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Both are intended for use in the detection of antibody to CMV .

The Abbott CMV Total AB Diagnostic EIA enzyme immunoassay is substantially equivalent to the CETUS Cytomegalovirus Indirect Hemagglutination Assay (IHA) which is based on the IHA of Yeager. and originally used for CMV antibody detection by Bernstein and Stewart prior to May 28, 1976. The Abbott CMV Total AB Diagnostic EIA and the CETUS CMV IHA are substantially equivalent in that:

• a. Both are intended for use in the detection of antibody to CMV .
• b. Both are in vitro immunological test systems.
• c. Both are used to determine serologic status on a single specimen.
• d. Both are based on the formation of complexes between CMV antigens and CMV antibody.

The assays differ in that:

The Abbott CMV Total AB Diagnostic EIA is designed to be used with a spectrophotometer to give an absorbance value which is interpreted objectively. The IHA result, on the other hand, is determined by a subjective interpretation of the erythrocyte settling pattern.

Here's a breakdown of the acceptance criteria and study information for the Abbott CMV Total AB Diagnostic EIA, based on your provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 2312 specimens were initially evaluated. After removing 23 uninterpretable IHA specimens, the primary analysis was based on 2289 specimens.
• Data Provenance: The specimens were sourced from random healthy adults. The specific country of origin is not explicitly stated, but it can be inferred to be from facilities conducting medical evaluations. The data collection was prospective in the sense that these specimens were likely collected for the purpose of this evaluation, though the specific clinical context for their initial collection isn't detailed.

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

• This study uses a comparator device (CETUS Cytomegalovirus Indirect Hemagglutination Assay (IHA)) as the de facto "ground truth" or reference method, rather than a panel of human experts interpreting the results.
• Therefore, the concept of "experts establishing ground truth" as it applies to image interpretation or diagnosis by human readers is not applicable in this context. The IHA is a laboratory test with its own established methodology. The IHA result, however, is mentioned to be determined by a "subjective interpretation of the erythrocyte settling pattern," implying that a trained individual performs this interpretation, though their specific qualifications or number are not provided.

4. Adjudication Method for the Test Set

• None directly applicable in the sense of expert adjudication of discrepancies between readers. The comparison is between two laboratory assays.
• Discrepancies exist where the two assays yield different results (e.g., one positive, one negative). However, the text does not describe an adjudication process for these discrepancies (e.g., a third, more definitive test being run). Instead, the statistical agreement (sensitivity, specificity, overall agreement) quantifies these differences.

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, an MRMC comparative effectiveness study was not done. This study evaluates the performance of a new diagnostic assay (Abbott CMV Total AB Diagnostic EIA) against an existing diagnostic assay (CETUS CMV IHA). It does not involve human readers' performance with or without AI assistance.

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

• Yes, a standalone performance evaluation was done. The Abbott CMV Total AB Diagnostic EIA is a laboratory assay that provides an objective absorbance value. The reported performance metrics (overall agreement, sensitivity, specificity) reflect the performance of this assay on its own when compared to the reference IHA method. There is no human interpretation required for the final result of the Abbott EIA itself.

7. The Type of Ground Truth Used

• The ground truth in this study is based on the results of a predicate device: the CETUS Cytomegalovirus Indirect Hemagglutination Assay (IHA). This IHA method is stated to be based on the IHA of Yeager and originally used by Bernstein and Stewart, implying a recognized and established method for CMV antibody detection.

8. The Sample Size for the Training Set

• The text does not explicitly mention a separate training set for the Abbott CMV Total AB Diagnostic EIA. This type of submission (510(k) for an in vitro diagnostic) often focuses on comparative performance against a predicate device using evaluation/test sets, rather than describing a training phase for an algorithm in the same way an AI/ML device would. The assay itself is a chemical/biological system, not an algorithm that "learns" from data.

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

• As a training set is not explicitly mentioned or applicable in the context of this device's development as described, this question is not applicable. The "ground truth" for the evaluation was established by the predicate IHA assay.

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