(115 days)
The GammaMedplus iX™ Series is indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of High Dose Rate (HDR) and Pulsed Dose Rate (PDR) remote-controlled brachytherapy.
The GammaMedplus iX Series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
The provided text is a 510(k) Summary for the GammaMedplus™ iX and GammaMedplus™ 3/24 iX afterloaders. This document focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical testing. It does not contain information about acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, nor does it describe a study proving the device meets such criteria in a clinical sense.
Medical devices like brachytherapy afterloaders are evaluated for safety and effectiveness through different types of assessments than, for example, diagnostic AI algorithms. Their "performance" is typically related to precise mechanical operation, safety mechanisms, and adherence to dose delivery protocols.
Here's an analysis based on the information provided and what is intentionally absent from this type of regulatory submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of sensitivity, specificity, or similar performance metrics typically seen for diagnostic AI. Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting safety and functional specifications. The "reported device performance" is a comparative analysis of its technological characteristics against the predicate devices (Nucletron MicroSelectron V3 and GammaMedplus iX Series HDR Afterloaders (K071381)).
Below is a table summarizing key characteristics that would be considered "performance" in the context of this device, comparing the proposed device (GammaMedplus™ iX, Console Software version 1.2) against its predicate (Nucletron MicroSelectron V3). The "acceptance criteria" are implied to be that the proposed device performs at least as well as or is equivalent to the predicate.
| Feature / Characteristic | Acceptance Criteria (Implied: Comparator = Nucletron MicroSelectron V3) | Reported Device Performance (GammaMedplus™ iX (Console SW v1.2)) |
|---|---|---|
| PDR (Pulsed Dose Rate) | Yes (Present in predicate) | Yes for GammaMedplus iX (No for GammaMedplus 3/24 iX) |
| Max. exposure rate at 1m distance (containing max activity) |
§ 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.