(223 days)
The intended use of the MICK Valencia Applicator is to facilitate the placement of a radioactive source near the target area on intact skin for remote afterloading brachytherapy treatment.
The Mick Valencia Applicator is used for remote afterloading treatment on intact skin/surface. The applicator with associated plastic cap is placed onto the patient, locked into position, and connected to the remote afterloading equipment (via transfer tube) to facilitate the brachytherapy treatment in accordance with the physician approved treatment parameters. The radioactive source travels from the machine into the applicator and deliver the desired dose distribution to the defined treatment volume. When the treatment is completed, the source returns to the machine. The applicator is disconnected from the treatment unit and removed from the patient.
The applicator does not control the treatment unit, it strictly provides a treatment path for the radioactive source. The Mick Valencia applicator is temporarily placed during the treatments designed as a closed system to prevent the radioactive source from coming in contact with bodily fluids.
The device is the same as the legally marketed device cited, both in design and materials.
The provided document (K230155) is a 510(k) premarket notification for the Mick Valencia Applicator Set. It does not contain information about a study proving device performance against acceptance criteria in the way one would expect for an AI/ML medical device.
This document describes a medical device used for brachytherapy, which is a physical applicator for radioactive sources. The determination of substantial equivalence for this type of device relies on demonstrating that its design, materials, and intended use are similar to a legally marketed predicate device, and that it performs similarly. The "non-clinical tests" mentioned are bench tests for connection compatibility, not performance trials for diagnostic accuracy or clinical outcomes.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details because the document does not report on a study that would typically have such components. There is no mention of a "device" in the context of an AI/ML algorithm that would require ground truth, expert consensus, MRMC studies, or training/test sets.
Here's why the requested information cannot be extracted:
- No AI/ML Component: The device, the Mick Valencia Applicator Set, is a physical medical instrument (an applicator for a radioactive source). It's not an AI or software device.
- Substantial Equivalence, Not Performance Study: The entire submission is built around demonstrating "substantial equivalence" to a predicate device (Nucletron/Elekta Valencia Skin Applicator K073107). This is a comparative assessment, not an independent performance study of a novel device
- No "Ground Truth" or "Experts": For a physical applicator, "ground truth" and "experts" in the context of diagnostic performance (e.g., radiologists interpreting images) are not relevant. The "ground truth" for this device's function would be its physical specifications and compatibility with afterloaders, which are verified through engineering tests and comparison to the predicate.
- No "Training/Test Sets": These concepts apply to machine learning models, which are absent here.
- No "MRMC Study": A Multiple Reader Multiple Case study is for evaluating human interpretation with and without AI assistance, which is not applicable to a physical brachytherapy applicator.
The document states:
- "Non-clinical testing is performed on the Mick Valencia Applicator connection to the transfer tube (the transfer tubes are supplied by the Afterloader manufacturer). These are bench top tests, performed on every applicator produced."
- "The Mick Valencia Applicator Sets are substantially equivalent in design, manufacture, construction and materials and have the same intended use and performance characteristics to the predicate device."
These statements indicate that the "proof" of the device meeting its acceptance criteria (which are implicitly its functional specifications, material properties, and compatibility) comes from bench testing and the demonstration of substantial equivalence to a device already on the market. There's no performance study in the sense of a clinical trial or algorithm validation study described.
§ 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.