(77 days)
The GammaMedplus Source Guide Tubes are intended to connect between the GammaMedplus Remote Afterloader system and its range of applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient´s tumor site.
Source Guide Tubes are Brachytherapy applicator accessories. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. They are designed to provide a path for the dummy and source wire from the Afterloader to the Applicator. The applicator end of a Source Guide Tube can vary in design to accommodate a range of Applicators.
This document describes the premarket notification for "GammaMedplus Source Guide Tubes." The provided text indicates that the device is an accessory for remote controlled radionuclide applicator systems used in brachytherapy. The submission is a 510(k) premarket notification, which means it seeks to demonstrate substantial equivalence to an existing legally marketed device, rather than proving novel safety and effectiveness. Therefore, the information provided focuses on comparative technological characteristics and non-clinical testing rather than extensive clinical studies or acceptance criteria for a novel device performance claim.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for an accessory device, the "acceptance criteria" are predominantly related to functional compatibility and durability, benchmarked against the predicate device. There aren't specific quantitative clinical performance metrics like sensitivity, specificity, or AUC that would typically be associated with AI/diagnostic devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Compatibility: Correct operation with specified afterloader and applicators. | Bench testing demonstrated that "the device functions correctly with the specified afterloader and applicators." |
| Durability/Lifetime: Withstand the number of cycles of use over its lifetime. | Bench testing demonstrated that "the device can withstand the number of cycles of use that it will experience in its lifetime." |
| Material Integrity (Radiation Exposure): Materials not significantly affected by radiation over product lifetime. | Bench testing demonstrated that "the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product." |
| Usability: Conformance to relevant usability standards. | Usability was assessed to the requirements of IEC 62366:2007, and "Results of Bench Testing showed conformance to applicable requirements and specifications." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified quantitatively in the document. The testing described is "Bench Testing," implying a set of physical devices subjected to various tests. The number of individual guide tubes tested is not provided.
- Data Provenance: The testing was "Bench Testing," which refers to laboratory or engineering tests. There is no mention of patient data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this submission. The "ground truth" concept is typically relevant for AI/diagnostic devices where expert consensus or pathological findings are used to label data. For this accessory device, the "truth" is whether it functions correctly, is durable, and its materials are radiation-resistant, which is assessed through engineering and functional tests.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts in labeling data for AI/diagnostic studies. The testing described here involves technical performance evaluations without expert adjudication of results.
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. A MRMC comparative effectiveness study was not done. This device is a mechanical accessory (source guide tubes) for a brachytherapy system, not an AI or diagnostic tool that involves human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This device is a physical component, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used:
As mentioned in point 3, the concept of "ground truth" as typically applied to clinical or diagnostic outcomes (e.g., expert consensus, pathology, outcomes data) is not applicable. For this device, the "ground truth" for acceptance criteria is its successful demonstration of functional compatibility, durability, material integrity under radiation, and usability validation through bench testing against engineering specifications and relevant standards.
8. The sample size for the training set:
This information is not applicable. This submission describes a physical medical device (guide tubes), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no AI algorithm or training set for this 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.