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Ventana Medical Systems, Inc. developed the Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system.

Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system.

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Device: Ventana Keratin Primary Antibody (clone 5D3) for use on the Ventana 320 automated immunohistochemistry system.

Description of Acceptance Criteria and Study:

The primary acceptance criteria for the Ventana Keratin Primary Antibody (clone 5D3) is its substantial equivalence to a commercially available anti-human cytokeratin (clone CAM 5.2). This equivalence is demonstrated through a comparative study evaluating staining patterns, intensity, specificity, and sensitivity in various tissue samples.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size:
  • Epithelial Line Cancers: 37 cases for sensitivity comparison.
  • Non-Epithelial Type Cancers: Number not explicitly stated, but "any of the nonepithelial type cancers" implies a set of such samples were used.
  • Normal Tissues: Breast, ureter, thyroid, skin, small intestine, stomach, liver, adrenal, muscle, prostate, tonsil, pituitary, thymus, esophagus, ovary, testes, pancreas, cardiac muscle, spinal cord, spleen, adenoid, kidney, connective tissue and salivary gland (number of samples for each not specified, but multiple types).
  • Overall: "Paraffin embedded preparations from normal and pathologic samples" were used. The total number of individual samples across all categories is not explicitly provided, but is greater than 37.
• Data Provenance: The data is retrospective. Samples were "obtained from excess tissues obtained for reasons other than the present study." The country of origin is not specified.

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

• The text does not explicitly state the number of experts used.
• It mentions that slides were "evaluated on a blind basis for specific staining intensity and background staining." While this implies expert evaluation, no specific qualifications for these evaluators (e.g., "radiologist with 10 years of experience") are provided. The term "evaluated" suggests trained personnel, likely pathologists or histotechnicians with expertise in immunohistochemistry interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• The text does not describe an explicit adjudication method (like 2+1 or 3+1) for resolving discrepancies. It only states that slides were "evaluated on a blind basis." This suggests individual evaluations, but doesn't detail how agreement was reached or conflicts resolved if multiple evaluators were involved.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study compares two antibodies against each other, not a human reader's performance with and without AI assistance. The "device" in this context is the antibody, not an AI system.

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

• Yes, this was a standalone study in the sense that the performance of the antibody (the "device") was assessed directly through its staining characteristics on tissue samples. There is no "algorithm" or "human-in-the-loop" interaction in the context of an antibody's performance. The automatic component is the Ventana 320 automated immunohistochemistry system that processes the slides, but the evaluation of the stained slides is a distinct step.

7. The type of ground truth used:

• The ground truth was established through a combination of:
  • Expert Consensus/Pathology: Implicitly, the classification of tissues as "epithelial line cancers," "non-epithelial type cancers," or specific "normal tissues" would be based on prior pathological diagnosis.
  • Comparative Analysis: The "ground truth" for the Ventana antibody's performance was its comparison to a "commercially available anti-human cytokeratin" (clone CAM 5.2), which served as the reference standard. The appropriateness of staining patterns was also likely based on expert pathological knowledge.

8. The sample size for the training set:

• The text does not mention a training set. This is a comparative study of two diagnostic reagents (antibodies), not a machine learning model that requires a training phase.

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

• Not applicable, as no training set was used.

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