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The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blakec. blaNDM, blackA-48-like, and blamp gene sequences associated with carbapenem-nonsusceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).

The GenePOC™ Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC™ Carba assay result does not preclude the presence of other resistance mechanisms.

The GenePOC™ Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a bland, blaym or blaviM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-ß-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.

The GenePOC™ Carba assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection and differentiation of the blaype, blayDM, blavin, blaoxA-48-ike, and blamp gene sequences in carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The GenePOC™ Carba assay is designed to be performed on the revogene™ instrument. The revogene™ is an instrument that automates sample homogenization, sample dilution, cells lysis, DNA amplification, and detection of the amplified PCR products.

The GenePOC™ Carba assay kit is comprised of single-use, disposable microfluidic cartridges (PIEs), Sample Buffer Tubes (SBT), and Disposable Transfer Tools (DTT). These components are used to dilute the sample, extract, amplify, and simultaneously detect blayDM, blavin, blaoxA-48-like, and blamp DNA. A Process Control (PrC) is also incorporated into each PIE to verify sample processing and amplification steps. The PrC allows for the verification of potential inhibitor substances as well as microfluidic, instrument or reagent failure.

Each GenePOC™ Carba assay kit contains 24 individual pouches. Each pouch has components for one (1) test including one (1) Carba PIE, one (1) SBT, and one (1) DTT. The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of the blaker, blands, blaoxa-48-like, and blanyp gene sequences from isolates of pure cultures of carbapenem-non-susceptible gram-negative bacteria in approximately 70 minutes. User intervention is only required for preparing the standardized 0.5 McFarland bacterial suspension from characterized carbapenem-non-susceptible isolated colonies, inoculating the bacterial suspension into the Sample Buffer Tube (SBT), transferring the sample into the single-use disposable PIE, and loading/unloading the PIEs into the revogene™ carousel. Each PIE is a completely integrated closed device in which a sample is dispensed and processed through different microfluidic chambers and channels that allow for the sample processing and subsequent real-time PCR steps.

Upon completion of a run, the results are interpolated by the revogene™ from measured fluorescent signals and embedded calculation algorithms. The output results include positive, negative, indeterminate, and unresolved. Upon completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. The results are automatically generated at the end of the process in a report that can be viewed and printed.

Here's a breakdown of the acceptance criteria and the study details for the GenePOC™ Carba assay, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical study's objective: to establish the performance characteristics (sensitivity and specificity) of the GenePOC™ Carba assay compared to a Reference Method for detecting carbapenemase genes. No explicit numerical acceptance criteria (e.g., "Sensitivity >= 95%") are formally stated in the provided text as pass/fail thresholds for clearance, but the reported performance represents what was achieved and found acceptable for substantial equivalence.

Table of Acceptance Criteria (Implied) and Reported Device Performance

The summary presents performance broken down by each target gene. The "Reference Method" in the clinical study refers to an FDA-cleared Nucleic Acid Amplification Test (NAAT) whose performance was established against PCR/bidirectional sequencing.

Performance on Isolated Colonies Grown on Blood Agar Relative to Reference Method (Overall by Target)

Performance on Isolated Colonies Grown on MacConkey Agar Relative to Reference Method (Overall by Target)

Study Details

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

   • Test Set Size: 512 fully compliant bacterial isolates.
     • 475 clinical stock isolates.
     • 57 prospectively collected fresh isolates.
   • Data Provenance: Three clinical centers (one in Canada and two in the United States of America).

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

   • The ground truth was established by a "Reference Method" (an FDA-cleared Nucleic Acid Amplification Test) whose performance was previously established against PCR/bidirectional sequencing. The document does not specify the number or qualifications of experts involved in running or interpreting this reference method or the PCR/bidirectional sequencing, nor in the initial characterization of the clinical isolates.

3. Adjudication method for the test set:

   • Discordant analysis: For samples with discrepant results between the GenePOC™ Carba assay and the Reference Method, further testing was performed using alternative PCR for each of the five assay analytes, followed by bi-directional Sanger sequencing. The results of this discrepant testing were then used to reconcile the initial findings (effectively re-evaluating the "true" status of the sample).

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, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not performed. This device is an automated in vitro diagnostic test, not an AI-assisted diagnostic imaging device targeting human interpretation.

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

   • Yes, the clinical study assessed the "standalone" performance of the GenePOC™ Carba assay. The device is an automated real-time PCR platform that extracts, amplifies, and detects target DNA, and "the results are interpolated by the revogene™ from measured fluorescent signals and embedded calculation algorithms." User interaction is primarily for sample preparation and loading/unloading. The reported sensitivity and specificity values represent this standalone algorithmic performance against the defined Reference Method.

6. The type of ground truth used:

   • The ground truth for the clinical study was established by a Reference Method, which was an FDA-cleared Nucleic Acid Amplification Test (NAAT). This NAAT itself had its performance previously established in comparison to PCR/bidirectional sequencing. For discordant results, alternative PCR followed by bi-directional Sanger sequencing was used for final adjudication, indicating that molecular sequencing data served as the ultimate ground truth for discrepant cases.

7. The sample size for the training set:

   • The document describes analytical and clinical performance studies, but it does not specify a separate "training set" for the algorithm's development in the context of machine learning. For an in vitro diagnostic like this, the "training" involves assay design, optimization, and establishment of thresholds. The document states, "The assay cut-offs were determined by testing a total of 599 samples" (Section N.1.g), which could be considered part of the internal development/training phase for establishing the algorithm's decision boundaries.

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

   • As noted above, for the "training" (assay cut-off determination), ground truth would have been established through well-characterized samples with known presence or absence of the target genes. The analytical reactivity (inclusivity) study also contributes to this, using 58 carbapenem-non-susceptible isolates with known resistance genes and variants, determined by their collection number, geographical/temporal origin, and reported resistance gene/variant. For the 599 samples used to determine assay cut-offs, the specific method for establishing their ground truth is not detailed, but it is implied to be based on the known genetic makeup of the strains, likely through sequencing or other established molecular methods.

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The GenePOC"M Strep A assay, performed on the revogene"14 instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC™ Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.

The GenePOC™ Strep A assay is a single-use test for qualitative detection of Streptococcus pyogenes (group A Streptococcus - GAS) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOCTM Strep A assay kit is comprised of the disposable Strep A microfluidic cartridge (PIE), Sample Buffer Tube (SBT), and Disposable Transfer Tool (DTT). These components are used to suspend the sample, extract, amplify, and detect Streptococcus pyogenes (S. pyogenes) nucleic acid.

A Process Control (PrC) is also incorporated into each PIE to verify sample processing and amplification steps. The PrC allows for the verification of potential inhibitor substances as well as microfluidic, instrument or reagent failure. The GenePOC™ Strep A assay is designed to be used on the revogene™. The revogene™ is an instrument that automates sample homogenization, sample dilution, cell lysis, DNA amplification and detection of the amplified PCR products.

Each GenePOC™ Strep A assay kit provides components for twenty-four (24) tests. User intervention is required for sample preparation, transferring throat swab specimen into the SBT, using the DTT to transfer the sample into the PIE, and loading the PIE into the revogene™ carousel. Each PIE is a completely integrated closed device in which a sample is dispensed and processed through different microfluidic chambers and channels that allow for the sample processing and subsequent real-time PCR steps.

During the run and at run completion, the results are computed by the revogene™ from measured fluorescent signals and embedded calculation algorithms. The output results include positive, negative, indeterminate, and unresolved. An Early Positive Result Outcome (E-PRO) feature provides positive result if the signal from the target DNA reaches a predetermined threshold before the full PCR cycles have been completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. Results may be viewed, printed, transferred, and/or stored by the user.

The provided text describes the acceptance criteria and the study proving the GenePOC™ Strep A device meets these criteria. Since the document is a 510(k) summary for an in vitro diagnostic (IVD) assay, the acceptance criteria are generally related to analytical performance (e.g., precision, detection limit, inclusivity, specificity, interference) and clinical performance (sensitivity and specificity compared to a reference method). The study design is focused on demonstrating the reliability and accuracy of the diagnostic test in detecting Streptococcus pyogenes.

Here's the breakdown of the information requested based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For an IVD such as this, the acceptance criteria are typically implicit in the "Performance Characteristics" section, where the manufacturer demonstrates that the device performs reliably and accurately for its intended use. There are no explicit pass/fail acceptance values stated for each measured characteristic, but the reported performance values are the data presented to demonstrate adequacy.

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

• Clinical Performance Test Set (Clinical Studies):

  • Sample Size: 604 fully compliant prospective specimens.
  • Data Provenance:
    • Country of Origin: Geographically diverse clinical trial sites; two (2) in Canada and six (6) in the United States.
    • Retrospective or Prospective: Prospective multicenter trial. Throat swab specimens were collected from patients with signs and symptoms of pharyngitis.

• Analytical Performance Test Sets (Examples):

  • Within-Laboratory Precision: 240 samples (80 low positive, 80 moderate positive, 80 negative samples) tested over 20 days.
  • Between-Laboratory Reproducibility: 300 samples (90 low positive, 90 moderate positive, 120 negative samples) tested across 3 sites over 5 days.
  • Between-Lot Reproducibility: 300 samples (90 low positive, 90 moderate positive, 120 negative samples) tested across 3 reagent lots over 15 days.
  • Limit of Detection: 24 replicates per concentration per strain (3 strains) with 3 kit lots; confirmation with 20 replicates per strain.
  • Analytical Reactivity/Inclusivity: 9 replicates per strain (12 strains total).
  • Analytical Specificity: 50 analytes, concentrations tested for each.
  • Carry-over and Cross-Contamination: 80 samples for cross-contamination, 80 samples for carry-over.

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

• Clinical Performance Test Set: The ground truth for the clinical study was established by a "Reference Method" which is explicitly stated as culture. The text does not mention the number or qualifications of human experts (e.g., microbiologists, lab technicians) involved in performing or interpreting the reference culture method, as culture is considered the gold standard and its results are objective.
  • For discrepancies in the clinical study, an "alternative PCR with bi-directional sequencing" was performed on the discordant samples. This suggests a secondary method for adjudication rather than expert consensus on the primary ground truth.

4. Adjudication Method for the Test Set

• Clinical Performance Test Set:
  • The primary ground truth was established by the Reference Method (culture).
  • For discordant results between the GenePOC™ Strep A assay and the culture, an alternative PCR with bi-directional sequencing was used for further investigation. This is a form of discrepancy resolution or adjudication for the clinical performance data. The results of this alternative PCR are footnoted in the clinical performance table (e.g., "17 of 24 were Strep A Positive" for samples positive by GenePOC but negative by culture).
  • The text does not indicate a system like 2+1 or 3+1 involving human experts directly adjudicating case outcomes for the primary study endpoint; rather, it uses a technical discrepancy resolution method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is an automated, qualitative in vitro diagnostic test for direct detection of nucleic acids. It does not involve human "readers" or image interpretation tasks where AI assistance would directly improve human reader performance. The device provides a direct positive/negative/indeterminate result.

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

• Yes, implicitly. The device, the GenePOC™ Strep A assay on the revogene™ instrument, is described as an "automated, qualitative in vitro diagnostic test." Once the sample is loaded, "No operator intervention is necessary once the PIE is loaded onto the revogene™." The results are "computed by the revogene™ from measured fluorescent signals and embedded calculation algorithms."
• The clinical performance study directly evaluates this standalone performance (assay results vs. culture ground truth). The human element is in sample preparation and loading, but the detection and result interpretation are automated by the device.

7. The Type of Ground Truth Used

• Clinical Performance Test Set: Culture (for Streptococcus pyogenes). This is the traditional "gold standard" for bacterial identification in clinical microbiology.
• Analytical Performance Test Sets: Defined scientific standards, such as known concentrations of specific bacterial strains (CFU/mL), absence of target (negative matrix), and specific interfering substances, or bioinformatic analysis for sequence specificity.

8. The Sample Size for the Training Set

• This document is a 510(k) summary for an IVD test, not a machine learning or AI algorithm summary. The "device" here refers to a diagnostic assay kit used on an automated instrument.
• The assay's "embedded calculation algorithms" determine the results based on fluorescent signals and pre-set thresholds/cut-offs for RNA/DNA detection. There is no mention of a "training set" in the context of machine learning model training. The cut-offs were determined by testing n=509 native and contrived samples, which could be considered an "assay development" or "validation" dataset rather than a "training set" for a continually learning algorithm.

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

• As noted above, there isn't a traditional "training set" in the machine learning sense. The assay cut-offs were established using a mix of "native (throat swab specimens) and contrived samples" (n=509). The ground truth for these would logically be established by the same reliable reference method (culture) or by known spiked concentrations for contrived samples.

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The GenePOC CDiff assay performed on the revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile( C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The GenePOC CDiff assay is intended to aid in the diagnosis of CDI.

The GenePOC™ CDiff assay is a single-use test for the qualitative detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens. The GenePOC™ CDiff assay kit is comprised of the disposable CDiff microfluidic cartridges (PIE), Disposable Transfer Loops (DTL), Sample Buffer Tubes (SBT), and Disposable Transfer Tools (DTT; pipette). These components are used to suspend the sample, extract, amplify, and detect C. difficile nucleic acid. A Process Control (PrC) is also incorporated into each PIE to verify sample processing and amplification steps. The PrC allows for the verification of potential inhibitor substances as well as microfluidic, instrument or reagent failure. The GenePOC™ CDiff assay is designed to be used on the revogene™. The revogene™ is an instrument that automates sample homogenization, sample dilution, cells lysis, DNA amplification and detection of the amplified PCR products.

Each GenePOC™ CDiff assay kit provides components for 24 tests. User intervention is required for sample preparation, transferring the stool specimen with the DTL into the SBT, using the DTT to transfer the sample into the PIE, and loading/unloading the PIE into the revogene™ carousel. Each PIE is a completely integrated closed device in which a sample is dispensed and processed through different microfluidic chambers and channels that allow for the sample processing and subsequent real-time PCR steps.

Upon completion of a run, the results are computed by the revogene™ from measured fluorescent signals and embedded calculation algorithms. The output results include positive, negative, indeterminate, and unresolved. Upon completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. Results may be viewed, printed, transferred, and/or stored by the user.

The provided document describes the regulatory submission for the GenePOC CDiff assay, a diagnostic test for Clostridium difficile infection (CDI). The document focuses on the analytical and clinical performance of the device to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a formal table. However, the performance characteristics sections imply the criteria for various analytical and clinical aspects. The reported performance is presented in the tables and text within the document.

Let's infer the acceptance criteria from the reported results, especially concerning agreement percentages and confidence intervals. Typically, for in vitro diagnostics, high sensitivity and specificity are desired, often above certain thresholds (e.g., 85% or 90% for sensitivity, and 95% or more for specificity). For reproducibility, high agreement is also expected (e.g., >95%).

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The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The GenePOC GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.

The GenePOC GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The GenePOC GBS LB assay is a single-use test for the qualitative detection of Group B Streptococcus (GBS) DNA from enriched vaginal/rectal swab specimens using realtime Polymerase Chain Reaction (PCR) technology with fluorogenic detection of the amplified DNA. The GenePOC GBS LB assay utilizes the GBS LB microfluidic cartridge for the simultaneous detection of the target GBS DNA and the internal process control (PrC) DNA (to monitor processing, amplification, and the absence of reaction inhibitors). The GenePOC GBS LB assay is an automated assay performed on the revogene™ including sample processing.

The GenePOC Group B Strep (GBS) LB is composed of a GBS specific disposable microfluidic cartridges, Sample Buffer Tube (SBT) and Disposable Transfer Tool (DTT). These components are used to lyse and dilute the sample, amplify, and detect GBS nucleic acid from vaginal/rectal swabs following LIM broth enrichment. User intervention is required for sample preparation, discharging the LIM broth enriched sample into the SBT, transferring the sample into the cartridge and loading/unloading the cartridge into the revogene instrument. Once the sample is added into the cartridge, the process is then fully automated.

Each GenePOC GBS LB Test kit contains 24 individual pouches, and each pouch has components for 1 test including 1 cartridge, 1 SBT, and 1 DTT. The GBS LB Test is run on the revogene instrument which can process from one up to a maximum of 8 samples simultaneously in the same run. On completion of a run, the results are interpolated by the revogene™ from measured fluorescent signals and embedded calculation algorithms. For the GBS application, two spectral signals are processed: GBS target and Internal Process Control. The output results include positive, negative, indeterminate, and unresolved. On completion of a run, the user removes the used cartridges and disposes of them in normal biological waste. Results may be viewed, printed, transferred, and/or stored by the user.

The provided document describes the GenePOC GBS LB assay, a qualitative in vitro diagnostic test for detecting Group B Streptococcus (GBS) DNA. Here's a breakdown of the acceptance criteria and the study proving the device meets them:

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

The document doesn't explicitly state "acceptance criteria" in a separate table. However, it presents performance metrics that serve as the basis for FDA's substantial equivalence determination. We can infer the "acceptance criteria" from the reported performance results, particularly from the overall clinical performance.

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

• Clinical Test Set Sample Size: A total of 771 compliant specimen results were used to determine the clinical performance.
  • 170 GBS positive samples
  • 601 GBS negative samples
• Data Provenance: The data was obtained from a prospective multicenter trial conducted at 4 geographically diverse clinical trial sites, consisting of two Canadian and two US clinical sites.

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

The document describes the ground truth for the clinical study as a "composite reference method consisting of LIM Broth enrichment of the vaginal/rectal swab followed by a subculture on blood agar plate and biochemical identification of GBS." This method is a laboratory-based standard and does not involve a subjective assessment by a human expert (like a radiologist reviewing an image). Therefore, the concept of "number of experts used to establish ground truth" with specific qualifications is not applicable in this context.

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

Since the ground truth is established by a laboratory-based composite reference method (culture and biochemical identification), no human expert adjudication method (like 2+1 or 3+1 for imaging studies) was performed or needed for the ground truth establishment. The results are based on objective laboratory testing.

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 a standalone in vitro diagnostic (IVD) assay designed for direct detection of GBS DNA, not an AI-assisted imaging analysis tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

Yes, a standalone performance evaluation was done. The entire performance characterization (analytical and clinical) presented in the document assesses the GenePOC GBS LB assay as a standalone device without human-in-the-loop performance modification. The revogene™ instrument processes the sample and provides the result based on its embedded calculation algorithms. User intervention is limited to sample preparation and loading/unloading.

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

The ground truth used for the clinical study was a laboratory-based composite reference method, specifically:

• LIM Broth enrichment of the vaginal/rectal swab
• Followed by subculture on blood agar plate
• And biochemical identification of GBS

8. The sample size for the training set:

The document does not specify a separate training set size. As this is an in vitro diagnostic device for molecular detection, the "training" aspect is typically related to the development and optimization of the assay itself (e.g., primer design, probe chemistry, algorithmic thresholds) rather than training a machine learning model on a distinct dataset with labeled ground truth in the same way an AI imaging algorithm would be trained. The performance data presented refers to the testing of the developed and finalized assay.

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

Since a distinct "training set" with ground truth (in the AI/ML sense) is not described, the question of how its ground truth was established is not directly applicable. However, the development of the assay itself would have relied on well-characterized GBS strains and clinical samples with known GBS status, likely determined through standard microbiological culture and identification methods (similar to the clinical ground truth). This iterative development-and-testing process leads to the final assay's performance characteristics.

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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. The 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.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to GENEPOC INC. regarding their Revogene device. It details the regulatory classification, general controls, and indications for use of the device.

However, the document does not contain the specific information required to answer your request about acceptance criteria and the study proving the device meets those criteria. Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Details on the sample size used for the test set or its data provenance.
• The number or qualifications of experts used for ground truth establishment.
• Information on adjudication methods.
• Details on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

The document is purely administrative, confirming the FDA's substantial equivalence determination and outlining regulatory obligations. It does not delve into the technical performance studies or the clinical trials typically associated with proving a device meets acceptance criteria.

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