(1350 days)
Ventana Leukocyte Common Antigen Primary Antibody (clone RP2/18) is substantially equivalent to a commercially available leukocyte common antigen (clones 2B11 and PD7/26).
Ventana Medical Systems, Inc. developed the Ventana Leukocyte Common Antigen Primary Antibody for use on the Ventana ES automated immunohistochemistry system. Ventana Leukocyte Common Antigen Primary Antibody (Clone RP2/18) contains a mouse monoclonal antibody directed against the CD45RB epitope found on the membrane of leukocytic cells.
This document describes the Ventana Leukocyte Common Antigen Primary Antibody (clone RP2/18) and its substantial equivalence to a predicate device. The information provided focuses on a comparative study rather than a standalone algorithm performance study for an AI device. Therefore, several requested points, particularly those related to AI-specific metrics, cannot be fully addressed from the provided text.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantifiable manner (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating equivalence to a commercially available predicate device. The primary performance metric reported is 100% agreement in staining tissues for lymphocytic line cancers and no staining in non-lymphocytic type cancers when compared to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to Commercially Available Predicate Antibody: | |
| Staining of Lymphocytic Line Cancers | "Ventana Leukocyte Common Antibody stained the same tissues 100% of the time in lymphocytic line cancers." and "the commercially available leukocyte common antigen stained 17 of 20 [lymphocytic cancers]." |
| Non-staining of Non-Lymphocytic Cancers | "Neither Ventana Leukocyte Common Antigen Primary Antibody nor the commercially available antibody stained any of the non-lymphocytic type cancers." and "Among non-hematopoietic neoplasms, breast, colon, oat cell, and ovarian carcinomas, there was no staining by anti-LCA (clone RP2/18)." |
| Appropriate Staining of Normal Tissues | "The staining patterns of the normal tissues were considered to be appropriate." (Details provided on specific normal tissue staining patterns, e.g., in lymph node, tonsil, bone marrow, spleen, and absence of staining in others like adrenal, breast, etc.) |
| Specificity | "Specificity of both antibodies was proven with appropriate staining of cells of leukocytic lineage and no staining of cells of non-leukocytic lineage." |
| Sensitivity (for Lymphocytic Cancers) | "Sensitivity of Leukocyte Common antigen antibodies, based on comparison of 20 lymphocytic cancers, showed that Ventana Leukocyte Common Antigen Primary Antibody stained 17 of 20 and the commercially available leukocyte common antigen stained 17 of 20." (This implies a sensitivity of 85% for both, based on this specific sample set). |
| Staining Intensity (Pathologic Tissue) | "Non parametric analysis of the staining intensity results from pathologic tissue (Wilcoxon matched pairs) shows no difference in the performance of the two antibodies tested, at the .01 level of significance." |
| Intra-run Reproducibility | "Intra-run reproducibility, based on 10 samples of the same tissue within one run, were similar for both antibodies." |
| Inter-run Reproducibility | "Inter-run reproducibility, based on samples of the same tissue on 10 different instrument runs, showed similar staining." |
2. Sample Size Used for the Test Set and Data Provenance
- Pathologic Samples: "Formally fixed, paraffin embedded preparations from pathologic samples" were tested.
- Lymphocytic Cancers: 20 cases were used to assess sensitivity for both the Ventana antibody and the predicate.
- Non-Lymphocytic Cancers: The text mentions "any of the non-lymphocytic type cancers" and specifically lists "breast, colon, oat cell, and ovarian carcinomas" as not staining, implying multiple cases of these types were included. The exact number of non-lymphocytic cancer cases is not specified for the overall comparison, but it suggests sufficient variety to ensure differentiation.
- Normal Samples: Various normal tissues were evaluated, including: adrenal, breast, cerebellum, cerebrum, cervix, colon, endometrium, esophagus, heart, kidney, liver, lung, mesothelium, ovary, pancreas, peripheral nerve, pituitary, prostate, salivary gland, skeletal muscle, skin, small intestine, stomach, testis, thyroid, lymph node, tonsil, bone marrow, and spleen. The exact number of samples for each normal tissue type is not specified.
- Data Provenance: "Samples were obtained from excess tissues obtained for reasons other than the present study." This indicates the data is retrospective and derived from existing clinical pathology archives. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: One "qualified pathologist."
- Qualifications: "qualified pathologist." No further specific details like years of experience are provided.
4. Adjudication Method for the Test Set
The evaluation was performed by a single pathologist on a "blinded basis." This suggests no formal adjudication method involving multiple experts for the test set was employed, as the ground truth was established by one pathologist.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The study compares the new antibody to a predicate antibody, not human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
This document describes the performance of an immunohistochemistry antibody on an automated system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable in this context. The Ventana ES system is an automated stainer, not an AI-driven diagnostic algorithm.
7. Type of Ground Truth Used
The ground truth was established through expert evaluation by a qualified pathologist who assessed specific staining patterns and background staining on pathologic and normal tissue samples. This is essentially pathology-based ground truth, determined by a human expert's microscopic interpretation.
8. Sample Size for the Training Set
The document describes a comparative study for regulatory submission (510(k)) and does not mention a "training set" in the context of machine learning. The term "training set" is not applicable here as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" is not applicable to this device described in the document.
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).