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The Aptima® CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther® system.

The Aptima CMV Quant Assay is intended for use to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from Aptima CMV Quant assay must be interpreted within the context of all relevant clinical and laboratory findings.

The Aptima CMV Quant Assay is not intended for use as a screening assay for the presence of CMV in blood or blood products.

The Aptima CMV Quant Assay is an in vitro nucleic acid amplification test that uses real-time transcription mediated amplification (TMA) technology on the Panther Fusion system to quantify CMV DNA, genotypes 1, 2, 3, and 4. The primer design targets the highly conserved UL56 gene to ensure accurate quantitation of the CMV DNA. The assay is standardized to the WHO International Standard for human cytomegalovirus. The Aptima CMV Quant Assay is intended for use to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients.

The addition of a protocol to treat specific plasma samples with proteinase K in the assay package insert will allow the retesting of those samples to obtain a valid result.

The provided text describes a 510(k) premarket notification for the "Aptima CMV Quant Assay" and specifically details an update to the assay's package insert to include a protocol for retesting plasma samples that initially yield an "ML2 flag" invalid result. This retesting involves a manual pretreatment with proteinase K. The information provided is for a diagnostic assay, not an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML development, such as training sets, ground truth establishment for AI/ML, expert consensus for imaging, MRMC studies, and effect sizes of AI assistance, are not applicable.

However, I can extract information related to the acceptance criteria and the study that proves the device (specifically, the proteinase K pretreatment protocol) meets the acceptance criteria within the context of a diagnostic assay's performance and validation.

Acceptance Criteria and Study for the Proteinase K Pretreatment Protocol

The primary acceptance criterion for this change is to demonstrate that the proteinase K pretreatment protocol effectively resolves the "ML2 flag" invalid results and does not negatively impact the accuracy of the CMV quantification.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Test Set Sample Sizes:
  • Without Proteinase K: 1039 plasma specimens
  • With Proteinase K: 4098 plasma specimens
• Data Provenance: The plasma specimens were collected from the transplant patient population by the National Institute of Health (NIH). This suggests a retrospective analysis of archived samples or a prospective study conducted at the NIH. The location is the USA.

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

• Not applicable as this is a quantitative diagnostic assay for DNA detection, not an image-based AI/ML device requiring expert interpretation of images for ground truth. The "ground truth" here is the actual CMV DNA concentration, which the assay is designed to measure.

4. Adjudication Method for the Test Set:

• Not applicable for a quantitative diagnostic assay. The performance is assessed against the ability to produce a valid quantitative result for CMV DNA and maintain accuracy, not against human consensus.

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

• No, this is not an MRMC study. MRMC studies are typically performed for visual diagnostic aids (e.g., medical imaging AI) to compare human reader performance with and without AI assistance. This device is a direct quantitative assay.

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

• Yes, in a sense. The study validates the protocol (which includes a manual pretreatment step) and its effect on the automated assay system's ability to produce a valid result. The "performance" refers to the assay's output after the sample preparation, not an AI algorithm's independent decision. The core assay itself operates in a "standalone" fashion once the sample is loaded onto the Panther system.

7. The type of ground truth used:

• The implicit ground truth is the actual CMV DNA concentration in patient samples (or spiked controls used in accuracy assessments), as determined by a reference method or known concentrations. The study's focus, however, is on resolving an assay technical issue (ML2 flag) and demonstrating that the resolution method maintains the accuracy of CMV quantification. The reference to the NIH demonstrating that "using proteinase K for pretreatment of specimens did not impact the accuracy of CMV quantification" confirms that accurate quantitation (the ground truth outcome) was assessed.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for such an assay would be its initial development and optimization, which isn't described in terms of a specific "training set" size for this modification. The data provided refers to validation/test sets for the new protocol.

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

• Not applicable, as it's not an AI/ML device with a training set for model development.

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