(213 days)
The Varian VariSource Remote High Dose Rate Afterloader system, including the applicators included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose.
The applicators for the Varian VariSource Remote High Dose Rate Afterloader are part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity to be placed at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be located for treatment.
This document describes an applicator system for radiation brachytherapy, not a diagnostic or AI-powered device. Therefore, many of the requested criteria, such as those related to AI performance, ground truth, sample sizes for training/testing, expert adjudication, and MRMC studies, are not applicable.
Here's an analysis based on the provided text, focusing on what is relevant for this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not outline specific numerical acceptance criteria (e.g., accuracy, sensitivity, specificity) or performance metrics as would be expected for a diagnostic or AI-driven device. Instead, the "acceptance criteria" for this type of device are primarily based on demonstrating substantial equivalence to predicate devices in terms of materials, intended use, and technological considerations.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Materials equivalence: Applicator materials are identical or equivalent to predicate devices. | "The applicators for the Varian VariSource Remote High Dose Rate Afterloader are identical or equivalent to the predicate devices in materials." |
| Intended Use equivalence: Device used for remote high dose rate brachytherapy with high specific activity radioisotope source. | "The Varian VariSource Remote High Dose Rate Afterloader system...is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source..." |
| Technological equivalence: Mechanism for remote positioning of radionuclide source, use of Iridium-192, shielded safe, and radiation detector. | "electromechanical device to enable an operator to apply, by remote control, a radionuclide source...mechanically driven from it to a precisely described position for a specified dwell time...source is iridium-192...retracted into the Afterloader and the source resides in a tungsten-shielded safe to limit personnel exposures...Afterloader contains a radiation detector which signals whenever the source is not in the safe." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for a physical medical device (applicators) and not a data-driven device. There is no "test set" in the context of diagnostic performance or AI model validation. The "testing" involves demonstrating physical and functional equivalence to predicate devices, and likely verifying manufacturing specifications.
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. There is no concept of "ground truth" established by experts for a test set in the context of this device's submission. The "truth" is established by the physical properties of the materials and the design's adherence to safety and functional standards, compared to previously cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the same reasons as #2 and #3.
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
Not applicable. This device is not an AI system nor a diagnostic imaging tool that would involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI/diagnostic sense. The "ground truth" for this device's clearance is conformity to engineering specifications, material composition, and functional principles demonstrated by previously cleared predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI device or a data-driven model.
9. How the ground truth for the training set was established
Not applicable.
§ 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.