(883 days)
Ventana Medical Systems, Inc. developed the Ventana Anti-CD5 (clone L17F12/Leu-1) for use on the Ventana ES automated immunohistochemistry system.
Ventana Anti-CD5 (clone L17F12/Leu-1) is substantially equivalent to antibodies detecting cellular elements of lymphocytic origin.
The provided text describes a study for the Ventana Anti-CD5 (clone L17F12/Leu-1) for use on the Ventana ES automated immunohistochemistry system. However, it does not explicitly define acceptance criteria in a quantitative table format or state precise performance metrics as acceptance thresholds. Instead, the study aims to demonstrate substantial equivalence to previously reported antibodies by showing appropriate staining and reactivity consistent with established literature.
Here's an attempt to extract the information based on the provided text, with an acknowledgment of the missing explicit quantitative acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from study goal) | Reported Device Performance |
|---|---|
| Appropriate staining of normal cells of lymphoid origin (e.g., tonsil, thymus, blood) | Demonstrated appropriate positive staining of lymphoid cells in normal tonsil, thymus, and blood. |
| Reactivity consistent with literature for T-cell lymphomas | Reactivity shown in 8 of 9 T-cell lymphomas. |
| Lack of reactivity (or minimal) in B-cell lymphomas | Reactivity shown in 0 of 11 B-cell lymphomas. |
| Lack of reactivity (or minimal) in Hodgkin's lymphomas | Reactivity shown in 0 of 11 Hodgkin's lymphomas. |
| Absence of "inappropriate staining" (e.g., non-lymphoid cells, non-specific background) | "There was no inappropriate staining of the specimens in this study." |
| Negative control antibody produced negative results | "The negative control antibody which was run with each tissue produced negative results." |
| Inter-run reproducibility (consistent positive staining of CD5 antigen) | All ten slides stained positively for CD5 antigen during ten different instrument runs. |
| Intra-run reproducibility (consistent positive staining of CD5 antigen) | All ten slides stained positively for CD5 antigen within one run. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Sizes:
- Normal samples: Number not explicitly stated, but included tonsil, thymus, cytospins, and blood smears.
- Pathological samples: 9 T-cell lymphomas, 11 B-cell lymphomas, 11 Hodgkin's lymphomas.
- Reproducibility samples: 10 samples for inter-run, 10 samples for intra-run (all from the same frozen tonsil tissue).
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: "Samples were obtained from excess tissues and specimens obtained for reasons other than the present study." This indicates the data was retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: One ("evaluated by a qualified independent pathologist").
- Qualifications of Experts: "A qualified independent pathologist." Specific years of experience or sub-specialty were not detailed, but 'qualified' implies appropriate expertise in pathology and immunohistochemistry interpretation.
4. Adjudication method for the test set
- Adjudication Method: None. The evaluation was performed by a single pathologist.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not explicitly described. The study compares the device's performance to literature reports and the negative control, not to human readers with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this was a standalone study of the device (antibody and automated stainer). The pathologist evaluated the slides produced by the automated system, effectively assessing the algorithm's (or system's) output.
7. The type of ground truth used
- The ground truth was based on:
- Pathology/Clinical Diagnosis: For the lymphoma specimens (T-cell, B-cell, Hodgkin's).
- Tissue Type/Anatomical Location: For normal samples (tonsil, thymus, blood smears, cytospins).
- Literature Reports: The results were compared to established knowledge and published data by Engleman et. al. and Chan et. al. to confirm appropriate, expected staining patterns.
8. The sample size for the training set
- The text does not mention a training set in the context of an algorithm. This device is an antibody and an automated staining system, not an AI/ML algorithm that requires a separate training set. The "Comparative Study" section describes the evaluation of the final product.
9. How the ground truth for the training set was established
- As no training set for an algorithm was described, this question is not applicable.
§ 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).