(168 days)
The Universal Segmented Cylinder Set and Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump and rectum using HDR or PDR brachytherapy.
The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The applicator sets in this submission are designed to be used with the GammaMed Plus afterloader series, Varisource 200 and IX afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynecological and rectal applications. The intracavitary applicators will be used for the treatment of cancerous tumors, and are designed to be inserted into a body cavity.
The provided document pertains to a 510(k) premarket notification for the "Universal Cylinder Applicator Family" by Varian Medical Systems. This family of devices is used for brachytherapy and its primary purpose is to deliver radioactive sources for cancer treatment.
The document indicates that this is a 510(k) submission, which means it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials. Therefore, the information provided focuses on engineering and bench testing rather than clinical study results demonstrating performance against acceptance criteria in a clinical context.
Here's an analysis of the requested information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics in a typical clinical study format. Instead, it lists several non-clinical tests and states that the "Results of Bench Testing showed conformance to applicable requirements and specifications" and "All the tests that were performed met the applied pass criteria."
Here's a summary of the stated performance based on the non-clinical tests:
| Acceptance Criteria (Implied from Test Purpose) | Reported Device Performance |
|---|---|
| Correct function with specified afterloaders. | Devices function correctly with the specified afterloaders (GammaMed Plus, VariSource 200, IX). |
| Withstand specified number of use cycles over lifetime. | Devices can withstand the number of cycles of use they will experience in their lifetime. |
| Accurate radioactive source location. | Devices enable the radioactive source to be located to the accuracy required. |
| Material integrity under radiation exposure over lifetime. | Devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product. |
| Effective sterilization. | Devices may be sterilized effectively. |
| Maintain usage and sterilization integrity for specified number of times. | Devices can be used and sterilized for the specified number of times. |
| Adequate positional accuracy of the source within the devices. | The positional accuracy of the source within the devices is adequate. |
| Biocompatibility according to ISO 10933 standards. | Devices are biocompatible as per ISO10933 standards. |
| Safe and effective use in CT environments. | Devices can be used safely and effectively in CT environments (CT compatible). |
| Safe use in MRI environments under specified conditions. | Testing in MRI environments has demonstrated they are safe to use under the conditions specified in the labeling (MR conditional). |
| Conformance to usability requirements (IEC 62366:2007). | Usability has been assessed to the requirements of IEC 62366:2007, and results showed conformance. |
2. Sample Size for the Test Set and Data Provenance
The document describes non-clinical bench testing. Therefore, there isn't a "test set" in the sense of patient data. The "samples" would be a certain number of the Universal Cylinder Applicator Family devices that underwent various physical and functional tests. The document does not specify the exact number of devices tested for each non-clinical test.
- Data Provenance: The tests are "Bench Testing," implying they were conducted in a laboratory or engineering environment. There is no mention of country of origin for this data or if it's retrospective or prospective, as these terms are generally applicable to human subject studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes non-clinical bench testing of a physical medical device (an applicator for brachytherapy), not an AI or diagnostic device that requires expert-established ground truth from medical images or patient cases.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. Adjudication is relevant for studies involving human interpretation or clinical outcomes, not for engineering bench tests.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests have been included in this pre-market submission." This type of study would compare human readers' performance with and without an AI-assisted device, which is not relevant for this physical brachytherapy applicator.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone study was not done. This device is a physical applicator system used in conjunction with "afterloaders" and operated by medical professionals. It is not an algorithm or a device that functions independently without human intervention in a diagnostic or interpretive capacity.
7. Type of Ground Truth Used
The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable in the context of this 510(k) submission. The "truth" for the bench tests would be defined by engineering specifications, material properties, and functional requirements (e.g., source position accuracy within manufacturing tolerances, sterilization efficacy according to validated protocols, biocompatibility meeting ISO standards).
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" as this device is a physical medical device, not a machine learning or AI model that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8. There is no training set for this type of device.
In summary, the provided document is a 510(k) premarket notification for a physical medical device, not a diagnostic or AI-based system. Therefore, many of the requested items related to clinical studies, AI performance, and ground truth establishment in a diagnostic context are not present or applicable. The submission relies solely on non-clinical bench testing to demonstrate substantial equivalence to a predicate 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.