Search Results

The VENTANA CD30 (Ber-H2) Assay is intended for laboratory use in the qualitative detection of the CD30 protein in formalin-fixed, paraffin-embedded tissue stained with a VENTANA BenchMark ULTRA instrument and OptiView DAB IHC Detection Kit. CD30 positive staining may aid in the identification of classical Hodgkin lymphoma (cHL), anaplastic large cell lymphoma (ALCL) and cutaneous T-cell lymphoma (CTCL). This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use.

The VENTANA CD30 (Ber-H2) Assay consists of the primary CD30 (Ber-H2) antibody, detection reagents and an instrument (BenchMark ULTRA automated staining instrument). The VENTANA CD30 (Ber-H2) Assay is a mouse monoclonal antibody (IgG1, kappa) directed against CD30. CD30 antigen is expressed in mononuclear Hodgkin's cells and multinucleated Reed Sternberg cells of Hodgkin Lymphoma as well as on anaplastic large cell lymphomas. This antibody variably produces membranous, cytoplasmic, and Golgi staining of both lymphoma cells and of scattered large activated B and T cells in lymph nodes, spleen, tonsil, and thymus. The OptiView DAB IHC Detection Kit is an indirect, biotin-free system for detecting mouse IgG, mouse IgM, and rabbit primary antibodies. This kit is intended to detect antigens by IHC in sections of formalin-fixed, paraffin-embedded (FFPE) and frozen tissues that are stained on the BenchMark ULTRA instrument (note: the VENTANA CD30 (Ber-H2) Assay will not be recommended for use in frozen tissue). The OptiView DAB IHC Detection Kit produces a visible dark brown precipitate (3, 3'-Diaminobenzidine) via a horseradish peroxidase (HRP) enzymatic reaction at the antigen site. The Pathologist evaluates the brown precipitate using Bright-field microscopy.

The provided text describes the 510(k) summary for the VENTANA CD30 (Ber-H2) Assay, an immunohistochemistry (IHC) assay. It details the device's intended use and compares it to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document implicitly defines acceptance criteria through the comparison to the predicate device. The primary stated performance metric is "overall percent agreement rate".

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

• Test Set Sample Size: The text mentions two sample sizes based on the number of readers:
  • 568 cases for the study involving three readers (resulting in 517 agreed cases).
  • 796 cases for the study involving four readers (resulting in 739 agreed cases).
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "premethod comparison study" conducted to demonstrate substantial equivalence. It's implied to be retrospective, as it compares the new device's staining results to those obtained with cases using the predicate device. The samples are described as "formalin-fixed, paraffin-embedded human tissue."

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

• Number of Experts: The study used three readers for one analysis and four readers for another.
• Qualifications of Experts: The document states that the product "should be interpreted by a qualified pathologist." While it doesn't provide specific experience levels (e.g., "10 years of experience"), it implies that the readers involved in the comparison study were qualified pathologists.

4. Adjudication method for the test set:

The document mentions "overall percent agreement rate between three readers" and "overall agreement rate between four readers." This strongly suggests a consensus-based adjudication method, where the aggregate agreement among the multiple readers determines the final result used for comparison. It doesn't specify if a particular threshold for agreement was used (e.g., 2 out of 3, or majority rule), but the "agreement rate" implies a comparison of individual reader interpretations against each other or potentially against a predefined "truth" established by the collective. It's not a 2+1 or 3+1 method explicitly stated, but rather a direct comparison of agreement.

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:

• MRMC Study: Yes, a multi-reader multi-case comparison study was implicitly done, as the performance metrics are based on agreement rates between multiple readers on a set of cases using both the new and predicate devices.
• Effect Size (AI Assistance): This study is not an AI-assisted study. It compares a new IHC assay (VENTANA CD30 (Ber-H2) Assay) against a predicate IHC assay (DAKO K965022). Therefore, there is no AI component and no mention of human readers improving with AI assistance.

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

This is an IHC assay, not an AI algorithm. The performance is inherently tied to the visual interpretation of stained tissue by a pathologist. Therefore, a standalone (algorithm only) performance is not applicable or discussed. The device is a reagent and an automated staining instrument for pathologist interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for this study appears to be expert consensus among the pathologists interpreting the slides stained with both the predicate and proposed devices. The "overall percent agreement rate" signifies how well the new device's results align with the interpretations obtained from the predicate device, or how consistently different pathologists interpreted the slides stained by the new device. The predicate device's performance, previously cleared by the FDA, serves as the reference for substantial equivalence.

8. The sample size for the training set:

The document does not explicitly mention a training set sample size. This is an analytical validation and method comparison study for a diagnostic assay, not a machine learning model. Therefore, the concept of a "training set" in the context of AI is not relevant here. The samples used are for the comparison study itself.

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

As this is not an AI/machine learning study, the concept of a "training set" and establishing its ground truth in that context is not applicable. The study focuses on demonstrating substantial equivalence of the new IHC assay to an existing, cleared predicate device through a comparison study. The "ground truth" in this context is the established performance and interpretation patterns of the predicate device, against which the new device's performance is measured by experienced pathologists.

Ask a specific question about this device