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The Bennett Profile mammography system, like the Bennett Contour M-CTR, LORAD M-IV, Instrumentarium Alpha RT, GE Senographe 700T and 800T, and Philips mammo DIAGNOST 3000 mammographic imaging systems, is a dedicated mammographic imaging system used for mammographic examinations.

The Bennett Profile Mammographic System, Model M-PRO, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations and can be adapted for biopsy and spot mammographic examinations. It consists of the following components; an x-ray generator cabinet, Model M-1500G; tube stand with non-tilting C-arm; mammographic collimator (DM-1500) and tube; an operator control panel, Model M-1500C; and image receptor (film cassette holder or bucky). The Profile Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz for operation. The Profile system's C-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The C-arm has a fixed source-to-image distance (SID) of 76 cm.

This document describes a mammography system (Bennett Profile Mammography System, Model M-PRO) and asserts its substantial equivalence to other marketed devices. It states that the system's safety functions have been rigorously tested and analyzed for conformance to requirements, and that they "performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions." However, the provided text does not contain specific acceptance criteria, reported device performance metrics, details of a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any information regarding AI components, MRMC studies, or standalone performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested details, as that information is not present in the provided text.

The closest information provided is:

• Device Name: Bennett Profile Mammography System, Model M-PRO
• Intended Use: Dedicated mammographic imaging system used for mammographic examinations.
• Claim of Equivalence: Substantially equivalent to Bennett Contour M-CTR, LORAD M-IV, Instrumentarium Alpha RT, GE Senographe 700T and 800T, and Philips mammo DIAGNOST 3000 mammographic imaging systems.
• Safety Testing: "The safety functions of the Profile Mammography System have been rigorously tested and analyzed for conformance to requirements. In each case, these functions have performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions."

Without explicit performance metrics (e.g., sensitivity, specificity, image quality parameters, dose limits), sample sizes, ground truth definitions, or details of a comparative study, the requested table and descriptive points cannot be generated.

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