(266 days)
The interstitial plastic needles with 2mm diameter are designed for interstitial treatment in areas such as the head and neck, gynaecological, breast and prostate.
The Plastic Interstitial Needles with mandrin, ø 2.0 mm diameter, are designed for interstitial radiotherapy treatments. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories. They 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.
The provided FDA 510(k) document for the "Interstitial Plastic Needles" (K141624) by Varian Medical Systems, Inc. details the device's technical specifications and non-clinical testing. However, it explicitly states: "No clinical tests have been included in this pre-market submission."
Therefore, a complete description of acceptance criteria and a study proving the device meets those criteria, as typically understood in a clinical efficacy or performance study, cannot be provided based on this document. The information below reflects what is available in the document regarding non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical bench testing and states that all tests met "pass criteria." However, specific numerical acceptance criteria (e.g., "positional accuracy within X mm") are not provided, nor are the detailed quantitative results for each test. Instead, the document lists areas of performance verified.
| Acceptance Criteria (General Description) | Reported Device Performance (Summary) |
|---|---|
| Device functions correctly with specified afterloaders. | Bench testing demonstrated correct function with specified afterloaders. |
| Device can withstand the number of cycles of use in its lifetime. | Bench testing demonstrated the device can withstand the specified number of cycles. |
| Device enables radioactive source to be located with required accuracy. | Bench testing confirmed adequate positional accuracy of the source within the applicator. (Specific accuracy not given) |
| Device materials are not significantly affected by radiation exposure over product lifetime. | Bench testing confirmed material integrity under radiation exposure. |
| Device can be effectively sterilized. | Bench testing confirmed effective sterilization. |
| Device can be used and sterilized for the specified number of times. | Bench testing confirmed the device can be used and sterilized for the specified number of times. |
| Positional accuracy of the source within the applicator is adequate. | Bench testing confirmed adequate positional accuracy of the source within the applicator. (Specific accuracy not given) |
| Usability conforms to IEC 62366:2007. | Usability assessment showed conformance to IEC 62366:2007 requirements. |
2. Sample size used for the test set and the data provenance
As per the document, no clinical tests were performed or submitted. The testing was non-clinical bench testing. The sample size for materials and devices tested on the bench is not specified in this summary. Data provenance is internal laboratory testing by Varian Medical Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical tests were performed requiring expert ground truth for a test set. The non-clinical tests would have pass/fail criteria based on engineering specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical tests were performed requiring expert adjudication.
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 an interstitial plastic needle for brachytherapy, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, validated measurement equipment, and adherence to industry standards (e.g., IEC 62366:2007 for usability). No clinical ground truth (like pathology or outcomes data) was used or required for this 510(k) submission.
8. The sample size for the training set
Not applicable, as no AI/machine learning component is described, and no clinical data was used for training purposes in this submission.
9. How the ground truth for the training set was established
Not applicable, as no AI/machine learning component is described, and no clinical data was used for training purposes in this submission.
§ 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.