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The BioGenex Mouse Monoclonal Anti-Progesterone Receptor Antibody (Clone PR88) is an immunohistochemical (IHC) assay and is intended for laboratory use to qualitatively identify by light microscopy human progesterone receptor in normal and/or pathological paraffin-embedded, formalin-fixed tissues. The PR88 antibody specifically binds to antigens located in the nucleus of cell populations that express progesterone 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 PR88 is a monoclonal antibody, which specifically binds to progesterone Dreceptor antigen located in the nuclear region of a variety of normal and abnormal tissues. It is a mouse monoclonal anti-progesterone receptor antibody from mouse ascites fluid diluted in phosphate buffered saline pH 7.6 containing bovine serum albumin as carrier and on and 0.09% sodium azide as preservative. The antibody is available in concentrated proximand 0.5970 bounds ready to use form (AM328-5M and AM328-10M). Refer to package insert for details.

This document appears to be a 510(k) summary for a medical device, the BioGenex Mouse Monoclonal Anti-Progesterone Receptor Antibody (Clone PR88). It does not contain explicit "acceptance criteria" in the format typically used for performance studies with predefined thresholds for success (e.g., a specific sensitivity or specificity target to be met). Instead, it describes a "performance data" section to demonstrate substantial equivalence to a predicate device and a reference method.

Therefore, the response below will present the reported device performance and infer the "acceptance criteria" based on the described concordance and the overall conclusion of substantial equivalence.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Specificity Test Set: 88 formalin-fixed and paraffin-embedded tissues covering a wide range of normal human tissue types. The document does not specify the country of origin or whether it was retrospective or prospective.
• Reproducibility Test Set:
  • Intra-run: 10 slides of the same tissues within a single run.
  • Inter-run: Slides containing the same tissues over 10 different runs.
  • Instrumental vs. manual: 10 slides for each tissue (selected for a wide range of reactivity) stained manually and using BioGenex Automated Stainer.
  • The document does not specify the country of origin or whether it was retrospective or prospective.
• Sensitivity (DCC Comparison) Test Set: A total of 134 specimens.
  • First batch: 41 specimens assayed for DCC at the University of Texas Health Science Center at San Antonio, Texas.
  • Second batch: 93 specimens assayed for DCC at Genesee Hospital, Rochester, NY.
  • The document does not explicitly state if the data was retrospective or prospective, but the description of "specimens were selected according to ... 1) formalin-fixed and paraffin-embedded tissue sections were available; 2) each tissue was initially assayed for PR by DCC" suggests a retrospective collection of existing samples. The origin appears to be the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• For the Sensitivity (DCC Comparison) Test Set: Each resulting slide was read independently by two pathologists.
• Qualifications: The document states they were "pathologists," but does not provide additional details such as years of experience. They reportedly had "no knowledge of any other laboratory or clinical data of the specimens."

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

• For the Sensitivity (DCC Comparison) Test Set: The document states "each resulting slide was read independently by two pathologists." It does not describe an adjudication method if there was disagreement between the two pathologists. The scoring was based on percentage of cells with positive nuclear staining, and a cut-off value of >10% of positive tumor cells was used to score a slide as positive or negative. The document reports a single concordance figure, implying agreement or a method not detailed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted as described in the context of human readers improving with AI assistance. This device is an immunohistochemical antibody, not an AI software. The study compared the IHC staining (read by pathologists) against a biochemical assay (DCC).

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

• No, a standalone algorithm-only performance assessment was not performed, as this is not an AI device. The device itself is an antibody reagent, and its performance (IHC staining) is evaluated by human pathologists. The "specificity" and "reproducibility" sections effectively describe the standalone performance of the antibody and staining system.

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

• For the Sensitivity (DCC Comparison) Test Set: The primary ground truth for comparison was the dextran-coated charcoal (DCC) technique, described as a biochemical assay and "considered the gold standard for PR assay" at the time. Pathologists' readings of IHC slides were then compared against this DCC ground truth.

8. The sample size for the training set

• This document does not describe a "training set" in the context of machine learning or AI. This is a traditional IVD device (antibody). The development and optimization of the antibody and staining protocols would have involved various internal tests, but these are not referred to as a "training set" in the provided text.

9. How the ground truth for the training set was established

• As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable to the provided document. The ground truth for the performance evaluation (test set) was established by the DCC assay.

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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.

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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