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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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