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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.

2. Sample Size Used for the Test Set and Data Provenance

The provided text discusses non-clinical bench testing. There is no mention of a "test set" in the context of clinical data or patient studies. The "test set" in this context refers to the samples of the device used for the various bench tests (e.g., individual balloons for leak, burst, and stopper resistance tests). The sample sizes for these specific bench tests are not explicitly stated in the document, only the results for a single device or a general statement of "device met acceptance criteria."

The data provenance is bench testing conducted by QLRAD International Ltd. (the manufacturer). There is no mention of country of origin for any clinical data, as no clinical studies are reported.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable. The "test set" here refers to the device and its components undergoing engineering and material performance tests, not clinical performance read by experts to establish a "ground truth" for a diagnostic or imaging device. The "ground truth" for these tests would be the measurement results against predefined engineering specifications.

4. Adjudication Method for the Test Set

This is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not the nature of the testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. The submission is a 510(k) for a device that stabilizes the prostate, not a diagnostic or imaging AI tool requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study, as this term typically applies to AI algorithms, was mentioned or performed. The device is a physical medical device.

7. Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" is established by engineering specifications and measurements performed on the device samples. For example:

• Biocompatibility: Results of standardized in vitro/in vivo tests against ISO 10993.
• Bioburden: Microbial count below a specified threshold (100 CFU).
• Leakage/Burst: Absence of leaks or rupture under specific pressure/volume/time conditions.
• Stopper Resistance: Force required to move the stopper meeting a defined threshold.
• Transportation: Device integrity after simulated transport according to ASTM D4169.

8. Sample Size for the Training Set

This is not applicable. There is no mention of any AI or machine learning algorithms, and therefore, no "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no training set for an AI algorithm.

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