Search Results

The OARtrac® System is specifically indicated for male prostate cancer treatment to measure photon beam therapy as an adjunct to treatment planning permitting measurement of in-vivo radiation dose received on the anterior surface of a modified Prostate Immobilization Endorectal Balloon (ERB) device to monitor and verify the surrounding organs at risk, specifically the protatic rectal interface.

The OARtrac® System provides radiation oncologists with near real- time, in-vivo, multipoint radiation-dose information obtained from two (2) Radiatrac® Plastic Scintillating Detectors (PSD) sensors located on the anterior surface of a modified clinically accepted OARtrac® prostate Endorectal Balloon (ERB) to monitor dose photon based radiation therapy for prostate cancer treatment. This information allows the physician to monitor the dose at the rectal prostatic interface, compare the actual dose relative to the planned dose, and provides graphs and dose information for both the current treatment as well as a log of dose from five previous treatments. The OARtrac® System also provides dose rate during actual treatment.

The function of the OARtrac® prostate ERB is to immobilize the prostate while at the same time positioning the Radiatrac® PSD sensors so that measurement of in-vivo radiation received on the anterior surface of the balloon can be monitored to verify the radiation dose to surrounding organs at risk, specifically the protatic rectal interface. The actual verification of the dose radiation is accomplished by the other main components of the OARtrac® System, those being the Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system's own proprietary dose management software that are further addressed in the remainder of this section.

The OARtrac® System is designed to provide near real-time, in-vivo, multipoint radiation-dose information during prostate cancer treatment. It measures photon-based radiation therapy using two Plastic Scintillating Detector (PSD) sensors located on the anterior surface of a modified Endorectal Balloon (ERB). The system monitors the dose at the rectal prostatic interface, compares it to the planned dose, and provides graphs and dose information for current and past treatments. The ERB also immobilizes the prostate and positions the sensors.

Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample Size and Data Provenance:

   • The document indicates that no human clinical testing was required. The "Non-Clinical Performance Data" section mentions "controlled phantom data" was used to obtain the radiation dose accuracy for the OARtrac® System.
   • No specific sample sizes for test sets (e.g., number of phantom measurements) or the data provenance (e.g., country of origin, retrospective/prospective) are explicitly provided in the provided text.

2. Number of Experts and Qualifications for Ground Truth (Test Set):

   • Not applicable, as no human clinical testing was performed for the test set. Ground truth for the non-clinical tests would be established through a controlled phantom setup and precise dose delivery.

3. Adjudication Method (Test Set):

   • Not applicable, as no human clinical testing requiring expert adjudication was performed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was mentioned. The device is a dosimeter aimed at objectively measuring radiation dose, not interpreting images or aiding human readers in decision-making in a way that an MRMC study would typically evaluate.

5. Standalone Performance Study:

   • Yes, a standalone performance study was done. The "Non-Clinical Performance Data" section details a series of tests, including "Dose Range Verification Testing," "Calibration Testing," and "Dose Accuracy" measurements using controlled phantom data. This implicitly demonstrates the algorithm's (or system's) standalone performance in measuring radiation dose.

6. Type of Ground Truth Used:

   • For the non-clinical testing, the ground truth was established through controlled phantom data and presumably the known, precisely delivered radiation doses from a calibrated source.

7. Sample Size for Training Set:

   • The document does not explicitly mention a separate "training set" or its sample size. For device calibration and verification, data would typically be collected from controlled experiments, but the text doesn't differentiate between training and testing data in a machine learning context.

8. How Ground Truth for Training Set was Established:

   • Ground truth for calibration and verification would be established using calibrated radiation sources and dosimetric standards applied to phantoms. The document mentions the device is "Pre-Calibrated (Cobalt-60)," indicating that Cobalt-60 sources were used in establishing foundational calibration.

Ask a specific question about this device