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NeoMarkers Rabbit Monoclonal anti-Human PR Antibody (Clone SP2) is an immunohistochemical (IHC) assay intended for laboratory use for the qualitative detection of PR 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.

Immunohistochemistry Assay, Antibody, Progesterone Receptor. Antibody for detection of progesterone receptor in histological tissue sections. NeoMarkers Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody (Clone SP2)

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) summary for a medical device called "NeoMarkers Rabbit Monoclonal Anti-Human PR Antibody (Clone SP2)".

The document focuses on:

• Device Identification: Name, classification, regulation number, product code, and regulatory class.
• Submission Details: Submitter information, contact person, and preparation date.
• FDA Correspondence: A letter from the FDA indicating that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• Indications for Use: The intended purpose of the device, which is an immunohistochemical (IHC) assay for the qualitative detection of Progesterone Receptor (PR) in formalin-fixed, paraffin-embedded tissues. This assay is intended as an aid in assessing response likelihood to therapy, prognosis, and management of breast cancer patients.

Therefore, I cannot provide the requested table and information, as the input does not describe a study with acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, or comparative effectiveness.

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