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Ventana Anti-Desmin Primary Antibody (clone DE-R-11) is substantially equivalent to other marketed immunohistochemical stians used in the identification of cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors.

Ventana Anti-Desmin Primary Antibody for use on the Ventana ES automated immunohistochemistry system.

The provided text describes a 510(k) summary for the Ventana Anti-Desmin Primary Antibody. However, it does not contain specific numerical acceptance criteria or detailed quantitative performance metrics typical of modern device studies. It focuses on qualitative observations of staining specificity, sensitivity, and reproducibility.

Therefore, many of the requested sections (e.g., specific acceptance criteria, statistical sample sizes for test sets in the modern sense) cannot be fully populated directly from the provided text. I will interpret the information as best as possible while highlighting what is missing.

Here's an analysis based on the provided text:

Description of Acceptance Criteria and Study to Prove Device Meets Them

The Ventana Anti-Desmin Primary Antibody is intended for use on the Ventana ES automated immunohistochemistry system to identify cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors. The study aimed to demonstrate substantial equivalence to other marketed immunohistochemical stains.

1. Table of Acceptance Criteria and Reported Device Performance

• Appropriately stained muscle cells in normal skin, small intestine, stomach, prostate, tonsil, esophagus, testes, pancreas, cardiac muscle, and kidney tissues.
• No staining of cells of non-muscle origin.
• Specificity observed in the study agreed with data published by Jones et et al, 1990. |
  | Sensitivity: Consistent staining of normal smooth and striated muscle, and appropriate staining of myocytic sarcomas, consistent with published literature (Jones et al, 1990). | Sensitivity met:
• Consistent staining of normal smooth and striated muscle.
• Appropriate staining of myocytic sarcomas.
• Consistently stained the same type of line cancers when compared with literature results.
• Negative control gave negative results with each tissue.
• Note: A general disclaimer notes sensitivity depends on fixation, tissue processing, and slide preparation parameters. |
  | Inter-run Reproducibility: Equivalent staining across multiple runs of the same tissue block. | Inter-run Reproducibility met:
• Staining was equivalent between all slides tested across 11 different instrument runs on samples from the same tissue block. |
  | Intra-run Reproducibility: Equivalent staining across multiple samples from the same tissue within a single run. | Intra-run Reproducibility met:
• Staining was equivalent between the ten slides tested from the same tissue within one run. |

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

• Sample Size: The text describes "paraffin embedded preparations from normal and pathologic samples" and later mentions "samples of the same intesting tissue block" for reproducibility studies (11 for inter-run, 10 for intra-run). However, the exact number and types of distinct patient/tissue samples used in the specificity and sensitivity assessment are not quantified. It's unclear how many unique normal tissues were tested or how many unique pathologic/tumor samples were included.
• Data Provenance: "Samples were obtained from excess tissues obtained for reasons other than the present study." This indicates a retrospective collection of banked tissue samples. 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

• Number of Experts: "evaluated by a qualified pathologist for specific staining intensity and background staining." This implies one qualified pathologist performed the evaluation.
• Qualifications: "qualified pathologist." No further details on years of experience or sub-specialization are provided.

4. Adjudication Method for the Test Set

• No explicit adjudication method is described. The evaluation was performed by a single pathologist.

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. This study is for an immunohistochemical stain, not an AI software/device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Yes, in spirit. The device (antibody + automated stainer) is evaluated in a "standalone" manner in that its staining characteristics are assessed qualitatively by a pathologist without human intervention in the staining process itself. The evaluation is of the device's output (stained slide), not of a human interpreter's performance on that output.

7. The Type of Ground Truth Used

• The ground truth was based on:
  • Expert Consensus/Reference: The study compared the observed staining patterns (specificity and sensitivity) to "published results (Jones et al, 1990)." This implies that widely accepted scientific literature served as a form of "ground truth" for expected staining characteristics of desmin in various tissues and tumors.
  • Pathologist Interpretation: The "qualified pathologist" directly assessed the staining intensity and background, effectively acting as the "ground truth" expert for each specific slide tested in the study.

8. The Sample Size for the Training Set

• This is a traditional diagnostic reagent/device, not an AI/machine learning model. Therefore, there is no "training set" in the context of algorithm development.

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

• Not applicable, as there is no training set for this type of device.

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