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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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The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simultaneous detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with cultures derived from human stool specimens to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC) infections. Test results are to be used in conjunction with the patient's clinical symptoms and history.

The Curian® Shiga Toxin assay is a qualitative in vitro diagnostic test for the detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in cultures derived from human stool specimens. The Curian® Shiga Toxin assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Stx1 and Stx2 in cultures derived from human stool.

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

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria, but it presents the performance of the Curian Shiga Toxin assay against a reference method (Vero cell Cytotoxin Assay). We can infer the implicit acceptance criteria from the reported performance, which demonstrates high sensitivity and specificity.

Note: The low end of the 95% CI for sensitivity in prospective specimens (e.g., 56.6% for Stx1) is due to the very small number of positive cases in that cohort (5 for Stx1 and 4 for Stx2). The 100% point estimate, while positive, has a wide confidence interval reflecting this small sample size. The archived cohort provides more robust sensitivity estimates.

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

• Prospective Test Set: 1,627 stool specimens collected from patients suspected of having a Shiga toxin-producing Escherichia coli (STEC) infection.
  • Evaluable Prospective Specimens: 1,538
  • Data Provenance: Prospective collection from five clinical study sites representing geographically distinct regions throughout the United States.
• Archived Test Set: 140 archived stool samples.
  • Evaluable Archived Specimens: 135 (5 excluded due to inconclusive reference results).
  • Data Provenance: Retrospective testing of archived samples at all five clinical study sites.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions that the reference method was the "Vero cell Cytotoxin Assay (with neutralization) performed on the broth culture obtained from the stool specimen." This is a laboratory-based assay, and its interpretation would typically be performed by trained laboratory personnel rather than a panel of clinical experts (e.g., radiologists).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set. The ground truth was established by the "Vero cell Cytotoxin Assay (with neutralization)."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. This device is an in vitro diagnostic (IVD) assay interpreted by an analyzer, not a medical imaging or diagnostic aid that multiple human readers would interpret with and without AI assistance. The Curian Analyzer automates the interpretation of results ("Results interpretation automated by Curian® Analyzer").

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the clinical performance study (both prospective and archived) represents the standalone performance of the device (Curian Shiga Toxin assay and Curian Analyzer). The results are "produced by the Curian Analyzer," indicating an automated, algorithm-only interpretation without a human-in-the-loop performance evaluation in the context of these clinical studies.

7. The Type of Ground Truth Used

The type of ground truth used was a laboratory reference method: the Vero cell Cytotoxin Assay (with neutralization) performed on broth cultures obtained from the stool specimens.

8. The Sample Size for the Training Set

The document does not provide information about the sample size for a training set. This is common for IVD submissions, where the focus is on the analytical and clinical performance of the device itself rather than the development of the underlying algorithms through a specific training set. The device is a "lateral flow fluorescent immunoassay," which is a biochemical detection method, not a machine learning algorithm that typically requires a large training dataset in the same way.

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

Since no training set information is provided, there is no description of how ground truth for a training set was established.

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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® 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 provided document is an FDA 510(k) Substantial Equivalence Determination Decision Summary for the Revogene instrument.
Crucially, this submission (K222779) is a "Special 510(k)" for a firmware modification only, specifically to add a cooling sequence before lid opening in the event of a run interruption.

Therefore, the document does not contain information about a study to prove the device's diagnostic performance against acceptance criteria in the typical sense of analytical or clinical performance (e.g., sensitivity, specificity for detecting a disease). Instead, the performance demonstrated here relates to the safety feature implemented by the firmware update.

Based on the provided text, here's an analysis of the acceptance criteria and study that address the firmware modification:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines the acceptance criteria for this specific modification: the firmware update must successfully implement a cooling sequence before lid opening when a run is interrupted, to prevent access to hot parts.

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

The document does not detail specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for testing this firmware modification. This is expected given the nature of a Special 510(k) for a safety-related firmware update. The FDA's decision to clear the device implies they were satisfied with the internal validation conducted by the manufacturer to demonstrate the successful implementation of this safety feature. No clinical data or large-scale analytical testing is typically required for such minor safety updates.

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

Not applicable for this type of firmware modification. The ground truth here is a functional safety requirement (i.e., "are hot parts accessible when a run is aborted after the update?"). This would be verified through engineering testing and safety assessments, not typically by expert consensus of clinical or radiological images.

4. Adjudication method for the test set:

Not applicable. This is not a study assessing diagnostic performance where adjudication of ambiguous results would be necessary.

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:

Not applicable. This device is an instrument for molecular diagnostics (nucleic acid testing), not an AI-assisted diagnostic imaging device.

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

Not directly applicable in the typical sense (e.g., for an AI algorithm). The device itself operates "standalone" in its function of automated lysis, amplification, and detection, but the "performance" discussed here is a safety feature of its firmware, not its diagnostic accuracy.

7. The type of ground truth used:

The ground truth for this specific firmware modification is a functional safety performance objective. The "truth" is whether the cooling sequence activates as intended upon run interruption and whether it effectively prevents access to hot parts, thereby improving user safety. This would be established through engineering functional testing and safety verification protocols.

8. The sample size for the training set:

Not applicable. This is a firmware modification for a safety feature, not a machine learning algorithm that requires a "training set."

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

Not applicable. As above, no training set for a machine learning model is involved.

Summary of the document's relevance to your request:

The provided document is an FDA clearance letter for a firmware upgrade to an existing medical device, the Revogene instrument. This is a very specific type of submission (Special 510(k)) that focuses on demonstrating that a minor change does not adversely affect the device's safety or effectiveness, or alter its fundamental scientific technology.

Therefore, the typical metrics and study designs used for evaluating the diagnostic performance of new AI/ML-based devices (e.g., sensitivity, specificity, MRMC studies, ground truth established by expert consensus or pathology) are not present or applicable here. The "acceptance criteria" and "study" are focused solely on verifying the successful and safe implementation of the firmware's added cooling sequence upon run interruption.

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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 was previously cleared under K170558. Meridian Biosciences, Inc. is submitting this 510(k) to implement a software modification to the Revogene that updates the current software with a PMT surveillance algorithm. The software monitors raw data fluorescence signal during assay testing and identifies issues due to a malfunction of the photomultiplier tube (the "PMT"), a key component in the Revogene instrument's optics system used in the management of fluorescence signals. Upon detection of a PMT malfunction, the PMT surveillance algorithm software produces a specific error code to the user labeled "Detection Error" and will lock the instrument thereby preventing further use.

The provided text describes a 510(k) submission for a software modification to the Revogene instrument, specifically the addition of a PMT (photomultiplier tube) surveillance algorithm. This modification is intended to monitor raw data fluorescence signals and identify issues due to a malfunction of the PMT, a key component in the instrument's optics system. Upon detection of a PMT malfunction, the algorithm produces an error code and locks the instrument, preventing further use.

The document states that this change does not affect the device's intended use nor alter the device's fundamental scientific technology. Therefore, the acceptance criteria and performance study details are focused on validating the new PMT surveillance algorithm's functionality and ensuring it does not negatively impact the previously cleared performance of the Revogene instrument.

Based on the provided text, a formal table of acceptance criteria and reported device performance, akin to what would be provided for a diagnostic or AI algorithm's clinical performance, is not explicitly present for the PMT surveillance algorithm itself. The document emphasizes that the modification is minor and focuses on the software's ability to detect and report PMT malfunctions.

However, we can infer the acceptance criteria and study proving the device meets them from the description of the software modification and the context of a 510(k) submission for a software update.

Here's a breakdown based on the provided information, addressing each point as much as possible:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this software modification is that the PMT surveillance algorithm successfully detects and reports PMT malfunctions. The reported performance would be the successful implementation of this functionality.

Inferred Acceptance Criteria Table:

Study Proving Acceptance Criteria:

The document implicitly indicates that a validation study was performed to demonstrate the functionality of the PMT surveillance algorithm. While details are scarce, the submission implies that the testing confirmed the algorithm's ability to detect PMT issues and trigger the appropriate error and lock-out mechanisms.

Detailed Study Information (Based on Inferences and General 510(k) Practices for Software Updates)

1. A table of acceptance criteria and the reported device performance:
   (See above table for inferred criteria and performance, as direct explicit table is not provided in the document for the new software feature). The document stresses that the overall performance characteristics of the Revogene instrument remain as previously cleared (K170558, K170557, etc.), and this software update doesn't change those.

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

   • Test Set Sample Size: Not explicitly stated for the PMT surveillance algorithm. For a software update of this nature (detecting a hardware malfunction), the "test set" would likely involve inducing PMT malfunctions (or simulating conditions that would lead to them) on multiple instruments to verify the algorithm's response. The general statement "The submitted information demonstrates that the modified Revogene instrument is safe, effective" implies a sufficient level of testing.
   • Data Provenance: Not specified. Given it's a software update for a commercialized instrument, the testing would typically be performed internally by the manufacturer (Meridian Bioscience, Inc.). It's likely retrospective in that it's testing a new feature on existing hardware, but the testing itself would be prospective for evaluating the new software. Country of origin not specified, but the manufacturer is based in Ohio, USA.

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

   • This is unlikely to involve a panel of "experts" in the same way an AI diagnostic algorithm's ground truth is established. The ground truth for a PMT malfunction would be a measurable hardware degradation or induced failure that clearly indicates the PMT is not functioning correctly. This would be established by engineers or instrument specialists, not clinical experts like radiologists.

4. Adjudication method for the test set:

   • Not applicable in the context of this software update. Adjudication methods like 2+1 or 3+1 are typically for establishing ground truth for subjective human interpretations (e.g., medical image reads). Here, the judgment is objective: either the PMT is malfunctioning or it's not, and the software either detects it or it doesn't.

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

   • No. An MRMC study is not relevant for this type of software modification. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance for tasks involving perception and interpretation (e.g., diagnosing disease from medical images). This software is performing an automated internal diagnostic check on the instrument itself, not assisting human clinical interpretation.

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

   • Yes, implicitly. The PMT surveillance algorithm operates automatically as an internal check. Its performance is evaluated purely on its ability to detect PMT malfunctions and trigger the pre-defined error and lock-out, without human intervention in its real-time operation.

7. The type of ground truth used:

   • Instrumental/Hardware Ground Truth: The ground truth would be based on objective measurements and engineered conditions that reliably indicate a PMT malfunction within the Revogene instrument's optics system. This could involve simulating PMT degradation, intentionally causing component failures, or verifying against known hardware states.

8. The sample size for the training set:

   • Not specified. For a diagnostic algorithm like this, the "training set" would involve data collected from instrument operations, potentially including data from instruments with known good or failing PMT conditions, to develop and refine the detection algorithms. The complexity of the algorithm (e.g., rule-based vs. machine learning) would influence the need for and size of a specific "training set." Given the description, it sounds more like a rule-based or threshold-based detection system rather than a complex machine learning model that requires a large, annotated training set in the typical sense.

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

   • If a "training set" was used (e.g., for setting detection thresholds or developing rules), the ground truth would have been established by engineering teams through controlled experiments, measurements of PMT performance over time, and potentially by inducing known PMT issues on instruments. This would involve characterization of the instrument's optical signals under various conditions, including states indicative of PMT malfunction.

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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:

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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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