(245 days)
The Intraluminal Applicator Set is indicated for use for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.
The Intraluminal Applicator Set is designed for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy. It is compatible with Varian GammaMedplus afterloaders and can be used in combination with the appropriate accessories. The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
This document describes the premarket notification for the "Intraluminal Applicator Set GM11000620" by Varian Medical Systems, Inc. The submission is for a Class II medical device, specifically a remote-controlled radionuclide applicator system, used for intraluminal brachytherapy treatments.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of quantitative acceptance criteria with corresponding performance metrics for the device. Instead, it lists the types of non-clinical tests performed and states that the "Results of Bench Testing showed conformance to applicable requirements and specifications." The "Conclusions" section reiterates that "All the tests that were performed met the applied pass criteria."
However, based on the non-clinical tests described, we can infer the broad categories of acceptance criteria and the claimed performance:
| Acceptance Criteria (Inferred from Non-Clinical Tests) | Reported Device Performance |
|---|---|
| Functional Compatibility: Device functions correctly with specified afterloaders. | Conforms to applicable requirements and specifications. |
| Durability/Lifetime: Device withstands the number of cycles of use over its lifetime. | Conforms to applicable requirements and specifications. |
| Positional Accuracy: Device enables the radioactive source to be located with required accuracy. | Positional accuracy of the source within the applicator is adequate; conforms to applicable requirements and specifications. |
| Material Radiation Resistance: Materials are not significantly affected by radiation exposure over the product's lifetime. | Conforms to applicable requirements and specifications. |
| Sterilization Efficacy: Device can be sterilized effectively. | Conforms to applicable requirements and specifications. |
| Reusability (Sterilization): Device can be used and sterilized for the specified number of times. | Conforms to applicable requirements and specifications. |
| Usability: Conformance to IEC 62366:2007. | Conforms to applicable requirements and specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient data or clinical cases. The tests performed are described as "Bench Testing," implying laboratory or engineering tests on the device hardware itself. There is no indication of retrospective or prospective data use from human subjects in these tests.
- Data Provenance: The data provenance is from bench testing conducted by Varian Medical Systems, Inc. This is not human patient data, therefore country of origin is not applicable in the context of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This question is not applicable as the study involved non-clinical bench testing. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The "ground truth" for these engineering tests would be derived from physical measurements (e.g., using calipers, gauges, radiation detectors) and engineering specifications, not expert medical opinion.
4. Adjudication Method for the Test Set
This question is not applicable as the study involved non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among expert readers in clinical or imaging studies.
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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical applicator set for brachytherapy, not an AI-powered diagnostic or treatment planning software meant to improve human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The device is a physical intraluminal applicator set, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would have been derived from:
- Engineering specifications and design documents: For functional compatibility, durability, material resistance, and physical dimensions.
- Calibration standards/measurement devices: For positional accuracy of the radioactive source.
- Sterilization efficacy testing protocols and standards: For sterilization effectiveness and reusability.
- IEC 62366:2007 standard requirements: For usability assessment.
It is not expert consensus, pathology, or outcomes data, as these are clinical ground truths.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this device is not an AI/machine learning algorithm. The tests described are engineering verification and validation tests for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set."
§ 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.