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Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV® is intended to be used in screening of patients for serological evidence of previous infection by CMV using manual and semiautomated methods, NEO Iris® and Galileo NEO®.

Capture-CMV® is a Solid Phase Red Cell Adherence System for the detection of IgG and lgM antibodies to Cytomegalovirus (CMV).
The CMV assay is to be used with NEO Iris® and the Galileo NEO® instruments. The NEO Iris®/Galileo NEO® is a microprocessor-controlled instrument that fully automates test processing, result interpretation and data management functions for the associated assays. The instrument is designed to automate, in addition to the CMV assay, standard immunohematology assays using a microplate-based platform. The originally cleared Galileo NEO® (BK100033) was updated with the following modifications in the current submission:

• The Digi CCD camera module was replaced with an IDS CMOS camera module
• Galileo NEO® software was replaced with NEO Iris® Install Set 3.0.1.0 U software and configuration files
• Galileo NEO® versions of the files OiBxEngl.dll and GalileoLogo.bmp were installed to preserve Galileo NEO® branding in the User Interface and on Reports

The provided text describes the regulatory clearance of the Immucor Capture-CMV® assay for use on an upgraded Galileo NEO® instrument. The core of the submission is to demonstrate that the upgraded Galileo NEO® is functionally identical to the NEO Iris® instrument, on which the Capture-CMV® assay was previously cleared. Therefore, no new primary studies were conducted for this specific submission; instead, data from the previous K183571 clearance for the NEO Iris® were presented.

Here's an analysis 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 acceptance criteria are implicitly defined by the reported performance metrics comparing the NEO Iris® (the predicate for the current submission and the reference for the data) to the original Galileo NEO® or the "FDA cleared assay." The key performance metrics are Sensitivity and Specificity.

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

• Test Set for Method Comparison (Clinical Performance):

  • Patient Specimens: N=501 total.
  • Breakdown by type: Not fully specified if all 501 were unique patients or if it includes serum/plasma duplicates. The table shows 26, 0, 195, and 280 patient specimens collected across 4 sites, summing to 501.
  • Breakdown by specimen type: Of the 501, 300 were serum and 201 were plasma.
  • Data Provenance: The studies were performed at "four clinical sites, three external sites and internally at Immucor, Inc. for donor specimens and at two external sites and internally at Immucor, Inc. for patient specimens." The specific country of origin is not explicitly stated, but Immucor Inc. is based in Norcross, Georgia, implying US-based studies. The studies are retrospective as the data was from a previously cleared device (K183571).

• Test Set for Reproducibility:

  • Panel of Coded Samples: 10 samples (5 CMV antibody positive, 5 CMV antibody negative).
  • Total Tests: 1200 (10 samples * 3 sites * 2 operators * 2 runs * 5 days = 1200 total tests). This implies each sample was run multiple times.

• Test Set for Specificity and Cross-reactivity:

  • Various numbers of samples for each category of lgG antibodies. For example, 16 for EBV, 23 for HSV, 5 for Hepatitis A, 11 for ANA, etc. The total number of unique samples for this section is the sum of these values.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. For the method comparison study, discordant specimens were further tested with a "commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV" which served as the reference method or "ground truth resolver" for discordant results.

4. Adjudication Method for the Test Set

For the method comparison study, the adjudication method for discordant results was further testing with a "commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV." This acts as a reference standard to resolve differences between the two systems being compared (NEO Iris® and original Galileo NEO®). This is a form of "tie-breaker" or "ground truth resolution" rather than expert consensus adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic (IVD) assay system and does not involve human readers interpreting images, so the concept of human readers improving with AI assistance is not applicable. The study focuses on the agreement between two automated instrument platforms (NEO Iris® and Galileo NEO®) and their performance against a reference assay.

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

Yes, this is essentially a standalone performance study. The Capture-CMV® assay, run on the NEO Iris® (and thus, by extension, the upgraded Galileo NEO®), provides a qualitative result (positive or negative) without human intervention in the interpretation of the primary result. The comparison is between two automated systems (NEO Iris® and Galileo NEO®).

7. The Type of Ground Truth Used

The ground truth for the clinical performance assessment (sensitivity and specificity) was established using:

• The results from the original Galileo NEO® instrument as a comparator, specifically for concordance.
• For discordant specimens, a "commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV" was used as the reference standard or "FDA cleared assay." This implies a laboratory-based reference standard or established diagnostic assay as the ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML device. The Capture-CMV® assay is an in vitro diagnostic test system based on a solid phase red cell adherence principle, not an AI/ML algorithm that requires training data in the conventional sense. The "development" and "verification" activities referenced are typical for IVD device development, not AI model training. Therefore, a sample size for a training set (as understood for AI/ML) is not applicable or provided.

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

As this is not an AI/ML device, the concept of a training set and its ground truth establishment does not apply in the same way. The development and verification process for IVD assays involves establishing performance characteristics against known positive and negative samples, and the consistency of these characteristics across manufacturing lots and instrument platforms.

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Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV is intended to be used in screening of blood and plasma donors or patients for serological evidence of previous infection by CMV.

Capture-CMV is a solid phase red cell adherence antibody detection system based on procedures of Plapp et al. This procedure is a modification of the mixed agglutination tests for antigen and antibody detection of Coombs et al. and Hogman employing anti-IgG and IgM-coated red cells as the indicator system. Serum or plasma samples are added to the viral-coated wells. The samples are incubated for five minutes; during which antibodies specific for CMV proteins bind to immobilized viral proteins. Unbound immunoglobulins are washed from the wells and replaced with a suspension of anti-IgG plus anti-IgM-coated indicator red cells. Centrifugation brings the indicator red cells in contact with antibodies bound to the immobilized viral proteins. In the case of a positive test, the migration of the indicator cells to the bottom of the well is impeded as the anti-IgG and anti-IgM bridges are formed between the indicator red cells and the viral-bound antibodies. As a consequence, the indicator red cells adhere over the surface of the test well. In contrast, in the absence of viral antigen-antibody interactions (i.e. a negative test) the indicator red cells are not impeded during their migration, and pellet to the bottom of the well as a packed, well-defined cell button. CMV antigen from cytomegalovirus strain AS 169 grown in human foreskin fibroblast cells is inactivated and coated onto microtitration wells and dried.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and the study proving the device meets them:

Device: Capture-CMV®
Intended Use: An in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Intended for use in screening of blood and plasma donors or patients for serological evidence of previous infection by CMV.

The document describes the performance of the Capture-CMV assay specifically when run on the NEO Iris instrument, comparing it to the predicate device (Capture-CMV on Galileo Neo). The "acceptance criteria" here are implied by the clinical performance targets for sensitivity and specificity necessary to demonstrate substantial equivalence to the predicate device and suitability for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate table with quantified thresholds before presenting the results. Instead, it presents the results of clinical performance studies (sensitivity and specificity) and reproducibility, which implicitly demonstrate that the device meets the required performance for its intended use and substantial equivalence to the predicate. The performance of the predicate device (Galileo Neo) serves as the de facto benchmark.

Based on the "CMV Resolved Results" and "Concordance by Site" tables, the performance targets appear to be very high agreement with the predicate and high sensitivity/specificity.

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

• Test Set Sample Size: N=501 patient samples were used for the method comparison study (sensitivity and specificity analysis). For reproducibility, 10 coded samples (5 positive, 5 negative) were tested for 400 total tests per site across 3 sites, totaling 1200 tests.
• Data Provenance: The studies were conducted at three clinical sites: two external sites and internally at Immucor, Inc. The document does not specify the country of origin but implies a US context given the FDA submission. The study appears to be retrospective as it uses existing patient samples and compares the new device to a predicate device and a commercial particle agglutination assay.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth.

However, the ground truth for discordant results was established by further testing with a commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV. This implies that the accepted "gold standard" or reference method for CMV antibody detection served as the arbiter, rather than human experts reviewing raw data. For reproducibility, "Expected Positive" and "Expected Negative" values were used for the coded samples, implying a pre-established ground truth for these control samples.

4. Adjudication Method for the Test Set

• For the sensitivity and specificity comparison: Discordant results between the NEO Iris and Galileo Neo were adjudicated using a commercially available particle agglutination assay for total antibody (IgG+IgM) to CMV. This acts as an objective, third-party reference method for reconciliation.
• For reproducibility: The reproducibility study used "coded samples" with "Expected Positive" and "Expected Negative" results, implying that these samples had a predetermined ground truth. No further adjudication method is described beyond comparing the device's output to these expected results.

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

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay that produces a qualitative (positive/negative) result, not an imaging device requiring human interpretation. Therefore, a multi-reader study is not applicable. The comparison here is between different automated analyzer platforms run by presumably trained lab technicians.

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

Yes, the performance presented is inherently standalone (algorithm/device only). The Capture-CMV assay on the NEO Iris instrument is an automated system that produces a result (positive/negative for CMV antibodies). The performance metrics (sensitivity, specificity, reproducibility) reflect the device's ability to correctly classify samples based on its internal processes, without direct human intervention in the result determination beyond loading samples and running the assay.

7. The Type of Ground Truth Used

• For the method comparison (sensitivity/specificity): The initial ground truth seems to be established by the predicate device (Capture-CMV on Galileo Neo), and discordant results were then resolved using an alternative commercial reference assay (particle agglutination assay). This is a form of reference standard test result.
• For reproducibility: The ground truth was based on pre-defined "expected" results for coded positive and negative control samples.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is typical for a traditional IVD device like this, which is validated through performance studies rather than developed using machine learning with distinct training and test sets in the same way an AI/ML algorithm would be. The "training" in this context would likely refer to the iterative development and optimization of the assay's biochemical components and the instrument's operational parameters, which is not usually quantified as a "training set" in regulatory submissions for non-AI devices.

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

As noted above, a distinct "training set" in the AI/ML sense is not described. The device's performance is validated against clinical samples and known control materials. Any "ground truth" during the development phase would have been established through a combination of well-characterized clinical samples, reference laboratory methods, and known concentrations of analytes, analogous to how IVD assays are traditionally developed and optimized.

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The Digene Hybrid Capture® CMV DNA Assay is a qualitative, in vitro, diagnostic assay intended for the detection of human cytomegalovirus (CMV) DNA in human peripheral white blood cells isolated from whole blood specimens collected in EDTA. It is indicated for use as an aid in diagnosing CMV infection in solid organ transplant, bone marrow transplant and HIV/AIDS patients. This assay has not been cleared by the FDA for blood/plasma donor screening.

The Hybrid Capture® CMV DNA Assay is a qualitative in vitro diagnostic assay. It is a nucleic acid, signal enhanced, solution hybridization, antibody capture assay that uses chemiluminescent signaling to detect CMV DNA. The assay kit consists of 13 reagents and two accessories.

Whole blood specimens are treated with an agent that lyses red blood cells, and the specimen is centrifuged, resulting in a pellet of white blood cells. The white blood cell pellet is then used in the Hybrid Capture CMV DNA Assay.

Specimens potentially containing CMV DNA are denatured and then hybridized with a specific CMV RNA probe cocktail. This cocktail contains a probe mixture chosen to eliminate cross-reactivity with human or other herpesvirus sequences. The CMV probe supplied with the Hybrid Capture CMV DNA Assay is complementary to approximately 40,000 base pairs or 17% of the CMV genome (230,000 base pairs).

The RNA:DNA hybrids resulting from hybridization are captured on the surface of a tube coated with affinity-purified polyclonal caprine antibodies specific for RNA:DNA hybrids. The immobilized hybrids are then reacted with alkaline phosphatase-conjugated, murine monoclonal antibody to RNA:DNA hybrids, and are detected with a chemiluminescent substrate. Several alkaline phosphatase molecules are conjugated to each antibody. Multiple conjugated antibodies bind to each captured hybrid, resulting in signal enhancement. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted and is measured in Relative Light Units (RLUs) on a standard commercial luminometer. The RLU value of a specimen is compared to a Positive Cutoff Value and to an Equivocal Cutoff Value to determine if the specimen is positive, equivocal, or negative for the presence of CMV DNA.

Here's a summary of the acceptance criteria and the study details for the Digene Hybrid Capture® System CMV DNA Assay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy derived from a pre-defined threshold. Instead, it describes analytical sensitivity and clinical performance relative to predicate devices and established methods.

The key performance metrics and their reported values are:

Study Details

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

   • Clinical Testing: The summary mentions "clinical testing in HIV/AIDS patients and patients who had undergone a solid-organ or bone marrow transplants" and "parallel testing of specimens from solid organ transplant, bone marrow transplant and HIV/AIDS patients." It also states testing in "a population comprised of approximately equal numbers of CMV seropositive and seronegative individuals."
   • Sample Size: The exact number of patients or specimens in these clinical test sets is not specified in the provided document.
   • Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective clinical studies, as indicated by "clinical testing" and "parallel testing of specimens."

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

   • The document implies that the ground truth for clinical performance was established by comparing the device's results to "shell vial culture and cell culture" and "expected results based on a combination of the cell culture result, the shell vial culture result, and clinical information."
   • It does not specify the number of individual experts (e.g., clinicians, microbiologists) involved in establishing the "clinical information" component of the ground truth or their specific qualifications (e.g., years of experience). The reference methods (cell culture, shell vial culture) are laboratory-based and generally performed by trained laboratory personnel.

3. Adjudication method for the test set:

   • The primary adjudication method for clinical performance appears to be a composite reference standard: "expected results based on a combination of the cell culture result, the shell vial culture result, and clinical information."
   • The specific method of combining these different results (e.g., how conflicts were resolved, if a 2+1 or 3+1 rule was used) is not detailed in the summary.

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:

   • This device is an in vitro diagnostic (IVD) assay for detecting CMV DNA, not an imaging device or an AI-assisted diagnostic system where "human readers" would be involved in interpreting images or other complex data. Therefore, an MRMC study related to human reader improvement with AI assistance is not applicable and was not performed. The assay generates a quantitative RLU value that is compared to predefined cutoffs.

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

   • Yes, this is a standalone assay. The entire evaluation described is of the assay itself (Hybrid Capture® System CMV DNA Assay) without human interpretation steps that would be "in-the-loop." The luminometer measures RLU values, and the comparison to cutoff values for positive, equivocal, or negative results is algorithm-driven (or rule-based), not requiring human reader judgment for the final diagnostic outcome from the assay itself.

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

   • For analytical performance, the ground truth was derived from known dilutions of plasmid CMV DNA.
   • For clinical performance, the ground truth was a composite reference standard using traditional laboratory methods (shell vial culture, cell culture) combined with "clinical information." This clinical information could encompass patient symptoms, serology, treatment response, and other relevant medical data, potentially involving physician adjudication or consensus, though specific details are not provided.

7. The sample size for the training set:

   • The document does not explicitly refer to a "training set" in the context of machine learning or AI. This is a traditional IVD assay. The development of the assay (e.g., defining the probe cocktail, optimizing reaction conditions, establishing cutoff values) would involve empirical studies and iterative testing/optimization, but these are not typically referred to as "training sets" in the same way as in AI/ML validation studies. The analytical sensitivity studies on known concentrations of CMV DNA would contribute to establishing cutoff values but aren't described as a "training set."

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

   • As there is no explicitly defined "training set" in the AI/ML sense, this question is not directly applicable. The establishment of assay parameters (like cutoff values for positive/equivocal results) would be based on studies using known CMV DNA concentrations (as mentioned for analytical sensitivity) and potentially retrospective clinical samples alongside the predicate methods.

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CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma (EDTA) to determine prior exposure to cytomegalovirus. This product is not FDA cleared for use in screening blood or plasma (EDTA) donors.

CMVgen is an in vitro diagnostic, rapid latex particle agglutination test for the qualitative and semiquantitative determination of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum or plasma (EDTA) to determine prior exposure to cytomegalovirus.

The provided text describes the CMVgen device, an in vitro diagnostic test for Cytomegalovirus (CMV) antibodies. However, the document does not explicitly state "acceptance criteria" for the device's performance. Instead, it presents performance data from method comparison studies and a reproducibility study.

Here's an analysis of the provided information, structured to address your questions based on the available text:

Acceptance Criteria and Device Performance

The document does not explicitly define "acceptance criteria" with numerical thresholds for sensitivity, specificity, or other metrics. Instead, it reports the performance of CMVgen against commercially available predicate or reference tests. We can infer that the reported sensitivities were considered acceptable for the 510(k) clearance process.

Table of Performance (Inferred from Study Results)

Study Details

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

   • Study 1: 165 serum samples.
     • Provenance: Performed at UMMC Clinical Microbiology Laboratories (Massachusetts). This indicates data from the USA and is retrospective as it refers to collected samples being evaluated.
   • Study 2: 131 serum samples.
     • Provenance: Performed at Cambridge University (U.K.). This indicates data from the UK. Ninety of these samples were collected from 31 organ transplant recipients who had experienced either a primary CMV infection or a reactivation of CMV post-transplant. This suggests a mix of retrospective and potentially prospective collection for the transplant recipient cohort, though the overall study presented is an evaluation of existing samples.
   • Reproducibility Study: Panels of 10 serum and plasma samples.
     • Provenance: Not explicitly stated, but likely conducted by the manufacturer or a collaborating lab.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The studies described are method comparison studies and a reproducibility study. The "ground truth" was established by commercially available, established assays (a "commercially available total antibody test" and a "commercially available IgG EIA test"), not by independent expert interpretation for each case. Therefore, the concept of "number of experts" or their qualifications for establishing ground truth in this context is not directly applicable.

3. Adjudication method for the test set:
   Not applicable, as ground truth was established by reference assays, not by subjective expert review requiring adjudication among multiple readers.

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, this is not an MRMC study. The CMVgen device is an in vitro diagnostic (IVD) assay, not an AI or imaging-based device requiring human reader interpretation or assistance. Therefore, this question is not relevant to the provided information.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, the performance presented for CMVgen is its standalone performance as an assay. It is inherently an "algorithm only" in the sense of a chemical/biological reaction and readout, without human-in-the-loop performance influencing the assay's result. The human reads the result of the assay.

6. The type of ground truth used:
   The ground truth was established by comparison to commercially available, established assays (reference tests). This is a common method for validating new IVD assays.

7. The sample size for the training set:
   The document does not mention a "training set" in the context of machine learning or AI. For IVD assays, products are typically developed and optimized using various samples, but these are not usually formally designated as "training sets" in the same way as in AI/ML validation. The samples mentioned (165 and 131 samples) are referred to as evaluation or test samples for performance assessment.

8. How the ground truth for the training set was established:
   Not applicable, as there is no explicitly defined "training set" as understood in AI/ML, nor is there a described process for establishing ground truth for such a set. Development and optimization of an IVD assay would involve a range of known positive and negative samples, but the method for establishing their "truth" is not detailed in this summary. It would typically involve clinical diagnosis, other gold-standard assays, or well-characterized patient cohorts.

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The CopalisTM CMV Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutinationbased immunoassay for the qualitative and semi-quantitative detection of total antibodies (IgG and IgM) to cytomegalovirus (CMV) in human serum using the CopalisTM One Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of this assay on a single serum specimen are used to indicate presence of antibody to CMV. When evaluating properly paired sera, the results of this assay are used to demonstrate seroconversion or a significant increase in antibody level as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

The Copalis CMV Total Antibody Assay is based on the principle of antibodydependent particle aggregation as detected by measurement of changes in light scattering. Latex particles coated with inactivated CMV antigens aggregate in the presence of antibodies to CMV. After 10 minutes of agitation, the level of aggregation is determined by measurement of the number of reacted and unreacted particles as they flow past a detector. The number of reacted particles is related to the level of CMV antibodies present in the test specimen. Without prior infection, antibody levels are absent or low. After infection, antibody levels rise and usually remain stable (but declining in titer) for years. Reactivity is assessed by the level of aggregation relative to a cutoff value. The Copalis CMV Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.

Here's a breakdown of the acceptance criteria and study details for the Copalis™ CMV Total Antibody Assay, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

• Clinical Comparison: 689 patient sera samples.
  • Provenance: Samples represented the mid-Atlantic and Gulf Coast regions of the U.S. (likely retrospective, as they are "patient sera samples" and not explicitly stated as prospectively collected for this study, though it's not definitively stated. The context of "tested at 2 clinical laboratories" implies existing samples).
• Reproducibility: 4 samples for general reproducibility (likely internal reference samples, not human patient samples). 30 sets of simulated acute and convalescent pairs for seroconversion reproducibility.
• CDC CMV Serum Panel: 1 panel, composition not specified but mentioned as "66% positive and 34% negative samples" (implies a total size for the panel, but not the exact number of individual samples within it).

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

• Clinical Comparison: The ground truth for relative sensitivity and specificity was established by the Becton Dickinson and Co. CMVscan Test (the predicate device). No information is provided about human expert involvement in establishing ground truth for the 689 patient samples, as the comparison is against an existing diagnostic test.
• CDC CMV Serum Panel: The panel was "characterized" by the CDC. No information on the number or qualifications of experts involved in the CDC's characterization or ground truth establishment.

3. Adjudication Method for the Test Set:

• Clinical Comparison: Not explicitly stated. The comparison is directly between the Copalis assay and the predicate device. There is no mention of a third adjudicator for discordant results.
• Reproducibility & CDC Panel: Not applicable, as these studies focused on agreement with known values or reproducibility, not a diagnostic decision requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic assay for antibody detection, not an imaging or diagnostic aid that involves human readers interpreting output.

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

• Yes, this is a standalone device. The Copalis™ CMV Total Antibody Assay is an automated immunoassay system. Its performance (sensitivity, specificity, reproducibility) is measured directly without human interpretation of the assay's output. The "human-in-the-loop" would be the laboratory technician running the assay and interpreting the quantitative results per the device's cutoff values, but the performance metrics provided reflect the device's analytical capability.

6. The Type of Ground Truth Used:

• Clinical Comparison: The ground truth was established by the results of the Becton Dickinson and Co. CMVscan Test (predicate device).
• Reproducibility: The ground truth was based on pre-defined reference standards (e.g., control samples with expected reactivity levels, simulated acute/convalescent pairs with known seroconversion status).
• CDC CMV Serum Panel: The ground truth was the "characterized" results from the CDC CMV Serum Panel.

7. The Sample Size for the Training Set:

• The document does not report information about a training set. This is common for traditional immunoassay development, where performance is optimized through assay formulation and component selection, rather than through machine learning models that require distinct training and testing datasets.

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

• Since no training set is reported, this information is not applicable.

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