ANTI-VIMENTIN PRIMARY ANTIBODY

• K Number: K941397
• Device Name: ANTI-VIMENTIN PRIMARY ANTIBODY
• Manufacturer: VENTANA MEDICAL SYSTEMS, INC.
• Date Cleared: 1997-02-10 ( 1056 days)
• Product Code: DEH
• Regulation Number: 866.5550
• Type: Traditional
• Panel: Immunology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Ventana Anti-Vimentin (clone VIM 3B4) is substantially equivalent to other marketed immunohistochemical stains used in the identification of cells of normal and abnormal lineage as an aid in the diagnosis of anaplastic tumors.

Device Description

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

AI/ML Overview

Here's an analysis of the provided text regarding the Ventana Anti-Vimentin Primary Antibody, structured according to your request. Unfortunately, the provided text is for an old 510(k) summary for an immunohistochemistry stain, not a modern AI device. Therefore, many of the requested fields are not applicable or the information is not present in the text. I will fill in what can be inferred and clearly state when information is missing or not applicable.

Acceptance Criteria and Device Performance

The provided text describes a comparative study for an immunohistochemical stain, not an AI device. The acceptance criteria aren't explicitly stated but can be inferred as "appropriate staining of cells of mesenchymal origin and agreement with reported literature," and high inter-run and intra-run reproducibility.

Acceptance Criteria (Inferred)	Reported Device Performance
Appropriate staining of cells of mesenchymal origin and agreement with reported literature.	Ventana Study:

• 20 of 20 melanomas stained positively.
• 8 of 8 sarcomas stained positively.
• 0 of 9 adenocarcinomas stained positively.
• 0 of 10 squamous cell carcinomas stained positively.
• 0 of 9 carcinoid tumors stained positively.

Comparison to Azumi and Battifora (Literature):

• Melanomas: Ventana (20/20) vs. Literature (16/18)
• Sarcomas: Ventana (8/8) vs. Literature (17/20)
• Adenocarcinoma: Ventana (0/9) vs. Literature (15/147)
• Squamous Cell Carcinoma: Ventana (0/10) vs. Literature (1/7)
• Carcinoid: Ventana (0/9) vs. Literature (1/10) |
  | High inter-run reproducibility (consistent staining across different instrument runs). | "Inter-run reproducibility, based on samples of the same tissue on 16 different instrument runs. Staining was equivalent for all slides." |
  | High intra-run reproducibility (consistent staining of the same tissue within a single instrument run). | "Intra-run reproducibility, based on 10 samples of the same tissue within one run. Staining was equivalent for all slides." |

Study Details for Acceptance Criteria

1. Sample size used for the Test Set and the data provenance:

   • Test Set Sample Size:
     • Melanomas: 20 samples
     • Sarcomas: 8 samples
     • Adenocarcinomas: 9 samples
     • Squamous Cell Carcinomas: 10 samples
     • Carcinoid Tumors: 9 samples
     • Total unique pathologic samples (summing the above): 56 (assuming these are distinct samples for each category).
     • Additionally, "normal samples" were tested, but their number is not specified.
     • For inter-run reproducibility: 16 runs of "samples of the same tissue" (implies one or more tissues repeatedly stained).
     • For intra-run reproducibility: 10 samples of "the same tissue" within one run.
   • Data Provenance: "Samples were obtained from excess tissues obtained for reasons other than the present study." This indicates the data is retrospective. The country of origin is not specified but is likely the USA given the context of a 510(k) submission.

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

   • The text states, "Slides were processed... then evaluated on a blind basis for specific staining intensity and background staining." It does not specify the number or qualifications of the experts who performed this evaluation. It can be inferred that these were pathologists or histotechnicians with expertise in evaluating immunohistochemical stains.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The text does not specify an adjudication method. It simply states "evaluated on a blind basis." It doesn't mention multiple readers or a consensus process.

4. 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:

   • Not Applicable. This is an immunohistochemistry stain, not an AI device. No MRMC study involving human readers and AI assistance was performed or described.

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

   • Not Applicable. This is an immunohistochemistry stain. The "device" is a primary antibody used in a laboratory setting by human operators, stains a tissue, and is then interpreted by a human pathologist. There is no algorithm-only performance to assess.

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

   • The ground truth for the classification of the tissue samples (e.g., melanoma, sarcoma, adenocarcinoma) would have been based on pathology reports/diagnosis by expert pathologists, which is standard practice for tissue samples. The "appropriate staining" and comparison to literature also imply that the "ground truth" for the expected staining pattern was established by expert consensus and existing knowledge in the field (cited literature).

7. The sample size for the training set:

   • Not Applicable. This is not an AI device, so there is no concept of a "training set" in the context of machine learning. The antibody's "training" would be through its development and validation against known tissue types by the manufacturer, but this is not a dataset in the AI sense.

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

   • Not Applicable. As there is no AI training set, this question is not relevant. The performance of the antibody is assessed against its known biochemical specificity and established diagnostic criteria within pathology.

Regulation Number and Section

§ 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).