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The RectalPro™15 Endorectal Balloon device is a single-use disposable, inflatable, non-powered positioning device intended for us in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose of the device is to stabilize the prostate during Computed Tomography (CT) exam, and X-Ray when these imaging techniques are used for Radiation Therapy (RT) planning.

The RectalPro™ 75 Endorectal Balloon (ERB) is single use, disposable, inflatable, non-powered rectal device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. The RectalPro75 is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The ERB is inserted into the rectum and inflated prior to the start of a CT scan or RT therapy procedure. The device stabilizes the prostate once the device is inflated. The ERB is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. The RectalPro ERB is designed with a slim curved, extended shaft and balloon. The device is provided non-sterile to the end user, is not intended to be sterilized by the end user. It is packaged in a kit configuration, consisting of three primary components: 1. ERB shaft This is the shaft with attached balloon and attached clear plastic tubing for filling the balloon with air / water. The end of the tubing has a female luer lock. There are white markings on the side of the ERB shaft as insertion depth markings. 2. Stopper This is the circular plastic piece with one flat side, and one side containing four prongs. There is a hole in the middle of the stopper for placement onto the ERB shaft. 3. Air / water valve This is the small plastic valve on the air tube connected to the ERB shaft. The clamp on the air / water tube stops the air / water flow by squeezing the tube closed. This component stops air / water from releasing out of the balloon after it has been filled. The kit also includes a standard 100 cc syringe with male luer lock connector, for connecting to the female luer connection of the ERB tubing, and is used to deliver the water or air to the ERB.

The provided text describes the RectalPro™75 Endorectal Balloon, a device intended for prostate immobilization during radiation therapy planning. It is a 510(k) submission, meaning the manufacturer is claiming substantial equivalence to a legally marketed predicate device, not necessarily proving novel safety and effectiveness through extensive clinical trials.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the performance of the predicate device and relevant international standards. The reported device performance is presented as meeting these criteria.

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