mycoplasma Test Device and microcentrifuge tubes. Respiratory specimens are combined with the illumigene Assay Control Reagent. The Speciment is manually extracted and purfied using a commercially available extraction kit (Qiagen, QlAamp® DSP DNA Mini Kit). Extracted DNA is heat-treated. Target and Control DNA are made available for isothermal amplification via heattreatment. The heat-treated Specimen/Control sample is added to the illumigene Reaction Buffer. DNA amplification occurs in the illumigene Test Device.

The illumipro-10 heats each illumigene Mycoplasma Test Device containing prepared Sample and Control material. facilitating amplification of target DNA. When M. pneumoniae is present in the specimen, a 200 base pair sequence of the M. pneumoniae genome is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture.

The illumipro-10 monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signalinia) S) and at the assay Run End (Signalmar, S). The illumipro-10™ calculates the ratio of the Run End (Signal final or S) reads with the Run Start (Signal Initial or S) reads and compares the ratio to an established cut-off value. The illumipro-10 performs this ratio calculation to both the TEST chamber and the CONTROL chamber.

Fixed cut-off values for the CONTROL chamber are used to determine validity. CONTROL chamber S;S; ratios less than 90% are considered valid and allow for reporting of TEST chamber results (POSITIVE, NEGATIVE). CONTROL chamber S; S; ratios greater than or equal to 90% are considered invalid. Results are reported as 'INVALD': Test chamber results are not reported. More stringent cut-off criteria are applied to the Control chamber reaction to ensure amplification is not inhibited, reagents are performing as intended and that sample processing was performed appropriately.

Fixed cut-off values for the TEST chamber are used to report sample results. TEST chamber Sy:S ratios less than 82% are reported as 'POSITIVE'; TEST chamber S;S; ratios greater than or equal to 82% are reported as 'NEGATIVE'. Numerical values are not reported.

The illumigene Mycoplasma External Controls Kit contains a Positive Control Reagent, External Control reagents are provided to aid the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. External Control reagents are provided for use in routine Quality Control testing.

illumipro-10™ Automated Isothermal Amplification and Detection System:

The illumipro-10™ heats each illumigene Mycoplasma Test Device containing prepared samples and Control Reagent, facilitating amplification of target DNA. When Mvcoplasma pneumoniae is present in the respiratory swab sample, a conserved sequence of the M. pneumoniae is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10 detects the change in light transmission through the reaction mixture created by the precipitating magnesium pyrophosphate. The illumipro-10 reports sample results as INVALID, POSITIVE or NEGATIVE based on the detected change in light transmission.

The illumipro-10™ System Description was reviewed in previous submission. K10012. K112125. K121044 and K122019. No system or software changes were made for the illumigene Mycoplasma assay.

Here's a summary of the acceptance criteria and the study that proves the illumigene® Mycoplasma DNA Amplification Assay meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance for illumigene® Mycoplasma DNA Amplification Assay

The illumigene® Mycoplasma DNA Amplification Assay is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs. The performance was evaluated through clinical and non-clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity or specificity. Instead, it presents the achieved performance characteristics, which are then compared to a predicate device (FilmArray® Respiratory Panel (RP) System). The "acceptance criteria" are implied by the results needing to be comparable or superior to the predicate and generally indicative of accurate diagnostic performance.

Below is a summary of the device's reported clinical performance:

illumigene® Mycoplasma DNA Amplification Assay Performance

Note: The performance values presented are against a Composite Reference Method. For retrospective throat swabs, an additional comparison to PCR with Bi-Directional Sequencing is provided, showing PPA of 100.0% (95% CI: 84.5 - 100.0%) and NPA of 97.2% (95% CI: 90.4 - 99.2%).

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

• Total Test Set Sample Size: 334 qualified throat and nasopharyngeal (NP) swab specimens.
• Split by Type:
  • Prospective Samples: 103 specimens
  • Retrospective Samples: 219 specimens
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submission is to the US FDA by a US-based company (Meridian Bioscience), implying clinical studies were likely conducted in the US.
  • Retrospective or Prospective: Both. The clinical study included both "leftover deidentified specimens submitted to the testing laboratories for routine M. pneumoniae testing. Specimens included in performance evaluation were prospective (never frozen) and retrospective (frozen prior to illumigene testing)."

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

The document does not mention the number or specific qualifications of experts for establishing ground truth. The ground truth was established using a "Composite Reference Method."

4. Adjudication Method for the Test Set

The adjudication method relies on a "Composite Reference Method" as the ground truth. This method included:

• M. pneumoniae bacterial culture with identification
• A validated real-time PCR assay followed by bi-directional sequencing.

Specimens were considered positive if they produced positive Mycoplasma pneumoniae results from either bacterial culture or real-time PCR and bi-directional sequencing. Specimens negative for both culture and PCR were considered negative. No mention of an explicit expert adjudication process for discordant results is made beyond the composite reference method itself.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is an automated DNA amplification assay, not an imaging device requiring human reader interpretation. Therefore, a study to assess human reader improvement with AI assistance is not applicable in this context.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was conducted. The "illumigene® Mycoplasma DNA Amplification Assay, performed on the illumipro-10™" is an automated device designed to produce results (POSITIVE, NEGATIVE, INVALID) directly. The performance data presented in the tables (sensitivity, specificity, PPA, NPA) reflect the standalone performance of the illumigene system.

7. Type of Ground Truth Used

The ground truth used was a Composite Reference Method which included:

• M. pneumoniae bacterial culture with identification.
• A validated real-time PCR assay followed by bi-directional sequencing.
  • Positive: A specimen was considered positive if either bacterial culture or real-time PCR and bi-directional sequencing yielded a positive result.
  • Negative: A specimen was considered negative if both culture and PCR were negative.

8. Sample Size for the Training Set

The document does not explicitly specify a "training set" for the clinical performance evaluation. The clinical studies evaluated the performance of the already developed assay on clinical specimens. The assay's internal "optimization" during development would have involved some form of training/tuning, but the size of data used for this is not detailed in the summary. For non-clinical performance (e.g., precision, LoD), contrived samples were used for development and internal testing.

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

For the clinical study used to demonstrate performance: The ground truth was established by the Composite Reference Method as described in point 7.

For the development/optimization of the assay: The document states that "Development optimization includes evaluation of characterized positive clinical specimens. Amplification reagent concentrations are adjusted during design as needed to ensure illumigene results are aligned with clinical specimen reported results." This implies that well-characterized clinical specimens and potentially cultured strains were used to refine the assay's parameters and establish cut-off values. However, details on the specific samples or methods for establishing ground truth for this development/training phase are not provided.

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