(351 days)
The Interstitial Needles and their corresponding obturators are indicated for use for interstitial irradiation treatments of soft tissues such as breast, head and neck, tongue.
The Interstitial Needles and their corresponding Obturators/Mandrins are intended for interstitial irradiation treatments of soft tissues including breast, head and neck, and tongue using HDR or PDR brachytherapy and are compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™ 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.
There are two versions of the needle included in this submission: titanium and stainless steel.
The provided text describes a 510(k) Premarket Notification for "Interstitial Needles" by Varian Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI/ML-driven medical device against specific acceptance criteria through a study involving human readers or standalone algorithm performance.
Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set ground truth are not applicable to this document. The device in question appears to be a physical medical instrument (needles for brachytherapy), not a software or AI-based diagnostic tool.
However, I can extract information related to the non-clinical testing performed to demonstrate the device's basic functionality and safety.
Here's a breakdown of what can be inferred from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines various "Non Clinical Tests" and states that "All the tests that were performed met the applied pass criteria." However, it does not explicitly list the quantitative acceptance criteria or detailed numerical results. Instead, it describes general functionalities that were tested.
| Acceptance Criteria (Inferred from "Non Clinical Tests") | Reported Device Performance |
|---|---|
| Correct functioning with specified afterloaders | Met applied pass criteria |
| Withstand specified number of cycles of use (lifetime) | Met applied pass criteria |
| Enable radioactive source to be located with required accuracy | Met applied pass criteria (positional accuracy is adequate) |
| Constructed of materials not significantly affected by radiation over product lifetime | Met applied pass criteria |
| Effective sterilization | Met applied pass criteria |
| Usable and sterilizable for specified number of times | Met applied pass criteria |
| Adequate positional accuracy of source within devices | Met applied pass criteria |
| Biocompatible as per ISO10993 standards | Met applied pass criteria |
| Safe and effective use in CT environments | Met applied pass criteria |
| Conformance to usability requirements of IEC 62366:2007 (for Usability assessment) | Met applied pass criteria (Results of Bench Testing showed conformance) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document refers to "Bench Testing" but does not detail the number of units or test repetitions.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are non-clinical, likely performed in a lab setting by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. This is a physical device, and performance is assessed through engineering and material tests, not expert interpretation of outputs like in an AI/ML study.
4. Adjudication Method for the Test Set:
- Not applicable. Performance determined by instrument measurements and material tests, not expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The document explicitly states: "No clinical tests have been included in this pre-market submission." An MRMC study would be a clinical test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of Ground Truth Used:
- Engineering specifications and material standards: For example, compliance with ISO10993 for biocompatibility and IEC 62366:2007 for usability. The "ground truth" for these tests would be established by the defined parameters and expected outcomes of the specific engineering and materials tests.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable (no training set for a physical device).
§ 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.