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Ventana Medical Systems, Inc. developed Anti-CD3 (Clone UCHT-1) for use on the Ventana ES automated immunohistochemistry system.
Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the supporting study:
The provided text describes a study for Ventana's Anti-CD3 (Clone UCHT-1) for use on the Ventana ES automated immunohistochemistry system.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specificity: Appropriate staining of cells of lymphoid origin and no staining of cells of non-lymphoid origin. | Shown with appropriate staining of cells of lymphoid origin and no staining of cells of non-lymphoid origin. Agrees with published data. |
| Sensitivity: Consistent staining of T cell lymphomas and appropriate staining of normal lymphoid tissue. | Consistent staining of 8 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissue. Sensitivity is dependent on tissue processing and slide preparation. |
| Negative Control: Negative results for negative control tissues. | Negative control tissue was all negative. Negative control run with each tissue gave negative results. |
| Inter-run Reproducibility: Consistent staining intensity across different runs. | Mean staining intensity and standard deviation of 4.00 ± 0.00 across 10 different instrument runs for samples of the same tissue. |
| Intra-run Reproducibility: Consistent staining intensity within a single run. | Mean staining intensity and standard deviation of 4.00 ± 0.00 for 10 samples of the same tissue within one run. |
| Background Staining: No inappropriate background staining. | No inappropriate staining of the tissues in this study. |
| Staining Pattern: Staining in the plasma membrane of cells. | Staining occurred in the plasma membrane of cells from normal tonsil, thymus, and blood. |
2. Sample sized used for the test set and the data provenance
- Sample Size:
- Normal samples: Number not explicitly stated, but "normal tonsil, thymus and blood" are mentioned.
- Pathologic samples: "8 of 9 T cell lymphomas" are specifically mentioned. The total number of pathologic samples beyond T cell lymphomas is not specified.
- "10 different instrument runs" and "10 samples of the same tissue within one run" were used for reproducibility testing, implying at least 10 tissue samples were involved in these specific tests.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: "Samples were obtained from excess tissues obtained for reasons other than the present study." This indicates a retrospective collection of tissue samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not explicitly stated, but "a qualified pathologist" (singular) is mentioned as evaluating the slides. This suggests one primary expert.
- Qualifications of Experts: "A qualified pathologist." Further detail (e.g., years of experience, specific sub-specialty) is not provided.
4. Adjudication method for the test set
- Adjudication Method: None explicitly stated. The evaluation was done by "a qualified pathologist," implying a single assessment without a multi-reader review or adjudication process.
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 a performance evaluation of an immunohistochemistry reagent and automated system, not an AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. This study evaluates the standalone performance of the Anti-CD3 (Clone UCHT-1) reagent and the Ventana ES automated system when processed for evaluation by a pathologist. While a human (pathologist) interprets the results, the study's focus is on the device's ability to correctly stain the tissues, rather than the pathologist's diagnostic performance. The "algorithm" here would be the staining protocol and reagent performance, which is assessed directly.
7. The type of ground truth used
- Expert Consensus/Pathological Diagnosis: The ground truth for the samples (e.g., T cell lymphomas, normal lymphoid tissue) appears to be established by prior pathological diagnosis or the inherent nature of the normal tissue. The pathologist then evaluates the staining against this established tissue identity. The published data by Reinherz, E. L., and S. F. Schlossman also serves as a reference for expected specificity.
8. The sample size for the training set
- Not applicable. The provided text describes a verification/validation study for a medical device (an IHC reagent and automated system), not a machine learning algorithm. Therefore, there is no explicit "training set" in the context of AI/ML. The development of such a reagent would involve internal R&D and optimization, but these preclinical activities are not described as a "training set" in this summary.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set as defined in AI/ML contexts. The reagent's development would be based on scientific understanding of antibody-antigen interaction and iterative testing by experts, but this is distinct from establishing ground truth for an AI training dataset.
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510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Ventana Medical Systems, Inc. developed Anti-CD3 (Clone UCHT-1) for use on the Ventana ES automated immunohistochemistry system. Ventana's Anti-CD3 (Clone UHCT-1) is substantially equivalent to antibodies detecting cellular elements of lymphocytic origin as reported by Reinherz, E. L., and S. F. Schlossman. The differentiation and function of human T lymphocytes. Cell. 1980; Vol 19, pp. 821-827.
Comparative Study
Supporting data for the equivalence statement is shown by the following study. Frozen preparations from normal and pathologic samples were tested using Ventana's Anti-CD3 (Clone UCHT-1). Samples were obtained from excess tissues obtained for reasons other than the present study. Pathologic and normal tissues were examined. Slides were processed on the Ventana ES Automated Slide Stainer, prepared for examination, and evaluated by a qualified pathologist for specific staining intensity and background staining.
Results
Staining occurred in the plasma membrane of cells from normal tonsil, thymus and blood. Negative control tissue was all negative. There was no inappropriate staining of the tissues in this study.
Specificity of the antibody was shown with appropriate staining of cells of lymphoid origin and no staining of cells of non-lymphoid origin. In addition, the specificity seen in this study agrees with the data published by Reinherz, E. L., and S. F. Schlossman, 1980.
The sensitivity of this antibody was shown by consistent staining of 8 of 9 T cell lymphomas, and appropriate staining of normal lymphoid tissue. As with any immunohistochemical reagent, the sensitivity is dependent on tissue processing and slide preparation parameters. The negative control which was run with each tissue gave negative results.
Staining intensity was scored on a scale of 0 - 4+. Inter-run reproducibility was determined based on samples of the same tissue on 10 different instrument runs with a mean staining intensity and standard deviation of 4.00 ± 0.00. Intra-run reproducibility was determined based on 10 samples of the same tissue within one run. The mean staining intensity and standard deviation of the ten slides was 4.00 ± 0.00.
§ 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).