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The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.

The Revogene is a PCR instrument that automates lysis and dilution of samples, followed by nucleic acid amplification, and detection of target sequences by fluorescence-based real-time PCR. Revogene runs are orchestrated by a combination of software, firmware and instrument control protocol that ensures the adequate combination times and temperatures for sample homogenization and PCR analysis. The Revogene instrument acquires fluorescence signals generated during amplification. The signals are then interpreted by the system using embedded calculation algorithms.

The Revogene requires the use of a 'PIE', i.e., an assay-specific cartridge to which a patient sample is added. The PIE contains the reagents needed to process a sample and to perform a PCR amplification. When the number of assay PIEs to be run is lower than eight, the user fills empty spaces with "MOCK PIE", which are cartridges that simulate the presence of an assay PIE to confer thermal and rotational balance.

The Revogene instrument subject of this Premarket Notification is substantially equivalent to the Revogene instrument cleared under K222779. Meridian is submitting this 510(k) Premarket Notification to implement a photomultiplier tube (PMT) cooling system. This cooling system keeps the PMT environment at a temperature that prevents the appearance of fluorescence glitches, which may stop the Revogene instrument

The provided document is a 510(k) Premarket Notification for a modified medical device, the Revogene instrument. It focuses on the changes made to an existing device (K222779) and its substantial equivalence to the predicate device.

The document does not contain information about acceptance criteria or a detailed study proving the device meets specific acceptance criteria, as one might find in a clinical trial report for an initial device clearance.

Instead, it describes the performance characteristics of functional testing conducted to demonstrate that the modifications (PMT cooling system and Windows 10 upgrade) do not adversely affect the device's performance compared to the predicate. The goal of this submission is to show substantial equivalence, not to establish new performance acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the traditional sense, nor can I answer many of your specific questions about study design, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided text.

However, I can extract the available information regarding the functional testing that was performed to support the substantial equivalence claim.

Summary of Available Information on Device Performance and Testing:

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

The document does not explicitly state quantitative acceptance criteria. Instead, it describes general observations and conclusions from functional testing. The implicit acceptance criterion is "no statistically significant differences" and "operates as expected and yields expected assay results."

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

• Sample Size for Test Set: The document states "contrived and negative samples in relevant clinical matrix using the following assays...". However, it does not specify the number of samples or runs used for this functional testing.
• Data Provenance: Not explicitly stated, but given it's a regulatory submission by a US company, the testing would typically be conducted according to established protocols within their R&D or QA departments. It is retrospective relative to the design changes, but the testing itself is performed to support the new device version. No information on country of origin of data beyond the manufacturer's location.

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

• This information is not provided as the testing described is functional performance testing of the instrument, not typically involving expert interpretation of patient samples for ground truth establishment. The "ground truth" here is the expected performance of control samples within the assays.

4. Adjudication method for the test set

• This is not applicable/provided. The testing focuses on the instrument's functional output (e.g., Ct values, glitch occurrence) rather than interpretation of results that would require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, this was not done. The device is an instrumentation for clinical multiplex test systems, meaning it processes samples and detects nucleic acids. It does not output images or data that require human readers for interpretation in the way an AI diagnostic imaging device would. Therefore, an MRMC study is not relevant to this type of device or its modifications.

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

• The device itself is a standalone instrument that performs automated lysis, dilution, amplification, and detection. The "algorithm" here refers to the embedded calculation algorithms within the system that interpret fluorescence signals to determine results. The functional testing described is a form of standalone performance evaluation for the modified instrument. There is no human-in-the-loop component mentioned for the actual nucleic acid detection and interpretation process of the instrument.

7. The type of ground truth used

• The ground truth for the functional testing appears to be based on the expected outcomes from known contrived and negative samples when run with specific IVD assays (Revogene® Strep A, Revogene® Carba C and Revogene® SARS-CoV-2). Essentially, the "ground truth" is the established performance of the assays themselves on control materials, and the instrument must correctly process these, showing no statistical degradation from the predicate.

8. The sample size for the training set

• This information is not provided and is generally not applicable in the context of hardware modifications to an existing IVD instrument as described. The "training set" concept is typically relevant for machine learning algorithms, which are not detailed here beyond "embedded calculation algorithms" that likely leverage established PCR physics and signal processing rather than iterative machine learning training.

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

• This information is not provided as there is no mention of a traditional "training set" in the machine learning sense. The established performance of the assays with known control materials serves as the reference for evaluating the modified instrument.

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The Premier HpSA Flex enzyme immunoasay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post- therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

Meridian Bioscience has modified its FDA-cleared PREMIER Platinum HpSA® PLUS assay (K182559), a qualitative, in vitro diagnostic test for the detection of Helicobacter pylori antigens present in unpreserved human stool specimens. This modification, to be marketed under new device trade name Premier HpSA® Flex upon FDA clearance, is the addition of a new specimen type claim to the intended use of the previously cleared device (K182559) whereby specimens may be preserved in Cary-Blair or Culture and Sensitivity (C&S) transport media.

The Premier HpSA Flex test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool specimens, either unpreserved in transport media. The test uilizes a plurality (mixture) of monoclonal anti-H. pylori capture antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text.

Acceptance Criteria and Device Performance

The core of this submission is about adding a new specimen type claim (preserved stool in Cary-Blair or C&S transport media) to an already FDA-cleared device. Therefore, the "acceptance criteria" revolve around demonstrating that the device performs equivalently with these new specimen types as it did with the original unpreserved stool and that the performance remains robust.

Here's a summary of the performance characteristics presented as implicit acceptance criteria and the reported device performance:

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Analytical Sensitivity (LoD): Not explicitly stated how many samples per lot were used in the LoD study, but it mentions "Three lots" and "positive results >= 95% of the time."
   • Precision/Reproducibility: 360 samples (10 panels x 12 blinded samples x 3 laboratories). The samples were "contrived stool samples" with H. pylori antigen spiked in. Data provenance is implied to be domestic (USA) due to the submission context, and it's a prospective study looking at controlled, contrived samples.
   • Preserved Specimen Storage Stability: Not explicitly stated how many samples were used, but the study was designed to validate stability claims.
   • Freeze/Thaw Stability: Not explicitly stated how many samples were used.
   • Analytical Specificity/Interference: Not explicitly stated how many samples were used, but testing was performed in the presence of various substances.
   • Analytical Specificity/Cross-reactivity: Not explicitly stated how many samples were used, but each organism was tested with a true negative and a contrived low positive sample at specified concentrations.
   • Method Comparison (Clinical Performance): 200 archived stool specimens were enrolled, of which 182 were evaluable and used for the comparison. Data provenance is of archived specimens from patients, suggesting retrospective data. The specific country of origin is not mentioned.

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

   • This device is an in-vitro diagnostic (IVD) for detecting antigens, not an imaging device requiring expert interpretation for ground truth.
   • For the Precision/Reproducibility study, "expected assay result" was used as ground truth for contrived samples. This implies the ground truth was based on the known concentration of spiked antigen.
   • For the Method Comparison study, the comparison was against an "FDA-cleared comparator device" and "Standard of Care (SoC) testing using an FDA-cleared commercial assay." The "ground truth" for clinical performance appears to be established by the results of these existing FDA-cleared methods. No human expert consensus was used to define the ground truth for individual samples.

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

   • No human adjudication method was mentioned or implied, as the device is an IVD detecting antigens, and ground truth was established either by known concentrations in contrived samples or by results from existing FDA-cleared assays.

4. 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:

   • No MRMC comparative effectiveness study was conducted. This type of study is typically performed for AI-assisted diagnostic imaging devices where human interpretation directly impacts results. This device is an immunoassay (IVD).

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

   • Yes, the performance data provided (LoD, Reproducibility, Interference, Cross-reactivity, Method Comparison) represent the standalone performance of the Premier HpSA Flex assay. It's an automated or semi-automated EIA, not an algorithm requiring human interaction for its direct output.

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

   • For analytical performance studies (LoD, Precision, Interference, Cross-Reactivity), the ground truth was known concentrations of H. pylori antigen in contrived samples or known presence/absence of interfering/cross-reacting substances/organisms.
   • For the method comparison (clinical performance), the ground truth was established by results from an FDA-cleared comparator device and Standard of Care (SoC) testing using an FDA-cleared commercial assay.

7. The sample size for the training set:

   • This is a traditional in-vitro diagnostic device (immunoassay), not a machine learning/AI algorithm that requires a "training set" in the conventional sense. The device's components and parameters are developed through standard chemistry and assay development processes, not through iterative training on a dataset.

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

   • As stated above, there is no "training set" for an immunoassay in the context of AI/ML. The "ground truth" for the development of the assay itself would align with standard analytical validation methods, ensuring the assay accurately detects the target analyte (H. pylori antigens) at various concentrations and in the presence of relevant interferents, against known standards.

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Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campylobacter-specific antigen in human fecal specimens. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in human stool from patients with signs and symptoms of gastroenteritis. The test is intended for use with unpreserved fecal specimens or preserved fecal specimens in transport media. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures. Curian Campy is intended to aid in the diagnosis of Campylobacter infection.

The Curian® Campy assay is a qualitative in vitro diagnostic test for the detection of Campylobacter-specific antigens in human stool samples collected from individuals with signs and symptoms of gastroenteritis. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in unpreserved or preserved stool in Cary-Blair or C&S transport media. The Curian® Campy assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Campylobacter-specific antigens in human stool.

Here's a breakdown of the acceptance criteria and study details for the Curian Campy device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate section with predefined thresholds. However, based on the presentation of clinical performance data, the implicit acceptance criteria for sensitivity and specificity are demonstrated by the confidence intervals achieved in the clinical studies. For analytical performance, 100% agreement for certain categories and no observed interference/cross-reactivity are the implicit acceptance criteria.

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

• Prospective Clinical Study:
  • Sample Size: 1,474 specimens
  • Data Provenance: Prospective, collected from July 2020 to December 2020 at five clinical study sites across geographically distinct regions throughout the United States.
• Archived Clinical Study:
  • Sample Size: 290 archived samples
  • Data Provenance: Retrospective. The samples had prior culture and speciation results and were retrospectively tested.
• Contrived Study:
  • Sample Size: 210 specimens (150 positive, 60 negative).
  • Data Provenance: Contrived samples (spiked with Campylobacter species).
• Reproducibility Study:
  • Sample Size: 320 samples (160 unpreserved stool, 160 preserved stool in C&S media).
  • Data Provenance: Contrived samples, tested across three sites (one internal, two external).
• Prozone / Hook Effect Study:
  • Sample Size: 14 dilutions (n=7 for preserved, n=7 for unpreserved) tested in replicates of 5.
  • Data Provenance: Contrived samples.
• Cross-Reactivity/Microbial Interference Study:
  • Sample Size: Not explicitly stated as a number, but involves testing various bacteria, fungi, and viral strains (spiked into stool, some clinical Norovirus samples).
  • Data Provenance: Primarily contrived samples, with 5 clinical Norovirus stool specimens.
• Interfering Substances Study:
  • Sample Size: Not explicitly stated, but involves testing C. jejuni low positive contrived samples in the presence of 27 different chemical and biological substances.
  • Data Provenance: Contrived samples.
• Assay Reactivity/Inclusivity Study:
  • Sample Size: Not explicitly stated, but involves testing multiple strains of C. jejuni, C. coli, C. upsaliensis, and C. lari.
  • Data Provenance: Laboratory strains.
• Brush Bridging Study:
  • Sample Size: 53 non-pipettable clinical stool specimens (5 positive, 48 negative) from the prospective and archived clinical studies, plus a panel of contrived samples (25 at 3x LoD, 25 at 5x LoD, 25 negative).
  • Data Provenance: Clinical (from prior studies) and contrived.

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

• Ground Truth for Clinical Studies (Prospective and Archived): The ground truth was established by "standard of care Campylobacter culture and speciation" which is a laboratory method. There is no mention of human experts directly establishing the ground truth for classification of individual samples.
• Ground Truth for Contrived Studies (Reproducibility, Analytical Sensitivity, Prozone, Cross-Reactivity, Interfering Substances, Assay Reactivity): The ground truth was established by creating samples with known concentrations of organisms or by confirming the absence of organisms. This suggests laboratory verification rather than expert clinical assessment.

4. Adjudication Method for the Test Set

• Prospective Clinical Study: For specimens with discordant results between the Curian Campy assay and the reference method (culture and speciation), further evaluation was done using "FDA-cleared commercial nucleic acid amplification test (NAAT)". This acts as a form of adjudication for discordant results, though it's not a human consensus process.
• Archived Study, Contrived Studies, Analytical Performance Studies: No adjudication method is explicitly described for these studies other than the initial ground truth determination.

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

• No MRMC comparative effectiveness study was done.
• This device is an in-vitro diagnostic assay (Curian Campy) read by an automated analyzer (Curian Analyzer), not an AI assisting human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

• Yes, the performance data presented for the Curian Campy assay is standalone. The device (Curian Campy assay with the Curian Analyzer) provides a qualitative result (positive/negative) automatically. The interpretation of results is "automated by Curian Analyzer," and the clinical studies directly evaluate this automated output against a reference standard.

7. The Type of Ground Truth Used

• Clinical Studies (Prospective and Archived): The primary ground truth was culture and speciation for Campylobacter. For discordant results in the prospective study, an FDA-cleared commercial nucleic acid amplification test (NAAT) was used for further evaluation.
• Analytical Performance Studies (Reproducibility, Analytical Sensitivity, Prozone, Cross-Reactivity, Interfering Substances, Assay Reactivity, Contrived Study): The ground truth was based on known concentrations of spiked organisms or known negative samples, verified by laboratory methods.

8. The Sample Size for the Training Set

• The document does not describe algorithmic training. This device appears to be a fluorescence immunoassay interpreted by an analyzer, not a machine learning or AI algorithm that requires a separate training set. The descriptions of "analytical performance" and "clinical performance" are for evaluating the performance of the device itself, not for training an AI model.

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

• As there is no mention of an AI algorithm requiring a training set, this question is not applicable to the information provided.

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Curian HpSA, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H, pylori infection and to demonstrate loss of H. pyloriantigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

The Curian™ HpSA® assay is a qualitative in vitro diagnostic test for the detection of Helicobacter pylori in human stool. The Curian™ HpSA® assay utilizes fluorescence technology with the newly developed Curian™ Analyzer to detect H. pylori antigen. The Curian™ Analyzer has been designed to disposition sample results from lateral flow immunoassays.

Here's a breakdown of the acceptance criteria and study information for the Curian™ HpSA® and Curian™ Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical performance study aiming for substantial equivalence to an FDA-cleared predicate device. The predicate device had a demonstrated sensitivity and specificity ≥ 95%, with a lower bound of the two-sided 95% confidence interval (CI) greater than 89% against a composite reference method. Therefore, the new device's agreement with this predicate is the key performance metric assessed.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: 542 evaluable specimens.
• Data Provenance: The specimens were from the intended use population, collected in a multi-center method comparison study conducted at three sites in the USA. The study appears to be prospective in nature, as it "evaluated" the device for detecting H. pylori stool antigen in human stool.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not explicitly provided in the document for the test set. The clinical study compares the new device to an "FDA-cleared H. pylori stool antigen EIA" which was itself previously evaluated against a composite reference method. The document does not describe the establishment of the ground truth for this specific study's test set, nor the number or qualifications of experts involved in that.

4. Adjudication Method (Test Set)

The primary comparison is between the new device and an FDA-cleared comparator EIA. However, in cases of discordance, PCR was used for adjudication:

• "2/3 Curian HpSA false negatives were dispositioned as negative by PCR"
• "8/14 Curian HpSA false positives were dispositioned as positive by PCR"

This suggests a form of supplementary adjudication using a molecular method for discordant results between the new device and the comparator EIA.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the performance of a diagnostic assay (Curian™ HpSA®) in a standalone clinical comparison against another assay, not the improvement of human readers with AI assistance.

6. Standalone Performance

Yes, a standalone performance study was done. The document explicitly describes the "Comparison of Curian™ HpSA® assay to an FDA-cleared H. pylori Stool Antigen EIA" focusing on the device's accuracy in detecting H. pylori antigen in human stool samples. The device itself (the Curian™ Analyzer) interprets the results from the lateral flow immunoassay.

7. Type of Ground Truth Used (Test Set)

The "ground truth" for the current study is effectively the results from an FDA-cleared H. pylori stool antigen EIA. This predicate EIA was, in turn, previously established against a "composite reference method (i.e., culture, histology, and RUT) for initial H. pylori diagnosis." So, indirectly, the ultimate ground truth is a composite reference method.

8. Sample Size for Training Set

The document does not provide information on the sample size used for the training set. This is an in vitro diagnostic device, and details about its internal algorithm training (if any is applicable beyond general assay development) are not disclosed in this 510(k) summary.

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

The document does not provide information on how the ground truth for the training set was established, as details about training sets are not included in this summary.

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The Alethia CMV Assay Test System includes separately provided test kits for the Alethia CMV DNA Amplification Assay and the Alethia CMV External Control Reagents.

The Alethia CMV DNA Amplification Assay, performed on the Alethia instrument, is a qualitative, in vitro diagnostic test system for the direct detection of Cytomegalovirus (CMV) DNA in saliva samples from neonates younger than 21 days of age. The test is used as an aid in the diagnosis of congenital CMV infection. The results of this test should be used in conjunction with the results of other clinical findings.

Flocked swabs should be used to collect saliva from neonates. The swab can be collected dry, without viral transport media (VTM), or placed in no more than 1 mL VTM.

The Alethia CMV External Control Reagents are used as part of a routine quality control program to aid the user in detection of unexpected conditions that may lead to test errors. The external controls are intended for use with the Alethia CMV DNA Amplification Assay; the controls are not intended for use with other assays or systems.

The Alethia CMV Assay Test System, including the Alethia CMV DNA Amplification Assay and the Alethia CMV External Controls, is based on loopmediated amplification (LAMP) technology. The assay targets a region of the Cytomegalovirus genome that is conserved across multiple CMV strains. The Alethia CMV target is a 194 base pair (bp) sequence of the Human herpesvirus 5 genome.

LAMP uses specially designed primers to provide for specific and continuous isothermal DNA amplification. A bv-product of amplification is magnesium pyrophosphate, which forms a white precipitate leading to a turbid solution. Reaction solution absorbance characteristics are monitored by the Alethia™ instrument.

Changes in reaction solution turbidity created by precipitation of magnesium pyrophosphate indicate the presence of target DNA. The absence of target DNA results in no significant change in sample absorbance.

The Alethia CMV DNA Amplification Assay is a qualitative in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva samples from neonates younger than 21 days of age. It aids in the diagnosis of congenital CMV infection.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Prospective Test Set:
  • Sample Size: 1,514 specimens.
  • Data Provenance: Prospectively collected from August 2017 to March 2018 at seven clinical study sites representing geographically distinct regions throughout the United States, Canada, Europe, and Australia.
• Archived Preselected Positive Samples:
  • Sample Size: 34 specimens.
  • Data Provenance: De-identified samples previously evaluated from prospective clinical studies and found to have CMV infection. Collected from infants less than 21 days of age and stored at -80 ℃. The provenance is retrospective, as they were existing samples used to supplement positive cases.

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

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish the ground truth.

Instead, the ground truth (Composite Reference Method - CRM) was established by a technical algorithm:

• Two manufacturer-developed and validated PCR assays were used.
• Samples positive by either PCR assay were further tested by bidirectional sequencing (BDS).
• Ground Truth: Samples were considered positive when BDS confirmed the presence of CMV DNA, and negative when neither PCR assay produced amplicon after 40 cycles or BDS was negative.

4. Adjudication Method for the Test Set:

The adjudication method for the test set relied on a defined algorithm using two PCR assays and bidirectional sequencing.

• If both PCRs were positive and BDS was positive, it was CRM positive.
• If both PCRs were positive and BDS was negative, it was CRM negative.
• If one PCR was positive and BDS was positive, it was CRM positive.
• If one PCR was positive and BDS was negative, it was CRM negative.
• If both PCRs were negative, it was CRM negative (BDS not applicable).

This is a rule-based algorithmic adjudication, not human consensus-based.

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:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an automated in vitro diagnostic test (qualitative LAMP technology) for direct detection of CMV DNA, not an AI-powered image analysis or diagnostic support tool intended to improve human reader performance. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, the studies presented are for the standalone performance of the Alethia CMV Assay Test System. The device is a qualitative, automated system that detects CMV DNA, providing a POSITIVE, NEGATIVE, or INVALID result based on its internal algorithms and measured absorbance characteristics. Human intervention is limited to sample preparation and operating the instrument, not interpretation of raw signals to determine positivity or negativity. The clinical performance (PPA, NPA) directly reflects the algorithm's accuracy against a molecular ground truth.

7. The Type of Ground Truth Used:

The ground truth used was a Composite Reference Method (CRM) based on molecular testing results (two PCR assays and bidirectional sequencing). This is a type of technical/laboratory ground truth, not expert consensus, pathology, or direct outcomes data.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size for a training set. This type of in vitro diagnostic assay, based on LAMP technology, would typically be developed and optimized using analytical studies (determining LoD, inclusivity, specificity, precision, etc.) and then validated in clinical studies, rather than relying on a separate "training set" in the machine learning sense. The performance characteristics represent the validation of the assay's design.

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

As no explicit training set is detailed for an algorithm in the machine learning sense, the method for establishing its ground truth is not described. The analytical performance evaluations (LoD, inclusivity, specificity) are based on contrived samples with known CMV status and concentration, which serve as the "ground truth" for evaluating those specific analytical characteristics.

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The PREMIER Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

The PREMIER Platinum HpSA® PLUS test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool. The test utilizes a plurality (mixture) of monoclonal antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically. No calculations are required and the visual color change makes the interpretation of results objective and simple.

In addition, the HpSA test permits assessment of established or novel anti-H. pylori treatment during and posttherapy to monitor for treatment effectiveness, relapse or eradication.

PREMIER Platinum HpSA PLUS (K053335), as the predicate device for this submission, was a modification of PREMIER Platinum HpSA (K983255, K980076) that provided increased signal strengths with positive test results and better discrimination between low positive and negative tests. This submission is for modifications to the antibodies used in the microwells and conjugate reagent.

The PREMIER Platinum HpSA PLUS assay is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool, intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy.

Here's the breakdown of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The modification being assessed is to the antibodies used in the microwells and conjugate reagent of the PREMIER Platinum HpSA® PLUS. The relevant performance characteristics for comparison are based on the predicate device.

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

• Sample Size for Clinical Study: 159 archived, unpreserved stool samples.
• Data Provenance: The samples were from symptomatic patients but no country of origin is specified. The samples were "archived," indicating a retrospective study.

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

The documentation does not provide details on the number or qualifications of experts used to establish the ground truth for this specific clinical study comparing the modified device to the predicate. The "ground truth" for this comparison was the result obtained from the predicate device itself.

4. Adjudication Method for the Test Set

Not applicable. The study involved a direct comparison of the modified device's results against the predicate device's results. There was no independent adjudication of individual cases against an external ground truth in the traditional sense, as the predicate served as the reference.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic (EIA) test for detecting antigens, not an imaging or diagnostic aid that involves human readers interpreting results in a variable manner. The interpretation of results is visual or spectrophotometric, implying a more objective, less reader-dependent outcome.

6. Standalone Performance Study

Yes, a standalone performance of the modified device was effectively demonstrated by comparing its results against the predicate device on the same set of samples. The performance metrics (sensitivity, specificity, reproducibility, analytical sensitivity, cross-reactivity, interfering substances) are all measures of the algorithm's (or device's) standalone performance under specified conditions.

7. Type of Ground Truth Used

For the clinical study, the ground truth was established by the predicate device (PREMIER Platinum HpSA® PLUS K053335). The study aimed to demonstrate substantial equivalence by showing agreement between the modified device and the predicate. For analytical studies, the ground truth was based on controlled experimental conditions (e.g., known concentrations of H. pylori protein for LoD, known presence/absence of microorganisms for cross-reactivity, known interfering substances).

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The PREMIER Platinum HpSA PLUS is an enzyme immunoassay, implying a deterministic chemical reaction, not a machine learning algorithm that requires a separate training phase. The development of the device would involve optimization and internal testing, which might be analogous to model training, but these details are not provided in terms of sample size or methodology.

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

As noted above, there's no mention of a traditional "training set" in the context of an EIA device. The "ground truth" during initial development and optimization would have been established through controlled experiments using known concentrations of H. pylori antigens and various other substances (cross-reactants, interferents) to characterize the assay's performance and specificity. This would involve laboratory standards and analytical methods to confirm the composition of samples.

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The TRU LEGIONELLA® assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

The TRU LEGIONELLA® assay is an in vitro, rapid, lateral-flow immunoassay.

This is a letter acknowledging the receipt of a 510(k) premarket notification for a medical device called "Legionella. Spp., Elisa." While it indicates that the device has been found substantially equivalent to a predicate device, this document does not contain the detailed study information, acceptance criteria, or performance data that you requested.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the FDA has evaluated the submission and deemed the device safe and effective for its stated indications based on comparisons to a legally marketed predicate. However, the supporting data and studies are part of the original 510(k) submission and are not publicly detailed in this acknowledgment letter.

Therefore, I cannot extract the requested information from the provided text. To obtain that level of detail, you would typically need to review the actual 510(k) summary and supporting documentation submitted by Meridian Bioscience, Inc. to the FDA, which is usually found in a separate, more comprehensive public document associated with the 510(k) number (K163273).

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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 Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.

The illumigene Pertussis DNA Amplification Assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to pertussis by targeting the IS481 insertional element of the B. pertussis genome. The 18481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results for the illumigene Pertussis DNA Amplification Assay do not precude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.

illumigene Pertussis DNA Amplification Assay is intended for use in hospital, reference or state laboratory settings. The device is point-of-care use.

The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples. The assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to target the IS481 insertional element of the B. pertussis genome.

Here's an analysis of the provided text regarding the illumigene Pertussis DNA Amplification Assay, structured to answer your questions about acceptance criteria and the supporting study:

The provided document is an FDA 510(k) clearance letter for the illumigene Pertussis DNA Amplification Assay. It primarily outlines the device's intended use and FDA's determination of substantial equivalence. Crucially, this document does NOT contain detailed information about the acceptance criteria or the specific study results proving the device meets those criteria.

Generally, for an in vitro diagnostic (IVD) like this, acceptance criteria would involve performance metrics such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) compared to a reference standard. The study data would then quantify these metrics.

Since the provided text does not contain this information, I will indicate where the information is not provided by the document.

Acceptance Criteria and Study Details for illumigene Pertussis DNA Amplification Assay

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not provided in this document.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in this document. Typically, clinical studies for IVDs involve prospective collection of samples from diverse geographic locations to ensure generalizability.

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

This information is typically relevant for image-based diagnostic devices or those requiring expert interpretation. For a DNA amplification assay, the "ground truth" for the test set is established by a reference method (e.g., culture, another highly sensitive PCR method with sequencing confirmation). Therefore, the concept of "experts establishing ground truth" in the same way it would apply to imaging interpretation is not directly applicable here.

• Number of experts: Not applicable in the context of this type of diagnostic test's ground truth.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

As the ground truth for a DNA amplification assay is typically established through laboratory reference methods (e.g., bacterial culture, validated PCR with sequencing), an "adjudication method" involving human readers (like 2+1, 3+1 for imaging) is not applicable. Discrepancies would be resolved by retesting or using a higher-level confirmatory test.

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

• MRMC Study: No, an MRMC study is not applicable for a standalone in vitro diagnostic (IVD) test like a DNA amplification assay. This type of study is designed for diagnostic tools that involve human interpretation, such as medical imaging analysis, often comparing AI-assisted performance against unassisted human performance. The illumigene Pertussis DNA Amplification Assay is a laboratory test that provides a quantitative or qualitative result directly, without requiring human "reading" in the same diagnostic sense.

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

Yes, for an IVD like the illumigene Pertussis DNA Amplification Assay, the performance data presented to the FDA always represents the standalone performance of the device (i.e., "algorithm only" in the context of an automated assay). The device generates a result which is then interpreted by a healthcare professional in conjunction with clinical information, but the core performance characteristics (sensitivity, specificity) are intrinsic to the assay itself.

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

For molecular diagnostic assays like the illumigene Pertussis DNA Amplification Assay, the ground truth is typically established using:

• Reference Culture: For bacterial infections, culture is often considered the gold standard, although its sensitivity for Bordetella pertussis can be low, especially in later stages of infection.
• Another highly sensitive and specific molecular method (e.g., a validated laboratory-developed PCR test or a previously cleared FDA PCR test), often with Sanger sequencing confirmation: This is frequently used as a composite reference standard when culture sensitivity is a concern.

The specific ground truth method used for this device is not provided in this document.

8. The sample size for the training set

• Training Set Sample Size: Not provided in this document. For molecular diagnostic assays, there isn't a "training set" in the machine learning sense. Instead, there are often development and validation phases where different sets of samples (sometimes called analytical and clinical validation sets) are used to establish performance. The term "training set" is more applicable to AI/ML devices.

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

As mentioned in point 8, the concept of a "training set" with ground truth in the AI/ML context doesn't directly apply here. For the various validation studies (analytical and clinical), ground truth would be established by the reference methods described in point 7. The specific methodology for establishing ground truth for any development or validation samples is not provided in this document.

In summary: The provided FDA 510(k) clearance document confirms the device's legal market entry based on substantial equivalence for its stated Indications for Use. However, it does not detail the specific performance acceptance criteria or the comprehensive study design and results (e.g., sample sizes, ground truth methodology, actual sensitivity/specificity values) that were submitted to justify that equivalence. Such detailed information would typically be found in the full 510(k) summary or the device's instructions for use.

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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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