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Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.

Estrogen Receptor Clone 6F1 I is indicated as an aid in the management, prognosis and predication of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by qualified pathologist.

Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond™ and the Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra™ are optimized for use on the Leica Biosystems Bond III staining platform using the Bond Polymer Refine Detection Kit.

Estrogen Receptor Clone 6F11 is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant. This antibody is utilized to perform a semi-quantitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in human breast cancer tissue routinely processed and paraffin-embedded for histological examination.

Estrogen Receptor Clone 6F11 primary antibody is provided in two formats, a Bond™ Ready-to-Use format (product code PA0151 (7mL) and PA0009 (30 mL)) and a concentrated liquid format (product code NCL-L-ER-6F11 (1mL) and is optimally diluted for use on the automated Bond System (Bond III ) in combination with Bond Polymer Refine Detection kit.

Total protein concentration for Estrogen Receptor clone 6F11 is approximately 3.8 g/L. The immunoglobulin concentration is approximately 75 mg/L.

The Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra" is recommended for use at a dilution of 1 in 50 when diluted in Bond Antibody Diluent (AR9352).

The Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond™ is a tissue culture supernatant prepared at a working immunoglobulin concentration of 0.88 µg/mL. It is supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin™ 950 as a preservative.

Acceptance Criteria and Device Performance for Estrogen Receptor Clone 6F11

The Leica Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) primary antibody, in both Ready-to-Use (PA0151) and Liquid Concentrate (NCL-L-ER-6F11) formats, demonstrated performance across several studies to meet acceptance criteria for its intended use in immunohistochemistry for ER antigen identification in breast cancer tissue.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance studies rather than explicit, pre-defined acceptance criteria with specific thresholds for each metric. However, the data presented strongly implies what would be considered acceptable performance for a device seeking governmental approval, particularly regarding reproducibility and correlation with existing methods and clinical outcomes.

Based on the studies, the implicit acceptance criteria for the device revolve around demonstrating high agreement in various precision and reproducibility studies, and acceptable clinical performance (sensitivity, specificity, PPV, NPV) when compared to a "gold standard."

Summary Table of Reported Device Performance against Implicit Acceptance Criteria:

2. Sample Size Used for the Test Set and Data Provenance

The document describes several distinct test sets:

• Clinical Outcome Study (Calgary Cohort):
  • Sample Size: n=532 breast cancer patients (retrospectively analyzed); n=473 for univariate analysis; n=363 for multivariate analysis.
  • Data Provenance: Retrospective, Calgary-based patient cohort (Canada), diagnosed between 1985 and 2000.
• Precision and Reproducibility Studies (TMA and Whole Tissue Sections): These studies used unspecified "breast cancer cases."
  • Within-Run Precision (PA0151): 108 test data points (presumably cases or samples).
  • Within-Instrument Precision (PA0151): 321 test data points.
  • Between-Run Precision (PA0151): 180 test data points.
  • Between Laboratory Precision (PA0151): 101 test data points from 3 investigational sites.
  • Lot to Lot Precision (PA0151): 100 test data points using 3 reagent lots.
  • Between Observer Precision (PA0151 & NCL-L-ER-6F11): 20 whole section breast cancer cases for each format (total 40 cases if both studies were distinct).
  • Inter-Site Reproducibility (PA0151 & NCL-L-ER-6F11): 18 cases evaluated at 3 sites over 5 days (9 replicates per case).
  • Lot to Lot Reproducibility (PA0151 & NCL-L-ER-6F11): 18 cases using 3 reagent lots.
• Inter-Platform Comparison Study:
  • Sample Size: 306 invasive breast cancer specimens. An additional 452 cases were assessed to enrich the cohort, but the final reported results are for the 306 cases.
  • Data Provenance: Clinical archives, from three independent US-based testing facilities. Specimens were formalin-fixed, paraffin-embedded.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Clinical Outcome Study (Calgary Cohort):
  • Number of Experts: 3 observers scored slides (likely pathologists, though specific qualifications were not given beyond "observers").
  • Qualifications: Not explicitly stated, but clinical outcome studies involving immunohistochemistry interpretation typically involve experienced pathologists.
• Precision, Reproducibility, and Inter-Platform Comparison Studies:
  • Number of Experts: 3 observers/investigational sites are mentioned for between-observer and inter-site studies.
  • Qualifications: Not explicitly stated beyond "observers" and "investigational sites." It's implied these are expert professionals (e.g., pathologists) involved in diagnostic interpretation.

4. Adjudication Method for the Test Set

• Clinical Outcome Study (Calgary Cohort): The scoring method was the "Allred scoring method." Cohen's Kappa statistic was used to quantify inter- and intra-observer reproducibility. While individual observer scores were compared, there is no explicit mention of an adjudication process (e.g., 2+1, 3+1) to establish a consensus ground truth solely among the experts for this specific test set. The ground truth for comparative effectiveness was primarily based on ligand-binding assay (LBA) and patient progression on tamoxifen.
• Precision, Reproducibility, and Inter-Platform Comparison Studies: For these studies, the "ground truth" often refers to a reference standard against which the test device is compared. For observer agreement studies, the "adjudication method" is the direct comparison of observer scores without necessarily establishing a final adjudicated truth.
  • In the inter-platform comparison study, the "reference standard device" (Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond™ on the Bond III) effectively served as the de facto ground truth against which the Liquid Concentrate format was compared.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, And the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of human readers with vs. without AI assistance.

This document describes the validation of an immunohistochemistry (IHC) assay and its accompanying primary antibody, not an AI or digital pathology device meant to assist human readers. The studies focus on the performance and reproducibility of the IHC staining method itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm only was not done.

As noted above, this submission is for an IHC primary antibody and its associated staining platform, which is interpreted by human observers (pathologists). There is no mention of an algorithm or AI component in this device.

7. The Type of Ground Truth Used

The ground truth varied depending on the specific study:

• Clinical Outcome Study (Calgary Cohort):
  • Ligand-binding assay (LBA): Used as a "gold standard" for calculating sensitivity, specificity, PPV, and NPV of the device.
  • Patient progression on tamoxifen: Used as another "gold standard" for calculating diagnostic performance metrics, indicating real clinical outcome.
• Precision and Reproducibility Studies: For these studies, the "ground truth" was often the consensus or established score from a reference method or a designated expert, against which other measurements/observers were compared. For the between-observer studies, direct comparison of observer agreement served as the assessment.
• Inter-Platform Comparison Study: The Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond™ on the Bond III (the existing, approved format) served as the "reference standard test" or ground truth against which the Liquid Concentrate format was evaluated.
• Stability Studies: A "control score" for Intensity Score and Proportion Score was used as the ground truth.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of a machine learning model, as the submission concerns an IHC assay and antibody, not an AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI model is described.

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Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) is intended for in vitro diagnostic use for the qualitative detection of estrogen receptor in routinely processed tissues. ER 6F11 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist.

Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.

ER 6F11 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

ER 6F11 is a monoclonal mouse antibody that detects a human estrogen receptor epitope located in the nucleus of ER positive cells.

The provided text is a 510(k) summary and associated FDA correspondence for the Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) device. It describes the device's intended use and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, and therefore doesn't contain most of the information requested in your prompt. This is typical for 510(k) summaries, which focus on substantial equivalence rather than detailed performance studies and acceptance criteria as might be found in a PMA.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text.

Here's a breakdown of what can be extracted and what is missing:

The document states: "ER 6F11 complies with the elements of FDA Guidance, "Guidance for Submission of Immunohistochemistry Applications to the FDA" and, "Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use." This implies the device meets certain regulatory expectations, but the specific performance acceptance criteria and study data are not included.

Information NOT present in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (e.g., country of origin, retrospective or prospective) for the test set.
• Number of experts used to establish ground truth for the test set.
• Qualifications of those experts.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
• The sample size for the training set.
• How ground truth for the training set was established.

Information that can be inferred (though not directly stated as study results):

• Type of Ground Truth: Given the device is an immunohistochemistry reagent for detecting Estrogen Receptor in tissue, the ground truth would inherently be based on pathology (histopathological assessment of tissue samples).

Summary of what's provided related to your request:

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