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510(k) Data Aggregation
(161 days)
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<0.0001) |
| Specificity in normal tissues (negative immunoreactivity). | ER88 antibody demonstrated negative immunoreactivity with most normal tissues except mammary gland, myometrium, and endometrium (where positive staining is expected for ER). |
| Reproducibility (Intra-run, Inter-run, Manual vs. Automated). | No significant variation observed in intra-run, inter-run, and instrumental vs. manual runs. |
| Stability for intended storage duration. | Stable for at least 24 months at 2-8°C. |
| Stability under shipping stress (elevated temperature). | Stable after continuous 48-hour exposure at 45°C. |
| Similarity in technological characteristics to predicate Dako device. | Demonstrated similar clone type, antibody, immunoglobulin class, specificity, total protein concentration, storage, and application (manual/automated use). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 122 specimens.
- Data Provenance: The specimens were clinical specimens from two different batches.
- Batch 1 (29 specimens): Assayed for DCC at the University of Texas Health Science Center at San Antonio, Texas. IHC staining was done at King's County Hospital, State University of New York, Health Science Center, Brooklyn, New York.
- Batch 2 (93 specimens): Assayed for DCC at Genesee Hospital, Rochester, NY. Tissue blocks were provided to BioGenex laboratories for slide preparation and IHC staining.
- Retrospective/Prospective: The study used existing formalin-fixed and paraffin-embedded tissue sections that had already been assayed for ER by DCC. This indicates a retrospective approach.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Each resulting slide from the IHC staining was read independently by two pathologists.
- Qualifications: The document states "two pathologists, who have no knowledge of any other laboratory or clinical data of the specimens." Specific experience levels (e.g., 10 years of experience) are not provided in this document.
4. Adjudication Method for the Test Set:
- The document states that "each resulting slide was read independently by two pathologists." It does not specify an adjudication method like 2+1 or 3+1 if their readings differed. It implies that their independent readings were used to establish the IHC interpretation, which was then compared to the DCC results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a MRMC comparative effectiveness study comparing human readers with AI vs. without AI assistance was not done. This document describes the performance of an immunohistochemical (IHC) assay (an antibody reagent), not an AI-powered diagnostic device. The "device" in this context is the antibody and associated detection system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. As stated above, this is about an antibody reagent for IHC, not an AI algorithm. The IHC slides are interpreted by human pathologists. The device itself is a reagent, not an automated interpretation system.
7. The Type of Ground Truth Used:
- The primary ground truth used for performance comparison was the dextran-charcoal coated (DCC) assay, which is a biochemical assay considered the "gold standard for ER assay" at the time. Pathologists' readings of the IHC slides were then compared to the DCC results.
8. The Sample Size for the Training Set:
- Not explicitly stated or applicable. Since this is a submission for an antibody reagent and not a machine learning model, there isn't a "training set" in the sense of data used to train an AI algorithm. The performance evaluation focuses on the reactivity and concordance of the antibody.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
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