(87 days)
Luneray is intended for interstitial brachytherapy of soft tissue that allows the insertion of this flexible applicator, e.g .:
- Abdominal structures / organs (e.g. urinary . bladder)
- Head and neck (e.g. ear, lip, nose, tongue, oral . mucosa)
- Skin (e.g. keloids) .
- Soft tissue sarcoma .
Luneray enables minimally invasive procedures to be performed both manually and laparoscopically.
Luneray is a pre-assembled, sterile needle-catheter combination for interstitial brachytherapy treatments. The needle is inserted into the tissue and pulls the catheter through the tissue. After insertion the needle is removed from the catheter by cutting it off the catheter.
Radiation treatment planning can be based on X-ray and CT images. X-ray markers shall be used during the imaging procedure, to enable catheter reconstruction in the planning software.
The applicator is connected to a Nucletron brachytherapy afterloader for radiation treatment.
I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for a medical device (Luneray) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing the acceptance criteria and study proving performance as typically found in clinical trials or performance verification reports.
The document discusses:
- Device description and indications for use.
- Comparison to predicate devices.
- Summary of testing: It mentions "Sterilization, Shelf Life, Biocompatibility, Functional verification testing and testing to Standards" and states that "Performance testing was performed at a hospital site, under clinical conditions and with the involvement of clinical personnel but excluding the delivery of treatment of patients." It also says, "Experienced users reviewed the device design and executed validation tests."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details on ground truth establishment for specific performance metrics.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance, as the device is a physical medical instrument, not an AI algorithm.
- Sample size for training sets, as concept of training sets is not applicable to a physical medical device.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.