(123 days)
The ERB is a single use, inflatable, non-powered positioning 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 ERB is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and Xray, 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 ERB is designed for single use, is provided non-sterile to the end user, and is not intended to be sterilized by the end user. The ERB consists of a balloon and tubing can be inflated with either water or air. The device can be locked into place once inserted into the rectum with a locking stopper.
The provided text is a 510(k) summary for the ERB Endorectal Balloon, a Class II medical device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.
However, it does mention "Non-Clinical Testing" and "Performance Data" in a general sense. Based on the provided text, a detailed table of acceptance criteria and reported device performance with specific metrics cannot be fully populated. The document only states that "Product testing was completed and met all of the acceptance criteria. Testing included dimensional, visual, mechanical and performance." and "All necessary verification and validation testing has been performed for the ERB to assure substantial equivalence to the predicate devices."
Here's an attempt to extract the information requested, with limitations due to the nature of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not list specific quantitative acceptance criteria or detailed performance metrics. It generally states that testing was completed and met all acceptance criteria, and that the device's performance attributes are equivalent to the predicate. Therefore, the "Reported Device Performance" column reflects generalized statements from the document.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional | Met all acceptance criteria. Dimensions are equivalent to predicate (minor differences in length/diameter not affecting safety/efficacy) |
| Visual | Met all acceptance criteria. |
| Mechanical | Met all acceptance criteria. |
| Performance | Met all acceptance criteria. Performance attributes are equivalent to predicate. |
| Biocompatibility | Passed ISO10993 testing (Cytotoxicity, Sensitization, Irritation). Materials are suitable for use and have been used in numerous previously cleared products. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set in non-clinical testing. It only mentions "Product testing" and "All necessary verification and validation testing."
Data Provenance: The testing appears to be non-clinical (laboratory/bench testing) rather than clinical studies on human subjects. The document does not specify the country of origin for the data or if it was retrospective or prospective, beyond stating that Edge Medical, LLC performed the testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document. The testing described is non-clinical (dimensional, visual, mechanical, performance, biocompatibility) of a physical device, not an AI/software device that would require expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document for the reasons stated in point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging interpretation devices, often involving AI assistance for human readers. The ERB Endorectal Balloon is a physical medical device for prostate immobilization during radiation therapy.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done, as the ERB is a physical device, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing mentioned (dimensional, visual, mechanical, performance), the "ground truth" would be established by engineering specifications, material standards, and benchmark measurements against known properties of the device and its predicate. For biocompatibility, the ground truth is established by adherence to ISO10993 standards.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. The ERB is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the document for the reasons stated in point 8.
§ 892.5720 Rectal balloon for prostate immobilization.
(a)
Identification. A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning 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.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing:
(i) Biocompatibility testing of the final finished device;
(ii) If provided sterile, sterilization validation;
(iii) If not provided sterile, bioburden testing of the final finished device;
(iv) Shelf life and expiration date validation; and
(v) Performance testing including but not limited to:
(A) Venting mechanism (if device has a vent mechanism);
(B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and
(C) Structural integrity testing (
e.g., tensile strength, balloon leakage and burst strength).(2) Labeling that includes:
(i) Appropriate warnings and contraindications, including, but not limited to the following statements:
(A) “Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.”;
(B) “Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.”;
(C) “Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.”; and
(D) “Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.”
(ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon;
(iii) Whether the device is sterile or non-sterile; and
(iv) An expiration date.