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510(k) Data Aggregation
(30 days)
MYA
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 6F11 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 a 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 (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.
This document is a 510(k) premarket notification decision letter for the Estrogen Receptor Clone 6F11 (ER 6F11) immunohistochemistry reagent. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter primarily states that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the content of this document.
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(352 days)
MYA
For in vitro diagnostic use.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis), is intended for use in immunohistochemistry with the EnVision FLEX visualization system together with the Dako Omnis instrument to qualitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody binds estrogen receptor a expressing cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.
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. This antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.
The FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis) antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in fixed human breast cancer tissues routinely processed and paraffin-embedded for histological examination.
The design of the proposed device is based on the design of its predicate FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α. Clone EP1, Ready-to-Use (Link) with adaptation of the product configuration, to be used on the Dako Omnis Instrument instead of the Autostainer Link 48 Instrument.
The antibody is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The antibody is intended for automated immunohistochemical (IHC) slide staining with the Dako Omnis Instrument and the software performing and controlling the automated slide staining process is validated for its intended use.
This document describes the Dako FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, Ready-to-Use (Dako Omnis) Immunohistochemistry (IHC) reagent system, referred to as GA084, and its equivalence to a predicate device (IR084).
Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All results from performance studies confirm that GA084 meets its acceptance criteria and is substantial equivalent to its predicate device IR084." However, it does not explicitly list the numerical acceptance criteria for each performance characteristic. Instead, it broadly indicates that the device met these criteria. The performance characteristics evaluated were:
| Performance Characteristic | Reported Device Performance (GA084) | Acceptance Criteria |
|---|---|---|
| Analytical Specificity | Met criteria | Not explicitly stated (implied specific staining of ER in normal tissues) |
| Reproducibility (Intra-run) | Met criteria | Not explicitly stated (implied consistent results within a run) |
| Reproducibility (Inter-lot) | Met criteria | Not explicitly stated (implied consistent results across different manufacturing lots) |
| Reproducibility (Inter-laboratory) | Met criteria | Not explicitly stated (implied consistent results across different laboratories) |
| Reproducibility (Inter-observer) | Met criteria | Not explicitly stated (implied consistent results between different pathologists) |
| Concordance with Predicate Device (IR084) | Demonstrated equivalence | Not explicitly stated (implied high agreement with predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set in the performance studies. It mentions that concordance studies were performed to establish equivalence.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth specifically for the test set. It mentions that clinical interpretation "should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist." This implies that qualified pathologists are involved in interpretation but doesn't detail their role in establishing ground truth for the study.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used for the test set.
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.
This device is an immunohistochemistry (IHC) reagent system, not an AI or imaging device. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not reported. The focus is on the performance of the staining reagent itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
As stated above, this is an IHC reagent system. There is no algorithm involved that operates in a standalone manner. The device's performance is inherently tied to the staining process and subsequent human interpretation by a pathologist.
7. The Type of Ground Truth Used
The type of ground truth used is expert evaluation by qualified pathologists of the stained tissue sections. 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." The antibody is intended to be used "after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains." This implies that the 'ground truth' for whether a tumor is present and for the ER status would ultimately rely on comprehensive pathological assessment.
8. The Sample Size for the Training Set
The document does not mention a training set as this is not an algorithm-based device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
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(635 days)
MYA
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:
| Study Type / Metric | Implicit Acceptance Criteria (Indicative) | Reported Device Performance (Leica Device) | Formats Studied |
|---|---|---|---|
| Clinical Outcome Study (Calgary Cohort) | Ready-to-Use (PA0151) | ||
| Inter-observer Kappa (ER Status) | High agreement (e.g., Kappa > 0.6) | 0.67 to 0.83 ("almost perfect agreement") | Ready-to-Use (PA0151) |
| Intra-observer Kappa (ER Status) | High agreement (e.g., Kappa > 0.8) | 0.91 ("almost perfect agreement") | Ready-to-Use (PA0151) |
| Univariate Kaplan-Meier HR (ER Status) | Statistically significant difference in survival between ER+ and ER- groups (p 0.90) | 0.97 (Figure 4) | Ready-to-Use (PA0151) |
| Specificity (vs. LBA Gold Standard) | Adequate (e.g., > 0.40) | 0.44 (Figure 4) | Ready-to-Use (PA0151) |
| PPV (vs. LBA Gold Standard) | High (e.g., > 0.90) | 0.96 (Figure 4) | Ready-to-Use (PA0151) |
| NPV (vs. LBA Gold Standard) | Adequate (e.g., > 0.60) | 0.70 (Figure 4) | Ready-to-Use (PA0151) |
| Precision Studies (TMA) | Overall, Positive, and Negative Percent Agreement with high confidence intervals (e.g., > 90%) | All precision studies reported 100% OPA, PPA, NPA with tight 95% CIs (e.g., 97-100% range) | Both formats |
| Between Observer Precision (TMA) | High Overall Percent Agreement (OPA) (e.g., > 90%) | 95% (PA0151, Obs1-Obs2/Obs3), 100% (PA0151, Obs2-Obs3), 98.33% (PA0151, All Obs) | Both formats |
| 89.47% (NCL-L-ER-6F11, Obs1-Obs2), 94.74% (NCL-L-ER-6F11, Obs1-Obs3/Obs2-Obs3), 96.49% (NCL-L-ER-6F11, All Obs) | Left panel for PA0151, right for NCL-L-ER-6F11 | ||
| Reproducibility Studies (Whole Tissue Sections) | Overall, Positive, and Negative Percent Agreement with high confidence intervals (e.g., > 90%) | Varies by site/comparison, generally high (e.g., 88.89% - 100% OPA), but some lower bounds on CIs (e.g., 72.71% NPA for Site A PA0151 overall) | Both formats |
| Inter-Platform Comparison Study | High Overall, Positive, and Negative Percent Agreement when compared to the reference standard device | Overall PA: 96.73%, Positive PA: 98.37%, Negative PA: 90.16% (95% CI reported) | Liquid Concentrate (NCL-L-ER-6F11) vs. Ready-to-Use (PA0151) |
| Stability Studies | Intensity Score and Proportion Score identical to control for variable ER expression in breast cancer cases. | Reported with 18 months shelf-life via accelerated testing, ongoing real-time testing. | All three product formats |
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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(344 days)
MYA
For in vitro diagnostic use.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Readyto-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen receptor in formalin-fixed, paraffinembedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.
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.
Dako Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 (Dako Anti-Human ER a, clone EP1) antibody is utilized to perform a semi-quantitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The ER a antibody is available in Ready-to-Use (RTU) format and is optimized for use with Dako Automated stainer Link 48. The RTU Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 is provided in one vial of ready-to-use monoclonal rabbit antibody contains 12 ml of reagent provided in liguid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The working Ig concentration of the antibody is approximately 3.7 ug/mL. Total protein concentration is approximately 10mg/mL.
The provided text is a 510(k) Pre-Market Notification for a medical device, specifically the Dako Anti-Human ER $\alpha$ Clone EP1. It describes the device, its intended use, and claims substantial equivalence to a predicate device, but does not contain typical acceptance criteria or a detailed study section with performance metrics like sensitivity, specificity, or concordance rates against a ground truth.
Instead, it states: "Performance characteristics evaluated in support of the Dako Anti-Human ER $\alpha$, clone EP1 IHC assay include results on specificity, sensitivity, reproducibility, and concordance testing. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate device listed above." However, the actual results of these tests are not present in this document.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, or expert details because this information is not included in the provided text.
The document only states that such studies were performed and showed "substantial equivalency" to the predicate device (ER $\alpha$ component of the Dako ER/PR pharmDx™ Kit, K042884).
If this were a typical AI/ML device submission, a dedicated section detailing these performance characteristics would be expected. Since this is an Immunohistochemistry (IHC) reagent, the performance evaluation methods might differ from those for an image-based AI device.
Without the actual performance data from the specific studies mentioned, I cannot complete the requested information.
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(719 days)
MYA
This antibody is intended for in vitro diagnostic (IVD) use.
CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody is intended for laboratory use for the qualitative detection of estrogen receptor (ER) antigen in sections of formalin-fixed, paraffin-embedded breast tissue on a Ventana automated slide stainer with Ventana detection kits and ancillary reagents. CONFIRM anti-ER (SP1) is directed against an epitope present on human ER alpha protein located in the nucleus of ER positive normal and neoplastic cells. CONFIRM anti-ER (SP1) is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
Prescription use only.
CONFIRM anti-ER (SP1) binds to human estrogen receptor alpha (ER) in paraffin embedded tissue sections. The antibody is diluted in 0.05 M Tris-HCl with 2% carrier protein, and 0.10% ProClin 300, a preservative. There is trace (~0.2%) fetal calf serum of U.S. origin from the stock solution. Total protein concentration of the reagent is approximately 20 mg/mL. Specific antibody concentration is approximately 1 ug/mL. CONFIRM anti-ER (SP1) is a rabbit monoclonal antibody produced as a cell culture supernatant.
CONFIRM anti-ER (SP1) is optimized for use on the BenchMark XT and BenchMark ULTRA automated slides stainers using iView DAB and ultraView DAB detection chemistries.
Here's a breakdown of the acceptance criteria and the study details for the CONFIRM anti-Estrogen Receptor (SP1) Rabbit Monoclonal Primary Antibody, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Method Comparison: Overall Percent Agreement (OPA) for ER status between BenchMark XT and BenchMark ULTRA instruments | 90.9% (95% CI: 86.2-94.1%) | Comparison of current device on two different automated stainers (BenchMark XT vs. BenchMark ULTRA) |
| Equivalence to Predicate: Overall Percent Agreement (OPA) for ER status between CONFIRM anti-ER (SP1) and FLEX anti-ER (SP1) | 97.8% (95% CI: 96.2-98.8%) | Comparison of current device (CONFIRM anti-ER (SP1)) with predicate device (FLEX anti-ER (SP1)) |
| Equivalence to Predicate: Comparison against patient outcome (median survival times in tamoxifen treated patients) | Identical median survival times (101.6 months in ER+ patients vs 47.2 months in ER- patients) for both assays. Log-rank test showed statistically significant difference between ER+/ER- relative to survival (P 0.999). | Comparison of current device and predicate device against a preceding technology (LBA) |
| Equivalence to Predicate: Negative Percent Agreement (NPA) with Ligand Binding Assay (LBA) for ER- cases | CONFIRM anti-ER (SP1): 27.6% | |
| FLEX anti-ER (SP1): 34.5% | ||
| Difference not statistically significant (McNemar's exact test p-value = 0.500). | Comparison of current device and predicate device against a preceding technology (LBA) |
Study Details
-
Sample size used for the test set and the data provenance:
- Method Comparison Study (BenchMark XT vs. BenchMark ULTRA): 120 ER negative and 132 ER positive breast cancer cases (total 252 cases). Data provenance is not explicitly stated in terms of country of origin but is presumed to be retrospective clinical samples. It is a prospective study in terms of evaluating the newly stained slides.
- Equivalence to Predicate Study (CONFIRM vs. FLEX and LBA): 820 invasive breast cancer cases in the clinical cohort, from which 594 breast cancer cases with primary tumor underwent IHC staining on 1907 tissue microarray cores. The study is described as having "available from the cohort database," suggesting retrospective data for patient outcome and LBA, but the IHC staining and evaluation of the tissue microarrays were performed as part of this study. The origin is implied to be a clinical cohort, but specific country is not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Method Comparison Study: Evaluated by "pathologists" for determining the percentage of stained tumor cells. The exact number of pathologists per case is not specified beyond "multi-reader study", nor are their qualifications.
- Equivalence to Predicate Study: Evaluated by "three independent pathologists" who determined the percentage of stained tumor cells. Their specific qualifications (e.g., years of experience, subspecialty) are not provided.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document implies that pathologists independently evaluated the slides and their interpretations were used to determine ER status. There is no explicit mention of an adjudication method for discordant reads (e.g., 2+1 rule). For the "Equivalence to Predicate Study," three independent pathologists evaluated the slides, but it's not stated how disagreements were resolved for the final ER status used in the analysis.
-
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 is not a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers improvement with or without AI assistance. This study evaluates the performance of an immunohistochemistry (IHC) antibody (CONFIRM anti-ER (SP1)) as a diagnostic reagent, comparing it to an existing predicate device and patient outcomes. The "multi-reader" aspect refers to multiple pathologists reading the slides to generate the initial data, not to an AI-assisted workflow.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is an immunohistochemistry antibody reagent, not an algorithm or AI product. Its performance is assessed through the staining of tissue samples, which are then interpreted by human pathologists. Therefore, a "standalone algorithm performance" study is not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For ER status determination on stained slides: The immediate "ground truth" used for calculating agreement percentages (OPA) was the interpretation by pathologists based on the percentage of stained tumor cells.
- For comparing against clinical relevance: Progression-free survival outcome data in tamoxifen-treated patients and Ligand Binding Assay (LBA) data were used as ground truth comparators for the "Equivalence to Predicate" study to assess the clinical utility and biological agreement of the IHC assays.
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The sample size for the training set:
- This document describes a performance study for an antibody reagent, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm. The antibody itself is "optimized" for use on specific instruments, which implies internal development and testing, but not a dataset-driven training process in the AI sense.
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How the ground truth for the training set was established:
- As there is no training set for an AI/algorithm, this question is not applicable. The antibody's specificity and reactivity are inherent to its design and manufacturing process, and its performance is validated in clinical studies like the ones described.
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(366 days)
MYA
For in vitro diagnostic use.
Monoclonal Rabbit Anti-Human Estrogen Receptor a (ER a) antibody, Clone SP1, may be used in the semi-quantitative detection of human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer by immunohistochemistry. The information gained by this assay can aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.
Clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Dako Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody, Clone SP1 is a semiquantitative immunohistochemical (IHC) kit assay to identify estrogen receptor (ER) expression in normal and neoplastic tissues routinely processed and paraffin-embedded.
The provided text describes the Dako Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody, Clone SP1, an immunohistochemical (IHC) assay. The document is a 510(k) summary and associated FDA correspondence, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed study results for a novel device.
Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies is not explicitly present in the provided text.
Here's an analysis of what can be extracted based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Performance characteristics evaluated for the Estrogen Receptor Clone SP1 IHC assay include results on analytical specificity and sensitivity, precision, reproducibility and method comparison testing." It then states: "Results of all testing conducted substantial equivalence to the predicate device listed above."
This implies that the acceptance criterion was achieving substantial equivalence to the predicate device, especially across these performance characteristics. However, specific numerical targets for these characteristics are not provided.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Demonstrate substantial equivalence to predicate device (Monoclonal Mouse ER 1D5/ER-2-123 in Dako ER/PR pharmDx™ Kit) for: | Substantial equivalence achieved. |
| - Analytical specificity | Met |
| - Analytical sensitivity | Met |
| - Precision | Met |
| - Reproducibility | Met |
| - Method comparison | Met |
2. Sample size used for the test set and data provenance:
- Sample size: The document does not specify the sample size (number of cases or samples) used for the testing that established substantial equivalence.
- Data provenance: Not explicitly stated. The document refers to "testing conducted," but provides no details on the origin, retrospective, or prospective nature of the data.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of experts: Not specified.
- Qualifications: "Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist." This indicates that pathologists are involved in interpretation but does not detail their role in establishing a ground truth for testing.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- An MRMC study is not mentioned. The focus is on the device's performance against a predicate device, not direct human reader improvement with or without the device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is an IHC antibody, which is a reagent used in a laboratory setting for manual or automated staining, subsequently interpreted by a pathologist. It is not an "algorithm" in the sense of AI. Therefore, the concept of "standalone performance" for an algorithm without a human-in-the-loop is not applicable in this context. The assay itself requires human interpretation.
7. The type of ground truth used:
- The document implies that the ground truth for comparing the new device against the predicate device would be based on the established accuracy of the predicate device and potentially agreement with clinical and morphological findings. The statement "Clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls" suggests that the ultimate ground truth incorporates pathological and clinical evaluation, but the specific method for establishing a gold standard for the comparison study is not detailed.
8. The sample size for the training set:
- This device is a biological reagent (antibody), not a machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set size is not applicable.
9. How the ground truth for the training set was established:
- As explained above, the concept of a training set is not applicable to this type of device.
In summary:
The provided document is a regulatory submission focused on demonstrating substantial equivalence of a new IHC reagent to an existing one. It does not provide the detailed study design, acceptance criteria, specific performance metrics, or ground truth establishment methods that would be expected for a novel diagnostic algorithm or AI device as the questions imply. The study described is primarily a comparative study to establish equivalency to a predicate, rather than a de novo performance validation with detailed acceptance criteria.
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(42 days)
MYA
NeoMarkers Rabbit Monoclonal anti-Human ER Antibody (Clone SP1) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of ER antigen by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.
Lab Vision's NeoMarkers Rabbit Monoclonal Anti-Human Estrogen Receptor (ER) Antibody (Clone SP1) binds to ER in the paraffin embedded tissue section. The specific antibody is localized by a biotin conjugated secondary antibody formulation that recognizes rabbit immunoglobulins. This step is followed by the addition of an avidin/streptavidin enzyme conjugate that binds to the biotin present on the secondary antibody. The specific antibody secondary antibody avidin/streptavidin enzyme complex is then visualized with a precipitating enzyme reaction product, which is readily detected by light microscopy. Each step is incubated for a precise time and at room temperature. At the end of each incubation step, the Lab Vision automated slide stainer (Lab Vision Autostainer) washes the sections to stop the reaction and remove unbound material that would interfere the desired reaction in subsequent steps.
This is a submission for a medical device called NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1), an in vitro diagnostic immunohistochemical (IHC) assay. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of substantial equivalence to a predicate device, as opposed to a standalone performance study with predefined numerical metrics.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For in vitro diagnostic devices seeking 510(k) clearance, the primary "acceptance criterion" is often substantial equivalence to a legally marketed predicate device. The "device performance" is then the evidence presented to support this claim.
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Device's intended use is the same or very similar to predicate. | Subject Device: NeoMarkers Rabbit Monoclonal Anti-Human ER Antibody (Clone SP1) is an IHC assay intended for laboratory use for the qualitative detection of ER antigen by light microscopy in sections of formalin fixed, paraffin embedded normal and neoplastic tissues on a Lab Vision automated slide stainer. It is indicated as an aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients. |
Predicate Device: Ventana ER Primary Antibody (Clone 6F11) is intended for laboratory use for the qualitative detection of ER antigen in sections of formalin fixed, paraffin embedded tissue on a Ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer.
(The intended uses are functionally equivalent.) |
| Target Epitope: Binds to the same biological target. | Subject Device: Estrogen Receptor
Predicate Device: Estrogen Receptor |
| Matrix: Used with the same sample type. | Subject Device: Tissue (Breast)
Predicate Device: Tissue (Breast) |
| Storage: Similar storage conditions. | Subject Device: 2°C to 8°C until expiration date
Predicate Device: 2°C to 8°C until expiration date |
| Stability: Similar stability profile. | Subject Device: Until expiration date noted on package
Predicate Device: Until expiration date noted on package |
| Technological Characteristics: Does not raise new questions of safety or effectiveness. | The main difference is the Clone: Subject device uses Rabbit Monoclonal Ab (Clone SP1), while the predicate uses Murine Monoclonal Ab (Clone 6F11). The submission implies that this difference does not raise new safety/effectiveness concerns, as substantial equivalence was granted. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a separate "test set" with a particular sample size or data provenance (e.g., country of origin, retrospective/prospective). This submission relies on demonstrating substantial equivalence to a predicate device primarily through comparison of intended use and physical properties, rather than a new clinical performance study with a dedicated test set designed to establish quantitative performance metrics like sensitivity, specificity, or AUC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As there is no mention of a traditional "test set" and a study to establish performance against a ground truth, this information is not applicable and not provided in the document. The submission focuses on comparing the new device's characteristics against a cleared predicate.
4. Adjudication Method for the Test Set
Since there is no described test set with human observer interpretations and ground truth, an adjudication method is not described or applicable in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission does not describe any study involving human readers or comparing their performance with or without AI assistance. This device is an antibody for immunohistochemistry, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study (algorithm only) was not done. This is an in vitro diagnostic antibody, not an algorithm or software. Its performance is demonstrated by its inherent binding characteristics and consistency with the predicate device.
7. The Type of Ground Truth Used
The term "ground truth" in the traditional sense of a clinical benchmark for diagnostic accuracy is not directly used or established in this submission. The "truth" for this 510(k) is the established performance and safety of the predicate device. The claim of substantial equivalence relies on the new device having similar characteristics and intended use to the predicate, assuming the predicate itself is safe and effective. The intrinsic validation of the antibody's binding to ER in tissues serves as the basis for its function, but this isn't detailed as a specific "ground truth" study in this document for 510(k purposes.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. This device is an antibody, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided in the document. As this is an antibody, there is no "training set" in the context of machine learning.
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(115 days)
MYA
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:
| Feature | Description / Status |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Not provided in the document. The document states "ER 6F11 complies with the elements of FDA Guidance, 'Guidance for Submission of Immunohistochemistry Applications to the FDA'," implying regulatory compliance but not specific performance criteria or results. |
| 2. Sample size and data provenance for test set | Not provided in the document. |
| 3. Number and qualifications of experts for ground truth (test set) | Not provided in the document. |
| 4. Adjudication method for test set | Not provided in the document. |
| 5. Multi Reader Multi Case (MRMC) comparative effectiveness study and effect size | Not provided in the document. This type of study is generally for AI/CAD devices, not for IHC reagents. |
| 6. Standalone (algorithm only) performance study | Not applicable. This device is an immunohistochemistry reagent, not an algorithm. |
| 7. Type of ground truth used | Inferred: Pathology (histopathological assessment of tissue samples). The device is an IHC reagent for tissue analysis, so ground truth would be based on expert pathological evaluation. |
| 8. Sample size for training set | Not provided in the document. (Training set concept likely not applicable in the same way for an IHC reagent as for a machine learning algorithm). |
| 9. How ground truth for training set was established | Not provided in the document. |
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(447 days)
MYA
The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape.
In this software application the ACIS device is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffinembedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR).
It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.
Automated Cellular Imaging System (ACIS) for detection of ER/PR
This is an FDA Premarket Notification (510(k)) letter for the Automated Cellular Imaging System (ACIS) for detection of ER/PR receptors. The information provided is a determination of substantial equivalence, and as such, it does not include detailed study data, acceptance criteria, or performance metrics. Therefore, I cannot provide a comprehensive answer to your request based solely on this document.
The document indicates that the device is intended to "detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape," and specifically "to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR)." It is indicated as an aid in the "management, prognosis and prediction of therapy outcomes of breast cancer."
To answer your specific questions, information from the actual 510(k) submission, not just the FDA's decision letter, would be required. The letter confirms that the device was found substantially equivalent to a predicate device, meaning the FDA found it performed as safely and effectively as a legally marketed device and had similar technological characteristics. However, the details of how that equivalence was demonstrated (e.g., specific acceptance criteria, study design, sample sizes, ground truth establishment, etc.) are not contained within this letter.
Without the full 510(k) submission, I can only state what is NOT available in this document regarding your questions:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- 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: Not present. This type of study is typically associated with AI-assisted diagnostic devices where human interpretation is part of the workflow. The ACIS is described as an "Automated Cellular Imaging System" intended to "measure, count, and quantitate," which suggests a more standalone analytical role rather than an assist to human readers in interpretation. However, without the full submission details, this is an assumption.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The description of the device as an "Automated Cellular Imaging System" strongly suggests standalone performance was evaluated, but the details of such a study are not in this letter.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
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(161 days)
MYA
The BioGenex Mouse Monoclonal Anti-Estrogen Receptor Antibody (Clone ER88) is an immunohistochemical (IHC) assay and is intended for laboratory use to qualitatively identify by light microscopy human estrogen receptor in normal and/or pathological paraffin-embedded, formalin-fixed tissues. The ER88 antibody specifically binds to antigens located in the nucleus of cell populations that express estrogen receptor in normal and abnormal tissues. This antibody is indicated as an aid in assessing patient response to hormonal therapy and as an aid in the prognosis and management of breast cancer patients. 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.
BioGenex ER88 is a monoclonal antibody, which specifically binds to estrogen receptor antigen located in the nuclear region of a variety of normal and abnormal tissues. It is a mouse monoclonal anti-estrogen receptor antibody from mouse ascites fluid diluted in phosphate buffered saline pH 7.6 containing bovine serum albumin as carrier protein and 0.09% sodium azide as preservative. The antibody is available in concentrated (MU368-UC) as well as ready to use form (AM368-5M and AM368-10M). Refer to package insert for details.
Here's a breakdown of the acceptance criteria and study detailed in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to existing methods rather than explicit, numerical acceptance criteria for a new AI diagnostic. However, the core performance metric for equivalency is the concordance between the new IHC assay and the established DCC assay.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate DCC assay. | Overall binary concordance of ER88 IHC to ER DCC assay was 75% |
| Confidence interval suggests robust concordance. | 95% confidence interval of 68% - 83% (p |
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