(89 days)
The Surface Applicator Set with Leipzig-style cone-GM11010080 is indicated for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy.
The Surface Applicator Set with Leipzig-style Cone is a Brachytherapy applicator set. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumour to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
The provided text describes a 510(k) submission for a medical device, the "Surface Applicator Set with Leipzig-style Cone," used for brachytherapy. The submission focuses on demonstrating substantial equivalence to a predicate device and includes details about non-clinical testing.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (as per "Non Clinical Tests Bericht" and "Conclusions") |
|---|---|
| Device functions correctly with the specified afterloaders. | Bench Testing showed conformance to applicable requirements and specifications. |
| Device can withstand the number of cycles of use that it will experience in its lifetime. | Bench Testing showed conformance to applicable requirements and specifications. |
| Device enables the radioactive source to be located to the accuracy required. | Bench Testing showed conformance to applicable requirements and specifications, and it was confirmed that "the positional accuracy of the source within the applicator is adequate." |
| Device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product. | Bench Testing showed conformance to applicable requirements and specifications. |
| Positional accuracy of the source within the applicator is adequate. | Bench Testing showed conformance to applicable requirements and specifications, and it was confirmed that "the positional accuracy of the source within the applicator is adequate." |
| Usability meets the requirements of IEC 62366:2007. | Usability was assessed to the requirements of IEC 62366:2007. Results of Bench Testing showed conformance to applicable requirements and specifications. |
| Overall safety and effectiveness compared to the predicate device. | "All the tests that were performed met the applied pass criteria. Varian considers the devices to be safe and effective and to perform as well or better than the predicate." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "Non Clinical Tests Bericht Testing has been performed" which refers to bench testing. There is no information provided about a "test set" in the context of patient data, clinical studies, or country of origin. The testing described is entirely physical and functional testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is not an AI/diagnostic device that requires expert opinion to establish ground truth for a test set. The acceptance criteria relate to engineering and functional performance, verified through bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this device did not involve patient data or readings that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is an applicator set for brachytherapy, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This device is a physical medical instrument, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was established by engineering specifications, design requirements, and relevant international standards (e.g., IEC 62366:2007). For example, the "accuracy required" for source location would be defined by the design and safety specifications for brachytherapy devices.
8. The sample size for the training set
Not applicable. This device is a physical medical instrument and does not involve AI or machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this device does not involve AI or machine learning algorithms, so there is no training set and no ground truth for a training set.
§ 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.